6.3Electrotherapy

STIM: In adults with OA, what are the relative benefits and harms of electrotherapy (ultrasound, laser, transcutaneous electrical nerve stimulation [TENS, TNS, AL-TENS], pulsed shortwave diathermy, interferential therapy) versus no treatment, placebo or other interventions with respect to symptoms, function, and quality of life?
Bibliographic reference L. Brosseau, A. Gam, K. Harman, M. Morin, V. A. Robinson, B. J. Shea, P. Tugwell, G. Wells, and R. A. deBie. Low level laser therapy (Classes I, II and III) for treating osteoarthritis. Cochrane Database of Systematic Reviews (1):CD002046, 2006.
Study type and evidence level SR/MA: 1++; RCT’s of MA: 1++ and 1+
Aim To assess the efficacy of low laser therapy (class I, II or III) in patients with OA.
Number of patients SR included: 7 RCT’s with N=345 participants which compared Laser therapy to sham or placebo Laser therapy.
Patient characteristics Trials varied in terms of:
• Site of OA (4 RCT’s knee, 1 RCT thumb, 1 RCT hand, 1 RCT not specified)
• Type of Laser used (2 RCT’s He-Ne laser of 632.8 nm; 1 RCT Space laser 904 nm; 4 RCT’s Galenium-Arsenide laser – either 830 or 860 nm)
• Treatment regimen (4 RCT’s 2–3 sessions/week; 1 RCT every day; 1 RCT twice a day; 1 RCT 3 times a week)
• Trial length (Range: 4 RCT’s 3–4 weeks; 3 RCT’s 10 days)
• Trial size (Range: N=29 to N=90)
• Study quality (4 RCT’s high quality; 3 RCT’s low quality)

Trials were similar in terms of:
• Trial design (parallel-group studies)
• Blinding (double blind)

NOTE: This Cochrane meta-analysis has assessed the included RCT’s for quality and pooled together all data for the outcomes of symptoms and function. QoL and AEs were not reported by the individual RCTs included in the SR. Only the outcomes that used pooled data from the RCT’s are included here. All other outcomes reported in the MA were based on individual studies and nearly always showed NS difference between Laser therapy and placebo.
Intervention Low level Laser therapy (class I, II and III)
Comparison Placebo/sham Laser therapy
Length of follow-up RCT’s ranged from immediate follow-up to 1 year
Outcome measures Pain; Stiffness; Function
Effect size NOTE: The Cochrane Review concludes that: Results for pain are conflicting; 3 trials using OA at different joints found no improvement in pain whereas 2 other RCT’s found that laser significantly improved pain relief compared to placebo. The results show NS difference between laser and placebo for localized swelling, muscle strength, functional status or global assessments.


LASER vs PLACEBO

Pain
• Laser therapy was found to be significantly better than placebo Laser therapy for:
 ○ Number of patients with no pain relief (1 RCT, N=8; Peto OR 0.06, 95% CI 0.00 to 0.88, p=0.04).

• The MA reported significant heterogeneity between studies for the following outcomes:
  ○ Patient pain - different scales (3 RCT’s, N=145; WMD −1.74, 95% CI −3.16 to −0.32, p=0.02).

Global Assessment
• There was NS difference between Laser therapy and placebo Laser therapy for:
 ○ Patient global assessment - improved (2 RCT’s, N=110);
 ○ Number of patients improved on pain or global assessment (4 RCT’s, N=147)


AUTHORS’ CONCLUSIONS
Conflicting evidence of the benefit of low level laser therapy (LLLT) for the treatment of OA. The pooled results indicated no effect of 1 month of LLLT on pain or overall patient-rated assessment of disease activity. However, 3 trials showed very positive effects on pain relief and 3 trials found no effect. Lower dosage of LLLT was found as effective as higher dose for reducing pain and improving knee range of motion.
Funding University of Ottawa, Canada.
Ref ID 419
Bibliographic reference J. Hulme, V. Robinson, R. DeBie, G. Wells, M. Judd, and P. Tugwell. Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database of Systematic Reviews (1):CD003523, 2002.
Study type and evidence level SR/MA: 1++; RCT’s of MA: 1++
Aim To assess the efficacy of pulsed electromagnetic fields (PEMF) versus placebo PEMF in patients with knee OA.
Number of patients SR included: 3 RCT’s with N=259 participants which compared PEMF with placebo PEMF.
Patient characteristics Trials varied in terms of:
• Type of electromagnetic field used and treatment regimen (2 RCT’s pulsed electromagnetic fields, PEMF, using non-contact devise delivering 3 signals ranging from 5–12Hz frequency at 10 G to 25 G of magnetic energy. These used 9 hours of stimulation over 1 month period; 1 RCT use pulsed electric devise delivering 100 Hz low-amplitude signal via skin surface electrodes for 6–10 hrs/day for 4 weeks)
• Trial length (Range: 4 weeks and 1 month)
• Trial size (Range: N=27 to N=81)

Trials were similar in terms of:
• Study quality (All RCT’s were high quality)
• OA diagnosis (clinical and/or radiographic information)
• OA site (Knee OA)
• Type of comparison used (All RCT’s used placebo)
• Trial design (parallel-group studies)
• Blinding (double blinded)

NOTE: This meta-analysis has assessed the included RCT’s for quality and pooled together all data for the outcomes of symptoms, function and AEs. Quality of Life was not reported by the individual RCT’s included in the systematic review.
Intervention PEMF and electric stimulation
Comparison Placebo PEMF/electric stimulation
Length of follow-up RCT’s assessed outcomes at end of treatment (4 weeks and 1 month)
Outcome measures Pain; Stiffness; Function; Withdrawals; AEs
Effect size PEMF vs PLACEBO

Pain
PEMF was found to be significantly better (p values and number of studies used not always reported) than placebo PEMF for:
 ○ Joint pain on motion (SMD: -0.59, 95% CI −0.98 to −2.0);
 ○ Improvements in knee tenderness (SMD −0.91, 95% CI −1.20 to −0.62);
 ○ Pain, ADL, (SMD −0.41, 95% CI −0.79 to −0.02);

Stiffness
• There was NS difference between PEMF and placebo PEMF for:
 ○ > 15 minutes improvement in morning stiffness (1 RCT, N=71);
 ○ 0–14 minutes improvement in morning stiffness (1 RCT, N=71).

Function
PEMF was found to be significantly better than placebo PEMF for:
 ○ Number of patients with 5 degrees improvement in flexion (1 RCT, N=71; OR 0.27, 95% CI 0.09 to 0.82, p=0.02);
 ○ Difficulty, ADL (SMD −0.71, 95% CI −1.11 to −0.31);
 ○ Number of patients with 0–4 degrees improvement in flexion (1 RCT, N=71).

Global assessment
PEMF was found to be significantly better (p values and number of studies used not always reported) than placebo PEMF for:
 ○ Physician’s global assessment (SMD −0.71, 95% CI −1.11 to −0.31).

• There was NS difference between PEMF and placebo PEMF for:
 ○ Patient’s global assessment (SMD −0.53, −0.97 to −0.08; 2 RCT’s N=108).

Withdrawals
• There was NS difference between PEMF and placebo PEMF for:
 ○ Total withdrawals (3 RCT’s, N=184)

AEs
• There was NS difference between PEMF and placebo PEMF for:
 ○ Adverse skin reactions (1 RCT, N=71).


AUTHORS’ CONCLUSIONS:
Electrical stimulation therapy had a small to moderate effect on outcomes for Knee OA, all statistically significant with clinical benefit ranging from 13–23% greater with active treatment than with placebo (questionable clinical significance from a patient’s perspective). There were no reported side-effects. Larger studies are needed to establish the clinical relevance of treatment.• PEMF was found to be significantly better (p values and number of studies used not always reported) than placebo PEMF for:
Funding Institute of Population Health, University of Ottowa, Canada.
Ref ID 175
Bibliographic reference C. J. McCarthy, M. J. Callaghan, and J. A. Oldham. Pulsed electromagnetic energy treatment offers no clinical benefit in reducing the pain of knee osteoarthritis: a systematic review. BMC Musculoskeletal Disorders 7:51, 2006.:51, 2006, 2006.
Study type and evidence level SR/MA: 1++; RCT’s of MA: 1++ and 1+
Aim To assess the efficacy of pulsed electromagnetic fields (PEMF) versus placebo PEMF in patients with knee OA.
Number of patients SR included: 5 RCT’s with N=276 participants which compared PEMF with placebo PEMF.
Patient characteristics Trials varied in terms of:
• Type of electromagnetic field used and treatment regimen (2 RCT’s low frequency PEMF ranging from 3–50Hz requiring long durations of treatment range 3–10 hrs/week; 3 RCT’s used ‘pulsed short wave’ high frequency devices with shorter treatment durations)
• Trial length (Range: 2 – 6 weeks)
• Trial size (Range: N=18 to N=83)

Trials were similar in terms of:
• Study quality (All RCT’s were high quality)
• OA diagnosis (clinical and/or radiographic information)
• OA site (Knee OA)
• Type of comparison used (All RCT’s used placebo)
• Trial design (parallel-group studies)
• Blinding (double blinded)
NOTE: This meta-analysis has assessed the included RCT’s for quality and pooled together all data for the outcomes of symptoms and function. However, Quality of Life and AEs were not assessed. The results for these outcomes have therefore been taken from the individual RCT’s in the systematic review and are reported below.
Intervention Electromagnetic field therapy
Comparison Placebo Electromagnetic field therapy
Length of follow-up RCT’s ranged from immediate follow-up to 12 weeks post-intervention
Outcome measures Pain; Function
Effect size PEMF vs PLACEBO

Pain

• No significant difference was found between PEMF and placebo for:
 ○ Pain (WOMAC and VAS), (5 RCT’s, N=276).

Function

• No significant difference was found between PEMF and placebo for:
 ○ Function (WOMAC and AIMS), (5 RCT’s, N=228).

QoL

• One RCT, N=75{Pipitone, 2001 2274 /id} found that PEMF was significantly better than placebo PEMF for improvement in EuroQoL perception of health status at study end (p=0.01).
• One RCT, N=90{Klaber Moffett, 1996 2279 /id} found there was NS difference between PEMF and placebo PEMF for the pattern of change in GHQ score over time.
• One RCT, N=27{Callaghan, 2005 2260 /id} found that PEMF was better than placebo for AIMS score (change from baseline was +0.3 for low dose PEMF, the same for high dose PEMF and −0.2 for placebo).

AEs

• One RCT, N=75{Pipitone, 2001 2274 /id} found that PEMF was better than placebo PEMF for number of patients with AEs (N=2, 2.7% and N=4, 5.3% respectively).
• One RCT, N=90{Thamsborg, 2005 2257 /id} found that PEMF was worse than placebo PEMF for number of patients with mild AEs (N=12, 13.3% and N=6, 6.7% respectively).

AUTHORS’ CONCLUSIONS:
PEMF has little value in the management of knee OA. There appears to be clear evidence that PEMF does not significantly reduce the pain of knee OA.
Funding Not mentioned.
Ref ID 2252
Bibliographic reference V. A. Robinson, L. Brosseau, J. Peterson, B. J. Shea, P. Tugwell, and G. Wells. Therapeutic ultrasound for osteoarthritis of the knee. Cochrane Database of Systematic Reviews (1):CD003132, 2006.
Study type and evidence level SR/MA: 1++; RCT’s of MA: 1+ and 1-
Aim To assess the efficacy of therapeutic ultrasound (continuous or pulsed) in patients with OA.
Number of patients SR included: 3 RCT’s with N=294 participants which compared Ultrasound with placebo (sham ultrasound) or short wave diathermy or galvanic current.
Patient characteristics Patient characteristics: all patients included in the studies had knee or hip OA which was diagnosed by clinical and/or radiographic information.

All trials were parallel group design. Trials varied in terms of:
• Type of comparison used (1 RCT placebo – sham ultrasound; 1 RCT short wave diathermy; 1 RCT galvanic current)
• Treatment regimen (stimulation frequency and intensity; placement of electrodes; lengths of stimulation time and how often TENS was applied)
• Trial length (Range: single treatment to 4–6 weeks treatment; Follow-up was: immediate to 2 months post-treatment)
• Trial size (Range: N=74 to N=120)
• Blinding (1 RCT was double blinded; 2 RCT’s were unblinded)
• Study quality (1 RCT high quality{Falconer, 1992 375 /id}; 2 RCT’s low quality).

NOTE: This Cochrane meta-analysis has assessed the included RCT’s for quality and pooled together all data for the outcomes of symptoms and function. Quality of Life and AEs were not reported by any of the RCT’s included in the Cochrane Review.
Intervention Ultrasound
Comparison Placebo; short wave diathermy; galvanic current
Length of follow-up RCT’s ranged from immediate follow-up to 2 months post treatment
Outcome measures Pain; Function; global assessment
Effect size
ULTRASOUND vs PLACEBO

1. Pain
• No significant difference was found between ultrasound and placebo for:
 ○ Pain (VAS), change from baseline (1 RCT, N=74) at 4–6 weeks (end of therapy) and at 3 months (2 months post-treatment).

2. Patient Function
• No significant difference was found between ultrasound and placebo for:
 ○ Knee ROM (flexion and extension, degrees), change from baseline (1 RCT, N=74) at 4–6 weeks (end of therapy) and at 3 months (2 months post-treatment).

ULTRASOUND vs GALVANIC CURRENT

1. Pain
• Ultrasound was found to be significantly worse than galvanic current for:
 ○ Decrease in pain (VAS) change from baseline (1 RCT, N=120; WMD −5.10, 95% CI −9.52 to −0.68, p=0.02).

2. Global assessment
• No significant difference was found between ultrasound and galvanic current for:
 ○ Patient and clinician global assessment (number of patients ‘good’ or ‘excellent’), change from baseline (1 RCT, N=108).


ULTRASOUND vs SHORT WAVE DIATHERMY

1. Pain
• No significant difference was found between ultrasound and diathermy for:
 ○ Pain (number of knees with subjective improvement), change from baseline (1 RCT, N=100);
 ○ Pain (number of knees with objective improvement), change from baseline (1 RCT, N=100);
 ○ Decrease in pain (VAS) change from baseline (1 RCT, N=120).

2. Global assessment
• No significant difference was found between ultrasound and diathermy for:
 ○ Patient and clinician global assessment (number of patients ‘good’ or ‘excellent’), change from baseline (1 RCT, N=120).


AUTHORS’ CONCLUSIONS:
Ultrasound therapy appears to have no benefit over placebo, galvanic current or short wave diathermy for people with knee or hip OA. These conclusions are limited by overall poor methodological quality of the comparative trials. No conclusions can be drawn about the use of ultrasound in smaller joints such as the wrist or hands.
Funding Not mentioned.
Ref ID 460
Bibliographic reference M. Osiri, L. Brosseau, J. McGowan, V. A. Robinson, B. J. Shea, P. Tugwell, and G. G. W. Wells. Transcutaneous electrical nerve stimulation for knee osteoarthritis. Cochrane Database of Systematic Reviews, 2000.
Study type and evidence level SR/MA: 1++; RCT’s of MA: 1+ and 1-
Aim To assess the efficacy of transcutaneous nerve stimulation (TENS) in patients with knee OA.
Number of patients SR included: 7 RCT’s with N=294 participants which compared TENS and AL-TENS with placebo.
Patient characteristics Patient characteristics: all patients included in the studies had Knee OA which was diagnosed by clinical and/or radiographic information.

Trials varied in terms of:
• Type of TENS used (4 RCT’s High frequency TENS; 1 RCT Strong burst TENS; 1 RCT High frequency and strong burst TENS; 1 RCT AL-TENS)
• Treatment regimen (modes of stimulation, optimal stimulation levels, pulse frequencies, electrode placements, lengths of stimulation time and how often TENS was applied)
• Trial length (Range: single treatment to 9 weeks treatment; Followup was: immediate to 1 year)
• Trial size (Range: N=12 to N=100)
• Trial design (4 RCT’s were parallel-group studies; 3 RCT’s were cross-over studies)
• Blinding (5 RCT’s double blinded; 1 RCT single blinded; 1 RCT unblinded)
• Study quality (4 RCT’s high quality; 3 RCT’s low quality)

NOTE: This Cochrane meta-analysis has assessed the included RCT’s for quality and pooled together all data for the outcomes of symptoms and function. Quality of Life and AEs were not reported by the individual RCT’s included in the systematic review.
Intervention TENS
Comparison Placebo
Length of follow-up RCT’s ranged from immediate follow-up to 1 year
Outcome measures Pain; Stiffness; Function
Effect size
TENS/AL-TENS vs PLACEBO

1. Symptoms

1.1 Pain
TENS/AL-TENS was found to be significantly better than placebo for:
 ○ Pain relief (VAS), (6 RCT’s, N=264; WMD −0.79, 95% CI −1.27 to −0.30, p=0.002).

1.2 Stiffness
TENS/AL-TENS was found to be significantly better than placebo for:
 ○ Knee stiffness, (2 RCT’s, N=90; WMD −6.02, 95% CI −9.07 to −2.96, p=0.0001).

AL-TENS vs PLACEBO

1. Symptoms

1.1 Pain
AL-TENS was found to be significantly better than placebo for:
 ○ Pain relief (VAS), (1 RCT, N=50; WMD −0.80, 95% CI −1.39 to −0.21, p=0.007).

1.2 Stiffness
AL-TENS was found to be significantly better than placebo for:
 ○ Knee stiffness, (1 RCT, N=50; WMD −7.90, 95% CI −11.18 to −4.62, p<0.00001).

2. Patient Function
AL-TENS was found to be significantly better than placebo for:
 ○ 50-foot walking time (minutes), (1 RCT, N=50; WMD −22.60, 95% CI −43.01 to −2.19, p=0.03);
 ○ Quadriceps muscle strength (kg), (1 RCT, N=50; WMD −5.20, 95% CI −7.85 to −2.55, p=0.0001);
 ○ Knee flexion (degrees), (1 RCT, N=50; WMD −11.30, 95% CI −17.59 to −5.01, p=0.0004).

TENS vs PLACEBO

1. Symptoms

1.1 Pain
TENS was found to be significantly better than placebo for:
 ○ Number of patients with pain improvement (5 RCT’s, N=214; Peto OR 3.91, 95% CI 2.13 to 7.17, p=0.00001)

• The MA reported significant heterogeneity between studies for the following outcomes:
 ○ Pain relief (VAS), (5 RCT’s, N=214)

Subgroup analysis: TENS vs PLACEBO after 1 application

• High rate TENS was found to be significantly better than placebo for:
 ○ Pain relief (VAS), (1 RCT, N=40; WMD −2.10, 95% CI −4.11 to −0.09, p=0.04).

• No significant difference was found between Strong burst mode TENS and placebo for:
 ○ Pain relief (VAS), (1 RCT, N=40).

Subgroup analysis: Types of TENS vs PLACEBO

• High rate TENS was found to be significantly better than placebo for:
 ○ Pain relief (VAS), (3 RCT’s, N=157; WMD −1.12, 95% CI −2.18 to −0.05, p=0.04).

AL-TENS was found to be significantly better than placebo for:
 ○ Pain relief (VAS), (1 RCT, N=50; WMD −0.80, 95% CI −1.39 to −0.21, p=0.007).

• The MA reported significant heterogeneity between studies for the following:
 ○ Burst mode TENS vs placebo: Pain relief (VAS), (2 RCT’s, N=77).

Subgroup analysis: Single and multiple applications of TENS

• Single application TENS was found to be significantly better than placebo for:
 ○ Pain relief (VAS), (1 RCT, N=40; WMD −2.10, 95% CI −4.11 to −0.09, p=0.04).

• Repeated application of TENS was found to be significantly better than placebo for:
 ○ Pain relief (VAS), (5 RCT’s, N=224; WMD −0.70, 95% CI −1.21 to −0.20, p=0.006).

Subgroup analysis: Trial quality

• No significant difference was found between TENS and placebo for:
 ○ Low quality trials: Pain relief (VAS), (3 RCT’s, N=119).

• The MA reported significant heterogeneity between studies for the following:
 ○ High quality trials: Pain relief (VAS), (3 RCT’s, N=145).

TENS vs ICE MASSAGE
• 1 RCT{Yurtkuran, 1999 2212/id}(N=100) found that there was NS difference between AL-TENS and Ice massage for:
 ○ Pain at rest (pain intensity score, PPI) at end of treatment (2 weeks);
 ○ Stiffness (verbal rating) at end of treatment (2 weeks);
 ○ 50-foot walk time at end of treatment (2 weeks);
 ○ Quadriceps muscle strength (kg) at end of treatment (2 weeks);
 ○ Flexion (degrees) at end of treatment (2 weeks).

AUTHORS’ CONCLUSIONS:
TENS and AL-TENS over at least 4 weeks are effective for pain control and relief of knee stiffness in OA. Heterogeneity of the included studies was observed, probably due to the different study designs and outcomes used. More standardized, large and well-designed studies are needed with a sufficient intervention period to evaluate efficacy of TENS/AL-TENS treatment.
Funding University of Ottawa, Institute of Population Health, Canada; Ottawa Health Research Institute, Canada; Faculty of Medicine, Chulalongkorn University, Thailand.
Ref ID 376
Bibliographic reference N. Paker, D. Tekdos, N. Kesiktas, and D. Soy. Comparison of the therapeutic efficacy of TENS versus intra-articular hyaluronic acid injection in patients with knee osteoarthritis: a prospective randomized study. Advances in Therapy 23 (2):342–353, 2006.
Study type and evidence level RCT: 1+
Aim To assess the efficacy and QoL outcomes of TENS versus IA Hylan GF-20 injection in adults with Knee OA.
Number of patients Total N=60; N=30 (TENS), N=30 (IA Hylan GF-20).
Single centre trial: Turkey
Patient characteristics Baseline characteristics TENS IA Hylan GF-20 p value
Age, years, mean (SD)54.2 (8.2)64.0 (8.6)<0.0001
Female, %160.3 (7.1)163.3 (8.8)NS
Weight, kg, mean (SD)78.0 (11.4)75.4 (9.0)NS
Duration of OA, months (SD)42.5 (50.6)56.5 (70.3)NS
WOMAC, mean (SD)
 Pain
 Stiffness
 Function

9.6 (3.9)
2.4
30.7 (15.5)

11.2 (3.6)
2.4
35.9 (10.8)

NS
Not mentioned
NS
Lequesne Index, mean (SD)
 Total
 Function

4.2 (1.7)
5.6

5.0 (1.6)
6.8

NS
Not mentioned
SF-36 total score, mean (SD)54.2 (27.1)59.9 (17.1)NS
• All participants had Knee OA (ACR criteria and radiological diagnosis – Kellgren and Lawrence Grade 2 or 3), were aged 40–80 years, had OA for more than 1 year and were ambulatory. Patients had received no previous IA HA injections at any time and no IA corticosteroid injections over the previous 3 months.
• Patients were excluded if they were taking glucosamine or chondroitin supplements, had inflammatory arthritis, previous fracture around the knee, knee arthroscopy, knee replacement surgery, significant comorbidity and bird hypersensitivity or egg allergy.
• All patients underwent a 2-week washout period for analgesic and NSAID drugs.
• Paracetamol adjuvant medication was allowed during the study if needed.
• There were no significant differences between the groups for any of the baseline characteristics except for age.
Intervention TENS, 5 times a week for 3 weeks.

20 mins of TENS at 150 Hz frequency.
Comparison IA Hyalan GF-20 injections, once a week for 3 weeks.
Length of follow-up 3 weeks (end of treatment) and follow-up at 1 month and 6 months post-treatment.
Outcome measures WOMAC (Pain, stiffness, function); Lequesne (total and function); SF-36 total.
Effect size Pain
• There was NS difference between TENS and IA Hylan GF-20 for:
 ○ WOMAC Pain at 3 weeks (end of treatment) and 1 month and 6 months post-treatment.

Stiffness
• There was NS difference between TENS and IA Hylan GF-20 for:
 ○ WOMAC Stiffness at 3 weeks (end of treatment)

TENS was significantly worse than IA Hylan GF-20 for:
 ○ WOMAC Stiffness at 1 month post-treatment (p<0.007) and 6 months post-treatment (p<0.05).

Function
TENS was significantly better than IA Hylan GF-20 for:
 ○ Lequesne function at 3 weeks (end of treatment), p<0.05.

• There was NS difference between TENS and IA Hylan GF-20 for:
 ○ WOMAC function at 3 weeks (end of treatment) and 1 month post-treatment;
 ○ Lequesne function at 1 and 6 months post-treatment;
 ○ Lequesne total at 3 weeks (end of treatment) and 1 month and 6 months post-treatment.

TENS was significantly worse than IA Hylan GF-20 for:
 ○ WOMAC function at 6 months post-treatment (p<0.05).

Quality of Life
• There was NS difference between TENS and IA Hylan GF-20 for:
 ○ All SF-36 dimensions at 3 weeks (end of treatment) and 1 month and 6 months post-treatment.

Withdrawals
• 3 patients withdrew from the TENS group and 5 patients withdrew from the IA Hylan group.
Outcome, mean TENS IA Hylan GF-20 p value
WOMAC pain, mean
 3 weeks (end of treatment)
 1 month post-treatment
 6 months post-treatment

5.3
4.7
5.2

5.8
5.1
4.6

NS
NS
NS
WOMAC stiffness, mean (SD)
 3 weeks (end of treatment)
 1 month post-treatment
 6 months post-treatment

1.5
1.5
1.5

1.7
1.3
1.2

NS
<0.007
<0.05
WOMAC function, mean (SD)
 3 weeks (end of treatment)
 1 month post-treatment
 6 months post-treatment

18.3
17.7
19.2

19.9
17.4
13.7

NS
NS
<0.05
Lequesne total, mean (SD)
 3 weeks (end of treatment)
 1 month post-treatment
 6 months post-treatment

2.1
2.0
2.5

3.0
2.4
2.5

NS
NS
NS
Lequesne function, mean (SD)
 3 weeks (end of treatment)
 1 month post-treatment
 6 months post-treatment

3.6
3.5
4.1

4.2
3.0
3.6

<0.05
NS
NS
SF-36 total, mean (SD)
 3 weeks (end of treatment)
 1 month post-treatment
 6 months post-treatment

58.1
53.8
54.2

63.2
59.9
58.4

NS
NS
NS
• Randomisation by ‘simple charts’
• Double blind
• No mention of ITT analysis
Funding Not mentioned
Ref ID 2253
Bibliographic reference G. L. Y. Cheing, C. W. Y. Huichan, and K. M. Chan. Does four weeks of TENS and/or isometric exercise produce cumulative reduction of osteoarthritic knee pain? Clinical Rehabilitation 16 (7):749–760, 2002.
Study type and evidence level RCT: 1+
Aim To assess the efficacy of AL-TENS versus placebo (sham AL-TENS) versus exercise versus TENS + exercise in adults with Knee OA.
Number of patients Total N=66; N=16 (AL-TENS), N=18 (Placebo – sham AL-TENS), N=15 (exercise), N=17 (AL-TENS + exercise).
Single centre trial: Hong Kong
Patient characteristics
NOTE: This study is the same as Cheing et al ID 1253; however, different outcomes were reported in each of the 2 published papers.

NOTE: Only data for TENS, placebo and exercise arms are reported here.
Baseline characteristics AL-TENS (N=16) Placebo – sham AL-TENS (N=16) Exercise (N=15)
Age, years, mean (SD)65.3 (8.3)64.1 (6.1)60.9 (7.3)
Female, %87.593.886.7
BMI, kg/m2 (SD)26.8 (4.0)28.8 (3.7)29.6 (4.3)
• All participants had Knee OA (clinical and radiological diagnosis – Kellgren and Lawrence Grade 2 or above), were aged 50–75 years, had OA fpr more than 6 months, been stable on their medication for 3 weeks before entering the study and received no paramedical treatment within the previous 2 weeks before entering the study. All participants were able to walk on their own for 10 mins.
• Patients were excluded they had prior knee surgery, prior experience with the use of TENS and/or having received an IA steroid injection in the previous 3 weeks.
• For patients with bilateral knee OA, data was obtained for the more affected knee.
• All patients were advised to keep their activity level and medication unchanged throughout the study period.
• There were no significant differences between the groups for any of the baseline characteristics.
Intervention AL-TENS – 5 days a week for 4 weeks

TENS was applied to the affected knee for 60 mins. Stimulation was given in continuous trains of 140 μs square pulses at 80 Hz. 4 surface electrodes were placed on 5 acupuncture points which in most caes coincided with the most tender points on the knee. Intensity of TENS was adjusted to produce a tingling sensation 3–4 times the subject’s sensory threshold.
Comparison Placebo – Sham AL-TENS – same sites and same duration and period as the AL-TENS group.

Exercise – Isometric exercise training for approx. 20 mins 5 days a week for 4 weeks.
Length of follow-up At each session measurements were made before treatment and 20 mins after treatment.
Treatment period was 4 weeks and follow-up at 4 weeks post-treatment.
Outcome measures Pain (VAS).
Effect size
Pain
AL-TENS was better than Placebo (sham AL-TENS) for:
 ○ Pain, VAS (difference between pre-and post-treatment scores) at Day 1 (−35.9 and −15.5 respectively), 2 weeks, mid-treatment (−7.9 and +2.7 respectively) and at 4 weeks, end of treatment (−11.9 and −6.2 respectively).
AL-TENS was worse than placebo (sham AL-TENS) for:
 ○ Pain, VAS (difference between pre-and post-treatment scores) at 4 weeks post-treatment (−7.8 and −19.3 respectively).

AL-TENS was better than exercise for:
 ○ Pain, VAS (difference between pre-and post-treatment scores) at Day 1 (−35.9 and +21.6 respectively), at 4 weeks, end of treatment (−11.9 and −7.6 respectively) and at 4 weeks post-treatment (−7.8 and +42.0 respectively).
AL-TENS was worse than exercise for:
 ○ Pain, VAS (difference between pre-and post-treatment scores) at Day 2 weeks, mid-treatment (−7.9 and −9.1 respectively).

Withdrawals
•2 patients withdrew from the placebo group.
Outcome, mean difference between before treatment score and 20 mins after treatment score AL-TENS Placebo – sham AL-TENS Exercise
Pain, VAS, mean (SD)
 Day 1
 2 weeks
 4 weeks
 4 weeks post-treatment
−35.9 (40.7)
−7.9 (16.8)
−11.9 (16.1)
−7.8 (10.6)
−15.5 (39.5)
+2.7 (33.4)
−6.2 (25.4)
−19.3 (2.9)
+21.6 (101)
−9.1 (40.7)
−7.6 (48.3)
+42.0 (20.1)
• Randomisation method not mentioned
• No mention of blinding
• No mention of ITT analysis
Funding Not mentioned
Ref ID 2298
Bibliographic reference CW Cheing, GL Hui-Chan. Would the addition of TENS to exercise training produce better physical performance outcomes in people with knee osteoarthritis than either intervention alone? Clinical Rehabilitation 18 (5):487–497, 2004.
Study type and evidence level RCT: 1+
Aim To assess the efficacy of AL-TENS versus placebo (sham AL-TENS) versus exercise versus TENS + exercise in adults with Knee OA.
Number of patients Total N=66; N=16 (AL-TENS), N=18 (Placebo – sham AL-TENS), N=15 (exercise), N=17 (AL-TENS + exercise).
Single centre trial: Hong Kong
Patient characteristics
NOTE: This study is the same as Cheing et al ID 2298; however, different outcomes were reported in each of the 2 published papers.

NOTE: Only data for TENS, placebo and exercise arms are reported here.
Baseline characteristics AL-TENS (N=16) Placebo – sham AL-TENS (N=16) Exercise (N=15)
Age, years, mean (SD)65.3 (8.3)64.1 (6.1)60.9 (7.3)
Female, %87.593.886.7
BMI, kg/m2 (SD)26.8 (4.0)28.8 (3.7)29.6 (4.3)
Duration of OA, months (SD)72.0 (66.9)59.2 (62.7)50.9 (51.8)
• All participants had Knee OA (clinical and radiological diagnosis – Kellgren and Lawrence Grade 2 or above), were aged 50–75 years, had OA fpr more than 6 months, been stable on their medication for 3 weeks before entering the study and received no paramedical treatment within the previous 2 weeks before entering the study. All participants were able to walk on their own for 10 mins.
• Patients were excluded they had prior knee surgery, prior experience with the use of TENS and/or having received an IA steroid injection in the previous 3 weeks.
• For patients with bilateral knee OA, data was obtained for the more affected knee.
• All patients were advised to keep their activity level and medication unchanged throughout the study period.
• There were no significant differences between the groups for any of the baseline characteristics.
Intervention AL-TENS – 5 days a week for 4 weeks

TENS was applied to the affected knee for 60 mins. Stimulation was given in continuous trains of 140 μs square pulses at 80 Hz. 4 surface electrodes were placed on 5 acupuncture points which in most caes coincided with the most tender points on the knee. Intensity of TENS was adjusted to produce a tingling sensation 3–4 times the subject’s sensory threshold.
Comparison Placebo – Sham AL-TENS – same sites and same duration and period as the AL-TENS group.

Exercise – Isometric exercise training for approx. 20 mins 5 days a week for 4 weeks.
Length of follow-up At each session measurements were made before treatment and 20 mins after treatment.
Treatment period was 4 weeks and follow-up at 4 weeks post-treatment.
Outcome measures Pain (VAS).
Effect size
AL-TENS vs PLACEBO

Function
AL-TENS was better than Placebo (sham AL-TENS) for:
 ○ Stride length (m) at 4 weeks, end of treatment (1.06 and 1.02 respectively) and 4 weeks post-treatment (1.07 and 1.04 respectively);
 ○ Cadence (steps/min) at 4 weeks, end of treatment (109 and 108 respectively) and 4 weeks post-treatment (110 and 107 respectively);
 ○ Velocity (m/s) at 4 weeks, end of treatment (0.97 and 0.92 respectively) and 4 weeks post-treatment (0.98 and 0.93 respectively);
 ○ ROM during walking (degrees) at 4 weeks, end of treatment (51.8 and 51.5 respectively) and 4 weeks post- treatment (53.1 and 51.2 respectively);
 ○ ROM at rest (degrees) at 4 weeks post-treatment (106 and 103 respectively).

AL-TENS was the same as Placebo (sham AL-TENS) for:
 ○ ROM at rest (degrees) at 4 weeks, end of treatment (both: 107);
 ○ Isometric peak torque of knee extensors and flexors at specified knee positions; NS difference was found at day 1, 2 weeks (mid treatment), 4 weeks (end of treatment) and at 4 weeks post-treatment.

AL-TENS was worse than placebo (sham AL-TENS) for:
 ○ Stride length (m) at Day 1 (0.95 and 0.99 respectively) and 2 weeks, mid-treatment (1.01 and 1.02 respectively);
 ○ Cadence (steps/min) at Velocity (m/s) at Day 1 (100 and 103 respectively) and 2 weeks, mid-treatment (105 and 108 respectively);
 ○ ROM during walking (degrees) at Day 1 (50.3 and 51.3 respectively) and 2 weeks, mid-treatment (51.7 and 52.3 respectively);
 ○ ROM at rest (degrees) at Day 1 (104 and 107 respectively) and 2 weeks, mid-treatment (102 and 104 respectively).

AL-TENS vs EXERCISE

Function
AL-TENS was better than exercise for:
 ○ Stride length (m) at 4 weeks, end of treatment (1.06 and 1.03 respectively) and 4 weeks post-treatment (1.07 and 1.03 respectively);
 ○ Cadence (steps/min) at 4 weeks, end of treatment (109 and 104 respectively) and 4 weeks post-treatment (110 and 107 respectively);
 ○ Velocity (m/s) at 4 weeks, end of treatment (0.97 and 0.89 respectively) and 4 weeks post-treatment (0.98 and 0.92 respectively);
 ○ ROM during walking (degrees) at Day 1 (50.3 and 48.7 respectively), 2 weeks, mid-treatment (51.7 and 48.6 respectively), 4 weeks, end of treatment (51.8 and 48.7 respectively) and 4 weeks post-treatment (53.1 and 48.3 respectively);
 ○ ROM at rest (degrees) at 4 weeks, end of treatment (107 and 106 respectively) and 4 weeks post-treatment (106 and 104 respectively).

AL-TENS was the same as exercise for:
 ○ Peak torque of knee extensors and flexors at specified knee positions; NS difference was found at day 1, 2 weeks (mid treatment), 4 weeks (end of treatment) and at 4 weeks post-treatment.

AL-TENS was worse than exercise for:
 ○ Stride length (m) at Day 1 (0.95 and 1.00 respectively) and 2 weeks, mid-treatment (1.01 and 1.02 respectively);
 ○ Cadence (steps/min) at at Day 1 (100 and 104 respectively) and 2 weeks, mid-treatment (105 and 106 respectively);
 ○ Velocity (m/s) at Day 1 (0.81 and 0.87 respectively) and 2 weeks, mid-treatment (0.89 and 0.90 respectively);
 ○ ROM at rest (degrees) at Day 1 (104 and 105 respectively) and 2 weeks, mid-treatment (102 and 105 respectively).

Withdrawals
• 2 patients withdrew from the placebo group.
Outcome, mean AL-TENS Placebo – sham AL-TENS Exercise
Stride Length, m, mean (SD)
 Day 1
 2 weeks
 4 weeks
 4 weeks post-treatment
0.95 (0.19)
1.01 (0.16)
1.06 (0.17)
1.07 (0.17)
0.99 (0.14)
1.02 (0.12)
1.02 (0.11)
1.04 (0.15)
1.00 (0.09)
1.02 (0.10)
1.03 (0.08)
1.03 (0.10)
Cadence, steps/min, mean (SD)
 Day 1
 2 weeks
 4 weeks
 4 weeks post-treatment
100 (13.5)
105 (10.9)
109 (10.3)
110 (9.3)
103 (11.2)
108 (11.5)
108 (12.7)
107 (13.1)
104 (9.8)
106 (11.8)
104 (9.8)
107 (10.6)
Velocity, m/s, mean (SD)
 Day 1
 2 weeks
 4 weeks
 4 weeks post-treatment
0.81 (0.24)
0.89 (0.20)
0.97 (0.19)
0.98 (0.21)
0.85 (0.18)
0.91 (0.17)
0.92 (0.17)
0.93 (0.21)
0.87 (0.14)
0.90 (0.14)
0.89 (0.10)
0.92 (0.13)
ROM at rest, degrees, mean (SD)
 Day 1
 2 weeks
 4 weeks
 4 weeks post-treatment
104 (13.4)
102 (13.1)
107 (14.3)
106 (13.4)
107 (13.5)
104 (13.2)
107 (14.3)
103 (13.5)
105 (13.9)
105 (13.5)
106 (14.6)
104 (13.8)
ROM during walking, degrees, mean (SD)
 Day 1
 2 weeks
 4 weeks
 4 weeks post-treatment
50.3 (9.6)
51.7 (9.3)
51.8 (8.8)
53.1 (8.5)
51.3 (9.6)
52.3 (9.4)
51.5 (8.9)
51.2 (8.5)
48.7 (9.9)
48.6 (9.6)
48.7 (9.1)
48.3 (8.7)

• Randomisation method not mentioned
• No mention of blinding
• No mention of ITT analysis
Funding Not mentioned
Ref ID 1253
Bibliographic reference F. Tascioglu, O. Armagan, Y. Tabak, I. Corapci, and C. Oner. Low power laser treatment in patients with knee osteoarthritis. Swiss Medical Weekly 134 (17–18):254–258, 2004.
Study type and evidence level RCT: 1+
Aim To assess the efficacy and safety of Low power laser treatment versus Placebo Laser in adults with Knee OA.
Number of patients Total N=60; N=20 (Laser, 3 joule), N=20 (Laser, 1.5 joule), N=20 (Placebo Laser).
Single centre trial: Turkey
Patient characteristics Baseline characteristics Laser, 3 joule (N=20) Laser, 1.5 joule (N=20) Placebo Laser (N=20)
Age, years, mean (SD)62.9 (7.3)59.9 (7.6)64.3(10.6)
Female, N (%)14 (70)15 (75)13 (65)
BMI, kg/m2, mean (SD)27.6 (5.7)28.6 (6.5)29.6 (9.5)
Kellgren Lawrence Grade, N (%)
 Grade II
 Grade III
12 (60)
8 (40)
10 (50)
10 (50)
11 (55)
9 (45)
WOMAC, mean (SD)
 Pain
 Stiffness
 Function
10.3 (3.6)
4.1 (3.0)
36.6 (7.1)
11.6 (4.8)
4.6 (1.9)
38.0 (9.7)
9.6 (3.9)
4.5 (2.5)
39.5 (12.6)
Pain intensity at rest, VAS, mean (SD)39.1 (14.9)41.6 (16.7)37.9 (11.0)
Pain intensity on activation, VAS, mean (SD)68.0 (15.5)65.7 (18.7)63.9 (16.1)

• All participants had Knee OA (ACR criteria and radiological diagnosis – Kellgren and Lawrence Grade 2 or 3) and were ambulatory.
• Patients were excluded if they were Kellgren and Lawrence Grade 1 or 4, had knee joint disease other than OA, serious concomitant diseases, IA fluid effusion, previous physical therapy and IA corticosteroid or HA injections during the last 6 months.
• Patients were allowed to take paracetamol (to a maximum of 2g daily) during the study period if needed.
• There were no significant differences between the groups for baseline characteristics.
Intervention Low power laser (3 joules at each point), once a day, 5 times a week for 10 days.

Laser with power output of 50 mW at a wavelength of 830 mm. 1mm diameter of laser beam sent to deliver a continuous form of energy at 5 painful points. A 2 minute irradiation at each point (total of 10 mins) was considered as 1 irradiation dose. The dose per tender joint was 3 joule; total dose per treatment was 15 joule (for 10 treatments the accumulated dose was 150 joules).
Comparison Low power laser (1.5 joules at each point), once a day, 5 times a week for 10 days.
Same as main Laser group except a 1 minute irradiation at each point (total of 5 mins) was considered as 1 irradiation dose.
The dose per tender joint was 1.5 joule; total dose per treatment was 7.5 joule (for 10 treatments the accumulated dose was 75 joules).
Placebo Laser – same time and frequency as the laser treatments.
Length of follow-up 10 days (end of treatment) and follow-up at 3 weeks and 6 months.
Outcome measures Pain (VAS); WOMAC (Pain, stiffness, function); AEs.
Effect size Pain
• There was NS difference between Laser therapy and Placebo laser for:
 ○ Pain intensity at rest (VAS) at 3 weeks and 6 months follow-up;
 ○ Pain intensity on activation (VAS) at 3 weeks and 6 months follow-up
 ○ WOMAC Pain at 3 weeks and 6 months follow-up.

Stiffness
• There was NS difference between Laser therapy and Placebo laser for:
 ○ WOMAC stiffness at 3 weeks and 6 months follow-up.

Function
• There was NS difference between Laser therapy and Placebo laser for:
 ○ WOMAC function at 3 weeks and 6 months follow-up.

AEs
• No systemic or local AEs were reported during or after the treatment period.
Outcome, mean Laser, 3 joule Laser, 1.5 joule Placebo Laser
WOMAC Pain, mean (SD)
 Week 3
 6 months
10.2 (2.6)
10.4 (3.0)
10.9 (3.5)
11.3 (2.4)
9.3 (4.4)
9.9 (3.6)
WOMAC Stiffness, mean (SD)
 Week 3
 6 months
4.0 (2.1)
3.9 (1.8)
4.7 (1.7)
4.5 (1.6)
4.4 (1.8)
4.2 (2.1)
WOMAC Function, mean (SD)
 Week 3
 6 months
35.0 (8.4)
34.8 (8.9)
36.0 (10.1)
38.5 (10.5)
37.5 (10.1)
38.7 (9.7)
Pain intensity at rest, VAS, mean (SD)
 Week 3
 6 months
36.8 (14.8)
38.7 (14.9)
38.1 (10.5)
40.0 (9.1)
36.0 (16.5)
38.9 (15.1)
Pain intensity on activation, VAS, mean (SD)
 Week 3
 6 months
65.0 (13.1)
66.8 (13.5)
60.3 (15.4)
61.8 (12.9)
59.8 (18.5)
62.0 (16.7)

• Randomisation by numbered envelopes
• Single blind (physician)
• No mention of ITT analysis or drop-outs.
Funding None.
Ref ID 2266
Reference Study type Evidence level Number of patients Patient characteristics Intervention Comparison Length of follow-up Outcome measures Source of funding
M. Yurtkuran, A. Alp, S. Konur, S. Ozcakir, and U. Bingol. Laser acupuncture in knee osteoarthritis: a double-blind, randomized controlled study. Photomedicine and Laser Surgery 25 (1):14–20, 2007.

ID 2753
RCT: 1+

Single centre trial: Turkey.


• Randomisation by computer generated table of random numbers
• Allocation concealment
• Triple blind
• No ITT analysis
Total N=55 (N=28 laser acupuncture + exercise, N=27 placebo laser + exercise).

Drop-outs:
N=3
Inclusion criteria: Knee OA (ACR criteria), K-L grade 2 or 3, average pain intensity ≥40 mm (VAS) for the last month; the most painful knee was used for evaluation.

Exclusion criteria: Patients who had knee surgery, physiotherapy in the last 6 months; serious valgus or varus deformity; hormonal, metabolic or systemic rheumatologic problems leading to secondary knee OA; local-oral nalgesic or NSAID use in the last 4 weeks; systemic disease that contraindicated to physiotherapy and exercise.

Baseline characteristics: LASER ACUPUNCTURE - 96% female; mean age 52 years (SD 6.8); BMI 32 kg/m2 (SD 8.8); symptom duration 62 months (SD 52); WOMAC index 66.5 (SD 17.6); Pain (VAS) 6.5 (SD 1.6); NHP 8.8 (SD 3.8).

CONTROL - 96% female; mean age 53 years (SD 7.1); BMI 32.7 kg/m2 (SD 3.7); symptom duration 67 months (SD 58); WOMAC index 51.3 (SD 19.0); Pain (VAS) 6.1 (SD 2.2); NHP 8.1 (SD 4.5).

Baseline characteristics were similar for both groups, however, WOAMC index was higher for the laser acupuncture patients.

Patients were instructed not to use any analgesia or NSAIDs during the follow-up period.
Laser acupuncture + exercise: Pulsed irradiation to the medial side of the knee to the acupuncture point associated with knee pain (Sp9).

20 mins/day for 5 days a week for 2 weeks (total 10 days therapy).

Both groups received home- based standard exercise programme given by a physiotherapist (sets of quadriceps muscle contraction and active ROM exercises for the knee)
Placebo laser therapy + exercise: laser not switched on, however red light appeared so that patients thought it was working.

20 mins/day for 5 days a week for 2 weeks (total 10 days therapy)
2 weeks (end of treatment) and follow-up at 12 weeks (10 weeks post- treatment).Pain (VAS); WOMAC (total, pain, stiffness, physical function); 50-foot walk time; Medical tenderness score (MTS); Quality of Life (NHP).Not mentioned.
Effect size

• There was NS difference between Laser Acupuncture and placebo laser acupuncture for:
 ○ WOMAC total at 2 weeks (end of treatment) and 12 weeks (10 weeks post-treatment);
 ○ Pain (VAS) at 2 weeks (end of treatment) and 12 weeks (10 weeks post-treatment);
 ○ 50-foot walk time at 2 weeks (end of treatment) and 12 weeks (10 weeks post-treatment);
 ○ Medical tenderness score at 2 weeks (end of treatment) and 12 weeks (10 weeks post-treatment);
 ○ Quality of Life (NHP score) at 2 weeks (end of treatment) and 12 weeks (10 weeks post-treatment).
Bibliographic reference E. Battisti, E. Piazza, M. Rigato, R. Nuti, L. Bianciardi, A. Scribano, and N. Giordano. Efficacy and safety of a musically modulated electromagnetic field (TAMMEF) in patients affected by knee osteoarthritis. Clinical & Experimental Rheumatology 22 (5):568–572, 2004.
Study type and evidence level RCT: 1−
Aim To assess the efficacy and safety of TAMMEF (musically modulated electromagnetic field) versus ELF (extremely low frequency field versus placebo ELF in adults with Knee OA.
Number of patients Total N=90; N=30 (TAMMEF), N=30 (ELF), N=30 (placebo ELF).
Single centre trial: Italy
Patient characteristics Baseline characteristics TAMMEF (N=30) ELF (N=30) Placebo ELF (N=30)
Lequesne Index, OA severity, mean (SD)
 Slight
 Moderate
 Serious

15 (50)
12 (40)
3 (10)

13 (43)
13 (43)
4 (14)

15 (50)
12 (40)
3 (10)
Lequesne Pain, mean (SD)*
 Slight disease group
 Moderate disease group
 Serious disease group

9.0
6.0
3.5

8.5
5.0
3.0

8.0
5.0
3.0
Lequesne Function, mean (SD)*
 Slight disease group
 Moderate disease group
 Serious disease group

2.5
4.5
5.5

3.0
5.0
6.0

2.5
4.0
5.0
*values are approximate as they have been taken from graphs presented in the published paper

• All participants had primary Knee OA (ACR criteria and radiological diagnosis – Kellgren and Lawrence Grading and Lequesne Index of severity) and were aged 59–76 years.
• Patients underwent a 15 day washout period for analgesic and NSAID drugs prior to the start of the study.
• There were no significant differences between the groups for any of the baseline characteristics.
Intervention TAMMEF, once a day for 15 days.

Electrical field is derived from recorded musical passages, thus its intensity, frequency and wave form are modified in time with random variation. The knee joint is placed between 2 electromagnets.
Comparison ELF, once a day for 15 days.
Placebo ELF, once a day for 15 days.

ELF frequency 100 Hz with sinusoidal wave form. The knee joint is placed between 2 electromagnets.
Length of follow-up 7 days (mid-study), 15 days (end of treatment) and follow-up at 30 days post-treatment.
Outcome measures Lequesne Pain and Function; AEs.
Effect size Pain
• Improvements in Lequesne Pain (at all time points) were similar in the TAMMEF and ELF groups and both groups were better than placebo.

Function
• Improvements in Lequesne Function (at all time points) were similar in the TAMMEF and ELF groups and both groups were better than placebo.

Withdrawals and AEs
• No patients withdrew from the study or reported side-effects that may have required suspension of treatment.
Outcome, mean change from baseline TAMMEF (N=30) ELF (N=30) Placebo ELF (N=30)
Lequesne Pain, mean (SD)
 Slight disease group
  Day 7 (mid point)
  Day 15 (end of treatment)
  30 days post-treatment
 Moderate disease group
  Day 7 (mid point)
  Day 15 (end of treatment)
  30 days post-treatment
 Serious disease group
  Day 7 (mid point)
  Day 15 (end of treatment)
  30 days post-treatment
−3.5
−7.5
−6.5

−2.0
−5.0
−5.0

−1.0
−3.0
−3.0
−2.5
−7.0
−6.0

−1.0
−4.0
−4.0

−0.5
−2.5
−2.5
−0.5
−0.5
+1.0

0.0
0.0
+1.0

−0.5
0.0
+0.5
Lequesne Function, mean (SD)
 Slight disease group
  Day 7 (mid point)
  Day 15 (end of treatment)
  30 days post-treatment
 Moderate disease group
  Day 7 (mid point)
  Day 15 (end of treatment)
  30 days post-treatment
 Serious disease group
  Day 7 (mid point)
  Day 15 (end of treatment)
  30 days post-treatment
+1.5
+2.5
+2.5

+1.0
+2.5
+2.5

+1.0
+2.5
+2.5
+1.5
+3.0
+3.0

+1.0
+2.0
+2.0

+1.5
+2.5
+2.5
0.0
0.0
0.0

−0.5
0.0
0.0

0.0
0.0
+0.5
*values are approximate as they have been taken from graphs presented in the published paper

• Randomisation method not mentioned
• Blinding not mentioned
• No mention of ITT analysis, however no dropouts
• Few baseline characteristics mentioned
Funding Partially supported by Fondazione del Monte dei Paschi di Siena, Italy.
Ref ID 2263

From: Compiled evidence tables - Chapter 6

Cover of Osteoarthritis
Osteoarthritis: National Clinical Guideline for Care and Management in Adults.
NICE Clinical Guidelines, No. 59.
National Collaborating Centre for Chronic Conditions (UK).
Copyright © 2008, Royal College of Physicians of London.

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