5.4Thermotherapy

THERMO: In adults with OA, what are the relative benefits and harms of local thermo-therapy (ice, cold, warmth, hot packs, wax baths, contrast baths) versus no treatment or other interventions with respect to symptoms, function and quality of life?
Bibliographic referenceL. Brosseau, K. A. Yonge, V. Robinson, S. Marchand, M. Judd, G. Wells, and P. Tugwell. Thermotherapy for treatment of osteoarthritis. Cochrane Database of Systematic Reviews (4):CD004522, 2003.
Study type and evidence levelSR/MA: 1++; RCT’s 1+
AimTo conduct a SR of RCTs of the efficacy and safety of thermotherapy for the treatment of Knee OA.
Number of patientsTotal N=3 RCTs (N=179 patients) reported thermotherapy versus placebo or other comparisons; however 1 of these RCT’s (Hecht et al) studied patients after they had undergone total knee arthroplasty, thus results for this study have not been reported here.
Patient characteristics

RCT’s varied in terms of:
• Type of thermotherapy used (1 RCT Ice application; 1 RCT Ice Massage)
• Type of comparison used (1 RCT SWD or placebo SWD; 1 RCT EA, AL-TENS or placebo AL-TENS)
• Treatment regimen (3 or 5 days/week)
• Trial length (Range:2 weeks to 3 weeks)
• Trial size (Range: N=48 to N=100)

RCTs were similar in terms of:
• OA site (Knee)
• OA diagnosis (clinical and radiographic features)
• Trial design (parallel group studies)
• Randomisation (randomised)
• Blinding (single-blind)

NOTE: This SR/MA receives a 1++ for its own internal methodological quality and presentation of results, but the body of studies it reviews differ in terms of methodological quality, study design, study duration, and outcomes measured. Tests for heterogeneity and sensitivity were not performed since data was not pooled.

NOTE: This meta-analysis has assessed the included RCT’s for quality and has included data for the outcomes of symptoms and function. However, Quality of Life and AEs were not assessed because these outcomes were not reported by the individual RCT’s in the systematic review. Additionally, pain was only reported from one of the trials therefore pain outcome results have additionally been taken from the other RCT in the SR{Yurtkuran, 1999 2212/id} and reported here.

AUTHORS’ CONCLUSION:
Ice massage was significantly better than control group after approximately 2 weeks of treatment. Improvements were reported in objective measures of ROM in knee flexion, function (time to walk 50 feet) and quadriceps strength. These improvements ranged from 8 to 29% greater improvement relative to the control group (Yurkurtan 1999). However, there was NS effect of ice over control of pain relief after 3 weeks of treatment (Clarke 1974). Cold packs were significantly better than control group and than hot packs after 10 treatment sessions for knee oedema. There were NS effects of hot packs for any measure when compared with control or alternative therapy (Hecht 1983).
InterventionThermotherapy (heat or cold)
ComparisonStandard treatment or placebo
Length of follow-upStudy duration ranged from 2 weeks to 3 weeks
Outcome measuresPain; 50-foot walk time; ROM (flexion); Change in mid-patellar knee circumference; Quadriceps strength.
Effect sizeICE MASSAGE vs CONTROL (1 RCT in MA)
• Ice Massage was found to be significantly better than control for:
 ○ Increasing quadriceps strength at week 2, end of treatment (1 RCT, N=50; WMD 2.30, 95% CI 1.08 to 3.52, p=0.0002);
 ○ Knee flexion, ROM (degrees) at week 2, end of treatment (1 RCT, N=50; WMD 8.80, 95% CI 4.57 to 13.03, p=0.00005);
 ○ 50- foot walk time (mins) at week 2, end of treatment (1 RCT, N=50; WMD −9.70, 95% CI −12.40 to −7.00, p<0.00001).

• Ice Massage was found to be clinically better than control for:
 ○ Increasing quadriceps strength at week 2, end of treatment (1 RCT, N=50; 29% relative difference).

• No clinical benefit was found for Ice Massage compared to control for:
 ○ ROM, degrees (change from baseline) at week 2, end of treatment (1 RCT, N=50; 8% relative difference);
 ○ 50- foot walk time, mins (change from baseline) at week 2, end of treatment (1 RCT, N=50; relative difference −11%).

NS difference was found between Ice Massage and control for:
 ○ Pain at rest, PPI score at week 2, end of treatment (1 RCT, N=50).

ICE MASSAGE vs AL-TENS (1 RCT in MA)
NS difference was found between Ice Massage and Al-TENS for:
 ○ Knee flexion, ROM (degrees) at week 2, end of treatment (1 RCT, N=50);
 ○ 50- foot walk time (mins) at week 2, end of treatment (1 RCT, N=50);
 ○ Pain at rest, PPI score at week 2, end of treatment (1 RCT, N=50).

• Ice Massage was found to be significantly worse than AL-TENS for:
 ○ Increasing quadriceps strength at week 2, end of treatment (1 RCT, N=50; WMD −3.70, 95% CI −5.70 to −1.70, p=0.0003).

ICE MASSAGE VS ELECTROACUPUNCTURE (1 RCT in MA)
• Ice Massage was found to be significantly worse than EA for:
 ○ Increasing quadriceps strength at week 2, end of treatment (1 RCT, N=50; WMD −2.80, 95% CI −4.14 to −1.46, p=0.00004);
 ○ 50- foot walk time (mins) at week 2, end of treatment (1 RCT, N=50; WMD 6.00, 95% CI 3.19 to 8.81, p=0.00003).

NS difference was found between Ice Massage and EA for:
 ○ Knee flexion, ROM (degrees) at week 2, end of treatment (1 RCT, N=50);
 ○ Pain at rest, PPI score at week 2, end of treatment (1 RCT, N=50).

COLD PACKS vs CONTROL (1 RCT in MA)
• There was NS difference between cold pack and control for:
 ○ Change on knee circumference (oedema) after the first application (1 RCT, N=23);
• Cold packs were found to be significantly better than control for:
 ○ Change on knee circumference (oedema) after 10 applications, end of treatment (1 RCT, N=23; WMD −1.0, 95% CI −1.98 to −0.02, p=0.04).

ICE PACKS vs CONTROL (1 RCT in MA)
• There was NS difference and no clinical difference between ice packs and control for:
 ○ Pain difference at 3 weeks (end of treatment) and at 3 months post-treatment (1 RCT, N=26).
FundingNot mentioned.
Ref ID2269
Bibliographic referenceJ. G. Martin, L. P. Rodriguez, C. D. Mora, R. R. Torres, F. P. Gomez, and L. G. Pellico. Liquid nitrogen cryotherapy effect on gait and pain in subjects with osteoarthritis of the knee. Europa Medicophysica 34 (1):17–24, 1998.
Study type & evidence levelNon-comparative study: 3+
AimTo assess the efficacy of Liquid nitrogen cryotherapy in adults with knee OA.
Number of patientsTotal N=26
Single centre trial: Spain
Patient characteristics
• All participants were aged 49 to 73 years, had minimum or moderate (Kellgren Index grade II or III) knee OA (diagnosed by ACR criteria) and had mechanical pain in both joints for at least 3 months, showed articular deformation and reported creaking of the joints but showed no inflammation.
• Patients were excluded if they had suspected conditions incompatible with cryotherapy, had unilateral OA of the knee or those with symptomatic degenerative joint disease of other lower limb joints, had prostheses of any lower limb joint, lower limb dysmetria of more than 2 cm, varus and valgus alterations of the static axis of the lower limbs more than 15°, any neurological disorder affecting the lower limbs.
• Participants were also excluded if they were taking analgesic drugs for other painful conditions.
• Participants receiving pharmacological treatment for arthritis had this suspended 5 days prior to the trial.
InterventionLiquid nitrogen cryotherapy – Treatment of 5 minute sessions for 5 days/week for 3 weeks (15 sessions total)

Vapourised liquid nitrogen was applied – a cryogenic probe was submerged in liquid nitrogen at −196°C for the extraction of a jet of nitrogen gas at a pressure of 5 bars and temperature between −120°C and −160°C. The gas was applied to the required area using a flexible tube (1.75m long) with a multidirectional nozzle. The jet was applied through the free end of the tube by continuous circular movement at 10 cm distance from the treatment zone. The cutaneous temperature of the knee area was maintained between 5°C and 10°C during the entire process.
ComparisonNo comparison – change from baseline
Length of follow-up3 weeks (end of treatment) and follow-up at 15 days post-treatment
Outcome measuresMcGill Pain questionnaire; Knee flexion and extension (degrees); quadriceps strength.
Effect size

• Compared to pre-treatment, Liquid nitrogen cryotherapy showed significant improvements in
 ○ Pain Rating Index Total (McGill Pain questionnaire), p=0.013;
 ○ Present Pain Intensity (McGill Pain questionnaire), p=0.002;
 ○ Right and left knee extension (p=0.04 and p=0.02 respectively);
 ○ Right and left quadriceps strength (p=0.01 and 0.006 respectively).

• There was NS difference between pre- and post-treatment values for Liquid nitrogen cryotherapy for:
 ○ Right and left knee flexion.
OutcomeBaselineAfter treatmentP value
McGill Pain Questionnaire, mean
  Pain rating index Total
  Present Pain Intensity

31.84 (11.4)
54.8 (18.3)

25.5 (12.1)
40.2 (22.5)

0.013
0.002
Right Knee flexion, degrees, mean104.96 (11.5)106.15 (8.6)0.42
Left Knee flexion, degrees, mean106.13 (8.8)106.3 (7.6)0.85
Right Knee extension, degrees, mean178.5 (4.5)179.7 (3.8)0.04
Left knee extension, degrees, mean179.12 (2.9)180.4 (2.8)0.02
Right quadriceps strength, mean4.56 (0.61)4.85 (0.53)0.01
Left quadriceps strength, mean4.65 (0.48)4.96 (0.44)0.006
FundingGrant from Spanish Education and Culture Ministry
Ref ID257
ReferenceStudy type
Evidence level
Number of patientsPatient characteristicsInterventionComparisonLength of follow-upOutcome measuresSource of funding
D. Evcik, V. Kavuncu, A. Yeter, and I. Yigit. The efficacy of balneotherapy and mud-pack therapy in patients with knee osteoarthritis. Joint, Bone, Spine: Revue du Rhumatisme 74 (1):60–65, 2007.

ID 2760
RCT: 1−

Turkey.

• Randomisation: poor method (patients assigned according to their order of admittance)
• No ITT analysis
• No mention of blinding
Total N=80 (N=25 balneotherapy, N=29 mud pack, N=26 hot-pack).

Drop-outs: 14% mud-pack, 3.8% hot pack.
Inclusion criteria: knee OA (ACR criteria).

Exclusion criteria: Effusion in knees, previous knee arthroplasty, severe cardiovascular diseases and peripheral vascular diseases, those having physical therapy, IA corticosteroids or hyaluronic acid injections within 6 months.

Baseline characteristics: MUD-PACK - 22% female; mean age 57 years (SD 9); BMI 30.6 kg/m2 ; disease duration 7 years (SD 4.9); WOMAC pain 11.0 (SD 3.3).

HOT-PACK - 24% female; mean age 60 years (SD 9.2); BMI 30.4 kg/m2 ; disease duration 6 years (SD 5.5); WOMAC pain 9.9 (SD 4.4).
Mud-pack therapy: heated to 42°C and applied over knees for 20 mins.

Therapies were administered once a day and five times/week for 2 weeks (10 sessions
Hot-pack therapy: heated to 42°C and applied over knees for 20 mins.

Therapies were administered once a day and five times/week for 2 weeks (10 sessions).
2 weeks (end of treatment).Pain (VAS); WOMAC (total, pain, physical function); Quality of Life (NHP); physician’s global assessment.Not mentioned.
Effect size

• There was NS difference between the groups for WOMAC Pain, WOMAC physical function, Pain (VAS).

From: Compiled evidence tables - Chapter 5

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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