6.4Podiatry (POD)

ReferenceStudy type
Evidence level
Number of patientsPatient characteristicsInterventionComparisonLength of follow-upOutcome measuresSource of funding
M. Egan, L. Brosseau, M. Farmer, M. A. Ouimet, S. Rees, G. Wells, and P. Tugwell. Splints and orthoses in the treatment of rheumatoid arthritis. Cochrane Database of Systematic Reviews (4):CD004018, 2001.

ID 741
MA: 1++
RCT’s of MA: 1− to 1++

SR and MA included: N=10 trials (12 papers) with suitable data (N=3 trials, 4 papers, on foot orthoses)
Trials were similar in terms of:
  • Study design (All RCTs for foot orthoses)
Trials differed with respect to:
  • Intervention (supporting insoles, extra depth shoes and insoles in extra depth shoes)
  • Comparison group (regular footwear, extra depth shoes, placebo insoles)
  • Study size (range N=28 to N=102 for foot orthosis)
  • Study quality – max score of 5 (All studies reasonable to good quality for foot orthoses)
  • Study duration – length of intervention (2 months to 3 years for foot orthoses)
Tests for heterogeneity and quality assessment performed.
Total N=449.

N=160 for foot orthoses
Inclusion criteria: All trial types; patients aged 18 years or older, diagnosed with RA; mixed populations had to have 50% or more of RA.

Search was up to 2002.

Exclusion criteria:
Joints of the neck or back
Orthoses – rigid, semi-rigid or soft orthotics designed to provide support and/or pain relief at all jointsPlacebo; active intervention or regular treatment

Treatment ranged from 2 months to 3 years for foot orthosesOMERACT; number of tender and swollen joints; Pain; physician’s and patient’s global assessment; functional status; radiological damage (OMERACT); morning stiffness; muscle strength; endurance; ROM; postural status; gait status; walking speed; walking distance; cadence; stride length; QoL; AEs.None
Effect size

ONLY DO DATA ON FOOT ORTHOSES

Extra depth shoes vs regular footwear (2 months)
  • Extra depth shoes were significantly better than regular footwear at 2 months for:
    • HAQ (change from baseline) (1 RCT, N=30; effect size WMD −0.20, 95% CI −0.35 to −0.05; p=0.01);
    • Pain on walking (change from baseline) (1 RCT, N=30; effect size WMD −18.7, 95% CI −28.5 to −8.9; p=0.0002);
    • Pain on climbing stairs(change from baseline) (1 RCT, N=30; effect size WMD −27.0, 95% CI −37.8 to −16.2; p<0.00001);
    • Pain-free walking time (change from baseline) (1 RCT, N=30; effect size WMD 18.2, 95% CI 8.2 to 28.2; p=0.0004);
  • There was NS difference between Extra depth shoes and regular footwear at 2 months for:
    • Fatigue (change from baseline) (1 RCT, N=30);
    • Subjective well-being (change from baseline) (1 RCT, N=30);
Semi-rigid insoles vs extra-depth shoes (12 weeks)
  • Semi-rigid insoles were significantly better than extra-depth shoes at 12 weeks for:
    • Pain, VAS (1 RCT, N=48; effect size WMD −1.9, 95% CI −3.3 to −0.51; p=0.007);
  • There was NS difference between Semi-rigid insoles and Extra depth shoes at 12 weeks for:
Soft insoles vs extra-depth shoes (12 weeks)
  • There was NS difference between Soft insoles and Extra depth shoes at 12 weeks for:
Semi-rigid insoles vs extra-depth shoes (12 weeks)
  • Supporting insoles (Rohadar posted foot orthoses) were significantly better than placebo insoles at 3 years for:
    • Hallux abductus angle remained < 21 degrees (1 RCT, N=98; effect size WMD RR 3.6, 95% CI 2.2 to 5.9; p<0.00001);
  • There was NS difference between Supporting insoles (Rohadar posted foot orthoses) and placebo insoles at 3 years for:
    • Painful foot joint count (1 RCT, N=88);
    • Foot function index (1 RCT, N=88);
    • Foot pain (1 RCT, N=88).
ReferenceStudy type
Evidence level
Number of patientsPatient characteristicsInterventionComparisonLength of follow-upOutcome measuresSource of funding
H. J. Davys, D. E. Turner, P. S. Helliwell, P. G. Conaghan, P. Emery, and J. Woodburn. Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial. Rheumatology 44 (2):207–210, 2005.

ID 3244
RCT: 1++
Single centre trial: UK
  • Randomised (random number codes and bock size of 4)
  • Allocation concealment
  • Single blind (patients) – second phase unblinded
  • ITT analysis Power study (VAS)
Total N=38 randomised (N=19 each group).

Drop-outs:
Treatment: N=1
Inclusion criteria: RA; symptomatic skin callosities overlying the plantar metatarsal heads that would have been routinely debrided by a podiatrist as part of normal foot care.

Exclusion criteria: Diabetes mellitius, neurological disease with lower limb symptoms or symptomatic peripheral vascular disease of the lower extremities.

Baseline characteristics:
Normal treatment: mean age 60 years; Female 84%; Duration of RA = Established RA (mean 21 years).

Sham treatment: mean age 58 years; Female 89%; Duration of RA = Established RA (mean 19 years).

The 2 groups were similar for all baseline characteristics.
Normal callus treatment

Sharp scalpel debridement of the callosity

Patients n both groups continued to use their normal orthopaedic footwear or orthoses during the study period
Sham callus treatment

Simulated normal callus treatment using blunt scalpel so that no callus material was debrided
Immediately after treatment, then follow-up at 7 days and once/week for 4 weeks (5 weeks post-treatment)Pain (VAS); radiographs (modified Larsen score); Plantar pressure measures; Spatial temporal gait measures; AEsMRC and ARC, UK
Effect size
  • There was NS difference between Normal callus debridement and sham callus debridement for:
    • Forefoot pain (VAS) at 5 weeks post-intervention
    • Plantar pressure measures at 5 weeks post-intervention
    • Spatial temporal gait measures at 5 weeks post-intervention
ReferenceStudy type
Evidence level
Number of patientsPatient characteristicsInterventionComparisonLength of follow-upOutcome measuresSource of funding
J. Woodburn, S. Barker, and P. S. Helliwell. A randomized controlled trial of foot orthoses in rheumatoid arthritis. Journal of Rheumatology 29 (7):1377–1383, 2002.

ID 3260
RCT: 1++
Single centre trial: UK
  • Randomised (blocks of 4, method not mentioned)
  • Single blind (physicians)
  • True ITT analysis
  • Slightly underpowered (Pain and disability)
Total N=101 randomised (50 – foot orthosis programme;
N=51 control programme).

Drop-outs:
Control: 21%
Intervention: 14%
Inclusion criteria: Definite RA (ARA criteria); history of bilateral subtalar and/or ankle and/or talonavicular pain and valgus heel deformity. Normal range of motions testing was used to ensure the valgus heel deformity was correctable with ≥10 degrees of subtalar joint inversion past neutral.

Exclusion criteria:
Concomitant endocrine disorders, especially diabetes mellitus; history of orthopaedic foot surgery; those currently using foot orthoses and those with inappropriate footwear.

Baseline characteristics:
Foot orthosis programme: mean age 54 years; Female 68%; Duration of RA = Established RA (mean 3 years); HAQ mean 1.0.

Foot orthosis programme: mean age 53 years; Female 65%; Duration of RA = Established RA (mean 3 years); HAQ mean 1.0.

There were NS differences between the groups for any of the baseline characteristics
Rigid foot orthoses under podiatry supervision

Orthoses were custom-designed and manufactured to a standardised protocol from impression casts. Inbuilt correction was customised for each patient, according to the degree of valgus heel deformity present and usedintrinsic posting in the rearfoot and maximum forefoot balancing techniques.
Control group

No prescribed foot orthoses at baseline; over 30 months these patients were permitted orthoses if prescribed at any subsequent outpatient medical consultation.
30 monthsFoot function Index (FFI) – pain and disability; DAS; HAQ; Radiographs (Larsen Index); ESR and CRP; AEsGrant from the ARC, UK and Yorkshire NHS R&D, UK.
Effect size
  • The customised foot orthosis was significantly better than the control group (no orthosis) for:
    • Foot function Index (total) at 30 weeks, p=0.026
    • Foot function Index (pain) at 30 weeks, p=0.014
    • Foot function Index (disability) at 30 weeks, p=0.016
  • There was NS difference between customised foot orthosis and the control group (no orthosis) for:
ReferenceStudy type
Evidence level
Number of patientsPatient characteristicsInterventionComparisonLength of follow-upOutcome measuresSource of funding
J. Woodburn, P. S. Helliwell, and S. Barker. Changes in 3D joint kinematics support the continuous use of orthoses in the management of painful rearfoot deformity in rheumatoid arthritis. Journal of Rheumatology 30 (11):2356–2364, 2003.

D 3261
RCT: 1++
Single centre trial: UK
  • Randomised (blocks of 4, method not mentioned)
  • Single blind (physicians)
  • True ITT analysis
  • Slightly underpowered (Pain and disability)
Total N=101 randomised (50 – foot orthosis programme; N=51 control programme).

Drop-outs:
Control: 21%
Intervention: 14%

As for ID 3260
Rigid foot orthoses under podiatry supervision

As for ID 3260
Control group (no orthosis)

As for ID 3260
30 months3D Joint kinematic measuresGrant from the ARC, UK and Yorkshire NHS R&D, UK.
Effect size
  • The customised foot orthosis was significantly better than the control group (no orthosis) for:
    • Dorsioflexion/plantarflexion motion at 30 weeks, p=0.005
    • Inversion/eversion motion at 30 weeks, p=0.0001
    • Internal/external AJC rotation at 30 weeks, p=0.006
    • Internal rotation at 30 weeks, p=0.007
ReferenceStudy type
Evidence level
Number of patientsPatient characteristicsIntervention and ComparisonLength of follow-upOutcome measuresSource of funding
C. Moncur and J. R. Ward. Heat-moldable shoes for management of forefoot problems in rheumatoid arthritis. Arthritis Care and Research 3 (4):222–226, 1990.

REF ID: 3256
Case-series: 3 Single centre, USA.

RA patients from out-patient clinic
N=25

Drop-outs:
None mentioned
Inclusion criteria: RA with metatarsalgria (RA - classic adult onset); forefoot pain not ameliorated by current footwear; ACR functional class II or III; most common lesions occurring in the forefoot were hallusx valgus, overlapping toes, cock-up toe deformities with dorsal callus formation, and prominent metatarsal heads on the plantar surface of the foot; patients could not find footwear which alleviated their pain.

Baseline characteristics:
Age mean 57, female 100%, disease duration
NOT MENTIONED.
Heat-mouldable extra-depth and extra-width shoe (Thermold, USA) Mouldable inlay that can be removed to insert an orthosis. Light-weight and heat-mouldable to accommodate prominences that are painful; on the sides and top of the foot.

Patients asked t wear the shoes in place of their usual shoes; if they had been wearing orthoses they placed these into their heat-mouldable shoes. Patients who had previously required medial or lateral stabilisation of their shoes had this same procedure done to their heat-mouldable shoes. Patients were followed as needed to modify the shoes and orthoses.

Patients were asked to walk 5–10 mins to identify painful areas where the foot touched the shoe. The shoe was then placed in a small oven to heat the mouldable lining for about 3–5 mins. Once removed from the oven, a shoe-stretching device was placed in the shoe to mould it to accommodate the patient’s forefoot deformities. Stretching of the upper shoe was continued until the patient was satisfied that the shoes were comfortable.
3 monthsWalking ability; satisfaction with footwearNot mentioned
Effect size*

Heat-mouldable shoes
  • 80% wore their shoes all the time during the day and 20% sometime during the day.
  • 72% wore their custom-made semi-rigid foot orthoses in their shoes and 28% did not
  • 20% had their shoes modified to control hindfoot vagus
  • 50% of those who had foot orthoses stated that they always wore their inserts in their shoes.
  • 80% of patients felt they walked better with the heat-mouldable shoes. 20% were not walking better
  • Significantly more patients found that they walked better with the heat-mouldable shoes compared to previous shoes (p<0.01)
  • Patients found that their heat-mouldable shoes were significantly better than previous shoes and were significantly more comfortable (p<0.001)
ReferenceStudy type
Evidence level
Number of patients1.6 Patient characteristicsInterventionComparisonLength of follow-upOutcome measuresSource of funding
A. E. Williams, K. Rome, and C. J. Nester. A clinical trial of specialist footwear for patients with rheumatoid arthritis. Rheumatology 46 (2):302–307, 2007.

ID 3258
RCT: 1−
Single centre trial: UK
  • Randomised (computer generated)
  • Single blind (patients)
  • No ITT analysis
  • Very high drop-outs (high bias due to no ITT analysis)
Power study (VAS) but with drop-outs is very underpowered
Total N=80 randomised (N=40 each group).

Drop-outs:
Traditional: N=31 (78%)
New: N=12 (30%)
Inclusion criteria: RA patients with established RA (>5 years duration) with foot deformity.New shoe design (based on patients’ opinions)Traditional shoe design12 weeksFoot health status questionnaire - FHSQ dimensions (Foot pain function, health; general health; physical activity; social capacity); SF-36; FFIMRC and ARC, UK
Effect size

Authors’ conclusion: Improvement in pain and patient satisfaction with the new design of footwear over the old design for patients with RA, indicates the importance of patients’ involvement in the design process and throughout the process of supplying and monitoring the footwear

From: Evidence Tables

Cover of Rheumatoid Arthritis
Rheumatoid Arthritis: National Clinical Guideline for Management and Treatment in Adults.
NICE Clinical Guidelines, No. 79.
National Collaborating Centre for Chronic Conditions (UK).
Copyright © 2009, Royal College of Physicians of London.

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