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Foot & AnkleRCT

Pulsed electromagnetic fields (PEMFs) in complex regional pain syndrome type I (CRPS-I) of the foot: a randomised controlled trial

Journal of Orthopaedics and Traumatology · 9 Sept 2026

Rigour62/100
Clinical47/100
Impact†49/100

† Impact is the editorial-priority score. All scores are out of 100. Clinical is a stored clinical-importance score from the earlier method; it has not been recalculated.

Why it matters

CRPS-I of the foot/ankle is a difficult, disabling condition with limited proven adjuncts, so evidence about a home-use, non-invasive PEMF device is relevant to orthopaedic and rehabilitation practice even though this trial is small and unblinded.

The evidence

This small RCT randomised 32 patients with chronic CRPS-I of the foot or ankle (all previously treated with IV neridronate but still symptomatic) to either standard rehabilitation exercise alone or the same exercise plus a home pulsed electromagnetic field device (I-One, 4h/day for 60 days). Over 12 months of follow-up, both groups improved from baseline, but the PEMF group had significantly greater reductions in pain (VAS 1.8 vs 5.5 at 12 months), better AOFAS scores (89 vs 64), and more resolution of allodynia and hyperalgesia. Oedema and NSAID use improved in both groups without significant between-group differences at most timepoints.

A coherent primary effect estimate is unavailable. Clinical relevance does not estimate treatment benefit.

Why this rigour score?

RCTDesign starting point: 59.5

62/ 100

Raised the score

  • Blinded outcome assessment+6.8
  • Adequately powered+6

Lowered the score

  • A positive result from only 32 patients−6.8
  • Per-protocol analysis only−6

Methods at a glance

Recorded assessment
  • Outcome assessors blindedMet
  • Allocation concealedNot reported
  • Random sequence generatedMet
  • Intention-to-treat analysisNot met
  • Adequate statistical powerMet
  • Prospective registrationMet

Not reported does not mean not done. Checks have different weights; this is not a count of boxes ticked.

See the full score breakdown
Study design starting point
59.5
Random sequence generation
+2.5
Compared against an accepted alternative
+1.7
Blinded outcome assessment
+6.8
Per-protocol analysis only
−6
0% crossover
+1.7
9% loss to follow-up
−1
Adequately powered
+6
Prospectively registered
+5.1
No correction for multiple comparisons
−3.4
A positive result from only 32 patients
−6.8
A positive result from a single centre
−4.3
Final rigour score rounded
62 / 100

Study design sets the starting point and a ceiling of 96. Recorded methods then adjust the score. Points are shown to one decimal place; the final score uses unrounded values.

Checklist from the stored appraisal. “Not met” describes the recorded criterion; it does not always produce a deduction. This overview supports reading the full study.

For journal club

1.If a patient remains symptomatic with CRPS-I pain (VAS ≥5) after IV neridronate, would you now add a home PEMF device to their rehabilitation plan, and how would you counsel them about the strength of the evidence?

2.Given that oedema and NSAID use did not differ significantly between groups, would you use PEMF specifically to target pain and allodynia rather than as a broad anti-inflammatory therapy?

Original publication title

Pulsed electromagnetic fields (PEMFs) in complex regional pain syndrome type I (CRPS-I) of the foot: a randomised controlled trial

Read original paper