An open-label pilot study of pulsed electromagnetic field therapy in the treatment of failed back surgery syndrome pain.

International medical case reports journal · 2015 · Mixed · Very low evidence

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MixedVery low evidencePaper 3058

Study snapshot

PublicationInternational medical case reports journal · 2015

Study typeother

Reported directionMixed

Evidence ratingVery low

Abstract

Persistent pain following back surgery remains a major treatment challenge. The primary objective of this open-label exploratory study was to investigate the analgesic effectiveness of pulsed electromagnetic field therapy administered twice daily over a 45-day period in 34 subjects (68% female) with persistent or recurrent pain following back surgery. A secondary goal was to guide the design of future randomized controlled trials that could target responsive subpopulations. All predefined primary and secondary outcomes, including change in pain intensity (PI), physical function (Oswestry Disability Index), analgesic consumption, and overall well-being (Patient Global Impression of Change), are reported. A responder analysis (≥30% reduction in PI versus baseline) was added as a post hoc evaluation. Safety outcomes, as well as results of a cost-avoidance survey, are also summarized. Of the 30 per-protocol subjects who completed the study, 33% reported a clinically meaningful (≥30%) reduction in PI. A higher response rate (60%) was reported for subjects who had undergone discectomy prior to the trial compared to subjects who had undergone other types of surgical interventions (decompression or fusion) without discectomy. Improvements in PI were paralleled by improvements in secondary outcomes. Relative to baseline, responders reported an average 44% and 55% reduction in back PI and leg PI (respectively), and an average 13% improvement in Oswestry Disability Index scores. In the per-protocol population, 50% of responders and 12% of nonresponders reported less analgesia consumption at the end of treatment versus baseline. Sixty-seven percent of per-protocol responders and 0% of nonresponders reported clinically meaningful improvement in overall well-being on the Patient Global Impression of Change scale.

Machine Enhanced Logic

AI evidence extraction

Structured fields below were generated from the paper’s abstract and metadata to make the evidence easier to inspect. Automated extraction may be incomplete or incorrect; verify important details against the original paper.

Study typeother

Effect directionmixed

PopulationSubjects with persistent or recurrent pain following back surgery (failed back surgery syndrome pain)

Sample size34

Exposuretwice daily over a 45-day period

Evidence strengthVery lowConfidence: 74% · Peer reviewed: yes

Main findings

In the per-protocol group (n=30), 33% reported a clinically meaningful (≥30%) reduction in pain intensity versus baseline after 45 days of twice-daily pulsed electromagnetic field therapy. Improvements in pain intensity were reported alongside improvements in secondary outcomes, with higher response among participants with prior discectomy (60%) compared with other surgical interventions (decompression or fusion) without discectomy.

Outcomes measured

Pain intensity (PI)
Physical function (Oswestry Disability Index)
Analgesic consumption
Overall well-being (Patient Global Impression of Change)
Safety outcomes
Cost-avoidance survey

Limitations

Open-label exploratory design
No control/sham group described
Responder analysis was added post hoc
Per-protocol analysis (only completers reported for main results)
Small sample size

View raw extracted JSON

{
  "study_type": "other",
  "exposure": {
    "band": null,
    "source": "pulsed electromagnetic field therapy",
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": "twice daily over a 45-day period"
  },
  "population": "Subjects with persistent or recurrent pain following back surgery (failed back surgery syndrome pain)",
  "sample_size": 34,
  "outcomes": [
    "Pain intensity (PI)",
    "Physical function (Oswestry Disability Index)",
    "Analgesic consumption",
    "Overall well-being (Patient Global Impression of Change)",
    "Safety outcomes",
    "Cost-avoidance survey"
  ],
  "main_findings": "In the per-protocol group (n=30), 33% reported a clinically meaningful (≥30%) reduction in pain intensity versus baseline after 45 days of twice-daily pulsed electromagnetic field therapy. Improvements in pain intensity were reported alongside improvements in secondary outcomes, with higher response among participants with prior discectomy (60%) compared with other surgical interventions (decompression or fusion) without discectomy.",
  "effect_direction": "mixed",
  "limitations": [
    "Open-label exploratory design",
    "No control/sham group described",
    "Responder analysis was added post hoc",
    "Per-protocol analysis (only completers reported for main results)",
    "Small sample size"
  ],
  "evidence_strength": "very_low",
  "confidence": 0.74,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "pulsed electromagnetic field therapy",
    "PEMF",
    "failed back surgery syndrome",
    "persistent pain",
    "analgesic consumption",
    "Oswestry Disability Index",
    "Patient Global Impression of Change",
    "open-label",
    "pilot study"
  ],
  "suggested_hubs": []
}

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AI-extracted fields are generated from the abstract and metadata and may be incomplete or incorrect. This material is for informational purposes and is not medical advice.

Identifiers and source

DOI: 10.2147/imcrj.s73068
PubMed: 25678825

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