Clinical Trials Directory

Trials / Completed

CompletedNCT07263737

Pulsed Electromagnetic Field Therapy for Neuropathic Pain in Lumbar Disc Herniation

Effectiveness of Pulsed Electromagnetic Field Therapy on Neuropathic Pain and Disability in Patients With Lumbar Disc Herniation: A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Haydarpasa Numune Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This randomized controlled study evaluated whether adding pulsed electromagnetic field (PEMF) therapy to conventional physical therapy provides additional benefits for neuropathic pain and disability in patients with lumbar disc herniation (LDH). → This study randomly assigned patients into groups to compare treatments. It examined whether adding pulsed electromagnetic field (PEMF) therapy to standard physical therapy could give extra improvement in nerve-related pain and daily function in people with a slipped disc in the lower back. Fifty-two patients with ≥3 months of radicular and neuropathic symptoms were enrolled and randomly assigned to a treatment group (PEMF + conventional therapy) or a control group (sham PEMF + conventional therapy). → Fifty-two patients who had leg pain and nerve-related symptoms for at least three months joined the study. They were randomly placed into either a treatment group (which received PEMF plus regular therapy) or a control group (which received a fake PEMF treatment plus regular therapy). Both groups received transcutaneous electrical nerve stimulation, hot packs, and a lumbar exercise program for 15 sessions. → Both groups also received the same standard treatments: electrical nerve stimulation, hot packs, and a lower-back exercise program for 15 sessions. Clinical outcomes-including Visual Analog Scale (VAS), pressure pain threshold, Modified Schober test, DN4, PainDetect, Oswestry Disability Index (ODI), and SF-36-were assessed at baseline, post-treatment, and one month after treatment. → Several health measures were checked before treatment, right after treatment, and again one month later. These included pain level (VAS), how sensitive the area was to pressure, lower-back flexibility, nerve-pain questionnaires (DN4 and PainDetect), disability level (ODI), and overall quality of life (SF-36). Forty-six patients completed the study. → A total of 46 patients finished the study. Both groups showed significant improvements in VAS scores, neuropathic pain questionnaires (DN4, PainDetect), ODI, and several SF-36 subscales (physical functioning, role-physical, and pain), with additional improvements in emotional role and social functioning observed only in the PEMF group. → Both groups improved in many areas: pain levels, nerve-pain scores, disability, and some parts of quality of life (such as physical functioning, daily roles, and pain). Only the PEMF group showed extra improvement in emotional well-being and social activities. However, none of the between-group comparisons demonstrated significant differences. * However, when the two groups were compared to each other, there were no meaningful differences. No meaningful changes were found in lumbar flexibility or pressure pain thresholds in either group. → Neither group showed important changes in lower-back flexibility or in how much pressure they could tolerate on painful areas. In conclusion, adding PEMF therapy to conventional physical therapy did not provide additional benefit for neuropathic symptoms, radicular pain, disability, lumbar flexibility, pressure pain threshold, or quality of life in patients with LDH-related neuropathic pain. → In summary, adding PEMF therapy to regular physical therapy did not give extra benefits for nerve pain, leg pain, disability, back flexibility, sensitivity to pressure, or quality of life in people with nerve-related pain caused by a slipped disc.

Conditions

Interventions

TypeNameDescription
DEVICEPulsed electromagnetic field (PEMF)In our study, the device used for PEMA application was the BTL-4000 Smart. The PEMA waves applied to the treatment group were elongated square-wave signals with a frequency of 55.55 Hz and a magnetic flux density of 30 mT. A 60-cm solenoid applicator of the device was used. With this applicator, a 30-minute treatment was delivered to cover the lumbar region.
DEVICESham PEMFSham application with the same device

Timeline

Start date
2022-10-30
Primary completion
2023-07-15
Completion
2023-08-15
First posted
2025-12-04
Last updated
2026-02-18

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07263737. Inclusion in this directory is not an endorsement.