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Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain

NCT07535047 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-16

No results posted yet for this study

Summary

The primary goal of this clinical trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT), considering recruitment, compliance with study protocols, and adverse events. The secondary goal is to evaluate the effectiveness of a video-based educational explanation of transcutaneous electrical nerve stimulation (TENS) in eliciting placebo-induced hypoalgesia and improving clinical outcomes in patients with acute low back pain.

The main question it aims to answer is: Does the addition of a video-based educational explanation of TENS to standard physical therapy rehabilitation, consisting of TENS and exercises, increase the pressure pain threshold, reduce pain intensity, and improve functional mobility, patient satisfaction, and quality of life in patients with acute low back pain?

Participants will be divided into two groups for comparison: the control group will receive standard physical therapy rehabilitation consisting of TENS and exercises, while the experimental group will receive the same program in addition to the video-based educational explanation of TENS.

Conditions

  • Low Back Pain (LBP)
  • Low Back Pain

Interventions

DEVICE

TENS

12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .

BEHAVIORAL

TENS educational explanation video

The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory

OTHER

Exercise

Participants will be provided with a home program consisting of exercises targeting trunk core activation, spinal mobility, and functional movement, as approved by the American Physical Therapy Association (APTA).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed El Melhat, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-05
Primary Completion
2026-08-20
Completion
2026-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535047 on ClinicalTrials.gov