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

Sponsor
Cairo University
Study ID
NCT07535047
Status
Recruiting
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Conditions

  • Low Back Pain
  • Low Back Pain (LBP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • TENS — DEVICE
    12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
  • TENS educational explanation video — BEHAVIORAL
    The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
  • Exercise — OTHER
    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).

Study Details

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.

Key Dates

First listed
Apr 16, 2026
Start date
Apr 5, 2026
Status verified
Apr 2026
Primary completion
Aug 20, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: TENS + Educational Video + Exercise Program
    Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program and will also view an educational video explaining TENS.
  • Active Comparator: Active Comparator: TENS + Exercise Program
    Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program.

Primary Outcome Measure

Feasibility assessed using a structured feasibility questionnaire [ Time Frame: Baseline (Day 1) and 4 weeks post-treatment. ]

Central Contacts

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