Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
Recruiting now · Not applicable
Conditions studied: Low Back Pain (LBP), Low Back Pain
In brief
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 facts
- Study ID
- NCT07535047
- Run by
- Cairo University
- People needed
- 40
- Starts
- 2026-04-05
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- acute low back pain without radicular pain to lower limbs
- minimal pain level of 4 on the 0-10 VAS
- 18-65 years of age
- TENS naïve or have not used TENS in the past 5 years.
You may not qualify if…
- Radicular pain to lower limbs
- Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease
- Nerve root disorders confirmed by neurological tests
- Neurological diseases
- Severe cardiorespiratory disease
- Pregnancy
- Skin infection or lesions or change in sensation at the TENS application site
- Cancer
- Cardiac pacemaker
- Allergy to electrodes
- use of opioids.
Where it is running
- Cairo University Hospitals — Giza, Giza Governorate, Egypt (enrolling)
Full record on ClinicalTrials.gov
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