Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation in Acute Low Back Pain
Cairo University
40 participants
Apr 5, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- acute low back pain without radicular pain to lower limbs
- minimal pain level of 4 on the 0-10 VAS
- -65 years of age
- TENS naïve or have not used TENS in the past 5 years.
Exclusion Criteria11
- 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.
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Interventions
12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
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).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07535047