Actively Recruiting
Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
Led by Cairo University · Updated on 2026-04-16
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute low back pain without radicular pain to lower limbs
- Pain level of at least 4 on a 0-10 scale
- Aged between 18 and 65 years
- No use of TENS in the past 5 years or TENS naive
You will not qualify if you...
- Radicular pain to lower limbs
- Serious spinal disorders such as fractures, tumors, or inflammatory arthritis
- Nerve root disorders confirmed by neurological tests
- Neurological diseases
- Severe cardiorespiratory disease
- Pregnancy
- Skin infection, lesions, or change in sensation at TENS application site
- Cancer
- Cardiac pacemaker
- Allergy to electrodes
- Use of opioids
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cairo University Hospitals
Giza, Giza Governorate, Egypt, 2356
Actively Recruiting
Research Team
A
Ahmed El Melhat, PhD
CONTACT
S
Sara Ahmad Manasfi, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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