NCT07535047 Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
| NCT ID | NCT07535047 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Low Back Pain (LBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-05 |
| Primary Completion | 2026-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-04-05 with a primary completion date of 2026-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Ahmed El Melhat, PhD
STUDY DIRECTOR
Cairo University
Frequently Asked Questions
Who can join the NCT07535047 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Low Back Pain (LBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07535047 currently recruiting?
Yes, NCT07535047 is actively recruiting participants. Contact the research team at ahmed.elmelhat@cu.edu.lb for enrollment information.
Where is the NCT07535047 trial being conducted?
This trial is being conducted at Giza, Egypt.
Who is sponsoring the NCT07535047 clinical trial?
NCT07535047 is sponsored by Cairo University. The principal investigator is Ahmed El Melhat, PhD at Cairo University. The trial plans to enroll 40 participants.