Educational video to boost TENS pain relief during exercises for acute low back pain
Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation in Acute Low Back Pain
This trial tries to see if adding a short educational video about how TENS works to standard TENS plus exercise helps adults with acute low back pain have less pain and better movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza, Giza Governorate) |
| Trial ID | NCT07535047 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled feasibility trial at Cairo University compares standard physical therapy (TENS plus exercises) with the same program plus a brief video-based educational explanation about TENS to strengthen expectations. The primary aim is to test feasibility outcomes such as recruitment, adherence to protocol, and adverse events, while secondary outcomes examine pressure pain threshold, pain intensity, functional mobility, patient satisfaction, and quality of life. Eligible participants are adults aged 18–65 with acute non-radicular low back pain and a baseline pain score of at least 4/10 who are TENS‑naive or have not used TENS in the past five years. Treatments and outcome assessments are delivered in person at Cairo University Hospitals, with participants randomly assigned to one of the two groups.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with acute non-radicular low back pain of at least 4/10 who are TENS‑naive (or haven't used TENS in five years) and do not have serious spinal disease, neurological disorders, implanted pacemakers, pregnancy, active skin lesions at the electrode site, cancer, or opioid use.
Not a fit: Patients with radicular leg pain, chronic or complex spinal disorders, implanted cardiac devices, active skin infection or sensory changes at the TENS site, pregnancy, current opioid use, or other excluded comorbidities are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the video could amplify expectation-driven pain relief and produce greater reductions in pain and improved function using the same TENS-plus-exercise program.
How similar studies have performed: Prior research shows that expectation can produce moderate-to-large placebo effects on experimental and acute pain, but applying a video-based educational explanation specifically to elicit placebo-induced hypoalgesia with TENS in clinical low back pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Giza, Giza Governorate
- Cairo University Hospitals — Giza, Giza Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed El Melhat, PhD
- Email: ahmed.elmelhat@cu.edu.lb
- Phone: +20 11 12595022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.