Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Pain modulation through expectation is a well-established phenomenon. Anticipating relief from a treatment can enhance the effects of both pharmacological and non-pharmacological analgesic interventions. The expectation of pain relief can reduce the perceived intensity of stimuli and is associated with changes in brain regions involved in pain processing, including the thalamus, prefrontal cortex, and somatosensory cortices. Previous research suggests that expectation can have a moderate to large effect on experimental and acute procedural pain.
Based on this, the investigators hypothesize that adding a video-based educational explanation of TENS to a standard physical therapy rehabilitation program will enhance patient expectations regarding the intervention. This may elicit placebo-induced hypoalgesia and improve clinical outcomes in patients with acute low back pain.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: TENS + Educational Video + Exercise Program | Experimental | Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program and will also view an educational video explaining TENS. |
|
| Active Comparator: TENS + Exercise Program | Active Comparator | Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | 12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility assessed using a structured feasibility questionnaire | Feasibility will be evaluated using a structured questionnaire designed to assess the practicality of conducting a future randomized controlled trial (RCT), including aspects such as recruitment, adherence, and data collection. Responses will be summarized descriptively. | Baseline (Day 1) and 4 weeks post-treatment. |
| Success rate of obtaining consent from those eligible participants | Number of participants enrolled/randomised | During the enrolment process |
| Retention rate of the participants | Retention rate is defined as proportion of people that finished the programme after 4 weeks. Retention data will be assessed based on (i) proportion of participants with complete outcome assessment; (ii) number of discontinuation and reasons. | Recorded at week 4 at the end of delivering the intervention. |
| Adherence of the participants | Adherence is defined as the number and proportion of scheduled sessions undertaken by the participants. | Recorded at week 4 at the end of delivering the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Pain Threshold measured using a pressure algometer | Pressure Algometer Device used to assess pain threshold with scores measured with kg/cm², with higher scores indicating greater tolerance to pressure-induced pain. | Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up. |
| Pain intensity measured using the Visual Analogue Scale (VAS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed El Melhat, PhD | Contact | +20 11 12595022 | ahmed.elmelhat@cu.edu.lb | |
| Sara Ahmad Manasfi, BSc | Contact | +961 76806944 | sarahms611998@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed El Melhat, PhD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Recruiting | Giza | Giza Governorate | 2356 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41106172 | Background | Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Dyrda A, Bialosky J, Rossettini G. Can pre-treatment verbal suggestions influence the short-term effects of spinal manipulation in young adults with chronic non-specific low back pain? A randomized controlled trial. Musculoskelet Sci Pract. 2025 Nov;80:103431. doi: 10.1016/j.msksp.2025.103431. Epub 2025 Oct 10. | |
| 37326688 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| TENS educational explanation video | Behavioral | The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory |
|
| Exercise | Other | 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). |
|
A Single-item pain scale to assess pain intensity at rest and during movement before and after intervention (at 3 time points).Scores range from 0 (no pain) to 10 (maximum pain).Higher scores indicate greater pain intensity. |
| Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up. |
| Functional disability measured using the Oswestry Disability Index (ODI) | Functional disability related to low back pain was assessed using the Oswestry Disability Index (ODI), a self-reported questionnaire scored from 0 to 100. Higher scores indicate greater disability, with 0 representing no disability and 100 representing maximum disability. | Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up. |
| Participant satisfaction measured using the Visual Analogue Scale (VAS) | Participant satisfaction will be assessed using a Visual Analogue Scale (VAS). Scores range from 0 (not satisfied at all) to 10 (completely satisfied), with higher scores indicating greater satisfaction with the intervention. | Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up. |
| Health-related quality of life measured using the 36-Item Short Form Survey (SF-36) | Health-related quality of life was assessed using the 36-Item Short Form Survey (SF-36), which evaluates eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health status and functioning. | Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up. |
| Meeuwis SH, Wasylewski MT, Bajcar EA, Bieniek H, Adamczyk WM, Honcharova S, Di Nardo M, Mazzoni G, Babel P. Learning pain from others: a systematic review and meta-analysis of studies on placebo hypoalgesia and nocebo hyperalgesia induced by observational learning. Pain. 2023 Nov 1;164(11):2383-2396. doi: 10.1097/j.pain.0000000000002943. Epub 2023 Jun 15. |
| 28850443 | Background | Ruzic V, Ivanec D, Stanke KM. Effect of expectation on pain assessment of lower- and higher-intensity stimuli. Scand J Pain. 2017 Jan;14:9-14. doi: 10.1016/j.sjpain.2016.09.013. Epub 2016 Oct 27. |
| 26945235 | Background | Peerdeman KJ, van Laarhoven AIM, Keij SM, Vase L, Rovers MM, Peters ML, Evers AWM. Relieving patients' pain with expectation interventions: a meta-analysis. Pain. 2016 Jun;157(6):1179-1191. doi: 10.1097/j.pain.0000000000000540. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |