Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
TENS in LBP
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2026
CompletedStudy Start
First participant enrolled
April 5, 2026
CompletedFirst Posted
Study publicly available on registry
April 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
April 16, 2026
April 1, 2026
5 months
April 2, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
Secondary Outcomes (5)
Pressure Pain Threshold measured using a pressure algometer
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Pain intensity measured using the Visual Analogue Scale (VAS)
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Functional disability measured using the Oswestry Disability Index (ODI)
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Participant satisfaction measured using the Visual Analogue Scale (VAS)
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)
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Study Arms (2)
Experimental: TENS + Educational Video + Exercise Program
EXPERIMENTALParticipants 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 COMPARATORParticipants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program.
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).
Eligibility Criteria
You may qualify if:
- acute low back pain without radicular pain to lower limbs
- minimal pain level of 4 on the 0-10 VAS
- years of age
- TENS naïve or have not used TENS in the past 5 years.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University Hospitals
Giza, Giza Governorate, 2356, Egypt
Related Publications (4)
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.
PMID: 41106172BACKGROUNDMeeuwis 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.
PMID: 37326688BACKGROUNDRuzic 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.
PMID: 28850443BACKGROUNDPeerdeman 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.
PMID: 26945235BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed El Melhat, PhD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of MSK Physical Therapy, BAU and Cairo university
Study Record Dates
First Submitted
April 2, 2026
First Posted
April 16, 2026
Study Start
April 5, 2026
Primary Completion (Estimated)
August 20, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share