Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain (TENS in LBP)

April 9, 2026 updated by: Ahmed ElMelhat, Cairo University

Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation in Acute Low Back Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Giza Governorate
      • Giza, Giza Governorate, Egypt, 2356
        • Recruiting
        • Cairo University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: TENS + Educational Video + Exercise Program
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.
Device: TENS
12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
Other Names:
  • Transcutaneous Electrical Nerve Stimulation
Behavioral: TENS educational explanation video
The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
Other: Exercise
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).
Active Comparator: Active Comparator: TENS + Exercise Program
Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program.
Device: TENS
12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
Other Names:
  • Transcutaneous Electrical Nerve Stimulation
Other: Exercise
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of obtaining consent from those eligible participants
Time Frame: During the enrolment process
Number of participants enrolled/randomised
During the enrolment process
Feasibility assessed using a structured feasibility questionnaire
Time Frame: Baseline (Day 1) and 4 weeks post-treatment.
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.
Retention rate of the participants
Time Frame: Recorded at week 4 at the end of delivering the intervention.
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
Time Frame: Recorded at week 4 at the end of delivering the intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold measured using a pressure algometer
Time Frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
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)
Time Frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
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)
Time Frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
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)
Time Frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
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)
Time Frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Ahmed El Melhat, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 5, 2026

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Placebo Induced Hypoalgesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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