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NCT Number: NCT07535047

Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in 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.

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Key information

Conditions

Low Back Pain (LBP) Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Giza, Giza Governorate, 2356, Egypt

Location status: Recruiting

Location contact

Ahmed El Melhat, PhD

CONTACT

[email protected]

01112595022

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS

Device

12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .

Other names: Transcutaneous Electrical Nerve Stimulation

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).

Primary outcomes

  1. 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.

  2. Success rate of obtaining consent from those eligible participants

    Time frame: During the enrolment process

    Number of participants enrolled/randomised

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed El Melhat, PhD

CONTACT

[email protected]

+20 11 12595022

Sara Ahmad Manasfi, BSc

CONTACT

[email protected]

+961 76806944

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: TENS in LBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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