Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TENS
Device12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
TENS educational explanation video
BehavioralThe video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
Exercise
Other interventionParticipants 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).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental: TENS + Educational Video + Exercise ProgramExperimental treatment 3 interventions
Group B: Active Comparator: TENS + Exercise ProgramActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 1) and 4 weeks post-treatment.2
Success rate of obtaining consent from those eligible participants
Number of participants enrolled/randomised
Time frame
During the enrolment process3
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.
Time frame
Recorded at week 4 at the end of delivering the intervention.4
Adherence of the participants
Adherence is defined as the number and proportion of scheduled sessions undertaken by the participants.
Time frame
Recorded at week 4 at the end of delivering the intervention.Secondary outcomes
1
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.
Time frame
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.2
Pain intensity measured using the Visual Analogue Scale (VAS)
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.
Time frame
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.3
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.
Time frame
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.4
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.
Time frame
Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.Sponsors and contacts
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Source ClinicalTrials.gov