Low Back Pain, Low Back Pain (LBP)
Conditions
Keywords
TENS, Transcutaneous Electrical Nerve Stimulation, Placebo, Hypolagesia
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.
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.
Interventions
DEVICETENS
12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
BEHAVIORALTENS educational explanation video
The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
OTHERExercise
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).
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility assessed using a structured feasibility questionnaire | 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. |
| Success rate of obtaining consent from those eligible participants | During the enrolment process | Number of participants enrolled/randomised |
| Retention rate of the participants | 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. |
| Adherence of the participants | 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
| Measure | Time frame | Description |
|---|---|---|
| Pressure Pain Threshold measured using a pressure algometer | 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. |
| Pain intensity measured using the Visual Analogue Scale (VAS) | 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. |
| Functional disability measured using the Oswestry Disability Index (ODI) | 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. |
| Participant satisfaction measured using the Visual Analogue Scale (VAS) | 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. |
| 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. | 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. |
Countries
Egypt
Contacts
CONTACTAhmed El Melhat, PhD
CONTACTSara Ahmad Manasfi, BSc
STUDY_DIRECTORAhmed El Melhat, PhD
Cairo University
Outcome results
None listed