TENS: 12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
TENS educational explanation video: The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
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).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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