Placebo-Induced Hypoalgesia During TENS Application in Low Back Pain
Summary
NIH's ClinicalTrials.gov registered a randomized controlled trial (NCT07535047) evaluating transcutaneous electrical nerve stimulation (TENS) combined with video-based education for acute low back pain. The study will enroll participants divided into control group (standard physical therapy with TENS and exercises) and experimental group (standard therapy plus video-based TENS educational explanation). The primary outcome measures are feasibility of conducting the full RCT, including recruitment, compliance, and adverse events. Secondary outcomes include pressure pain threshold, pain intensity, functional mobility, patient satisfaction, and quality of life.
What changed
NIH registered a new clinical trial (NCT07535047) on ClinicalTrials.gov investigating whether adding a video-based educational explanation of transcutaneous electrical nerve stimulation (TENS) to standard physical therapy improves outcomes in acute low back pain patients. The study uses a randomized controlled design with two arms: control receiving TENS with exercises and experimental group receiving the same plus video education. Participants will be followed through April 2026.
For healthcare providers and clinical investigators, this registration signals a forthcoming evidence base on placebo mechanisms in TENS therapy and potential benefits of patient education in pain management. Medical device manufacturers producing TENS units should monitor results for implications on product labeling and educational materials.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
N/A NCT07535047 Kind: NA Apr 16, 2026
Abstract
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.
Conditions: Low Back Pain (LBP), Low Back Pain
Interventions: TENS, TENS educational explanation video, Exercise
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