Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-04 @ 4:55 AM
Study NCT ID:
NCT07242235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Effects of TENS on Lumbar Erector Spinae Stiffness in Low Back Pain
Sponsor:
Erzurum Technical University
Organization:
Study Overview
Official Title:
Immediate Effects of Transcutaneous Electrical Nerve Stimulation on the Lumbar Erector Spinae Muscles' Stiffness and Pain: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENS-LUMBAR
Brief Summary:
Low back pain is frequently associated with increased tone and stiffness of the lumbar erector spinae muscles, which may contribute to pain and functional limitation. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, safe, and widely used modality for pain reduction, but its very short-term (immediate) effects on lumbar muscle stiffness have not been clearly demonstrated. This randomized controlled trial will compare a single 20-minute session of conventional TENS with a control/rest condition in patients with non-specific low back pain. The primary outcomes will be change in lumbar erector spinae muscle stiffness (Myoton) and change in pain intensity (VAS) from baseline to immediately after the intervention. We hypothesize that TENS will produce a greater immediate reduction in muscle stiffness and pain than control.
Detailed Description:
Low back pain (LBP) is one of the most common musculoskeletal problems and often presents with increased paraspinal muscle activity and perceived stiffness around the lumbar region. Increased stiffness of the lumbar erector spinae may perpetuate pain and restrict movement. TENS provides afferent stimulation that can modulate pain through gate-control and descending inhibitory mechanisms and may secondarily reduce muscle tone. However, evidence about its acute influence on objective muscle stiffness parameters in LBP is limited.
This single-center, parallel-group, randomized controlled trial will recruit adults with chronic or recurrent non-specific low back pain who meet the eligibility criteria. Participants will be randomly assigned (1:1) to (1) an experimental group receiving conventional TENS applied bilaterally over the lumbar paraspinal area for 20 minutes (frequency \~80-100 Hz, pulse width \~100-150 μs), or (2) a control group undergoing the same positioning and timing without active TENS. All assessments will be performed immediately before and immediately after the intervention by an outcome assessor blinded to group allocation.
Primary outcomes are: (a) lumbar erector spinae muscle stiffness measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels, and (b) pain intensity measured with a 10-cm visual analog scale (VAS). Secondary observations may include participant-reported comfort/tolerance of TENS and adverse events. The study is designed as a short-term physiological and symptomatic trial; no long-term follow-up is planned. Ethical approval was obtained from the Erzurum Technical University Ethics Committee (Meeting 13, Decision 04, 18.09.2025)
This single-center, parallel-group, randomized controlled trial will recruit adults with chronic or recurrent non-specific low back pain who meet the eligibility criteria. Participants will be randomly assigned (1:1) to (1) an experimental group receiving conventional TENS applied bilaterally over the lumbar paraspinal area for 20 minutes (frequency \~80-100 Hz, pulse width \~100-150 μs), or (2) a control group undergoing the same positioning and timing without active TENS. All assessments will be performed immediately before and immediately after the intervention by an outcome assessor blinded to group allocation.
Primary outcomes are: (a) lumbar erector spinae muscle stiffness measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels, and (b) pain intensity measured with a 10-cm visual analog scale (VAS). Secondary observations may include participant-reported comfort/tolerance of TENS and adverse events. The study is designed as a short-term physiological and symptomatic trial; no long-term follow-up is planned. Ethical approval was obtained from the Erzurum Technical University Ethics Committee (Meeting 13, Decision 04, 18.09.2025)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: