Immediate Effects of TENS on Lumbar Erector Spinae Stiffness in Low Back Pain (TENS-LUMBAR)

November 17, 2025 updated by: esedullah akaras, Erzurum Technical University

Immediate Effects of Transcutaneous Electrical Nerve Stimulation on the Lumbar Erector Spinae Muscles' Stiffness and Pain: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 18-30 years

Non-specific low back pain persisting or recurring for ≥3 months

Reported tenderness/stiffness on palpation of the lumbar erector spinae muscles

Able to understand the study procedures and provide written informed consent

Able to attend on the same day for TENS application and pre-/post-intervention measurements

Exclusion Criteria:

  • Low back pain with a specific cause (e.g. lumbar disc herniation with radiculopathy, infection, tumor, fracture, severe deformity)

Open wound, dermatitis, or any skin condition in the lumbar area that prevents electrode placement

Presence of a cardiac pacemaker or other implanted electronic device

Electrotherapy, injection, or manual therapy applied to the lumbar region within the previous 48 hours

Pregnancy

Severe neurological deficit or sensory loss

Use of analgesics/NSAIDs at a level that may interfere with pain or stiffness assessment at the time of evaluation

Any other condition deemed unsafe or inappropriate by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: TENS
Participants receive a single 30-minute session of conventional TENS applied bilaterally over the lumbar paraspinal (erector spinae) region. Pre- and post-intervention Myoton and VAS measurements are taken.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Conventional TENS; frequency 80-100 Hz, pulse width 100-150 μs, intensity adjusted to strong but comfortable sensory level without muscle contraction; total duration 20 minutes; electrodes placed bilaterally at lumbar erector spinae level.
Other Names:
  • Rest/Observation
Other: Control: Rest/Positioning
Participants are positioned in the same way and remain at rest for 20 minutes without active TENS. Pre- and post-intervention Myoton and VAS measurements are taken.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Conventional TENS; frequency 80-100 Hz, pulse width 100-150 μs, intensity adjusted to strong but comfortable sensory level without muscle contraction; total duration 20 minutes; electrodes placed bilaterally at lumbar erector spinae level.
Other Names:
  • Rest/Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lumbar erector spinae muscle stiffness
Time Frame: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Muscle stiffness of the lumbar erector spinae will be measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels. The outcome is the change score (post - pre) between TENS and control groups. Lower values indicate reduced stiffness.
Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Change in pain intensity (VAS)
Time Frame: Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst pain). The outcome is the change score (post - pre) to compare TENS and control groups. Lower scores indicate pain reduction.
Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzurum Technical University

Collaborators

Amasya University

Investigators

  • Principal Investigator: Gökhan YAĞIZ, Dr., Amasya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 25, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETU-TENS-LBP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study is small, single-center, and includes identifiable clinical measurements that could risk participant privacy despite de-identification.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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