Immediate Effects of TENS on Lumbar Erector Spinae Stiffness in Low Back Pain

NCT07242235 | Not Yet Recruiting

• 1 other identifier: ETU-TENS-LBP-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Non-specific Low Back Pain; Lumbar Muscle Stiffness

Keywords

TENS; Low Back Pain; Muscle Stiffness; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Change in lumbar erector spinae muscle stiffness

  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)

  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)

Study Arms (2)

Experimental: TENS

EXPERIMENTAL

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)

Control: Rest/Positioning

OTHER

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)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

Also known as: Rest/Observation

Control: Rest/Positioning; Experimental: TENS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzurum Technical University: lead
• Amasya University: collaborator

Study Sites (1)

Erzurum Technical University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Gökhan YAĞIZ, Dr.

  Amasya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esedullah AKARAS, Dr.

CONTACT

4445388; esedullah.akaras@erzurum.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor who performs Myoton and VAS measurements will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants will be randomized (1:1) to active TENS or control/rest; both groups are assessed pre- and immediately post-intervention

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 25, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)