Acute Effects of TENS on Cervical Muscle Stiffness and Pain in Neck Pain

NCT07244861 | Enrolling By Invitation

• 2 other identifiers: ETU-TENS-NECK-RCT-02Erzurum Technical University
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial investigates the acute effects of transcutaneous electrical nerve stimulation (TENS) on passive cervical muscle stiffness (MyotonPro "dynamic stiffness", N/m) and pain (0-10 VAS) in adults with chronic/mechanical neck pain. Participants will be allocated 1:1 to TENS or control/sham. Outcomes are measured immediately before and immediately after a single 15-minute session.

Conditions

Neck Pain; Chronic Neck Pain; Muscle Stiffness; Transcutaneous Electrical Nerve Stimulation

Keywords

TENS; MyotonPro; VAS pain

Outcome Measures

Primary Outcomes (1)

• Change in upper trapezius dynamic stiffness

  Passive muscle dynamic stiffness (N/m) measured with MyotonPro at a standardized landmark on the upper trapezius (midpoint along the C7-acromion line; side = most symptomatic or bilateral mean).

  Pre-session (T0) and immediately post-session (T1; within 5 minutes of session end)

Secondary Outcomes (1)

• Change in pain intensity

  T0 and immediately post-session

Study Arms (2)

TENS

EXPERIMENTAL

Participants receive a single session of conventional TENS targeting painful/stiff cervical muscle regions (typically upper trapezius ± suboccipital) with immediate post-session assessments.

Device: Transcutaneous Electrical Nerve Stimulation; Device: Sham TENS

Sham TENS

SHAM COMPARATOR

Participants undergo a sham stimulation session with identical setup and timing to mimic TENS without delivering therapeutic current.

Device: Transcutaneous Electrical Nerve Stimulation; Device: Sham TENS

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

Conventional mode TENS, frequency \~80 Hz, pulse width ≤150 µs, duration 20 minutes. Intensity set to "strong but tolerable" without visible muscle contraction. Electrodes placed bilaterally over the most painful/stiff segments (e.g., upper trapezius midpoint along C7-acromion line; adjustments per comfort

Also known as: Conventional TENS; TENS therapy

Sham TENS; TENS

Sham TENS DEVICE

Electrodes applied at the same anatomical sites as the active arm. Device indicators remain on; intensity is ramped to perception briefly and then reduced to sub-sensory/zero so that no effective current is delivered for the remainder of the 20-minute session. Procedures and clinician-participant interactions mirror the active arm

Also known as: Placebo TENS

Sham TENS; TENS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years.
• Neck pain VAS ≥ 3/10 at screening and on test day.
• Clinical diagnosis of chronic or mechanical neck pain (≥6 weeks).
• Able to understand study procedures and provide written informed consent.
• Willing to refrain from analgesics/muscle relaxants and vigorous neck/shoulder exercise for 24 hours before testing.

You may not qualify if:

• Cervical radiculopathy or neurological signs (myotomal weakness, dermatomal sensory loss, reflex changes).
• Recent invasive procedures to the neck/shoulder (e.g., surgery, injections, radiofrequency/neurotomy) within 6 weeks.
• Pacemaker/implantable cardioverter, or other active implanted electronic device.
• Pregnancy or planning pregnancy.
• Skin conditions at electrode sites (open wounds, infection, severe dermatitis) or known allergy to electrode adhesive/gel.
• History of epilepsy or unexplained syncope.
• Acute neck trauma (\<6 weeks) or red flags (fracture, malignancy, infection, inflammatory rheumatic disease).
• Systemic disorders likely to affect outcomes (e.g., uncontrolled diabetes with neuropathy, severe cardiovascular disease, fibromyalgia with widespread pain).
• Ongoing electrotherapy to the neck region or botulinum toxin injections to cervical muscles within 3 months.
• Inability to comply with procedures (e.g., severe communication/cognitive impairment), or insufficient proficiency in Turkish to complete measures.

Sponsors & Collaborators

• Erzurum Technical University: lead
• Amasya University: collaborator
• Bangor University: collaborator
• Ataturk University: collaborator

Study Sites (1)

Erzurum Technical University Faculty of Health Sciences

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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 YAGİZ, Dr.

  Amasya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. Participants are not blinded when the comparator is "no intervention." If a sham TENS comparator is used, participants will also be blinded (double-blind: participant and outcomes assessor). Randomization is concealed using sequentially numbered, opaque, sealed envelopes (SNOSE); assessors do not have access to the allocation list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Two parallel arms with 1:1 allocation (TENS vs control/sham). Randomization is computer-generated with allocation concealment using sequentially numbered, opaque, sealed envelopes (SNOSE). Outcomes are assessed pre-session and immediately post-session in a single visit. Outcome assessors are blinded; participant blinding is applied if the sham TENS arm is used.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: September 23, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 15, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)