Acute Effects of Therapeutic Ultrasound on Passive Muscle Stiffness and Pain in Patients With Neck Pain

NCT07203040 | Enrolling By Invitation

• 1 other identifier: ETU-EC-2025/123
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether one session of therapeutic ultrasound can immediately reduce muscle stiffness and pain in adults with neck pain. Participants aged 18-50 years who report neck pain of at least 3 out of 10 will be randomly assigned to one of two groups: (1) active ultrasound or (2) sham ultrasound. Both groups will receive the same 10-minute procedure with the probe moved slowly over the painful neck muscles; however, the sham device will not deliver ultrasound energy. Before and right after the session, we will measure passive muscle stiffness at standard points on the neck and shoulder muscles using a handheld device and will record pain intensity on a 0-10 scale. We will also record the Neck Disability Index on the same day. The main question is whether active ultrasound produces a larger immediate decrease in muscle stiffness than sham. We will also examine changes in pain and neck function. The session is performed by trained physiotherapists in a clinic setting. Potential risks are minimal (such as temporary warmth or mild skin redness). There is no cost to participate. Results may help guide safe, non-drug treatment options for neck pain.

Conditions

Neck Pain

Keywords

Neck Pain; Therapeutic Ultrasound; Muscle Stiffness; Myotonometry

Outcome Measures

Primary Outcomes (1)

• Change in passive cervical muscle stiffness

  Dynamic stiffness (N/m) recorded with a handheld myotonometer at predefined points (sternocleidomastoid; upper/middle/lower trapezius; cervical extensors). Each site measured 3 taps and averaged; the limb-side with greater baseline pain is prioritized. Higher values indicate greater stiffness. Primary analysis compares between-group difference in change scores, adjusted for baseline.

  Baseline (pre-treatment) to immediately after the single 20-minute session (same visit)

Secondary Outcomes (1)

• Change in Neck Disability Index

  Baseline to immediately after the session (same visit)

Study Arms (2)

Therapeutic Ultrasound (Active)

EXPERIMENTAL

Single session of continuous therapeutic ultrasound applied to painful/stiff cervical musculature (e.g., upper trapezius and suboccipital/cervical extensors) during one clinic visit.

Device: Therapeutic Ultrasound

Sham Ultrasound

SHAM COMPARATOR

Single session mimicking the active procedure (identical probe movement, contact time, and instructions) but without acoustic output.

Device: Sham Ultrasound

Interventions

Therapeutic Ultrasound DEVICE

Continuous ultrasound applied to painful/stiff cervical muscles during a single clinic visit; frequency 1-3 MHz, intensity 1.0-1.5 W/cm²

Therapeutic Ultrasound (Active)

Sham Ultrasound DEVICE

Single session mimicking active procedure; device displays appear normal but acoustic output is 0 W/cm²; \~10 minutes;

Sham Ultrasound

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 with baseline intensity ≥ 3/10 on a 0-10 scale
• Able to understand the study procedures and provide written informed consent
• No invasive neck treatment within the past 6 weeks

You may not qualify if:

• Neurological signs suggesting cervical radiculopathy or serious spinal pathology
• Open wounds, infection, or severe skin disease at the treatment area
• Pregnancy or implanted pacemaker
• Acute cervical trauma or fracture history
• Use of other neck-targeted physical therapies or analgesic procedures on the day of assessment
• Any condition judged by the investigators to interfere with safe ultrasound application or outcome measurements

Sponsors & Collaborators

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

Study Sites (1)

Erzurum Technical University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sham ultrasound matches probe movement and duration; device shows normal indicators but delivers no acoustic output. Outcome measurements are performed by a blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Principal Investigator; Department of Physiotherapy and Rehabilitation, Erzurum Technical University

Model Details: Single-session, parallel-group, randomized, sham-controlled interventional mode

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 25, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

TU (1)