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

NCT ID: NCT07203040

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2025-11-30

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.

Detailed Description

Background and Rationale. Therapeutic ultrasound is commonly used to manage musculoskeletal pain and stiffness, yet immediate, objective effects on cervical muscle stiffness are not well established. This trial evaluates whether a single session of continuous ultrasound produces a greater immediate reduction in passive cervical muscle stiffness and pain than a sham procedure.

Study Design. Single-session, parallel-group, randomized, sham-controlled clinical trial (1:1). Masking: participants and outcomes assessor (double-blind). Primary purpose: treatment. Setting: outpatient physiotherapy clinics at Erzurum (university/affiliated hospital).

Participants. Adults 18-50 years with neck pain and baseline pain ≥3/10 on a 0-10 scale. Key exclusions include neurological signs suggesting radiculopathy, pregnancy, pacemaker, open skin lesions/infection at the treatment area, and invasive neck treatment within the past 6 weeks.

Interventions.

Active ultrasound: Continuous therapeutic ultrasound applied to painful/stiff cervical musculature (e.g., upper trapezius and suboccipital/cervical extensors) for ~10 minutes. Frequency 1-3 MHz; intensity 1.0-1.5 W/cm² (adjusted to tolerance); slow, overlapping circular probe movement with standard coupling gel.

Sham ultrasound: Identical device appearance, probe movement, contact time, and instructions, but no acoustic output.

Outcomes and Timing.

Primary outcome: Change in passive muscle stiffness (N/m) measured with a handheld myotonometer at predefined points (e.g., sternocleidomastoid, upper/middle/lower trapezius, cervical extensors), averaged over three taps per site.

Secondary outcomes: Pain intensity (0-10) and Neck Disability Index (0-50). All measures are collected immediately before and immediately after the single treatment session during the same clinic visit.

Randomization and Allocation Concealment. A computer-generated sequence with variable block sizes will assign participants 1:1 to active or sham. Group assignments are concealed in sequentially numbered, opaque envelopes (or via a secure electronic system) opened immediately before treatment by a therapist not involved in outcome assessment.

Blinding. Participants are informed that two forms of ultrasound are being compared. The outcomes assessor is blinded to allocation. Therapists delivering the intervention do not perform outcome measurements.

Sample Size. The target sample is 24 participants (12 per group), which is feasible for a single-session, mechanistic trial and expected to detect a moderate to large between-group difference in immediate stiffness change for planning larger studies.

Statistical Analysis. Analyses will follow the intention-to-treat principle. The primary analysis compares pre-to-post change in stiffness between groups using an analysis of covariance (ANCOVA) with baseline stiffness as a covariate. Secondary outcomes are analyzed similarly. Effect sizes and 95% confidence intervals will be reported. Missing post values (if any) will be handled with appropriate single-visit imputation (e.g., baseline-carried-forward sensitivity analysis).

Safety Monitoring. Ultrasound settings follow standard safety guidelines. Expected minor, transient events include warmth or mild skin redness. Adverse events are recorded throughout the visit; any unexpected event stops the session and triggers medical review.

Data Management. Paper/electronic case report forms are stored in locked/secured systems; records are coded with unique IDs. Only authorized personnel have access. Data are retained per institutional policy.

Participant Timeline. Screening and consent → baseline assessments → randomization → one treatment session (~10 minutes) → immediate post-treatment assessments → discharge and adverse-event check.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Therapeutic Ultrasound (Active)

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

Group Type: EXPERIMENTAL

Therapeutic Ultrasound

Intervention Type: 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

Sham Ultrasound

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

Group Type: SHAM_COMPARATOR

Sham Ultrasound

Intervention Type: DEVICE

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

Interventions

Therapeutic Ultrasound

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

Intervention Type: DEVICE

Sham Ultrasound

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

Amasya University

OTHER

Sponsor Role: collaborator

Bangor University

OTHER

Sponsor Role: collaborator

Erzurum Technical University

OTHER

Sponsor Role: lead

Responsible Party

esedullah akaras

Assistant Professor & Principal Investigator; Department of Physiotherapy and Rehabilitation, Erzurum Technical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erzurum Technical University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ETU-EC-2025/123

Identifier Type: -

Identifier Source: org_study_id