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

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.

• Change in Neck Disability Index [Срок оценки: Baseline to immediately after the session (same visit)]