NCT07662772

Brief Summary

Rotator cuff-related shoulder pain (RCRSP) is one of the most common musculoskeletal disorders affecting the shoulder and is frequently associated with pain, reduced muscle strength, and impaired upper extremity function. Although previous studies have primarily focused on structural and functional changes around the shoulder, little is known about the potential adaptations occurring in the distal upper extremity, particularly the forearm muscles and tendons. Altered upper extremity use, pain-related muscle inhibition, and compensatory movement patterns associated with prolonged shoulder pain may lead to morphological changes in the forearm musculature and tendons. However, the relationship between symptom duration and these structural adaptations has not yet been investigated. The aim of this cross-sectional study is to evaluate forearm muscle and tendon thickness using portable ultrasonography in individuals with RCRSP and to investigate whether these parameters differ according to symptom duration. In addition, hand grip strength, pain intensity, and upper extremity function will be assessed to explore their associations with ultrasonographic findings. The findings of this study are expected to provide new insights into distal upper extremity adaptations associated with RCRSP and may contribute to the development of more comprehensive rehabilitation strategies that address not only the shoulder but also the forearm musculature.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

July 18, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2026

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Forearm Muscle and Tendon Thickness

    Forearm muscle and tendon thickness will be measured using portable B-mode ultrasonography. Measurements will be obtained from standardized anatomical landmarks with participants in a standardized position. The thickness (mm) of selected forearm flexor and extensor muscles and tendons will be recorded and compared between healthy controls and participants with rotator cuff-related shoulder pain according to symptom duration.

    Baseline (single assessment)

Secondary Outcomes (5)

  • Hand Grip Strength

    Baseline (single assessment)

  • Upper Extremity Function

    Baseline (single assessment)

  • Shoulder Pain Intensity

    Baseline (single assessment)

  • Symptom Duration

    Baseline

  • Shoulder Proprioception

    Baseline

Study Arms (3)

Healthy Controls

Healthy individuals without shoulder pain or a history of shoulder pathology, matched to the patient groups by age and sex where possible.

Short-Duration RCRSP

Participants diagnosed with rotator cuff-related shoulder pain with symptom duration of less than 6 months.

Long-Duration RCRSP

Participants diagnosed with rotator cuff-related shoulder pain with symptom duration of 6 months or longer.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\### Study Population Description The study population will consist of adult individuals aged 18-65 years, including both patients with rotator cuff-related shoulder pain (RCRSP) and healthy control participants. Participants with RCRSP will be recruited based on clinical diagnosis confirmed by physical examination and positive clinical tests consistent with rotator cuff-related shoulder pain. Healthy controls will be recruited from the community and hospital staff and will have no history of shoulder pain or upper extremity musculoskeletal disorders. Patients with RCRSP will be further categorized according to symptom duration into subgroups for comparative analysis. All participants will undergo a single assessment session including ultrasonographic evaluation of forearm muscle and tendon thickness, hand grip strength measurement, and standardized functional and pain assessments. Participants will be recruited from outpatient physiotherapy and orthopedic clinics of the participatin

You may qualify if:

  • RCRSP Group Adults aged 18-65 years. Clinical diagnosis of rotator cuff-related shoulder pain (RCRSP). Unilateral shoulder pain lasting at least 6 weeks. Pain localized around the anterolateral shoulder, aggravated by arm elevation and/or overhead activities.
  • Positive findings on at least three clinical tests suggestive of RCRSP (e.g., painful arc, Hawkins-Kennedy test, Neer test, Jobe/Empty Can test, resisted external rotation).
  • Ability to understand the study procedures and provide written informed consent.
  • Healthy Control Group Adults aged 18-65 years. No current shoulder pain. No history of shoulder pain, shoulder surgery, or upper extremity musculoskeletal disorders during the previous 12 months.
  • Ability to provide written informed consent.

You may not qualify if:

  • Previous shoulder surgery on either upper extremity. History of shoulder fracture, shoulder dislocation, or major upper extremity trauma.
  • Full-thickness rotator cuff tear or other shoulder pathology requiring surgical management.
  • Clinical signs of adhesive capsulitis. Cervical radiculopathy or other neurological disorders affecting the upper extremity.
  • Systemic inflammatory, rheumatologic, or neuromuscular diseases. Peripheral nerve entrapment (e.g., carpal tunnel syndrome, cubital tunnel syndrome).
  • Previous surgery or significant injury involving the forearm, wrist, or hand. Corticosteroid injection into the affected shoulder within the previous 3 months.
  • Current pregnancy. Inability to complete study assessments or provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ömer ÖZÇELEP, PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

July 18, 2026

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

December 19, 2026

Last Updated

June 23, 2026

Record last verified: 2026-06