Rotator Cuff SyndromeNCT07662772
Forearm Muscle and Tendon Thickness in Rotator Cuff-Related Shoulder Pain
An observational study of Rotator Cuff Syndrome, run by Kirsehir Ahi Evran Universitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Syndrome
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 18 Jul 2026to 19 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasonographic Assessment of Forearm Muscle and Tendon Thickness According to Symptom Duration in Individuals With Rotator Cuff-Related Shoulder Pain
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.
Read more
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.
Read the detailed description
Rotator cuff-related shoulder pain (RCRSP) is one of the leading causes of shoulder pain and disability in adults. In addition to local impairments such as pain, muscle weakness, and reduced range of motion, individuals with RCRSP frequently demonstrate altered upper extremity movement patterns and reduced functional performance. These adaptations may extend beyond the shoulder joint and influence distal segments of the upper extremity.
Previous research has primarily focused on structural changes in the rotator cuff muscles and tendons, scapular musculature, and shoulder biomechanics. However, the potential morphological adaptations of the forearm muscles and tendons remain largely unexplored. Persistent pain, reduced upper limb use, altered neuromuscular control, and compensatory motor strategies associated with prolonged shoulder symptoms may contribute to changes in forearm muscle and tendon morphology. Understanding these adaptations may improve the current understanding of the regional effects of RCRSP.
Musculoskeletal ultrasonography provides a valid, reliable, non-invasive, and accessible method for evaluating muscle and tendon morphology. The increasing availability of portable ultrasound devices has expanded the feasibility of assessing musculoskeletal structures in both clinical and research settings. Despite these advantages, ultrasonographic evaluation of forearm muscles and tendons has rarely been performed in individuals with RCRSP.
This cross-sectional study aims to investigate the association between symptom duration and forearm muscle and tendon thickness measured by portable ultrasonography in individuals with RCRSP. The study also seeks to explore whether structural changes in the forearm are accompanied by alterations in hand grip strength, pain intensity, and upper extremity function. The findings may contribute to a better understanding of distal musculoskeletal adaptations associated with prolonged shoulder pain and provide evidence for incorporating forearm assessment into rehabilitation programs for individuals with RCRSP.
- Conditions
- Rotator Cuff Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single assessment)
Secondary outcomes (5)
Hand Grip Strength
Maximum isometric hand grip strength will be assessed using a calibrated hand dynamometer. Three consecutive measurements will be obtained from the affected upper extremity with standardized positioning, and the highest value (kg) will be used for analysis.
Measured: Baseline (single assessment)
Upper Extremity Function
Upper extremity disability and symptoms will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline (single assessment)
Shoulder Pain Intensity
Shoulder pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Baseline (single assessment)
Symptom Duration
Symptom duration will be recorded in months based on participant self-report and clinical history. Participants with rotator cuff-related shoulder pain will be categorized into groups according to symptom duration for comparative analyses.
Measured: Baseline
Shoulder Proprioception
Shoulder joint position sense (JPS) will be assessed using a laser pointer repositioning test. Repositioning error will be recorded in centimeters, with greater deviation indicating poorer proprioceptive accuracy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start18 Jul 2026 (estimated)
- Primary completion18 Dec 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662772
- Sponsor's protocol ID
- KAEÜFTR-4
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Forearm Muscle and Tendon Thickness According to Symptom Duration in Individuals With Rotator Cuff-Related Shoulder Pain
- ClinicalTrials.gov ID
- NCT07662772
- Acronym / sponsor ID
- KAEÜFTR-4
- Conditions
- Rotator Cuff Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 18 Jul 2026 (estimated)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rotator cuff-related shoulder pain (RCRSP) is one of the leading causes of shoulder pain and disability in adults. In addition to local impairments such as pain, muscle weakness, and reduced range of motion, individuals with RCRSP frequently demonstrate altered upper extremity movement patterns and reduced functional performance. These adaptations may extend beyond the shoulder joint and influence distal segments of the upper extremity.
Previous research has primarily focused on structural changes in the rotator cuff muscles and tendons, scapular musculature, and shoulder biomechanics. However, the potential morphological adaptations of the forearm muscles and tendons remain largely unexplored. Persistent pain, reduced upper limb use, altered neuromuscular control, and compensatory motor strategies associated with prolonged shoulder symptoms may contribute to changes in forearm muscle and tendon morphology. Understanding these adaptations may improve the current understanding of the regional effects of RCRSP.
Musculoskeletal ultrasonography provides a valid, reliable, non-invasive, and accessible method for evaluating muscle and tendon morphology. The increasing availability of portable ultrasound devices has expanded the feasibility of assessing musculoskeletal structures in both clinical and research settings. Despite these advantages, ultrasonographic evaluation of forearm muscles and tendons has rarely been performed in individuals with RCRSP.
This cross-sectional study aims to investigate the association between symptom duration and forearm muscle and tendon thickness measured by portable ultrasonography in individuals with RCRSP. The study also seeks to explore whether structural changes in the forearm are accompanied by alterations in hand grip strength, pain intensity, and upper extremity function. The findings may contribute to a better understanding of distal musculoskeletal adaptations associated with prolonged shoulder pain and provide evidence for incorporating forearm assessment into rehabilitation programs for individuals with RCRSP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forearm Muscle and Tendon Thickness
Time frame: Baseline (single assessment)
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.
5 secondary outcomes
Hand Grip Strength
Time frame: Baseline (single assessment)
Upper Extremity Function
Time frame: Baseline (single assessment)
Shoulder Pain Intensity
Time frame: Baseline (single assessment)
Symptom Duration
Time frame: Baseline
Shoulder Proprioception
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Syndrome, run by Kirsehir Ahi Evran Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ömer ÖZÇELEP, PhD. (+905319463799, omer.ozcelep@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm Muscle and Tendon Thickness (time frame: Baseline (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.