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NCT07235969
New Therapeutic Interventions and Imaging Techniques for Prolonged Shoulder Disorders
Conditions: Shoulder Pain, Pain Management, Physical Therapy
Sex: All
Ages: 20 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: University of Oulu
Location: Oulu University Hospital Oulu
Summary
The RESPECT study compares three types of physical therapy for adults aged 20-60 years with prolonged shoulder disorders, aiming to find better ways to help people recover and improve daily function. The study also examines modern imaging tests (X-ray, ultrasound, MRI) to see how well imaging findings match real symptoms, and tests new imaging technologies that may provide a more accurate diagnosis. The study improves future shoulder pain care by addressing both physical and psychological factors and advancing diagnostic imaging.
Participants are randomly assigned to one of three groups:
1. Routine physical therapy (usual occupational care),
2. Tendon-Specific Exercise Program (TSEP): targeted exercises to build shoulder strength and
3. Psychologically Informed Physical Therapy (PIPT): combining physical rehabilitation with advice and emotional support.
All participants get complete imaging of both shoulders and a clinical evaluation by a physiotherapist at the start of the study. Complete imaging is also done for all participants after twelve and thirty-six months. Surveys about pain, movement, mood, sleep, and quality of life are collected electronically at the start of the study, and at three, six, twelve, and 36 months. The main outcome is how well each person resumes everyday activities affected by shoulder pain (Patient-Specific Functional Scale, PSFS).
Group 1 will receive routine occupationally led physiotherapy, and groups 2 and 3 will receive five physiotherapist-guided sessions during the first six month-period. Advanced imaging techniques will deployed in conjunction with standard imaging methods and compared to see whether new technologies help explain symptoms or guide care.
To join, participants must have had prolonged shoulder disorders in one shoulder for at least four consecutive weeks, be employed or self-employed, and be willing to take part in rehabilitation activities. Certain medical conditions, prior surgery, and pregnancy are exclusion criteria. Inclusion and exclusion criteria are systematically reviewed in a structured phone interview at the start of the study. Baseline imaging is also viewed preliminarily for certain conditions which would require urgent medical care. If necessary, participants are contacted, informed and subsequently excluded from the study.
The trial takes place at Oulu University Hospital, Finland. Approximately 300 people are recruited to the study through local occupational health care providers. Informed consent is required for the study, and participants can withdraw at any time. All procedures meet ethical standards.
This study will help determine:
1. Which therapy works best overall
2. Whether some people benefit more from certain therapies
3. If imaging findings help predict outcomes or aid treatment decisions
4. Whether new imaging technology improves diagnosis
Eligibility Criteria
Inclusion Criteria:
* Age of 20-60 years
* Active participation in the workforce (employed or entrepreneur)
* Active occupational health care services available
* Daily unilateral shoulder pain for at least four consecutive weeks
* Willingness to participate in independent rehabilitation and PT visits
Exclusion Criteria:
* Bilateral shoulder pain
* Previous humerus fracture or current acute upper limb injury
* Prolonged dysfunction or pain of the upper limb attributable to trauma, neurologic disease or cervical spine disorders
* Diagnosed musculoskeletal disorders affecting the upper limb (e.g. rheumatoid arthritis)
* Severe disability, mental or memory disorder
* Advanced cancer
* History of shoulder PT or corticosteroid injection in the last six months
* Previous or planned shoulder surgery
* Confirmed or possible pregnancy
* Contraindications to MRI
* Severe chronic kidney disease
* Evidence unaccounted malignancy or other exclusionary findings in the initial eligibility assessment on either side
Source: ClinicalTrials.gov (NCT07235969). StuddyBuddy aggregates publicly available trial information.