New Therapeutic Interventions and Imaging Techniques for Prolonged Shoulder Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorUniversity of Oulu

About this trial

The RESSPECT 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 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 via local ads. 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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Tendon-Specific Exercise Program (TSEP)
  • Psychologically Informed Physical Therapy (PIPT)
  • Occupational health care led physiotherapy

Treatment groups

300 Participants
are divided into 3 treatment groups

Locations

1
Oulu University Hospital90220, Oulu Finland

Sponsors and collaborators

University of Oulu

Lead sponsor