New Therapeutic Interventions and Imaging Techniques for Prolonged Shoulder Disorders

NCT07235969 | Not Yet Recruiting

• 1 other identifier: 151/2025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Routine physical therapy (usual occupational care),
2. 2.Tendon-Specific Exercise Program (TSEP): targeted exercises to build shoulder strength and
3. 3.Psychologically Informed Physical Therapy (PIPT): combining physical rehabilitation with advice and emotional support.
4. 4.Which therapy works best overall
5. 5.Whether some people benefit more from certain therapies
6. 6.If imaging findings help predict outcomes or aid treatment decisions
7. 7.Whether new imaging technology improves diagnosis

Conditions

Shoulder Pain; Pain Management; Physical Therapy

Keywords

Pain Management; Psychologically Informed Physical Therapy; Magnetic resonance fingerprinting; Diagnostic Imaging; Microvascular Flow Imaging; Tendon-Specific Exercise Program; Shear Wave Elastography

Outcome Measures

Primary Outcomes (1)

• Patient-Specific Functional Scale

  The personal participant-named activities in the structured PSFS form at baseline will be carried over to the follow-up surveys, against which patients will do the scoring.

  From baseline to the end of the follow-up at 36 months

Study Arms (3)

Occupational physiotherapy (control group)

ACTIVE COMPARATOR

Other: Occupational health care led physiotherapy

Physiotherapist-guided Tendon-Specific Exercise Program (TSEP)

EXPERIMENTAL

Other: Tendon-Specific Exercise Program (TSEP)

Physiotherapist-guided Psychologically Informed Physical Therapy (PIPT)

EXPERIMENTAL

Other: Psychologically Informed Physical Therapy (PIPT)

Interventions

Tendon-Specific Exercise Program (TSEP) OTHER

The aims of the TSEP are to improve RC muscle strength and increase tendon stiffness. The principles of exercise intervention are based on High-Loading Tendon Exercise (HLTE) and Heavy Slow Resistance (HSR) Training programs, and the Pain Monitoring Model (PMM).

Physiotherapist-guided Tendon-Specific Exercise Program (TSEP)

Psychologically Informed Physical Therapy (PIPT) OTHER

The aims of PIPT are biopsychosocial framework, patient-centered care and communication, good patient-therapist relationship, and consideration of patient's beliefs, fears and attitudes, behavior change, and guided self-management.

Physiotherapist-guided Psychologically Informed Physical Therapy (PIPT)

Occupational health care led physiotherapy OTHER

Subjects will be advised to contact the occupational health care to receive routine physiotherapy for their shoulder symptoms.

Occupational physiotherapy (control group)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

MeSH Terms

Conditions

Shoulder Pain; Agnosia

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Antti Kemppainen, Dr.

  University of Oulu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research nurse

CONTACT

+358405087506; anne.kukkonen@pohde.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants are not masked to their respective treatment, but are masked to the treatment other study groups receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after the publication of results and ending 3 years after.

Locations

FI (1)