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Comparison of intervention with conventional exercises and graded exposure for the treatment of shoulder pain

Graded exposure-based approach compared with a strengthening exercises and manual therapy in patients with chronic shoulder pain: a randomized controlled trial with economic evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-835hmdg
Enrollment
Unknown
Registered
2022-07-19
Start date
2022-07-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder injuries

Interventions

A total of 180 individuals will participate in the study, which will be randomized in a 1:1 ratio for the control group and the gradual exposure group. Individuals who agree to participate in the stud
E02.760.169.063.500.387.875

Sponsors

Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto - USP
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Individuals with shoulder pain in the proximal anterolateral aspect of the shoulder; aggravated by movement; who present symptoms lasting at least three months and who present a minimum score of 50 points on the disability scale (Shoulder Pain and Disability Index)

Exclusion criteria

Exclusion criteria: Individuals with a history of trauma or surgery in the shoulder; total rupture of the rotator cuff and biceps tendon; practitioners of sports-level physical activity involving the upper limbs; individuals with a history of cancer; neurological; cardiac and systemic disorders (rheumatoid arthritis or fibromyalgia) in order not to compromise the study objectives; reproduction of shoulder pain with radiating pain; numbness or tingling in the upper limb as an indication of primary involvement in the cervical or thoracic region; presence of wrist dysfunctions (eg. carpal tunnel syndrome); have undergone physical therapy treatment for the shoulder or any other musculoskeletal condition in the last six months; individuals who have contraindications for physical activity

Design outcomes

Primary

MeasureTime frame
Primary 1: Assess the difference between groups for the function outcome at baseline, four and eight weeks after randomization using the Brazilian version of the Shoulder Pain and Disability Index questionnaire;Primary 2: Assess the difference between groups for the pain outcome at baseline, four and eight weeks after randomization by numerical pain scale

Secondary

MeasureTime frame
Secondary 1: Assess the difference between the groups for the function outcome in the six and twelve month assessments after the randomization using the Brazilian version of the Shoulder Pain and Disability Index questionnaire;Secondary 2: Evaluate the difference between groups for the pain outcome at six and twelve months after the randomization by the numerical pain scale;Secondary 3: Assess the difference between groups for the avoidance outcome at baseline, four and eight weeks and six and twelve months after randomization by the Avoidance Daily Activities Photo Scale;Secondary 4: Assess the difference between groups for the self-efficacy outcome at baseline, four and eight weeks and six and twelve months after randomization by the Chronic Pain Self-efficacy Scale;Secondary 5: Evaluate the difference between groups for the kinesiophobia outcome at baseline, four and eight weeks and six and twelve months after randomization by the Tampa Kinesiophobia Scale;Secondary 6: Assess the difference between groups for the catastrophizing outcome at baseline, four and eight weeks, and six and twelve months after randomization by the Pain Catastrophizing Scale (BP-PCS);Secondary 7: Assess the difference between groups for the outcome expectation of improvement at baseline, four and eight weeks, and six and twelve months after randomization using the 5-point Likert scale;Secondary 8: Assess the difference between groups for the health-related quality of life outcome at baseline, four and eight weeks, and six and twelve months after randomization using the 12 Item Short-form Health Survey (SF-12) questionnaire;Secondary 9: Assess the difference between groups for the quality of life outcome at baseline, four and eight weeks and six and twelve months after randomization using the Euroqol 5 and 3 dimensions questionnaire (EQ-5D-3L);Secondary 10: Assess the difference between groups for the central sensitization outcome at baseline, four and eight weeks, and six and twelve mon

Countries

Brazil

Contacts

Public ContactAnamaria de Oliveira

Faculdade de Medicina de Ribeirão Preto - USP

siriani@fmrp.usp.br+55 16 33154415

Outcome results

None listed

Source: REBEC (via WHO ICTRP)