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Effect of adding Self-Efficacy Strategies to Strengthening Exercises and Manual Therapy on functionality and self-efficacy of patients with shoulder pain: a randomized controlled trial with economic evaluation

Efficacy of adding Self-Efficacy Strategies to Strengthening Exercises and Manual Therapy for disability and self-efficacy of individuals 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-8k98md3
Enrollment
Unknown
Registered
2023-01-18
Start date
2023-03-01
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

Subacromial Impingement Syndrome

Interventions

Individuals who agree to participate in the study will undergo an initial assessment to assess inclusion criteria and apply questionnaires for outcome measures. The therapist responsible for the evalu
E02.190.599
E02.779.483.250

Sponsors

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

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals who have one of the following diagnostic terms “Anterior shoulder pain”; “Subacromial Impingement Syndrome”; “Subacromial Impingement Syndrome”; “Painful shoulder”; “Shoulder Tendinitis” or specific rotator cuff tendonitis; “Subacromial bursitis” or “Subdeltoid bursitis” in the diagnostic field; Both sexes; Age from 18 years old; Shoulder pain for more than 12 weeks; 3 or more positive findings in the “Painful arch in flexion or abduction” tests; “Neer”; “Hawkins-Kennedy Test”; “pain on resisted external humeral rotation” or “Jobe's Test”

Exclusion criteria

Exclusion criteria: Previous history of shoulder surgery or injuries caused by external forces; full-thickness tear of the rotator cuff as evidenced by imaging (US or MRI); shoulder instability; adhesive capsulitis; or if they are involved in cognitive-behavioral and cognitive-functional therapy due to conflicting literature on possible changes in self-efficacy in this population; Cardiovascular and neurological disorders including cervical and arm nerve entrapment syndromes; pregnant women; those who are unable to perform the required clinical assessment tasks, answer the questionnaires, or attend the required assessment and intervention sessions

Design outcomes

Primary

MeasureTime frame
We will assess shoulder disability using the Shoulder Pain and Disability Index version Brazil (SPADI-Br), which is composed of 13 items divided into subscales of pain (5 items) and disability (8 items), in which a higher score high indicates worse shoulder function. A difference between groups of 13.2 points in SPADI is expected (Santello et al., 2020). The significance level was set at 0.05.;We will assess self-efficacy using the Pain Self-Efficacy Questionnaire (PSEQ-10), which has 10 items, with a total score ranging from 0 to 60, with higher scores indicating high self-efficacy. A difference of 8.5 points is expected on the PSEQ-10 (Maughan et al., 2010). The significance level was set at 0.05.

Secondary

MeasureTime frame
We will assess self-regulation using the Short Self-Regulation Questionnaire (SSRQ). Patients with chronic shoulder pain who receive self-efficacy strategies associated with strengthening exercises and manual therapy are expected to present, immediately after the intervention, 6 and 12 months after randomization, an improvement in self-regulation. The significance level was set at 0.05.;We will assess the intensity of pain using the Numerical Rating Pain Scale (NRPS). Patients with chronic shoulder pain who receive self-efficacy strategies associated with strengthening exercises and manual therapy are expected to present, immediately after the intervention, 6 and 12 months after randomization, a greater reduction in pain intensity. The significance level was set at 0.05.;We will assess quality of life using the Euroqol 5 dimensions (EQ-5D-3L) and the 12-Item Short-Form Health Survey (SF-12). Patients with chronic shoulder pain who receive self-efficacy strategies associated with strengthening exercises and manual therapy are expected to present, immediately after the intervention, 6 and 12 months after randomization, an improvement in their quality of life. The significance level was set at 0.05.;We will assess the number of new medical consultations related to shoulder pain through a simple question, “How many times did you visit the doctor due to shoulder pain?”. Patients with chronic shoulder pain who receive self-efficacy strategies associated with strengthening exercises and manual therapy are expected to present, immediately after the intervention, 6 and 12 months after randomization, a decrease in the number of new medical appointments due to shoulder pain shoulder. The significance level was set at 0.05.;We will assess analgesic use for shoulder pain by asking a simple question, “How often do you use analgesics for shoulder pain?”. Patients with chronic shoulder pain who receive self-efficacy strategies associated with strengthening exercises and manual ther

Countries

Brazil

Contacts

Public ContactCarolina Souza

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

carolina.matiello.souza@usp.br+55 16 3315-4585

Outcome results

None listed

Source: REBEC (via WHO ICTRP)