Authors
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Universidade de São Paulo -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2021
INTERVENTION: Initially, a blind evaluator will interview patients in order to obtain self‐reported variables, such as the SPADI‐Br questionnaire, numerical pain scale, Tampa kinesiophobia scale and global perception of change. Subsequently, patients will undergo physical assessments of proprioception (sense of passive / active joint position and kinesthesia) in isokinetic and muscle strength in isokinetic that will be performed in a single step at Hospital das Clínicas in Ribeirão Preto. After the evaluations, the 68 patients will undergo the treatment protocol, with 34 patients in the control group that includes muscle strengthening exercises and 34 patients in the intervention group where muscle strengthening exercises and joint positioning exercises will be performed. After 8 weeks of treatment, patients will undergo a complete reassessment of all self‐reported variables and physical assessments by the same blind assessor to whom the treatment was submitted. In addition, the SPADI questionnaire will be applied after 4 weeks, 8 weeks and 12 weeks after starting treatment. Therefore, the data will be computed and treated statistically. D011434 D055070 CONDITION: D020069 subacromial pain syndrome PRIMARY OUTCOME: The primary outcome will be the Shoulder Pain and Disability Index (SPADI) questionnaire consisting of 13 items divided into the subscales of pain (5 items) and disability (8 items), in which a higher score indicates worse shoulder function (Martins et al., 2010). A difference between groups of 13.2 points without SPADI and a standard deviation of 16 SPADI points is expected (Santello et al., 2020). The level of significance was set at 0.05 and power at 90%.; SECONDARY OUTCOME: The secondary outcome will be kinesthesia, a sense of passive and active joint positioning (proprioception assessment) and shoulder strength (internal and external rotation) measured using an isokinetic dynamometer, pain intensity measured with a numerical pain scale (NPRS, 0‐ In addition, we will also apply a TAMPA scale (FS et al., 2008), the Pain Catastrophization Scale (Sehn et al., 2012) and the Chronic Pain Self‐Efficacy Scale, Likert Scale patient. All of these variables will be measured at the beginning and after the 8‐week training programs. The global effect of perceived change will be measured by the Global Perceived Effect Scale (‐5 to +5) (Costa et al., 2008). It is expected to find a difference between the groups in all these variables considering the level of significance established at 0.05 and the power at 90%. INCLUSION CRITERIA: Participants will be recruited through access to regulation guides for the orthopedics sector in partnership with the Municipal Health Secretariat of the city of Ribeirão Preto. Thereafter, the screening of patients will be performed at the Centro de Saúde Escola, Cuiabá, in which patients will be included in the study if they meet the following criteria: pain during active arm elevation movement (“painful arch”), positivity in the tests specific orthopedic: Neer and / or Hawkins‐Kennedy, Jobe and / or pain test during resisted lateral rotation (MICHENER et al. 2009) and minimum amplitude of 120 ° of elevation.
Epistemonikos ID: ae4f39b205afad9636282cc328f9a19ea38c9fe8
First added on: Aug 24, 2024