Effectiveness of Pain Education Elderly Subacromial Pain

Last updated: July 27, 2022
Sponsor: Rodrigo Gustavo da Silva Carvalho
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04941586
MT-Subacromial
  • Ages 65-85
  • All Genders

Study Summary

Objective: To verify the effectiveness of education in pain added to other treatment modalities (manual therapy and exercises) in the outcomes of pain, functionality, depression, anxiety, stress, kinesiophobia, self-efficacy and strength.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 65 and 85 years old;
  • Singns and symptoms of subacromial pain for at least 24 weeks;
  • Medical diagnosis and ultrasound examination;
  • Who do not have diseases such as: cervical radiculopathies, fractures, massive tendonruptures, glenohumeral instabilities, dislocations and descompensated diabetes, andwho have undergone surgery, infiltration or physiotherapy in the last 3 months.

Exclusion

Exclusion Criteria:

  • Patients who do not undergo treatment in one of the groups for two consecutivesessions will be excluded from the study;
  • In case the participants have any discomfort or any adverse reaction, the treatmentwill be suspended, after the evaluation of the evaluating researchers.

Study Design

Total Participants: 74
Study Start date:
May 29, 2021
Estimated Completion Date:
July 30, 2023

Study Description

Introduction: Shoulder pain is one of the most common causes of musculoskeletal complaints found in primary care, with subacromial impact syndrome being the most common. Aging is one of the risk factors for shoulder pain. While psychological factors, which include negative beliefs about pain, catastrophization, kinesiophobia and low self-efficacy, all are related to high levels of pain and disability in the shoulder, predisposing to failure in conservative treatment. Objectives: To verify the effectiveness of pain education added to other treatment modalities (manual therapy and exercises) in the outcomes of pain, functionality, depression, anxiety, stress, kinesiophobia, self-efficacy and strength. Methodology: Randomized controlled clinical trial, which will last for one month of intervention and follow-up for three months. Primary Outcomes: Shoulder Pain and Disability Index Questionnaire that evaluates (pain and disability), Pressure Algometer (pain to pressure) and Visual Analogue Scale (pain). Secondary outcomes: Questionnaire (DASS-21), which evaluates depression, anxiety and stress, Tampa Scale (kinesiophobia), Chronic Pain Self-Efficacy Scale (Self-efficacy) and manual dynamometer that evaluates strength. 74 patients with a diagnosis of subacromial pain, of both sexes, aged between 65 and 85 years will be treated, who will be allocated into two groups: (37 patients for each group). Group A: Manual Therapy + Exercises, individual assistance, twice a week lasting 40 min. (20 min. For each therapy); Group B: Manual Therapy + Exercises + Pain Education, individual care, twice a week lasting 60 min. (20 min. For each therapy. Statistical analysis: The normality distribution will be through the Shapiro-Wilk test. For comparisons of means between and within the groups of outcomes, they will be used using the Generalized Estimation Equations and when necessary , multiple comparisons will be performed using the Bonferroni test, calculated for comparisons between the final and initial moments and initial follow-up in each group: difference in means, 95% confidence interval, effect size (d Cohen). statistical significance adopted will be 5% and the analyzes will be carried out in the statistical programs SPSS 22.0 and R 3.2.4.

Connect with a study center

  • Physical Education College

    Petrolina, Pernambuco 56304917
    Brazil

    Active - Recruiting

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