Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shoulder Pain
- Sponsor
- Rodrigo Gustavo da Silva Carvalho
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Functionality
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Rodrigo Gustavo da Silva Carvalho
Clinical Professor
Universidade Federal do vale do São Francisco
Eligibility Criteria
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 tendon ruptures, glenohumeral instabilities, dislocations and descompensated diabetes, and who have undergone surgery, infiltration or physiotherapy in the last 3 months.
Exclusion Criteria
- •Patients who do not undergo treatment in one of the groups for two consecutive sessions will be excluded from the study;
- •In case the participants have any discomfort or any adverse reaction, the treatment will be suspended, after the evaluation of the evaluating researchers.
Outcomes
Primary Outcomes
Functionality
Time Frame: change functionality at four weeks and follow-up at four weeks
Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)
Shoulder Pain
Time Frame: change pain at four weeks and follow-up at four weeks
Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)
Secondary Outcomes
- Self-Efficacy(change self-efficacy at four weeks and follow-up at four weeks)
- Depression, Anxiety and Stress(change depression, anxiety and stress at four weeks and follow-up at four weeks)
- Pressure Pain(change at four weeks and follow-up at four weeks)
- Kinesiophobia(change kinesiophobia at four weeks and follow-up at four weeks)
- Muscle Strength(change muscle Strength at four weeks and follow-up at four weeks)
- Subjective Pain(change at four weeks and follow-up at four weeks)