Clinical trial NCT04941586: Effectiveness of Pain Education Elderly Subacromial Pain
Official title: Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Keywords: Shoulder Pain
Psychological Changes
Education in pain
Lead sponsor: Universidade Federal do vale do São Francisco
Sponsor class: OTHER
Collaborators: name: University of Pernambuco
First posted: 2021-06-28
Enrollment: 74
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: Education in Pain plus Manual Therapy plus Exercises Control group: Manual Therapy plus Exercises
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Shoulder Pain
timeFrame: change pain at four weeks and follow-up at four weeks
measure: Functionality
timeFrame: change functionality at four weeks and follow-up at four weeks
Secondary outcomes:
measure: Depression, Anxiety and Stress
timeFrame: change depression, anxiety and stress at four weeks and follow-up at four weeks
measure: Kinesiophobia
timeFrame: change kinesiophobia at four weeks and follow-up at four weeks
measure: Self-Efficacy
timeFrame: change self-efficacy at four weeks and follow-up at four weeks
measure: Muscle Strength
timeFrame: change muscle Strength at four weeks and follow-up at four weeks
measure: Pressure Pain
timeFrame: change at four weeks and follow-up at four weeks
measure: Subjective Pain
timeFrame: change at four weeks and follow-up at four weeks
Other outcomes:
Locations:
city: Petrolina
country: Brazil
facility: Physical Education College
state: Pernambuco
Study officials:
References: