Effectiveness of Pain Education Elderly Subacromial Pain

Rodrigo Gustavo da Silva Carvalho

Status: Enrolling

Conditions: Shoulder Pain

Treatments: Other: Education in pain, Manual Therapy and Exercises; Other: Manual Therapy and Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT04941586

MT-Subacromial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Education in pain, Manual Therapy and Exercises

Experimental group

Description:

The therapies will be performed by one a physical therapist with experience in rehabilitation, twice a week, lasting 60 minutes, for one month. Each therapy will last 20 minutes.

Treatment:

Other: Education in pain, Manual Therapy and Exercises

Manual Therapy and Exercises

Active Comparator group

Description:

The terapies will be performed by one a physical therapist with experience in rehabilitation, twice a week, lasting 40 minutes, for one month. Each therapy will last 20 minutes.

Treatment:

Other: Manual Therapy and Exercises