Effectiveness of Pain Education Elderly Subacromial Pain

Not Applicable

• Conditions: Shoulder Pain
• Interventions: Other: Manual Therapy and Exercises; Other: Education in pain, Manual Therapy and Exercises

• Registration Number: NCT04941586
• Lead Sponsor: Rodrigo Gustavo da Silva Carvalho

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.

Study Timeline

• Study Start: 2021-05-29
• Study First Submitted: 2021-05-29
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-06-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Therapy and Exercises	Manual Therapy and Exercises	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.
Education in pain, Manual Therapy and Exercises	Education in pain, Manual Therapy and Exercises	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.

Primary Outcome Measures

Name	Time	Method
Functionality	change functionality at four weeks and follow-up at four weeks	Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)
Shoulder Pain	change pain at four weeks and follow-up at four weeks	Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)

Secondary Outcome Measures

Name	Time	Method
Self-Efficacy	change self-efficacy at four weeks and follow-up at four weeks	Chronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)
Depression, Anxiety and Stress	change depression, anxiety and stress at four weeks and follow-up at four weeks	Depression, Anxiety and Stress Scale (DASS-21) (better 0 - 63 worse point)
Pressure Pain	change at four weeks and follow-up at four weeks	Pressure Algometer (an average of three applications will be the pressure-supported pain threshold)
Kinesiophobia	change kinesiophobia at four weeks and follow-up at four weeks	Tampa Scale (better 0 - 68 worse points)
Muscle Strength	change muscle Strength at four weeks and follow-up at four weeks	Hand-Held (less force worse - more strength better)
Subjective Pain	change at four weeks and follow-up at four weeks	Analogic Visual Scale (EVA) (better 0-10 worse points)

Trial Locations

Locations (1)

Physical Education College; 🇧🇷 Petrolina, Pernambuco, Brazil