Effectiveness of Pain Education Elderly Subacromial Pain

NCT ID: NCT04941586

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-29
• Study Completion Date: 2023-07-30

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Education in pain, Manual Therapy and Exercises

Intervention Type: OTHER

twice a week, lasting 60 minutes, for one month

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.

Group Type: ACTIVE_COMPARATOR

Manual Therapy and Exercises

Intervention Type: OTHER

twice a week, lasting 40 minutes, for one month

Interventions

Education in pain, Manual Therapy and Exercises

twice a week, lasting 60 minutes, for one month

Intervention Type: OTHER

Manual Therapy and Exercises

twice a week, lasting 40 minutes, for one month

Intervention Type: OTHER

Other Intervention Names

Education Therapy; Manipulation Therapy; Exercises Therapy

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pernambuco

OTHER

Sponsor Role: collaborator

Rodrigo Gustavo da Silva Carvalho

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Gustavo da Silva Carvalho

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Physical Education College

Petrolina, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Rodrigo GS Carvalho, PhD

Role: CONTACT

rodrigocarvalhofisio@gmail.com

+5587999832015

Facility Contacts

Rodrigo GS Carvalho, PhD

Role: primary

rodrigo.carvalho@univasf.edu.br

8721016856

Rodrigo GS Carvalho, PhD

Role: backup

rodrigocarvalhofisio@gmail.com

8721016856

Other Identifiers

MT-Subacromial

Identifier Type: -

Identifier Source: org_study_id