Effectiveness of Pain Education Elderly Subacromial Pain

Shoulder Pain Clinical Trial

— Subacromial  

Official title:

Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04941586
• Other study ID #: MT-Subacromial
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: July 2022
• Source: Universidade Federal do vale do São Francisco
• Contact: Rodrigo GS Carvalho, PhD
• Phone: +5587999832015
• Email: rodrigocarvalhofisio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: July 30, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Education in pain, Manual Therapy and Exercises
twice a week, lasting 60 minutes, for one month
• Manual Therapy and Exercises
twice a week, lasting 40 minutes, for one month

Locations

Country	Name	City	State
Brazil	Physical Education College	Petrolina	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Rodrigo Gustavo da Silva Carvalho	University of Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain	Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)	change pain at four weeks and follow-up at four weeks
Primary	Functionality	Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)	change functionality at four weeks and follow-up at four weeks
Secondary	Depression, Anxiety and Stress	Depression, Anxiety and Stress Scale (DASS-21) (better 0 - 63 worse point)	change depression, anxiety and stress at four weeks and follow-up at four weeks
Secondary	Kinesiophobia	Tampa Scale (better 0 - 68 worse points)	change kinesiophobia at four weeks and follow-up at four weeks
Secondary	Self-Efficacy	Chronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)	change self-efficacy at four weeks and follow-up at four weeks
Secondary	Muscle Strength	Hand-Held (less force worse - more strength better)	change muscle Strength at four weeks and follow-up at four weeks
Secondary	Pressure Pain	Pressure Algometer (an average of three applications will be the pressure-supported pain threshold)	change at four weeks and follow-up at four weeks
Secondary	Subjective Pain	Analogic Visual Scale (EVA) (better 0-10 worse points)	change at four weeks and follow-up at four weeks