- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941586
Effectiveness of Pain Education Elderly Subacromial Pain (Subacromial)
July 27, 2022 updated by: Rodrigo Gustavo da Silva Carvalho
Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rodrigo GS Carvalho, PhD
- Phone Number: +5587999832015
- Email: rodrigocarvalhofisio@gmail.com
Study Locations
-
-
Pernambuco
-
Petrolina, Pernambuco, Brazil, 56304917
- Recruiting
- Physical Education College
-
Contact:
- Rodrigo GS Carvalho, PhD
- Phone Number: 8721016856
- Email: rodrigo.carvalho@univasf.edu.br
-
Contact:
- Rodrigo GS Carvalho, PhD
- Phone Number: 8721016856
- Email: rodrigocarvalhofisio@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
twice a week, lasting 60 minutes, for one month
Other Names:
|
Active Comparator: 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.
|
twice a week, lasting 40 minutes, for one month
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Pain
Time Frame: change pain at four weeks and follow-up at four weeks
|
Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)
|
change pain at four weeks and follow-up at four weeks
|
Functionality
Time Frame: change functionality at four weeks and follow-up at four weeks
|
Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)
|
change functionality at four weeks and follow-up at four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Anxiety and Stress
Time Frame: 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)
|
change depression, anxiety and stress at four weeks and follow-up at four weeks
|
Kinesiophobia
Time Frame: change kinesiophobia at four weeks and follow-up at four weeks
|
Tampa Scale (better 0 - 68 worse points)
|
change kinesiophobia at four weeks and follow-up at four weeks
|
Self-Efficacy
Time Frame: change self-efficacy at four weeks and follow-up at four weeks
|
Chronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)
|
change self-efficacy at four weeks and follow-up at four weeks
|
Muscle Strength
Time Frame: change muscle Strength at four weeks and follow-up at four weeks
|
Hand-Held (less force worse - more strength better)
|
change muscle Strength at four weeks and follow-up at four weeks
|
Pressure Pain
Time Frame: change at four weeks and follow-up at four weeks
|
Pressure Algometer (an average of three applications will be the pressure-supported pain threshold)
|
change at four weeks and follow-up at four weeks
|
Subjective Pain
Time Frame: change at four weeks and follow-up at four weeks
|
Analogic Visual Scale (EVA) (better 0-10 worse points)
|
change at four weeks and follow-up at four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
July 30, 2023
Study Registration Dates
First Submitted
May 29, 2021
First Submitted That Met QC Criteria
June 25, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
July 29, 2022
Last Update Submitted That Met QC Criteria
July 27, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-Subacromial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Publish Study Protocol, Randomized Controlled Trial
IPD Sharing Time Frame
The data will become available as of 07/18/2022.
IPD Sharing Access Criteria
Sharing access by repository on line and journal.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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