search
Back to results

Effectiveness of Pain Education Elderly Subacromial Pain (Subacromial)

Primary Purpose

Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Education in pain, Manual Therapy and Exercises
Manual Therapy and Exercises
Sponsored by
Rodrigo Gustavo da Silva Carvalho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain, Psychological Changes, Education in pain

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Physical Education CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Education in pain, Manual Therapy and Exercises

Manual Therapy and Exercises

Arm 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.

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.

Outcomes

Primary Outcome Measures

Shoulder Pain
Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)
Functionality
Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)

Secondary Outcome Measures

Depression, Anxiety and Stress
Depression, Anxiety and Stress Scale (DASS-21) (better 0 - 63 worse point)
Kinesiophobia
Tampa Scale (better 0 - 68 worse points)
Self-Efficacy
Chronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)
Muscle Strength
Hand-Held (less force worse - more strength better)
Pressure Pain
Pressure Algometer (an average of three applications will be the pressure-supported pain threshold)
Subjective Pain
Analogic Visual Scale (EVA) (better 0-10 worse points)

Full Information

First Posted
May 29, 2021
Last Updated
July 27, 2022
Sponsor
Rodrigo Gustavo da Silva Carvalho
Collaborators
University of Pernambuco
search

1. Study Identification

Unique Protocol Identification Number
NCT04941586
Brief Title
Effectiveness of Pain Education Elderly Subacromial Pain
Acronym
Subacromial
Official Title
Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rodrigo Gustavo da Silva Carvalho
Collaborators
University of Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder Pain, Psychological Changes, Education in pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group: Education in Pain plus Manual Therapy plus Exercises Control group: Manual Therapy plus Exercises
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education in pain, Manual Therapy and Exercises
Arm Type
Experimental
Arm 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.
Arm Title
Manual Therapy and Exercises
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Education in pain, Manual Therapy and Exercises
Other Intervention Name(s)
Education Therapy
Intervention Description
twice a week, lasting 60 minutes, for one month
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Exercises
Other Intervention Name(s)
Manipulation Therapy, Exercises Therapy
Intervention Description
twice a week, lasting 40 minutes, for one month
Primary Outcome Measure Information:
Title
Shoulder Pain
Description
Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)
Time Frame
change pain at four weeks and follow-up at four weeks
Title
Functionality
Description
Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)
Time Frame
change functionality at four weeks and follow-up at four weeks
Secondary Outcome Measure Information:
Title
Depression, Anxiety and Stress
Description
Depression, Anxiety and Stress Scale (DASS-21) (better 0 - 63 worse point)
Time Frame
change depression, anxiety and stress at four weeks and follow-up at four weeks
Title
Kinesiophobia
Description
Tampa Scale (better 0 - 68 worse points)
Time Frame
change kinesiophobia at four weeks and follow-up at four weeks
Title
Self-Efficacy
Description
Chronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)
Time Frame
change self-efficacy at four weeks and follow-up at four weeks
Title
Muscle Strength
Description
Hand-Held (less force worse - more strength better)
Time Frame
change muscle Strength at four weeks and follow-up at four weeks
Title
Pressure Pain
Description
Pressure Algometer (an average of three applications will be the pressure-supported pain threshold)
Time Frame
change at four weeks and follow-up at four weeks
Title
Subjective Pain
Description
Analogic Visual Scale (EVA) (better 0-10 worse points)
Time Frame
change at four weeks and follow-up at four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo GS Carvalho, PhD
Phone
+5587999832015
Email
rodrigocarvalhofisio@gmail.com
Facility Information:
Facility Name
Physical Education College
City
Petrolina
State/Province
Pernambuco
ZIP/Postal Code
56304917
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Phone
8721016856
Email
rodrigo.carvalho@univasf.edu.br
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Phone
8721016856
Email
rodrigocarvalhofisio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Effectiveness of Pain Education Elderly Subacromial Pain

We'll reach out to this number within 24 hrs