Effectiveness of Pain Education Elderly Subacromial Pain

Sponsor
Rodrigo Gustavo da Silva Carvalho (Other)
Overall Status
Recruiting
CT.gov ID
NCT04941586
Collaborator
University of Pernambuco (Other)
74
1
2
26
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Education in pain, Manual Therapy and Exercises
  • Other: Manual Therapy and Exercises
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Experimental group: Education in Pain plus Manual Therapy plus Exercises Control group: Manual Therapy plus ExercisesExperimental group: Education in Pain plus Manual Therapy plus Exercises Control group: Manual Therapy plus Exercises
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial
Actual Study Start Date :
May 29, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

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.

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

    Other: Manual Therapy and Exercises
    twice a week, lasting 40 minutes, for one month
    Other Names:
  • Manipulation Therapy
  • Exercises Therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Shoulder Pain [change pain at four weeks and follow-up at four weeks]

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

    2. Functionality [change functionality at four weeks and follow-up at four weeks]

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

    Secondary Outcome Measures

    1. 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)

    2. Kinesiophobia [change kinesiophobia at four weeks and follow-up at four weeks]

      Tampa Scale (better 0 - 68 worse points)

    3. 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)

    4. Muscle Strength [change muscle Strength at four weeks and follow-up at four weeks]

      Hand-Held (less force worse - more strength better)

    5. 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)

    6. Subjective Pain [change at four weeks and follow-up at four weeks]

      Analogic Visual Scale (EVA) (better 0-10 worse points)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Physical Education College Petrolina Pernambuco Brazil 56304917

    Sponsors and Collaborators

    • Rodrigo Gustavo da Silva Carvalho
    • University of Pernambuco

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rodrigo Gustavo da Silva Carvalho, Clinical Professor, Universidade Federal do vale do São Francisco
    ClinicalTrials.gov Identifier:
    NCT04941586
    Other Study ID Numbers:
    • MT-Subacromial
    First Posted:
    Jun 28, 2021
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rodrigo Gustavo da Silva Carvalho, Clinical Professor, Universidade Federal do vale do São Francisco
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2022