Effectiveness of Pain Education Elderly Subacromial Pain

NCT04941586 | Unknown DMC

• 1 other identifier: MT-Subacromial
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Shoulder Pain; Psychological Changes; Education in pain

Outcome Measures

Primary Outcomes (2)

• Shoulder Pain

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

  change pain at four weeks and follow-up at four weeks

• Functionality

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

  change functionality at four weeks and follow-up at four weeks

Secondary Outcomes (6)

• Depression, Anxiety and Stress

  change depression, anxiety and stress at four weeks and follow-up at four weeks

• Kinesiophobia

  change kinesiophobia at four weeks and follow-up at four weeks

• Self-Efficacy

  change self-efficacy at four weeks and follow-up at four weeks

• Muscle Strength

  change muscle Strength at four weeks and follow-up at four weeks

• Pressure Pain

  change at four weeks and follow-up at four weeks

Study Arms (2)

Education in pain, Manual Therapy and Exercises

EXPERIMENTAL

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

Manual Therapy and Exercises

ACTIVE COMPARATOR

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

Interventions

Education in pain, Manual Therapy and Exercises OTHER

twice a week, lasting 60 minutes, for one month

Also known as: Education Therapy

Education in pain, Manual Therapy and Exercises

Manual Therapy and Exercises OTHER

twice a week, lasting 40 minutes, for one month

Also known as: Manipulation Therapy, Exercises Therapy

Manual Therapy and Exercises

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rodrigo Gustavo da Silva Carvalho: lead
• University of Pernambuco: collaborator

Study Sites (1)

Physical Education College

Petrolina, Pernambuco, 56304917, Brazil

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Educational Status; Musculoskeletal Manipulations; Exercise; Exercise Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

Rodrigo GS Carvalho, PhD

CONTACT

+5587999832015; rodrigocarvalhofisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Experimental group: Education in Pain plus Manual Therapy plus Exercises Control group: Manual Therapy plus Exercises

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: June 28, 2021
• Study Start: May 29, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 30, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available as of 07/18/2022.
• Access Criteria: Sharing access by repository on line and journal.

Locations

BR (1)