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Effectiveness of Pain Education Elderly Subacromial Pain

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04941586
Acronym
Subacromial
Enrollment
74
Registered
2021-06-28
Start date
2021-05-29
Completion date
2023-07-30
Last updated
2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Shoulder Pain, Psychological Changes, Education in pain

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.

Interventions

OTHEREducation in pain, Manual Therapy and Exercises

twice a week, lasting 60 minutes, for one month

twice a week, lasting 40 minutes, for one month

Sponsors

University of Pernambuco
CollaboratorOTHER
Rodrigo Gustavo da Silva Carvalho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Painchange pain at four weeks and follow-up at four weeksShoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)
Functionalitychange functionality at four weeks and follow-up at four weeksShoulder Pain and Disability Index (SPADI) (better 0-100 worse points)

Secondary

MeasureTime frameDescription
Self-Efficacychange self-efficacy at four weeks and follow-up at four weeksChronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)
Muscle Strengthchange muscle Strength at four weeks and follow-up at four weeksHand-Held (less force worse - more strength better)
Depression, Anxiety and Stresschange depression, anxiety and stress at four weeks and follow-up at four weeksDepression, Anxiety and Stress Scale (DASS-21) (better 0 - 63 worse point)
Subjective Painchange at four weeks and follow-up at four weeksAnalogic Visual Scale (EVA) (better 0-10 worse points)
Pressure Painchange at four weeks and follow-up at four weeksPressure Algometer (an average of three applications will be the pressure-supported pain threshold)
Kinesiophobiachange kinesiophobia at four weeks and follow-up at four weeksTampa Scale (better 0 - 68 worse points)

Countries

Brazil

Contacts

Primary ContactRodrigo GS Carvalho, PhD
rodrigocarvalhofisio@gmail.com+5587999832015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026