Shoulder PainSubacromialNCT04941586
Effectiveness of Pain Education Elderly Subacromial Pain
A study testing Education in pain, Manual Therapy and Exercises and Manual Therapy and Exercises in people with Shoulder Pain, run by Rodrigo Gustavo da Silva Carvalho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Education in pain, Manual Therapy and Exercises and Manual Therapy and Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 29 May 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Physical Education College
Petrolina, Pernambuco, 56304917
Rodrigo GS Carvalho, PhD, 8721016856, rodrigo.carvalho@univasf.edu.br
Rodrigo GS Carvalho, PhD, 8721016856, rodrigocarvalhofisio@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Education in pain, Manual Therapy and Exercises, Manual Therapy and Exercises
- Keywords
- Shoulder Pain, Psychological Changes, Education in pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in pain, Manual Therapy and ExercisesOther
Also called Education Therapy
twice a week, lasting 60 minutes, for one month
Manual Therapy and ExercisesOther
Also called Manipulation Therapy, Exercises Therapy
twice a week, lasting 40 minutes, for one month
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Manual Therapy and Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain
Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)
Measured: change pain at four weeks and follow-up at four weeks
Functionality
Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)
Measured: change functionality at four weeks and follow-up at four weeks
Secondary outcomes (6)
Depression, Anxiety and Stress
Depression, Anxiety and Stress Scale (DASS-21) (better 0 - 63 worse point)
Measured: change depression, anxiety and stress at four weeks and follow-up at four weeks
Kinesiophobia
Tampa Scale (better 0 - 68 worse points)
Measured: change kinesiophobia at four weeks and follow-up at four weeks
Self-Efficacy
Chronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)
Measured: change self-efficacy at four weeks and follow-up at four weeks
Muscle Strength
Hand-Held (less force worse - more strength better)
Measured: change muscle Strength at four weeks and follow-up at four weeks
Pressure Pain
Pressure Algometer (an average of three applications will be the pressure-supported pain threshold)
Measured: change at four weeks and follow-up at four weeks
Subjective Pain
Analogic Visual Scale (EVA) (better 0-10 worse points)
Measured: change at four weeks and follow-up at four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start29 May 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Education in Pain plus Manual Therapy plus Exercises Control group: Manual Therapy plus Exercises
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodrigo Gustavo da Silva Carvalho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pernambuco
- Responsible party
- Sponsor-investigator, Rodrigo Gustavo da Silva Carvalho, Universidade Federal do vale do São Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941586
- Sponsor's protocol ID
- MT-Subacromial
- Acronym
- Subacromial
- Status last verified
- Jul 2022
- First submitted
- 29 May 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish Study Protocol, Randomized Controlled Trial
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04941586
- Acronym / sponsor ID
- Subacromial / MT-Subacromial
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain, Psychological Changes, Education in pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Rodrigo Gustavo da Silva CarvalhoUniversity, hospital or other
- Collaborators
- University of Pernambuco
- Study start
- 29 May 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: Education in Pain plus Manual Therapy plus Exercises Control group: Manual Therapy plus Exercises
| Arm | Type | Receives |
|---|---|---|
| Education in pain, Manual Therapy and Exercises | Experimental | Other: Education in pain, Manual Therapy and ExercisesThe 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. |
| Manual Therapy and Exercises | Active comparator | Other: Manual Therapy and ExercisesThe 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education in pain, Manual Therapy and ExercisesAlso: Education Therapytwice a week, lasting 60 minutes, for one month | Other | Education in pain, Manual Therapy and Exercises |
| Manual Therapy and ExercisesAlso: Manipulation Therapy, Exercises Therapytwice a week, lasting 40 minutes, for one month | Other | Manual Therapy and Exercises |
Primary outcome
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)
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)
6 secondary outcomes
Depression, Anxiety and Stress
Time frame: 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
Self-Efficacy
Time frame: 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
Pressure Pain
Time frame: change at four weeks and follow-up at four weeks
Subjective Pain
Time frame: change at four weeks and follow-up at four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: Yes. Publish Study Protocol, Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in pain, Manual Therapy and Exercises and Manual Therapy and Exercises in people with Shoulder Pain, run by Rodrigo Gustavo da Silva Carvalho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo GS Carvalho, PhD (+5587999832015, rodrigocarvalhofisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: change pain at four weeks and follow-up at four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.