Shoulder PainNCT03962231
Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear
A study testing Rotator Cuff Unloading Exercise Program and Rotator Cuff Loading Exercise Program in people with Shoulder Pain and Rotator Cuff Injuries, run by Larissa Pechincha Ribeiro at 1 site in Brazil.
Trial summary
Introduction: Atraumatic and degenerative rotator cuff tears are common in individuals over 55 years of age. This condition can have a high impact on social life and is associated with chronic pain, weakness and dysfunction of the upper limb. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Shoulder Pain, Rotator Cuff Injuries, Rehabilitation
- What is being tested?
- Rotator Cuff Unloading Exercise Program and Rotator Cuff Loading Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2019to 31 Jan 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 55 years or over;
- shoulder pain;
- at least 90° of arm elevation;
- atraumatic rotator cuff tear.
Who cannot join
- Individuals with a history of trauma associated with onset of symptoms;
- fracture and/or previous surgery on upper limbs;
- pain related to the cervical spine;
- inflammatory arthritis;
- adhesive capsulitis;
- cognitive alteration that makes it impossible to perform the questionnaires.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Carlos
São Carlos, São Paulo, 13565-905
Larissa P Ribeiro, MD, 55 16 3306 6695, larissapechincha@hotmail.com
About this study
Official title: Rotator Cuff Unloading Versus Loading Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear: a Randomized Clinical Trial
Introduction: Atraumatic and degenerative rotator cuff tears are common in individuals over 55 years of age. This condition can have a high impact on social life and is associated with chronic pain, weakness and dysfunction of the upper limb. There is evidence that conservative approaches should be the first treatment option. Conservative treatment usually addresses a variety of therapeutic behaviors without providing scientific arguments for the choice and progression of exercises. At that, there is a gap in the literature on the best exercises for this population, whether they are exercises to strengthen the remaining fibers of the rotator cuff or exercises focused on strengthening other shoulder muscles with rotator cuff unload exercise program. Objective: To compare the effects of two different exercise programs based on the load of the rotator cuff on a population with shoulder pain and rotator cuff tear. Methods: This is a controlled, randomized, blinded clinical trial. In this study 78 individuals with shoulder pain and presence of atraumatic rupture of the rotator cuff muscle tendon will participate and will be randomly distributed between two groups. The primary outcome will be quality of life (WORC index), and secondary outcomes will include pain, function (DASH), fear avoidance beliefs (FABQ-Brazil), kinesiophobia (Tampa Scale), pain catastrophizing scale, muscle strength of abductors, lateral and medial rotators of the shoulder, range of motion of arm elevation and patient satisfaction. All outcomes will be measured before and after 12 weeks of treatment (2x/week), and 1 month after the end of treatment. The normality of the data will be verified by the Kolmogorov Smirnov test. The differences between the groups will be verified using the mixed linear models with the terms of interaction versus time. The effect size will be calculated for the variables between the groups. The level of significance will be 5%.
Read the detailed description
BACKGROUND The presence of atraumatic and degenerative ruptures in the rotator cuff is a common finding in imaging studies due to the natural aging process. Several exercise protocols have been proposed for this population. However, there is still a gap in the literature about what exercises are best for these individuals: exercises to strengthen the remaining fibers of the rotator cuff or exercises focused on strengthening other shoulder muscles with little emphasis on the rotator cuff. Both types of exercises are performed jointly in most treatment programs, or the tension in the rotator cuff is not taken into account during exercise selection.
Despite the lack of consensus on which exercises or exercises are more effective in conservative treatment, there is evidence that therapeutic exercises should be the first treatment option in individuals with chronic, atraumatic, degenerative, and rotator cuff tears. Thus, it is expected that this study may contribute to filling the existing gap, re-adjusting treatment techniques for this population and provide scientific bases that support the clinical practice of physiotherapists.
RESEARCH QUESTION:
Are the results of a rotator cuff unloading exercise program different than rotator cuff loading exercise program in individuals with shoulder pain and rotator cuff tear? This research question is relevant to clinical practice once that so far there are no specific treatment guidelines for patients with degenerative ruptures of the rotator cuff tendons.
Primary Aim The primary aim of this study will be to verify the effects of 12-week unloading rotator cuff exercise program compared to an usual exercise program with an emphasis on the rotator cuff on quality of life in patients with shoulder pain and and rotator cuff tear.
Secondary Aim
The secondary aim will be to verify the effects of 12-week unloading rotator cuff exercise program compared to an usual exercise program with an emphasis on the rotator cuff on quality of life in patients with shoulder pain and and rotator cuff tear following variables:
- Pain at rest, during arm movement, maximum and minimum referred in the last week;
- Function of upper limbs;
- Fear-Avoidance Beliefs;
- Kinesiophobia;
- Pain Catastrophizing;
- Strength of abductors, lateral and medial rotators of the shoulder;
- Range of movement during arm elevation;
- Satisfaction of patients with the treatment;
HYPOTHESES The hypothesis of this study is that the exercise program with no emphasis on the rotator cuff will produce different results on quality of life, pain, function, fear-avoidance beliefs, kinesiophobia, pain catastrophizing, muscle strength of abductors, lateral and medial rotators of the arm, range of motion during arm elevation and treatment satisfaction when compared to the exercise program with an emphasis on the rotator cuff.
METHODOLOGY
- Study Design Controlled, randomized, blind and two-group clinical trial parallel. Evaluators will be blinded to the treatment group.
- Ethical Aspects This study was sent to the Research Ethics Committee of the University and registered in clinicaltrials.gov, respecting the norms of experimental conduct with humans (CNS Resolution 466/12). Participants will receive verbal and written explanation of the research objectives and procedures. They will also be informed of all the risks and benefits of their participation, as well as the freedom to give up participating in the research at any time. Individuals who agree to participate will sign the Free and Informed Consent Form. Any changes that are made to the research protocol will be submitted to the UFSCar Research Ethics Committee and registered at clinicaltrials.gov.
- Sample The sample size was performed based on the minimum important difference of 282.6 points of the Western Ontario Rotator Cuff Index (WORC) 50 with standard deviation of 400 points, 80% power, and significance level of 5%. WORC was selected because it evaluates the quality of life of individuals with rotator cuff diseases. Considering a sample loss of 15%, 9 will be included in the study 78 subjects, randomly assigned to two treatment groups: Rotator Cuff Unloading Exercise Program (n = 39) and Rotator Cuff Loading Exercise Program (n = 39).
Block randomization between groups will be performed by the site www.randomization.com and the sequence will be stored in sealed and opaque envelopes to maintain allocation secrecy. This process will be performed by an independent researcher, that is, who will not be involved with the evaluation and treatment. The allocation of individuals will be revealed to the investigator responsible for the treatment with the opening of the envelope before the beginning of the intervention. The researcher responsible for the evaluation will be blinded on the treatment group. The subjects will be blinded to the hypothesis of the study, and in addition, the treatment will be performed individually, that is, they will not have contact between the participants of the same or the other group.
STATISTICAL ANALYSIS Recruitment information and data of subjects included, and dropouts of all evaluations will be collected and manually inserted into Excel software (Microsoft version 2016). The confidentiality of the data will be guaranteed by transforming the individuals' names into identifier codes. In addition, only study researchers will have access to survey material and database.
Statistical Package for Social Sciences version 23 will be used to analyze the data. Continuous data will be presented by mean, standard deviation and mean difference between the groups with 95% confidence interval, and the categorical ones by frequency and percentage. The normality of the data will be verified through the Kolmogorov Smirnov test and observation of histograms for each variable in each group. Statistical analysis will follow the principles of intention-to-treat analysis.
Linear mixed models will be used to calculate the differences between the groups using the terms of group interaction (Rotator Cuff Unloading Exercise Program and Rotator Cuff Loading Exercise Program) versus time (pre-treatment, 12 weeks at the end of treatment, and one month after the end of treatment) for the variables of quality of life (WORC index), pain, function (DASH questionnaire), fear-avoidance beliefs (FABQBrasil), kinesiophobia, pain catastrophizing scale (PCS), muscle strength of abductors, lateral and medial rotators of the shoulder and range of motion of arm elevation. The models will be adjusted to baseline values for all variables and for multiple comparisons.
The effect size will also be calculated between groups, where an effect greater than 0.8 will be considered large, about 0.5 moderate, and less than 0.2 small.80 A significance level of 5% (p <0.05).
- Conditions
- Shoulder Pain, Rotator Cuff Injuries, Rehabilitation
- Being tested
- Rotator Cuff Unloading Exercise Program, Rotator Cuff Loading Exercise Program
- Keywords
- Treatment, Physiotherapy, Impingement Syndrome
- Medical subject headings
- Shoulder Pain, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator Cuff Unloading Exercise ProgramOther
Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid reeducation exercises, assisted arm elevation and scapular control exercises.
Rotator Cuff Loading Exercise ProgramOther
Patients in this group will perform conventional exercises focusing on lateral rotation, medial rotation and arm elevation.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Cuff Unloading Exercise Program | Active comparator | Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid re-education exercises, assisted arm elevation and scapula control exercises. Receives: Other: Rotator Cuff Unloading Exercise Program |
| Rotator Cuff Loading Exercise Program | Active comparator | Patients in this group will perform conventional exercises with focus on lateral rotation, medial rotation and arm elevation. Receives: Other: Rotator Cuff Loading Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC)
The Western Ontario Rotator Cuff Index (WORC) contains 21 questions distributed in five domains, each question can be scored between 0 and 100 on the Analogic visual scale. The final result of WORC varies from 0 to 2100, higher value indicates worse the quality of life of the individual.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Secondary outcomes (8)
Change from Baseline Shoulder Pain at 12 weeks and 1 month (follow-up)
The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Upper Limb Function at 12 weeks and 1 month (follow-up)
The Function will be measured with Disabilities of the Arm, Shoulder and Hand with scores ranging from 0 to 100 (higher score reflects greater disability)
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Fear Avoidance Beliefs at 12 weeks and 1 month (follow-up)
The Fear-Avoidance Beliefs Questionnaire (FABQ) contains 2 scales: FABQ work scale (with range from 0 to 42) and FABQ physical activity scale (with range from 0 to 24). Higher scores indicate higher levels of fear-avoidance beliefs.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Kinesiophobia at 12 weeks and 1 month (follow-up)
The Kinesiophobia will be measured with Tampa Scale of Kinesiophobia (TKS) with scores ranging from 17 to 68. Higher scores indicate higher degree of kinesiophobia.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Pain Catastrophizing at 12 weeks and 1 month (follow-up)
The Pain Catastrophizing Scale is self-administered and contains 13 items. Scale scores range from 0 to 52, with higher values indicating a higher degree of catastrophic thoughts.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Muscle Strength at 12 weeks and 1 month (follow-up)
The abductors, lateral and medial rotators of the arm will be tested using handheld dynamometer.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Range of Motion at 12 weeks and 1 month (follow-up)
The maximum range of motion during arm elevation, the range of onset and end of pain in the sagittal and scapular planes will be recorded using a digital inclinometer.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline self-perception of improvement at 12 weeks and 1 month (follow-up)
The Overall improvement of Symptoms will be measured with the Global Rating of Change Scale with scores ranging from -7 to +7 (A higher score indicates higher recovery from the condition).
Measured: Post treatment (12 weeks) and after 1 month (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start5 Aug 2019
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa Pechincha Ribeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor-investigator, Larissa Pechincha Ribeiro, Universidade Federal de Sao Carlos
- Investigators
- Larissa P Ribeiro, MD, Principal investigator, Department of Physical Therapy - Universidade Federal de São Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962231
- Sponsor's protocol ID
- UFSCarShoulderLabRC
- Status last verified
- Mar 2022
- First submitted
- 20 May 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the clinical trial will be published the Study Protocol and Statistical Analysis Plan (SAP), if any researcher wants more information can request. The Informed Consent Form (ICF) can also be available.
Publications
Ribeiro LP, Cools A, Camargo PR. Rotator cuff unloading versus loading exercise program in the conservative treatment of patients with rotator cuff tear: protocol of a randomised controlled trial. BMJ Open. 2020 Dec 12;10(12):e040820. doi: 10.1136/bmjopen-2020-040820.
PubMed 33310803
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Unloading Versus Loading Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03962231
- Acronym / sponsor ID
- UFSCarShoulderLabRC
- Conditions
- Shoulder Pain, Rotator Cuff Injuries, Rehabilitation
- Keywords
- Treatment, Physiotherapy, Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Larissa Pechincha RibeiroUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 23 May 2019 (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.
Introduction: Atraumatic and degenerative rotator cuff tears are common in individuals over 55 years of age. This condition can have a high impact on social life and is associated with chronic pain, weakness and dysfunction of the upper limb. There is evidence that conservative approaches should be the first treatment option. Conservative treatment usually addresses a variety of therapeutic behaviors without providing scientific arguments for the choice and progression of exercises. At that, there is a gap in the literature on the best exercises for this population, whether they are exercises to strengthen the remaining fibers of the rotator cuff or exercises focused on strengthening other shoulder muscles with rotator cuff unload exercise program. Objective: To compare the effects of two different exercise programs based on the load of the rotator cuff on a population with shoulder pain and rotator cuff tear. Methods: This is a controlled, randomized, blinded clinical trial. In this study 78 individuals with shoulder pain and presence of atraumatic rupture of the rotator cuff muscle tendon will participate and will be randomly distributed between two groups. The primary outcome will be quality of life (WORC index), and secondary outcomes will include pain, function (DASH), fear avoidance beliefs (FABQ-Brazil), kinesiophobia (Tampa Scale), pain catastrophizing scale, muscle strength of abductors, lateral and medial rotators of the shoulder, range of motion of arm elevation and patient satisfaction. All outcomes will be measured before and after 12 weeks of treatment (2x/week), and 1 month after the end of treatment. The normality of the data will be verified by the Kolmogorov Smirnov test. The differences between the groups will be verified using the mixed linear models with the terms of interaction versus time. The effect size will be calculated for the variables between the groups. The level of significance will be 5%.
Detailed description
BACKGROUND The presence of atraumatic and degenerative ruptures in the rotator cuff is a common finding in imaging studies due to the natural aging process. Several exercise protocols have been proposed for this population. However, there is still a gap in the literature about what exercises are best for these individuals: exercises to strengthen the remaining fibers of the rotator cuff or exercises focused on strengthening other shoulder muscles with little emphasis on the rotator cuff. Both types of exercises are performed jointly in most treatment programs, or the tension in the rotator cuff is not taken into account during exercise selection.
Despite the lack of consensus on which exercises or exercises are more effective in conservative treatment, there is evidence that therapeutic exercises should be the first treatment option in individuals with chronic, atraumatic, degenerative, and rotator cuff tears. Thus, it is expected that this study may contribute to filling the existing gap, re-adjusting treatment techniques for this population and provide scientific bases that support the clinical practice of physiotherapists.
RESEARCH QUESTION:
Are the results of a rotator cuff unloading exercise program different than rotator cuff loading exercise program in individuals with shoulder pain and rotator cuff tear? This research question is relevant to clinical practice once that so far there are no specific treatment guidelines for patients with degenerative ruptures of the rotator cuff tendons.
Primary Aim The primary aim of this study will be to verify the effects of 12-week unloading rotator cuff exercise program compared to an usual exercise program with an emphasis on the rotator cuff on quality of life in patients with shoulder pain and and rotator cuff tear.
Secondary Aim
The secondary aim will be to verify the effects of 12-week unloading rotator cuff exercise program compared to an usual exercise program with an emphasis on the rotator cuff on quality of life in patients with shoulder pain and and rotator cuff tear following variables:
- Pain at rest, during arm movement, maximum and minimum referred in the last week;
- Function of upper limbs;
- Fear-Avoidance Beliefs;
- Kinesiophobia;
- Pain Catastrophizing;
- Strength of abductors, lateral and medial rotators of the shoulder;
- Range of movement during arm elevation;
- Satisfaction of patients with the treatment;
HYPOTHESES The hypothesis of this study is that the exercise program with no emphasis on the rotator cuff will produce different results on quality of life, pain, function, fear-avoidance beliefs, kinesiophobia, pain catastrophizing, muscle strength of abductors, lateral and medial rotators of the arm, range of motion during arm elevation and treatment satisfaction when compared to the exercise program with an emphasis on the rotator cuff.
METHODOLOGY
- Study Design Controlled, randomized, blind and two-group clinical trial parallel. Evaluators will be blinded to the treatment group.
- Ethical Aspects This study was sent to the Research Ethics Committee of the University and registered in clinicaltrials.gov, respecting the norms of experimental conduct with humans (CNS Resolution 466/12). Participants will receive verbal and written explanation of the research objectives and procedures. They will also be informed of all the risks and benefits of their participation, as well as the freedom to give up participating in the research at any time. Individuals who agree to participate will sign the Free and Informed Consent Form. Any changes that are made to the research protocol will be submitted to the UFSCar Research Ethics Committee and registered at clinicaltrials.gov.
- Sample The sample size was performed based on the minimum important difference of 282.6 points of the Western Ontario Rotator Cuff Index (WORC) 50 with standard deviation of 400 points, 80% power, and significance level of 5%. WORC was selected because it evaluates the quality of life of individuals with rotator cuff diseases. Considering a sample loss of 15%, 9 will be included in the study 78 subjects, randomly assigned to two treatment groups: Rotator Cuff Unloading Exercise Program (n = 39) and Rotator Cuff Loading Exercise Program (n = 39).
Block randomization between groups will be performed by the site www.randomization.com and the sequence will be stored in sealed and opaque envelopes to maintain allocation secrecy. This process will be performed by an independent researcher, that is, who will not be involved with the evaluation and treatment. The allocation of individuals will be revealed to the investigator responsible for the treatment with the opening of the envelope before the beginning of the intervention. The researcher responsible for the evaluation will be blinded on the treatment group. The subjects will be blinded to the hypothesis of the study, and in addition, the treatment will be performed individually, that is, they will not have contact between the participants of the same or the other group.
STATISTICAL ANALYSIS Recruitment information and data of subjects included, and dropouts of all evaluations will be collected and manually inserted into Excel software (Microsoft version 2016). The confidentiality of the data will be guaranteed by transforming the individuals' names into identifier codes. In addition, only study researchers will have access to survey material and database.
Statistical Package for Social Sciences version 23 will be used to analyze the data. Continuous data will be presented by mean, standard deviation and mean difference between the groups with 95% confidence interval, and the categorical ones by frequency and percentage. The normality of the data will be verified through the Kolmogorov Smirnov test and observation of histograms for each variable in each group. Statistical analysis will follow the principles of intention-to-treat analysis.
Linear mixed models will be used to calculate the differences between the groups using the terms of group interaction (Rotator Cuff Unloading Exercise Program and Rotator Cuff Loading Exercise Program) versus time (pre-treatment, 12 weeks at the end of treatment, and one month after the end of treatment) for the variables of quality of life (WORC index), pain, function (DASH questionnaire), fear-avoidance beliefs (FABQBrasil), kinesiophobia, pain catastrophizing scale (PCS), muscle strength of abductors, lateral and medial rotators of the shoulder and range of motion of arm elevation. The models will be adjusted to baseline values for all variables and for multiple comparisons.
The effect size will also be calculated between groups, where an effect greater than 0.8 will be considered large, about 0.5 moderate, and less than 0.2 small.80 A significance level of 5% (p <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator Cuff Unloading Exercise Program | Active comparator | Other: Rotator Cuff Unloading Exercise ProgramPatients in this group will perform semi-closed kinetic chain elevation exercises, deltoid re-education exercises, assisted arm elevation and scapula control exercises. |
| Rotator Cuff Loading Exercise Program | Active comparator | Other: Rotator Cuff Loading Exercise ProgramPatients in this group will perform conventional exercises with focus on lateral rotation, medial rotation and arm elevation. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 55 years or over;
- shoulder pain;
- at least 90° of arm elevation;
- atraumatic rotator cuff tear.
Key exclusion criteria (6 listed)
- Individuals with a history of trauma associated with onset of symptoms;
- fracture and/or previous surgery on upper limbs;
- pain related to the cervical spine;
- inflammatory arthritis;
- adhesive capsulitis;
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 |
|---|---|---|
| Rotator Cuff Unloading Exercise ProgramPatients in this group will perform semi-closed kinetic chain elevation exercises, deltoid reeducation exercises, assisted arm elevation and scapular control exercises. | Other | Rotator Cuff Unloading Exercise Program |
| Rotator Cuff Loading Exercise ProgramPatients in this group will perform conventional exercises focusing on lateral rotation, medial rotation and arm elevation. | Other | Rotator Cuff Loading Exercise Program |
Primary outcome
Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
The Western Ontario Rotator Cuff Index (WORC) contains 21 questions distributed in five domains, each question can be scored between 0 and 100 on the Analogic visual scale. The final result of WORC varies from 0 to 2100, higher value indicates worse the quality of life of the individual.
8 secondary outcomes
Change from Baseline Shoulder Pain at 12 weeks and 1 month (follow-up)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Upper Limb Function at 12 weeks and 1 month (follow-up)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Fear Avoidance Beliefs at 12 weeks and 1 month (follow-up)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Kinesiophobia at 12 weeks and 1 month (follow-up)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Pain Catastrophizing at 12 weeks and 1 month (follow-up)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Muscle Strength at 12 weeks and 1 month (follow-up)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline Range of Motion at 12 weeks and 1 month (follow-up)
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
Change from Baseline self-perception of improvement at 12 weeks and 1 month (follow-up)
Time frame: Post treatment (12 weeks) and after 1 month (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 33310803Ribeiro LP, Cools A, Camargo PR. Rotator cuff unloading versus loading exercise program in the conservative treatment of patients with rotator cuff tear: protocol of a randomised controlled trial. BMJ Open. 2020 Dec 12;10(12):e040820. doi: 10.1136/bmjopen-2020-040820.
- Individual participant dataSharing planned: Yes. At the end of the clinical trial will be published the Study Protocol and Statistical Analysis Plan (SAP), if any researcher wants more information can request. The Informed Consent Form (ICF) can also be available.
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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.
Larissa P Ribeiro, MD principal investigator
Department of Physical Therapy - Universidade Federal de São Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator Cuff Unloading Exercise Program and Rotator Cuff Loading Exercise Program in people with Shoulder Pain and Rotator Cuff Injuries, run by Larissa Pechincha Ribeiro 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 6 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 16 Mar 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 Larissa P Ribeiro, MD (55 16 3306 6695, larissapechincha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC) (time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962231, which also lists 1 linked publication.
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 16 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.