Shoulder PainNCT03528499
Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain
A study testing Scapular Movement Training and General Exercises in people with Shoulder Pain and Musculoskeletal Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Interventions focused on the scapula have been frequently used to treat shoulder pain. However, most studies do not assess the contribution of scapular movement alteration for the symptoms. Objectives: To compare the effects of two interventions for shoulder pain: Scapular Movement Training and General Exercises. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Pain, Musculoskeletal Disease, Joint Disease
- What is being tested?
- Scapular Movement Training and General Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Aug 2018to 1 Nov 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Shoulder pain intensity ≥ 3 points on Numerical Rating Scale;
- Shoulder pain lasting ≥ 3 months;
- Scapular dyskinesis;
- Positive Scapular Assistance Test;
- Arm elevation ≥ 150°;
Who cannot join
- Body Mass index > 28Kg/m
- History of humerus, clavicle and scapula fracture and/or surgery;
- History of rotator cuff surgery or tears, shoulder dislocation, and instability;
- Frozen Shoulder;
- Neurological or systemic disease which may alter the muscle strength and sensibility;
- Positive Upper Limb Tension Test and/or Spurling's test
Show all 10Show fewer
- Pregnancy;
- Physical therapy within 6 months;
- Corticosteroid injection within 3 months
- Transpore tape allergy;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain: Randomized Controlled Trial
Interventions focused on the scapula have been frequently used to treat shoulder pain. However, most studies do not assess the contribution of scapular movement alteration for the symptoms.
Objectives: To compare the effects of two interventions for shoulder pain: Scapular Movement Training and General Exercises.
Read the detailed description
This is a double-blinded randomized controlled trial. Sixty-four subjects with shoulder pain, scapular dyskinesis, and positive scapular assistance test will be randomized in two groups: 1) Scapular Movement Training, and 2) General Exercises. The Scapular Movement Training Group will receive the orientation about proper scapular position and movement, and will be trained to modify the scapular movement pattern. The General Exercises Group will perform scapulothoracic stretching and strengthening exercises.
Both groups will be treated twice a week for eight weeks. The following outcomes will be collected at baseline and follow-up: scapular kinematics, electromyographic muscle activity of the upper, middle and lower trapezius, and serratus anterior, as well as pain intensity, function, and fear avoidance beliefs. Also, pain intensity, function, and fear-avoidance beliefs will be assessed at the fourth week of follow-up after the end of treatment's period.
- Conditions
- Shoulder Pain, Musculoskeletal Disease, Joint Disease, Shoulder Injury
- Being tested
- Scapular Movement Training, General Exercises
- Keywords
- Scapula, Physical Therapy, Movement, Rehabilitation
- Medical subject headings
- Shoulder Pain, Musculoskeletal Diseases, Joint Diseases, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular Movement TrainingOther
Also called Orientation and training
Orientation about the proper scapular position and movement and training to modify the scapular movement pattern.
General ExercisesOther
Also called Exercises
Strengthening and stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| Scapular Movement Training | Experimental | Orientation and scapular exercises, performed twice a week, for 8 weeks. Receives: Other: Scapular Movement Training |
| General Exercises | Active comparator | Scapulothoracic muscle stretching and strengthening exercises, performed twice a week, for 8 weeks. Receives: Other: General Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Three-Dimensional Scapular Kinematics from baseline to 8 weeks.
3-D Scapular kinematics (upward/downward rotation; internal/external rotation; anterior/posterior tilt) will be measured by an electromagnetic tracking system (in degrees).
Measured: Pre (baseline) and post Treatment (8 weeks)
Secondary outcomes (6)
Change in Muscle activity from baseline to 8 weeks.
Surface electromyographic recorded from scapulothoracic muscles (Upper trapezius, Middle Trapezius, Lower Trapezius and Serratus Anterior).
Measured: Pre (baseline) and post Treatment (8 weeks)
Change in Pain from baseline to 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), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Function from baseline to 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), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Fear-Avoidance Beliefs from baseline to 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), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Overall improvement of Symptoms from baseline to 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: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Kinesiophobia from baseline to 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), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start21 Aug 2018
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danilo Harudy Kamonseki, Universidade Federal de Sao Carlos
- Investigators
- Paula Camargo, PhD, Study director, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528499
- Sponsor's protocol ID
- 86974318.7.0000.5504
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamonseki DH, Haik MN, Ribeiro LP, Almeida RF, Camargo PR. Scapular movement training is not superior to standardized exercises in the treatment of individuals with chronic shoulder pain and scapular dyskinesis: randomized controlled trial. Disabil Rehabil. 2023 Sep;45(18):2925-2935. doi: 10.1080/09638288.2022.2114552. Epub 2022 Aug 24.
PubMed 36000960Kamonseki DH, Haik MN, Camargo PR. Scapular movement training versus standardized exercises for individuals with chronic shoulder pain: protocol for a randomized controlled trial. Braz J Phys Ther. 2021 Mar-Apr;25(2):221-229. doi: 10.1016/j.bjpt.2020.08.001. Epub 2020 Aug 18.
PubMed 32855073
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Movement Training Versus General Exercises for Individuals With Shoulder Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03528499
- Acronym / sponsor ID
- 86974318.7.0000.5504
- Conditions
- Shoulder Pain, Musculoskeletal Disease, Joint Disease, Shoulder Injury
- Keywords
- Scapula, Physical Therapy, Movement, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 17 May 2018 (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.
Interventions focused on the scapula have been frequently used to treat shoulder pain. However, most studies do not assess the contribution of scapular movement alteration for the symptoms.
Objectives: To compare the effects of two interventions for shoulder pain: Scapular Movement Training and General Exercises.
Detailed description
This is a double-blinded randomized controlled trial. Sixty-four subjects with shoulder pain, scapular dyskinesis, and positive scapular assistance test will be randomized in two groups: 1) Scapular Movement Training, and 2) General Exercises. The Scapular Movement Training Group will receive the orientation about proper scapular position and movement, and will be trained to modify the scapular movement pattern. The General Exercises Group will perform scapulothoracic stretching and strengthening exercises.
Both groups will be treated twice a week for eight weeks. The following outcomes will be collected at baseline and follow-up: scapular kinematics, electromyographic muscle activity of the upper, middle and lower trapezius, and serratus anterior, as well as pain intensity, function, and fear avoidance beliefs. Also, pain intensity, function, and fear-avoidance beliefs will be assessed at the fourth week of follow-up after the end of treatment's period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scapular Movement Training | Experimental | Other: Scapular Movement TrainingOrientation and scapular exercises, performed twice a week, for 8 weeks. |
| General Exercises | Active comparator | Other: General ExercisesScapulothoracic muscle stretching and strengthening exercises, performed twice a week, for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Shoulder pain intensity ≥ 3 points on Numerical Rating Scale;
- Shoulder pain lasting ≥ 3 months;
- Scapular dyskinesis;
- Positive Scapular Assistance Test;
- Arm elevation ≥ 150°;
Key exclusion criteria (10 listed)
- Body Mass index > 28Kg/m
- History of humerus, clavicle and scapula fracture and/or surgery;
- History of rotator cuff surgery or tears, shoulder dislocation, and instability;
- Frozen Shoulder;
- Neurological or systemic disease which may alter the muscle strength and sensibility;
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 |
|---|---|---|
| Scapular Movement TrainingAlso: Orientation and trainingOrientation about the proper scapular position and movement and training to modify the scapular movement pattern. | Other | Scapular Movement Training |
| General ExercisesAlso: ExercisesStrengthening and stretching exercises. | Other | General Exercises |
Primary outcome
Change in Three-Dimensional Scapular Kinematics from baseline to 8 weeks.
Time frame: Pre (baseline) and post Treatment (8 weeks)
3-D Scapular kinematics (upward/downward rotation; internal/external rotation; anterior/posterior tilt) will be measured by an electromagnetic tracking system (in degrees).
6 secondary outcomes
Change in Muscle activity from baseline to 8 weeks.
Time frame: Pre (baseline) and post Treatment (8 weeks)
Change in Pain from baseline to follow-up.
Time frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Function from baseline to follow-up.
Time frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Fear-Avoidance Beliefs from baseline to follow-up.
Time frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Overall improvement of Symptoms from baseline to follow-up.
Time frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Change in Kinesiophobia from baseline to follow-up
Time frame: Pre (baseline), 4 weeks, post Treatment (8 weeks), and follow-up (4 weeks after treatment )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 36000960Kamonseki DH, Haik MN, Ribeiro LP, Almeida RF, Camargo PR. Scapular movement training is not superior to standardized exercises in the treatment of individuals with chronic shoulder pain and scapular dyskinesis: randomized controlled trial. Disabil Rehabil. 2023 Sep;45(18):2925-2935. doi: 10.1080/09638288.2022.2114552. Epub 2022 Aug 24.
- Derived from this study: PubMed 32855073Kamonseki DH, Haik MN, Camargo PR. Scapular movement training versus standardized exercises for individuals with chronic shoulder pain: protocol for a randomized controlled trial. Braz J Phys Ther. 2021 Mar-Apr;25(2):221-229. doi: 10.1016/j.bjpt.2020.08.001. Epub 2020 Aug 18.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
Not yet recruitingPhase 4
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
Shoulder
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, Ansd Function
Shoulder Pain and Stiffness
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.
Paula Camargo, PhD study director
Universidade Federal de Sao 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 Scapular Movement Training and General Exercises in people with Shoulder Pain and Musculoskeletal Disease, run by Universidade Federal de Sao Carlos 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 9 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Three-Dimensional Scapular Kinematics from baseline to 8 weeks. (time frame: Pre (baseline) and post Treatment (8 weeks)). 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 NCT03528499, which also lists 2 linked publications.
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 9 Nov 2020.