- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03127839
Type of Exercise and Education in Patients With SubAcromial Pain Syndrome (SAPS)
The Effectiveness of Exercise and Education Type in Patients With SubAcromial Pain Syndrome (SAPS): A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients seeking care for their shoulder in a primary care setting will be recruited to participate in a trial investigating the value of different exercise and education regimens. Patients that choose to participate will be randomized to 1 of 4 different treatment groups focused on strengthening of the rotator cuff and shoulder girdle muscles: eccentric strengthening alone; traditional strengthening alone; eccentric strengthening plus education focused on pain neuroscience, traditional strengthening plus education focused on pain neuroscience. All patients will be seen in the clinic for 4-6 sessions over a 4-week period, as well receive a home exercise program that aligns with the exercise group there were randomized to.
One-year outcomes will be compared across all 4 groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78219
- Brooke Army Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 to 65
- Read and speak English well enough to provide informed consent, follow study instructions, and independently answer the questionnaires/surveys
- TRICARE beneficiary (eligible for medical benefits in the Military Health System)
- Primary complaint of new episode of unilateral shoulder pain; defined as not having sought care for shoulder condition in 6 months prior
- Meets criteria for SAPS, as determined upon physical exam
- At least 20% on either pain or disability subscales of the SPADI outcome measure
- Available and willing to come in for treatment up to 8 sessions over a 4-week period
Exclusion Criteria:
- History of shoulder dislocation, subluxation, fracture, adhesive capsulitis of the glenohumeral joint, or cervical/shoulder/upper back surgery, or shoulder injury as the result of trauma (e.g. fall, MVA)
- Presence of cervical radiculopathy, radiculitis, or referral from cervical spine (reproduces shoulder symptoms)
- Patient reports their condition is "acceptable" on Patient Acceptable Symptom State (PASS) at baseline
- Anyone pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
- Unable to give informed consent to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Eccentric Strengthening Exercise
Patients will be asked to complete at least 6 outpatient PT sessions over a 4-week period.
This will include an individualized impairment-focused approach, utilizing eccentric strengthening exercises of the rotator cuff to address any impairments or reinforce any standard of care manual treatment.
Patients will also be given a home exercise program with instructions so that they can perform the eccentric strengthening exercises daily at home.
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Use of eccentric strengthening exercises in treatment plan during visits and at home.
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Active Comparator: Traditional Strengthening Exercise
Patients will be asked to complete at least 6 outpatient PT sessions over a 4-week period.
This will include an individualized impairment-focused approach, utilizing traditional rotator cuff strengthening exercises to address any impairments or reinforce any standard of care manual treatment.
Patients will also be given a home exercise program with instructions so that they can perform the traditional rotator cuff strengthening exercises daily at home.
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Use of traditional strengthening exercises in treatment plan during visits and at home.
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Active Comparator: Eccentric Exercise + pain education
In addition to the treatment provided in the "Eccentric Exercise" Arm patients will receive additional self-management training education focused on neuroscience of pain principles. This will include e a 5-minute video called "Understanding pain in less than 5 minutes, and what to do about it!", or aka "explain pain" video. The patients will also receive an interactive education booklet and review session with their PT, a series of weekly e-mails that reinforce key components of the booklet and video; and reinforcing messages when in the clinic doing their exercises. |
Use of eccentric strengthening exercises in treatment plan during visits and at home.
Addition of pain neuroscience-focused education in addition to strengthening exercise program
Other Names:
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Active Comparator: Traditional Exercise + pain education
In addition to the treatment provided in the "Traditional Exercise" Arm patients will receive additional self-management training education focused on neuroscience of pain principles. This will include e a 5-minute video called "Understanding pain in less than 5 minutes, and what to do about it!", or aka "explain pain" video. The patients will also receive an interactive education booklet and review session with their PT, a series of weekly e-mails that reinforce key components of the booklet and video; and reinforcing messages when in the clinic doing their exercises. |
Use of traditional strengthening exercises in treatment plan during visits and at home.
Addition of pain neuroscience-focused education in addition to strengthening exercise program
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Pain and Disability Index (SPADI)
Time Frame: 1 year
|
This is a 100-point, 13-item self-administered questionnaire.
It is divided into two subscales: a five-item pain subscale and an eight-item disability subscale.
It is responsive to change and accurately discriminates between patients who are improving or worsening and has been reported to have a high test-retest reliability and internal consistency.
A recent systematic review that compared four common shoulder questionnaires determined the SPADI was strongly correlated with the Disabilities of the Arm and Hand (DASH), American Shoulder and Elbow Surgeons (ASES) questionnaires and suitable for clinical use.
The systematic review identified a minimal detectable change of 18 and a minimally clinically important difference of between 8-13 points.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Acceptable Symptom Scale (PASS)
Time Frame: 1 year
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Often defined as "the highest level of symptoms beyond which patients consider themselves well."
This outcome measure has been used in previous studies looking at the effects of cervical thoracic thrust manipulation on shoulder pain.
The question that will be asked to assess this level is, "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?"
Individuals who respond "yes" will be categorized as a success; thus, anyone reporting "yes" at baseline will be excluded from participation in the study.
Between group differences at four time points will be assessed as percentage of subjects who find their current state acceptable, or answering "yes."
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1 year
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Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0
Time Frame: 1 year
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The PROMIS 57 efficiently assesses several outcomes important to patients including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input.
This is a 57-item questionnaire with 8 questions per domain.
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1 year
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Revised Neurophysiology of Pain Questionnaire (NPQ)
Time Frame: 6 weeks
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The revised NPQ is a 12-item questionnaire that assesses a patient's understanding about pain and how it is produced in the body.
The 12-item version was derived from the original 19-item Moseley Pain Questionnaire, after the removal of 7 items that did not function properly, and was found to have good test-retest reliability.
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6 weeks
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Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale
Time Frame: 1 year
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The full SOPA-35 is a 35-item shortened questionnaire from the original SOPA-57.
The SOPA-35 Harm Scale is a subset of 5 items from the SOPA-35.
This subset measures a person's belief that pain indicates damage and that activity can cause harm.
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1 year
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Healthcare Utilization
Time Frame: 2 years
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Shoulder-related healthcare costs
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Rhon, DPT, DSc, Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center
Publications and helpful links
General Publications
- Dejaco B, Habets B, van Loon C, van Grinsven S, van Cingel R. Eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy: a randomized, single blinded, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):2051-2059. doi: 10.1007/s00167-016-4223-x. Epub 2016 Jun 28.
- Blume C, Wang-Price S, Trudelle-Jackson E, Ortiz A. COMPARISON OF ECCENTRIC AND CONCENTRIC EXERCISE INTERVENTIONS IN ADULTS WITH SUBACROMIAL IMPINGEMENT SYNDROME. Int J Sports Phys Ther. 2015 Aug;10(4):441-55.
- Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Hanratty CE, McVeigh JG, Kerr DP, Basford JR, Finch MB, Pendleton A, Sim J. The effectiveness of physiotherapy exercises in subacromial impingement syndrome: a systematic review and meta-analysis. Semin Arthritis Rheum. 2012 Dec;42(3):297-316. doi: 10.1016/j.semarthrit.2012.03.015. Epub 2012 May 18.
- Hsiao MS, Cameron KL, Tucker CJ, Benigni M, Blaine TA, Owens BD. Shoulder impingement in the United States military. J Shoulder Elbow Surg. 2015 Sep;24(9):1486-92. doi: 10.1016/j.jse.2015.02.021. Epub 2015 Apr 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.2017.018d
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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