Back to resultsType of Exercise and Education in Patients With SubAcromial Pain Syndrome (SAPS)
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric Strengthening
Traditional Strengthening
Pain education
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Exercise, Pain Neuroscience Education, Physical Therapy, Subacromial Pain, Rotator Cuff
Eligibility Criteria
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.
Sites / Locations
- Brooke Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Eccentric Strengthening Exercise
Traditional Strengthening Exercise
Eccentric Exercise + pain education
Traditional Exercise + pain education
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Shoulder Pain and Disability Index (SPADI)
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.
Secondary Outcome Measures
Patient Acceptable Symptom Scale (PASS)
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."
Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0
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.
Revised Neurophysiology of Pain Questionnaire (NPQ)
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.
Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale
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.
Healthcare Utilization
Shoulder-related healthcare costs
Full Information
NCT ID
NCT03127839
First Posted
April 17, 2017
Last Updated
July 13, 2022
Sponsor
Brooke Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03127839
Brief Title
Type of Exercise and Education in Patients With SubAcromial Pain Syndrome
Acronym
SAPS
Official Title
The Effectiveness of Exercise and Education Type in Patients With SubAcromial Pain Syndrome (SAPS): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients seeking care for shoulder pain will be recruited to enroll will be randomized to one of four combined treatment groups; eccentric or traditional strengthening alone and eccentric or traditional strengthening with pain neuroscience education. Patients will be followed for 1 year.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Exercise, Pain Neuroscience Education, Physical Therapy, Subacromial Pain, Rotator Cuff
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eccentric Strengthening Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional Strengthening Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Eccentric Exercise + pain education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional Exercise + pain education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Eccentric Strengthening
Intervention Description
Use of eccentric strengthening exercises in treatment plan during visits and at home.
Intervention Type
Procedure
Intervention Name(s)
Traditional Strengthening
Intervention Description
Use of traditional strengthening exercises in treatment plan during visits and at home.
Intervention Type
Behavioral
Intervention Name(s)
Pain education
Other Intervention Name(s)
Pain Neuroscience Education, Therapeutic Neuroscience Education
Intervention Description
Addition of pain neuroscience-focused education in addition to strengthening exercise program
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient Acceptable Symptom Scale (PASS)
Description
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."
Time Frame
1 year
Title
Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0
Description
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.
Time Frame
1 year
Title
Revised Neurophysiology of Pain Questionnaire (NPQ)
Description
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.
Time Frame
6 weeks
Title
Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale
Description
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.
Time Frame
1 year
Title
Healthcare Utilization
Description
Shoulder-related healthcare costs
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rhon, DPT, DSc
Organizational Affiliation
Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Requests for data must go through a Data Sharing Agreement Application submitted and approved through the Defense Health Agency
IPD Sharing Time Frame
DHA usually approves Data Sharing Agreements for 1 year at a time.
IPD Sharing Access Criteria
Requires a Data Sharing Agreement Application to be submitted through the US Defense Health Agency
IPD Sharing URL
https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application
Citations:
PubMed Identifier
27351548
Citation
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.
Results Reference
background
PubMed Identifier
26346332
Citation
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.
Results Reference
background
PubMed Identifier
22133255
Citation
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.
Results Reference
background
PubMed Identifier
22607807
Citation
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.
Results Reference
background
PubMed Identifier
25865088
Citation
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.
Results Reference
background
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Type of Exercise and Education in Patients With SubAcromial Pain Syndrome
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