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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eccentric Strengthening Exercise | Active Comparator | 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. |
|
| Traditional Strengthening Exercise | Active Comparator | 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. |
|
| Eccentric Exercise + pain education | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eccentric Strengthening | Procedure | Use of eccentric strengthening exercises in treatment plan during visits and at home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rhon, DPT, DSc | Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | San Antonio | Texas | 78219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27351548 | Background | 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. | |
| 26346332 | Background |
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Requests for data must go through a Data Sharing Agreement Application submitted and approved through the Defense Health Agency
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DHA usually approves Data Sharing Agreements for 1 year at a time.
Requires a Data Sharing Agreement Application to be submitted through the US Defense Health Agency
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2026 | |
| Reset | Jun 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2026 | Jun 23, 2026 |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| Traditional Exercise + pain education | Active Comparator | 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. |
|
| Traditional Strengthening | Procedure | Use of traditional strengthening exercises in treatment plan during visits and at home. |
|
| Pain education | Behavioral | Addition of pain neuroscience-focused education in addition to strengthening exercise program |
|
|
| 1 year |
| 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. | 1 year |
| 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. | 6 weeks |
| 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. | 1 year |
| Healthcare Utilization | Shoulder-related healthcare costs | 2 years |
| 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. |
| 22133255 | Background | 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. |
| 22607807 | Background | 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. |
| 25865088 | Background | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |