Shoulder PainSAPSNCT03127839
Type of Exercise and Education in Patients With SubAcromial Pain Syndrome
A study testing Eccentric Strengthening, Traditional Strengthening and Pain education in people with Shoulder Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Eccentric Strengthening, Traditional Strengthening and Pain education
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2017to 30 Apr 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78219
About this study
Official title: The Effectiveness of Exercise and Education Type in Patients With SubAcromial Pain Syndrome (SAPS): A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Eccentric Strengthening, Traditional Strengthening, Pain education
- Keywords
- Exercise, Pain Neuroscience Education, Physical Therapy, Subacromial Pain, Rotator Cuff
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric StrengtheningProcedure or surgery
Use of eccentric strengthening exercises in treatment plan during visits and at home.
Traditional StrengtheningProcedure or surgery
Use of traditional strengthening exercises in treatment plan during visits and at home.
Pain educationBehavioural
Also called Pain Neuroscience Education, Therapeutic Neuroscience Education
Addition of pain neuroscience-focused education in addition to strengthening exercise program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Eccentric Strengthening |
| 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. Receives: Procedure: Traditional Strengthening |
| 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. Receives: Procedure: Eccentric Strengthening; Behavioral: Pain education |
| 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. Receives: Procedure: Traditional Strengthening; Behavioral: Pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Healthcare Utilization
Shoulder-related healthcare costs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start10 Mar 2017
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dan Rhon, Brooke Army Medical Center
- Investigators
- Daniel Rhon, DPT, DSc, Principal investigator, Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127839
- Sponsor's protocol ID
- C.2017.018d
- Acronym
- SAPS
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2017
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for data must go through a Data Sharing Agreement Application submitted and approved through the Defense Health Agency
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.
PubMed 27351548Blume 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.
PubMed 26346332Louw 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.
PubMed 22133255Hanratty 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.
PubMed 22607807Hsiao 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.
PubMed 25865088
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exercise and Education Type in Patients With SubAcromial Pain Syndrome (SAPS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03127839
- Acronym / sponsor ID
- SAPS / C.2017.018d
- Conditions
- Shoulder Pain
- Keywords
- Exercise, Pain Neuroscience Education, Physical Therapy, Subacromial Pain, Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 25 Apr 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eccentric Strengthening Exercise | Active comparator | Procedure: Eccentric StrengtheningPatients 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 | Procedure: Traditional StrengtheningPatients 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 | Procedure: Eccentric Strengthening, Behavioral: Pain educationIn 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. |
| Traditional Exercise + pain education | Active comparator | Procedure: Traditional Strengthening, Behavioral: Pain educationIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Eccentric StrengtheningUse of eccentric strengthening exercises in treatment plan during visits and at home. | Procedure or surgery | Eccentric Exercise + pain education, Eccentric Strengthening Exercise |
| Traditional StrengtheningUse of traditional strengthening exercises in treatment plan during visits and at home. | Procedure or surgery | Traditional Exercise + pain education, Traditional Strengthening Exercise |
| Pain educationAlso: Pain Neuroscience Education, Therapeutic Neuroscience EducationAddition of pain neuroscience-focused education in addition to strengthening exercise program | Behavioural | Eccentric Exercise + pain education, Traditional Exercise + pain education |
Primary outcome
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.
5 secondary outcomes
Patient Acceptable Symptom Scale (PASS)
Time frame: 1 year
Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0
Time frame: 1 year
Revised Neurophysiology of Pain Questionnaire (NPQ)
Time frame: 6 weeks
Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale
Time frame: 1 year
Healthcare Utilization
Time frame: 2 years
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 3 Jul 2025.
- Background: PubMed 27351548Dejaco 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.
- Background: PubMed 26346332Blume 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.
- Background: PubMed 22133255Louw 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.
- Background: PubMed 22607807Hanratty 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.
- Background: PubMed 25865088Hsiao 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.
- Individual participant dataSharing planned: Yes. Requests for data must go through a Data Sharing Agreement Application submitted and approved through the Defense Health Agency
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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.
Daniel Rhon, DPT, DSc principal investigator
Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Strengthening, Traditional Strengthening and Pain education in people with Shoulder Pain, run by Brooke Army Medical Center at 1 site in United States.
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 7 inclusion and 5 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 3 Jul 2025. 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 United States. 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?
Shoulder Pain and Disability Index (SPADI) (time frame: 1 year). 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 NCT03127839, which also lists 5 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 3 Jul 2025.