Shoulder PainCRISPNCT06536114
Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
A study testing CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries in people with Shoulder Pain and Shoulder Injuries, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, criteria-based approach (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Shoulder Injuries
- What is being tested?
- CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Active-duty Service members over the age of 18 who are seeking medical attention for shoulder pain or injury will be recruited to participate in this study.
Who cannot join
- The exclusion criteria include individuals who have sustained cervical or thoracic spine injury in the past year; an upper extremity or spine injury within the past year and have not been cleared to perform their previous duty requirements; a diagnosis of adhesive capsulitis; individuals referred to post-operative rehabilitation for the shoulder; individuals who are scheduled for shoulder surgery within the following 12 weeks; pain originating from a body region other than shoulder or is non-orthopaedic in nature; individuals who have sustained an upper extremity limb loss; individuals pending a medical evaluation board, discharge from the military, or pending litigation for an injury.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, criteria-based approach (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness. The main questions it aims to answer are:
- Are there differences in patient reported outcomes between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries?
- Are there differences in clinical measures (strength, etc.) between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries?
- Are there clinical or rehabilitation factors, or participant characteristics, that contribute to return to duty readiness?
Read more
Participants will be randomized to either complete their rehabilitation per the standard of care with a physical therapist in a Military Treatment Facility or complete the CRISP program with a research physical therapist. Participants will:
- Attend physical therapy for a non-operative shoulder injury
- Attend initial and final clinical assessments at the clinic
- Complete patient reported outcomes at 1-, 3-, 6- and 12-month timepoints
Read the detailed description
Without a data-driven pathway to assess and rehabilitate shoulder injuries, clinicians may be using time rather than criteria to guide rehabilitation and clearance for return to duty. Delayed return to duty and subsequent injury or surgery contribute to time lost from duty, negative financial implications for the Military Health System, and adversely affect Service members' mental health and quality of life. Therefore, we propose a study determining the optimal treatment progression to reduce unnecessary variability in management of non-operative of shoulder injuries for Service members through a phased, criteria-based clinical pathway: Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness.
To demonstrate the benefits of the CRISP program, we will determine the differences in physical, psychological, and quality of life patient-reported questionnaires, and clinical assessments of shoulder strength and function between the novel criteria-based rehabilitation program and the current standard of care for Service members with non-operative shoulder injuries within the Military Health System. To accomplish this, we will conduct a multi-site, single-blinded, randomized controlled trial in active duty Service members seeking care for a non-operative shoulder injury referred to physical therapy. We will recruit 250 Service members from the Naval Medical Forces (Pacific Region) and Brooke Army Medical Center/Center for the Intrepid. Participating Service members will complete clinical assessments and questionnaires at initial and final assessments; additionally, a link will be sent to participants to fill out questionnaires virtually at 1-, 3-, 6-, and 12-month time intervals. The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. This approach has three phases: stabilization, for joint protection; strength and endurance, for functional capacity; and power, to prepare the Service member for returning to previous level of duty. The standard of care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions. To our knowledge, this is the first study to compare a criteria-based exercise intervention approach to the usual standard of care for the conservative treatment of shoulder injuries as well as identifying factors which contribute to RTD readiness.
Without using a data-driven pathway to assess and rehabilitate shoulder injuries, Service members may experience a potential delay in returning to their previous military occupational specialty or deployability, and residual impairments may persist. In turn, this could lead to a higher incidence of re-injury or referral to surgical intervention. In the near-term, the findings from this study will enhance individual patient care within the MHS, accelerating return to duty for our Service members and with fewer physical limitations. We also anticipate our findings will help identify the predictors of shoulder function and return to duty readiness. This study's findings will directly influence patient care by elucidating which treatment paradigm optimizes shoulder function in Service members, ultimately leading to improvements in quality of life for Service members, reducing time lost from injuries, as well as maximizing Service members' readiness, unit cohesion, and mission accomplishment.
- Conditions
- Shoulder Pain, Shoulder Injuries
- Being tested
- CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries, Standard of Care
- Keywords
- shoulder, return-to-duty, physical therapy, rehabilitation
- Medical subject headings
- Shoulder Pain, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder InjuriesOther
The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. This approach has three phases: stabilization, to facilitate joint protection; strength and endurance, to optimize functional capacity; and power, to prepare the Service member for returning to previous level of duty.
Standard of CareOther
The Standard of Care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions.
| Study group | Role | What they receive |
|---|---|---|
| Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). | Experimental | The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. Receives: Other: CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries |
| Standard of Care | Active comparator | The standard of care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn Shoulder Score
Patient-reported outcome with shoulder pain, satisfaction, and function subscales
Measured: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Secondary outcomes (4)
Referral to Surgical Intervention
Participant was referred to surgical invention for their shoulder injury.
Measured: 3-, 6-, 12- months
Patient-Reported Outcomes Measurement Information System (PROMIS®)
Patient-reported outcome measuring physical, mental, and social health among individuals with various chronic conditions.
Measured: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Optimal Screening for Prediction of Referral and Outcome- Yellow Flag (OSPRO-YF)
The OSPRO-YF is a 10-item screening tool which incorporates several psychosocial domains, namely, mood, fear avoidance, and positive affect-coping.
Measured: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab Questionnaire
The Readiness Rehab Questionnaire assesses deployment readiness, containing questions including, "if called for a 6 month deployment today, my confidence to travel to/within a combat zone, carry/wear/use all required equipment and/or weapon, and perform required military duties for the duration of the 6 month deployment is:" and "my confidence to do my specific military duties with well managed pain is:__", both scored on 0-100 scales.
Measured: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Mar 2025 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Model description
- multi-site, single-blinded, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Brooke Army Medical Center, Congressionally Directed Medical Research Programs, Henry M. Jackson Foundation for the Advancement of Military Medicine, The Geneva Foundation
- Responsible party
- Sponsor
- Investigators
- Marisunta Pontillo, PhD, Principal investigator, Extremity Trauma and Amputation Center of Excellence, Defense Health Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536114
- Sponsor's protocol ID
- NMCSD.0024.0048
- Acronym
- CRISP
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barber P, Pontillo M, Bellm E, Davies G. Objective and subjective measures to guide upper extremity return to sport testing: A modified Delphi survey. Phys Ther Sport. 2023 Jul;62:17-24. doi: 10.1016/j.ptsp.2023.05.009. Epub 2023 May 27.
PubMed 37300969Owens BD, Dawson L, Burks R, Cameron KL. Incidence of shoulder dislocation in the United States military: demographic considerations from a high-risk population. J Bone Joint Surg Am. 2009 Apr;91(4):791-6. doi: 10.2106/JBJS.H.00514.
PubMed 19339562Pontillo M, Sennett BJ, Bellm E. USE OF AN UPPER EXTREMITY FUNCTIONAL TESTING ALGORITHM TO DETERMINE RETURN TO PLAY READINESS IN COLLEGIATE FOOTBALL PLAYERS: A CASE SERIES. Int J Sports Phys Ther. 2020 Dec;15(6):1141-1150. doi: 10.26603/ijspt20201141.
PubMed 33344031Pontillo M, Spinelli BA, Sennett BJ. Prediction of in-season shoulder injury from preseason testing in division I collegiate football players. Sports Health. 2014 Nov;6(6):497-503. doi: 10.1177/1941738114523239.
PubMed 25364482
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries
- ClinicalTrials.gov ID
- NCT06536114
- Acronym / sponsor ID
- CRISP / NMCSD.0024.0048
- Conditions
- Shoulder Pain, Shoulder Injuries
- Keywords
- shoulder, return-to-duty, physical therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Brooke Army Medical Center, Congressionally Directed Medical Research Programs, Henry M. Jackson Foundation for the Advancement of Military Medicine, The Geneva Foundation
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 2 Aug 2024 (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.
The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, criteria-based approach (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness. The main questions it aims to answer are:
- Are there differences in patient reported outcomes between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries?
- Are there differences in clinical measures (strength, etc.) between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries?
- Are there clinical or rehabilitation factors, or participant characteristics, that contribute to return to duty readiness?
Participants will be randomized to either complete their rehabilitation per the standard of care with a physical therapist in a Military Treatment Facility or complete the CRISP program with a research physical therapist. Participants will:
- Attend physical therapy for a non-operative shoulder injury
- Attend initial and final clinical assessments at the clinic
- Complete patient reported outcomes at 1-, 3-, 6- and 12-month timepoints
Detailed description
Without a data-driven pathway to assess and rehabilitate shoulder injuries, clinicians may be using time rather than criteria to guide rehabilitation and clearance for return to duty. Delayed return to duty and subsequent injury or surgery contribute to time lost from duty, negative financial implications for the Military Health System, and adversely affect Service members' mental health and quality of life. Therefore, we propose a study determining the optimal treatment progression to reduce unnecessary variability in management of non-operative of shoulder injuries for Service members through a phased, criteria-based clinical pathway: Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness.
To demonstrate the benefits of the CRISP program, we will determine the differences in physical, psychological, and quality of life patient-reported questionnaires, and clinical assessments of shoulder strength and function between the novel criteria-based rehabilitation program and the current standard of care for Service members with non-operative shoulder injuries within the Military Health System. To accomplish this, we will conduct a multi-site, single-blinded, randomized controlled trial in active duty Service members seeking care for a non-operative shoulder injury referred to physical therapy. We will recruit 250 Service members from the Naval Medical Forces (Pacific Region) and Brooke Army Medical Center/Center for the Intrepid. Participating Service members will complete clinical assessments and questionnaires at initial and final assessments; additionally, a link will be sent to participants to fill out questionnaires virtually at 1-, 3-, 6-, and 12-month time intervals. The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. This approach has three phases: stabilization, for joint protection; strength and endurance, for functional capacity; and power, to prepare the Service member for returning to previous level of duty. The standard of care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions. To our knowledge, this is the first study to compare a criteria-based exercise intervention approach to the usual standard of care for the conservative treatment of shoulder injuries as well as identifying factors which contribute to RTD readiness.
Without using a data-driven pathway to assess and rehabilitate shoulder injuries, Service members may experience a potential delay in returning to their previous military occupational specialty or deployability, and residual impairments may persist. In turn, this could lead to a higher incidence of re-injury or referral to surgical intervention. In the near-term, the findings from this study will enhance individual patient care within the MHS, accelerating return to duty for our Service members and with fewer physical limitations. We also anticipate our findings will help identify the predictors of shoulder function and return to duty readiness. This study's findings will directly influence patient care by elucidating which treatment paradigm optimizes shoulder function in Service members, ultimately leading to improvements in quality of life for Service members, reducing time lost from injuries, as well as maximizing Service members' readiness, unit cohesion, and mission accomplishment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- multi-site, single-blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). | Experimental | Other: CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder InjuriesThe CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. |
| Standard of Care | Active comparator | Other: Standard of CareThe standard of care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active-duty Service members over the age of 18 who are seeking medical attention for shoulder pain or injury will be recruited to participate in this study.
Key exclusion criteria (1 listed)
- The exclusion criteria include individuals who have sustained cervical or thoracic spine injury in the past year; an upper extremity or spine injury within the past year and have not been cleared to perform their previous duty requirements; a diagnosis of adhesive capsulitis; individuals referred to post-operative rehabilitation for the shoulder; individuals who are scheduled for shoulder surgery within the following 12 weeks; pain originating from a body region other than shoulder or is non-orthopaedic in nature; individuals who have sustained an upper extremity limb loss; individuals pending a medical evaluation board, discharge from the military, or pending litigation for an injury.
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 |
|---|---|---|
| CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder InjuriesThe CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. This approach has three phases: stabilization, to facilitate joint protection; strength and endurance, to optimize functional capacity; and power, to prepare the Service member for returning to previous level of duty. | Other | Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP). |
| Standard of CareThe Standard of Care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions. | Other | Standard of Care |
Primary outcome
Penn Shoulder Score
Time frame: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Patient-reported outcome with shoulder pain, satisfaction, and function subscales
4 secondary outcomes
Referral to Surgical Intervention
Time frame: 3-, 6-, 12- months
Patient-Reported Outcomes Measurement Information System (PROMIS®)
Time frame: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Optimal Screening for Prediction of Referral and Outcome- Yellow Flag (OSPRO-YF)
Time frame: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) Readiness Rehab Questionnaire
Time frame: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 37300969Barber P, Pontillo M, Bellm E, Davies G. Objective and subjective measures to guide upper extremity return to sport testing: A modified Delphi survey. Phys Ther Sport. 2023 Jul;62:17-24. doi: 10.1016/j.ptsp.2023.05.009. Epub 2023 May 27.
- Background: PubMed 19339562Owens BD, Dawson L, Burks R, Cameron KL. Incidence of shoulder dislocation in the United States military: demographic considerations from a high-risk population. J Bone Joint Surg Am. 2009 Apr;91(4):791-6. doi: 10.2106/JBJS.H.00514.
- Background: PubMed 33344031Pontillo M, Sennett BJ, Bellm E. USE OF AN UPPER EXTREMITY FUNCTIONAL TESTING ALGORITHM TO DETERMINE RETURN TO PLAY READINESS IN COLLEGIATE FOOTBALL PLAYERS: A CASE SERIES. Int J Sports Phys Ther. 2020 Dec;15(6):1141-1150. doi: 10.26603/ijspt20201141.
- Background: PubMed 25364482Pontillo M, Spinelli BA, Sennett BJ. Prediction of in-season shoulder injury from preseason testing in division I collegiate football players. Sports Health. 2014 Nov;6(6):497-503. doi: 10.1177/1941738114523239.
- Individual participant dataSharing planned: No
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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.
Marisunta Pontillo, PhD principal investigator
Extremity Trauma and Amputation Center of Excellence, Defense Health Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries in people with Shoulder Pain and Shoulder Injuries, run by United States Naval Medical Center, San Diego 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marisunta Pontillo, PhD (215-266-1904, marisunta.l.pontillo.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn Shoulder Score (time frame: Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization). 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 NCT06536114, which also lists 4 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 2 Aug 2024.