Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries

NCT06536114 | Not Yet Recruiting

• 1 other identifier: NMCSD.0024.0048
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Shoulder Pain; Shoulder Injuries

Keywords

shoulder; return-to-duty; physical therapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Penn Shoulder Score

  Patient-reported outcome with shoulder pain, satisfaction, and function subscales

  Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization

Secondary Outcomes (4)

• Referral to Surgical Intervention

  3-, 6-, 12- months

• Patient-Reported Outcomes Measurement Information System (PROMIS®)

  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)

  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

  Initial and final clinical study assessments; 1-, 3-, 6- and 12-months post-randomization

Study Arms (2)

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.

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.

Other: Standard of Care

Interventions

CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries OTHER

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.

Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP).

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Brooke Army Medical Center: collaborator
• Congressionally Directed Medical Research Programs: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator
• The Geneva Foundation: collaborator

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (4)

• 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.

  PMID: 37300969 BACKGROUND

• Owens 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.

  PMID: 19339562 BACKGROUND

• Pontillo 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.

  PMID: 33344031 BACKGROUND

• Pontillo 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.

  PMID: 25364482 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marisunta Pontillo, PhD

  Extremity Trauma and Amputation Center of Excellence, Defense Health Agency

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisunta Pontillo, PhD

CONTACT

215-266-1904; marisunta.l.pontillo.civ@health.mil

Sara Gorczynski

CONTACT

619-532-9704; sara.r.gorczynski.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not be a physical therapist and thus not involved with the participant's medical treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: multi-site, single-blinded, randomized controlled trial

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 2, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)