Type of Exercise and Education in Patients With SubAcromial Pain Syndrome

NCT03127839 | Completed

• 1 other identifier: C.2017.018d
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Exercise; Pain Neuroscience Education; Physical Therapy; Subacromial Pain; Rotator Cuff

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Patient Acceptable Symptom Scale (PASS)

  1 year

• Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0

  1 year

• Revised Neurophysiology of Pain Questionnaire (NPQ)

  6 weeks

• Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale

  1 year

• Healthcare Utilization

  2 years

Study Arms (4)

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.

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.

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.

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.

Procedure: Traditional Strengthening; Behavioral: Pain education

Interventions

Eccentric Strengthening PROCEDURE

Use of eccentric strengthening exercises in treatment plan during visits and at home.

Eccentric Exercise + pain education; Eccentric Strengthening Exercise

Traditional Strengthening PROCEDURE

Use of traditional strengthening exercises in treatment plan during visits and at home.

Traditional Exercise + pain education; Traditional Strengthening Exercise

Pain education BEHAVIORAL

Addition of pain neuroscience-focused education in addition to strengthening exercise program

Also known as: Pain Neuroscience Education, Therapeutic Neuroscience Education

Eccentric Exercise + pain education; Traditional Exercise + pain education

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Related Publications (5)

• 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.

  PMID: 27351548 BACKGROUND

• 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.

  PMID: 26346332 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.

  PMID: 22133255 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.

  PMID: 22607807 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.

  PMID: 25865088 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Rhon, DPT, DSc

  Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Outcomes Research at the Center for the Intrepid

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 25, 2017
• Study Start: March 10, 2017
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: DHA usually approves Data Sharing Agreements for 1 year at a time.
• Access Criteria: Requires a Data Sharing Agreement Application to be submitted through the US Defense Health Agency

Locations

US (1)