Clinical trial NCT03127839: Type of Exercise and Education in Patients With SubAcromial Pain Syndrome
Official title: The Effectiveness of Exercise and Education Type in Patients With SubAcromial Pain Syndrome (SAPS): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Exercise
Pain Neuroscience Education
Physical Therapy
Subacromial Pain
Rotator Cuff
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-04-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 65
2. Read and speak English well enough to provide informed consent, follow study instructions, and independently answer the questionnaires/surveys
3. TRICARE beneficiary (eligible for medical benefits in the Military Health System)
4. Primary complaint of new episode of unilateral shoulder pain; defined as not having sought care for shoulder condition in 6 months prior
5. Meets criteria for SAPS, as determined upon physical exam
6. At least 20% on either pain or disability subscales of the SPADI outcome measure
7. Available and willing to come in for treatment up to 8 sessions over a 4-week period

Exclusion Criteria:

1. 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)
2. Presence of cervical radiculopathy, radiculitis, or referral from cervical spine (reproduces shoulder symptoms)
3. Patient reports their condition is "acceptable" on Patient Acceptable Symptom State (PASS) at baseline
4. Anyone pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
5. Unable to give informed consent to participate in the study.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 1 year
Secondary outcomes:
measure: Patient Acceptable Symptom Scale (PASS)
timeFrame: 1 year
measure: Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0
timeFrame: 1 year
measure: Revised Neurophysiology of Pain Questionnaire (NPQ)
timeFrame: 6 weeks
measure: Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale
timeFrame: 1 year
measure: Healthcare Utilization
timeFrame: 2 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center
name: Daniel Rhon, DPT, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.