Type of Exercise and Education in Patients With SubAcromial Pain Syndrome

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Procedure: Eccentric Strengthening; Procedure: Traditional Strengthening; Behavioral: Pain education

• Registration Number: NCT03127839
• Lead Sponsor: Brooke Army Medical Center

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eccentric Strengthening Exercise	Eccentric Strengthening	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.
Eccentric Exercise + pain education	Pain education	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.
Traditional Strengthening Exercise	Traditional Strengthening	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.
Eccentric Exercise + pain education	Eccentric Strengthening	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.
Traditional Exercise + pain education	Traditional Strengthening	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.
Traditional Exercise + pain education	Pain education	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.

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Acceptable Symptom Scale (PASS)	1 year	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."
Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0	1 year	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.
Revised Neurophysiology of Pain Questionnaire (NPQ)	6 weeks	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.
Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale	1 year	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.
Healthcare Utilization	2 years	Shoulder-related healthcare costs

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States