Type of Exercise and Education in Patients With SubAcromial Pain Syndrome (SAPS)

July 13, 2022 updated by: Dan Rhon, Brooke Army Medical Center

The Effectiveness of Exercise and Education Type in Patients With SubAcromial Pain Syndrome (SAPS): A Randomized Controlled Trial

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78219
        • Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eccentric Strengthening Exercise
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.
Use of eccentric strengthening exercises in treatment plan during visits and at home.
Active Comparator: Traditional Strengthening Exercise
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.
Use of traditional strengthening exercises in treatment plan during visits and at home.
Active Comparator: Eccentric Exercise + 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.

Use of eccentric strengthening exercises in treatment plan during visits and at home.
Addition of pain neuroscience-focused education in addition to strengthening exercise program
Other Names:
  • Pain Neuroscience Education
  • Therapeutic Neuroscience Education
Active Comparator: Traditional Exercise + 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.

Use of traditional strengthening exercises in treatment plan during visits and at home.
Addition of pain neuroscience-focused education in addition to strengthening exercise program
Other Names:
  • Pain Neuroscience Education
  • Therapeutic Neuroscience Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Rhon, DPT, DSc, Director, Primary Care Musculoskeletal Research Center, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Requests for data must go through a Data Sharing Agreement Application submitted and approved through the Defense Health Agency

IPD Sharing Time Frame

DHA usually approves Data Sharing Agreements for 1 year at a time.

IPD Sharing Access Criteria

Requires a Data Sharing Agreement Application to be submitted through the US Defense Health Agency

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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