Type of Exercise and Education in Patients With SubAcromial Pain Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Exercise Interventions in Adults With Subacromial Impingement Syndrome

NCT01508715

Shoulder Impingement Syndrome

COMPLETED NA

Self-Management for Persistent Subacromial Pain

NCT04190836

Shoulder Pain Chronic

COMPLETED PHASE1

Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome

NCT03468088

Impingement Syndrome, Shoulder

UNKNOWN NA

Dry Needling for Sub Acromial Pain Syndrome

NCT03442894

Subacromial Impingement Syndrome

COMPLETED NA

Exercise Into Pain in Subacromial Shoulder Pain

NCT04553289

Shoulder Impingement Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Eccentric Strengthening

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Traditional Strengthening

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Eccentric Strengthening

Intervention Type PROCEDURE

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

Pain education

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Traditional Strengthening

Intervention Type PROCEDURE

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

Pain education

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eccentric Strengthening

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

Intervention Type PROCEDURE

Traditional Strengthening

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

Intervention Type PROCEDURE

Pain education

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pain Neuroscience Education Therapeutic Neuroscience Education

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No