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Completed

NCT Number: NCT03127839

Type of Exercise and Education in Patients With SubAcromial Pain Syndrome

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.

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Key information

Conditions

Shoulder Pain Arthralgia Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Eccentric Strengthening

Procedure

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

Traditional Strengthening

Procedure

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

Pain education

Behavioral

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

Other names: Pain Neuroscience Education, Therapeutic Neuroscience Education

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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."

  2. 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.

  3. 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.

  4. 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.

  5. Healthcare Utilization

    Time frame: 2 years

    Shoulder-related healthcare costs

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

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

Acronym: SAPS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2017
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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