The Effectiveness of Exercise and Education Type in Patients With SubAcromial Pain Syndrome (SAPS): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Eccentric Strengthening (Procedure)
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.
干预措施: Traditional Strengthening (Procedure)
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.
干预措施: Eccentric Strengthening (Procedure)
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.
干预措施: Pain education (Behavioral)
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.
干预措施: Traditional Strengthening (Procedure)
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.
干预措施: Pain education (Behavioral)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: 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.
次要结局
- Patient Acceptable Symptom Scale (PASS)(1 year)
- Patient Reported Outcomes Measurement Information System 57-Item Profile (PROMIS-57) v2.0(1 year)
- Revised Neurophysiology of Pain Questionnaire (NPQ)(6 weeks)
- Survey of Pain Attitudes-35 (SOPA-35); 5-item Harm Scale(1 year)
- Healthcare Utilization(2 years)
研究者
Dan Rhon
Director of Clinical Outcomes Research at the Center for the Intrepid
Brooke Army Medical Center