Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
- Conditions
- Shoulder Pain
- Interventions
- Procedure: Manipulation + Exercise GroupProcedure: Exercise Group
- Registration Number
- NCT01571674
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
The purpose of this study is to determine the validity of previously identified prognostic variables that may identify patients with shoulder pain that are likely to benefit from cervicothoracic spine manipulation.
- Detailed Description
The investigators have recently identified prognostic variables in a preliminary Clinical Prediction Rule (CPR) that are purported to identify patients with shoulder pain who respond favorably to cervicothoracic spinal manipulative therapy (SMT) and daily home exercises of cervical and thoracic active range of motion exercises. These prognostic variables have been identified in a single study, and therefore it is not known if these factors will be valid in a different group of patients, even ones with similar characteristics as those used in the investigators' initial exploratory study. Further study of these identified factors is needed for validation in an independent sample of patients, which will improve generalizability for clinical practice. In this study, patients with a primary complaint of shoulder pain will be randomly assigned to receive cervicothoracic spine manipulation followed by therapeutic exercises or therapeutic exercise alone. If the variables are in fact meaningful, patients who exhibit 3 or more of the identified prognostic variables and receive cervicothoracic SMT should experience improved outcomes compared to patients who have less than 3 of these variables and receive the same intervention. Additionally, patients who exhibit 3 or more of the identified variables that receive cervicothoracic SMT should also have superior outcomes to patients who exhibit 3 or more of the identified variables and receive an alternate intervention (exercise only). Finally, the investigators will determine if the addition of cervicothoracic SMT to exercise improves outcomes as compared to exercise alone.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- Primary complaint of shoulder pain (defined as pain between the neck and the elbow at rest or during movement of the upper arm, see diagram to the right)
- Age between 18-65 years old
- Shoulder Pain and Disability (SPADI) score > 20 points
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Medical red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
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Acute fractures in the shoulder region.
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Acute severe trauma in the cervical or thoracic region in the last 6 weeks.
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Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).
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Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
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Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
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Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Muscle weakness involving a major muscle group of the upper extremity
- Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps brachii reflexes)
- Diminished or absent sensation to pinprick in any upper extremity dermatome
-
Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation.
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Insufficient English language skills to complete all questionnaires
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Inability to comply with treatment and follow-up schedule
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manipulation + Exercise Group Exercise Group The treatment received by the manipulation+exercise group will differ from the exercise group for the first week only (two treatment sessions). During the first two sessions, patients in the manipulation+exercise group will receive cervicothoracic spine manipulations and range of motion (ROM) exercises only. Beginning on the third session these patients will receive the same exercise program as the exercise group. Exercise Group Exercise Group The exercise group will be treated with a stretching and strengthening program. Manipulation + Exercise Group Manipulation + Exercise Group The treatment received by the manipulation+exercise group will differ from the exercise group for the first week only (two treatment sessions). During the first two sessions, patients in the manipulation+exercise group will receive cervicothoracic spine manipulations and range of motion (ROM) exercises only. Beginning on the third session these patients will receive the same exercise program as the exercise group.
- Primary Outcome Measures
Name Time Method Change in Shoulder Pain and Disability Index (SPADI) Score 1 week, 4 weeks, 6 months The SPADI is a 13 item questionnaire. The pain domain consists of five questions and the disability domain consists of eight. Each question refers to the past week.
- Secondary Outcome Measures
Name Time Method Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH) 1 week, 4 weeks and 6 months The QuickDASH4 is an eleven-item questionnaire that addresses symptoms and physical function in people with any or multiple disorders involving the upper limb.
Global Rating of Change (GROC) 1 week, 4 weeks, 6 months The GROC asks patients to rate whether their health condition has improved or deteriorated over time to determine the efficacy of a particular treatment. Scores range from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Change in the Numeric Pain Rating Scale (NPRS) 1 week, 4 weeks, 6 months An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain". Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ) 1 week, 4 weeks, 6 months The FABQ is a 16-item questionnaire designed to quantify fear and avoidance beliefs in patients with musculoskeletal disorders. The FABQ has two sub-scales, a 7-item scale to measure fear-avoidance beliefs about work and a 4-item scale to measure fear-avoidance beliefs about physical activity. Each item is scored from 0-6 with possible scores ranging between 0-24 and 0-42 for the physical activity and work subscales, respectively, with higher scores representing increased fear-avoidance beliefs.
Trial Locations
- Locations (9)
Franklin Pierce University
🇺🇸Concord, New Hampshire, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Waldron's Peak Physical Therapy
🇺🇸Boulder, Colorado, United States
Wardenburg Health Center at the University of Colorado
🇺🇸Boulder, Colorado, United States
University of Puget Sound
🇺🇸Tacoma, Washington, United States
Northern Navajo Medical Center
🇺🇸Shiprock, New Mexico, United States
VCUHS- Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Gundersen Lutheran
🇺🇸Onalaska, Wisconsin, United States