Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial

Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial

Sponsors

Lead sponsor: University of Colorado, Denver

Collaborator: Virginia Commonwealth University
University of Colorado, Boulder
Northern Navajo Medical Center
Gundersen Lutheran Health System
Waldron’s Peak Physical Therapy
Temple University

Source 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.

Overall Status Completed
Start Date January 2012
Completion Date June 2015
Primary Completion Date December 2014
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Shoulder Pain and Disability Index (SPADI) Score 1 week, 4 weeks, 6 months
Secondary Outcome
Measure Time Frame
Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH) 1 week, 4 weeks and 6 months
Global Rating of Change (GROC) 1 week, 4 weeks, 6 months
Change in the Numeric Pain Rating Scale (NPRS) 1 week, 4 weeks, 6 months
Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ) 1 week, 4 weeks, 6 months
Enrollment 140
Condition
Intervention

Intervention type: Procedure

Intervention name: Manipulation + Exercise Group

Description: First 2 sessions High-velocity, low-amplitude manipulations to the thoracic spine. Low-velocity mid to end-range mobilizations to the cervical spine. Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program

Arm group label: Manipulation + Exercise Group

Intervention type: Procedure

Intervention name: Exercise Group

Description: First 2 sessions ◦ Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program

Eligibility

Criteria:

Inclusion Criteria:

1. 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)

2. Age between 18-65 years old

3. Shoulder Pain and Disability (SPADI) score > 20 points

Exclusion Criteria:

1. 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.)

2. Acute fractures in the shoulder region.

3. Acute severe trauma in the cervical or thoracic region in the last 6 weeks.

4. Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).

5. 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.

6. Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms

7. 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

8. Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation.

9. Insufficient English language skills to complete all questionnaires

10. Inability to comply with treatment and follow-up schedule

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Paul Mintken, DPT Principal Investigator University of Colorado, Denver
Location
facility
University of Colorado Denver | Aurora, Colorado, 80045, United States
Waldron's Peak Physical Therapy | Boulder, Colorado, 80303, United States
Wardenburg Health Center at the University of Colorado | Boulder, Colorado, 80303, United States
Franklin Pierce University | Concord, New Hampshire, 03461, United States
Northern Navajo Medical Center | Shiprock, New Mexico, 87420, United States
Temple University | Philadelphia, Pennsylvania, 19140, United States
VCUHS- Virginia Commonwealth University Health System | Richmond, Virginia, 23298, United States
University of Puget Sound | Tacoma, Washington, 98416, United States
Gundersen Lutheran | Onalaska, Wisconsin, 54650, United States
Location Countries

United States

Verification Date

May 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Manipulation + Exercise Group

Arm group type: Experimental

Description: 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.

Arm group label: Exercise Group

Arm group type: Active Comparator

Description: The exercise group will be treated with a stretching and strengthening program.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov