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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Virginia Commonwealth University
University of Colorado, Boulder
Northern Navajo Medical Center
Gundersen Lutheran Health System
Waldron’s Peak Physical Therapy
Temple University
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01571674
First received: March 30, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Shoulder Pain
Procedure: Manipulation + Exercise Group
Procedure: Exercise Group
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change in Shoulder Pain and Disability Index (SPADI) Score [ Time Frame: 1 week, 4 weeks, 6 months ] [ Designated as safety issue: No ]
    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:
  • Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH) [ Time Frame: 1 week, 4 weeks and 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 week, 4 weeks, 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 week, 4 weeks, 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 week, 4 weeks, 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 140
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: Manipulation + Exercise Group

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

Procedure: Exercise Group

First 2 sessions

◦ Active Range of Motion Exercises for the cervicothoracic spine

Final 6 sessions

◦ Evidence based shoulder girdle exercise program

Active Comparator: Exercise Group
The exercise group will be treated with a stretching and strengthening program.
Procedure: Exercise Group

First 2 sessions

◦ Active Range of Motion Exercises for the cervicothoracic spine

Final 6 sessions

◦ Evidence based shoulder girdle exercise program


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, we will determine if the addition of cervicothoracic SMT to exercise improves outcomes as compared to exercise alone.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571674

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Waldron's Peak Physical Therapy
Boulder, Colorado, United States, 80303
Wardenburg Health Center at the University of Colorado
Boulder, Colorado, United States, 80303
United States, New Hampshire
Franklin Pierce University
Concord, New Hampshire, United States, 03461
United States, New Mexico
Northern Navajo Medical Center
Shiprock, New Mexico, United States, 87420
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Virginia
VCUHS- Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
United States, Washington
University of Puget Sound
Tacoma, Washington, United States, 98416
United States, Wisconsin
Gundersen Lutheran
Onalaska, Wisconsin, United States, 54650
Sponsors and Collaborators
University of Colorado, Denver
Virginia Commonwealth University
University of Colorado, Boulder
Northern Navajo Medical Center
Gundersen Lutheran Health System
Waldron’s Peak Physical Therapy
Temple University
  More Information

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01571674     History of Changes
Other Study ID Numbers: 12-0040
Study First Received: March 30, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Cervical
Clinical Prediction Rule
Exercise
Manipulation
Manual therapy
Mobilization
Physical Therapy
Prognosis
Shoulder pain
Thoracic

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014