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 currently recruiting participants.
Verified November 2012 by University of Colorado, Denver
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: November 20, 2012
Last verified: November 2012

March 30, 2012
November 20, 2012
June 2012
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01571674 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Shoulder Pain
  • 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

  • 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.
    Interventions:
    • Procedure: Manipulation + Exercise Group
    • Procedure: Exercise Group
  • Active Comparator: Exercise Group
    The exercise group will be treated with a stretching and strengthening program.
    Intervention: Procedure: Exercise Group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Amy McDevitt, DPT (303) 902-3312 amy.mcdevitt@ucdenver.edu
Contact: Paul Mintken, DPT (303) 724-9545 paul.mintken@ucdenver.ecu
United States
 
NCT01571674
12-0040
Yes
University of Colorado, Denver
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
Not Provided
University of Colorado, Denver
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP