Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00835302
First received: February 2, 2009
Last updated: January 29, 2013
Last verified: February 2009
  Purpose

The investigators seek to develop a clinical prediction rule (CPR) to identify patients with a primary complaint of shoulder pain who are likely to benefit from manual therapy to the neck and upper back regions. Manual therapy will include mobilizations (therapist moves the joints in an oscillating fashion) and manipulations (therapist performs a high velocity low amplitude movement) The investigators hypothesize that a cluster of signs and symptoms from the subject history and physical examination will exist that maximize the accuracy of identifying patients with a primary complaint of shoulder pain likely to benefit from this manual therapy treatment based on a reference standard of patient-reported improvement.

The investigators also seek to investigate the psychometric properties (how good a test is), including test retest reliability of a modified version of the Fear Avoidance Beliefs Questionnaire (FABQ) and the shortened Tampa Scale for Kinesiophobia (TSK-11) in patients with shoulder pain. The investigators will also look at the convergent validity (determine if measures that should be related are in reality related) and discriminant validity (show that measures that should not be related are in reality not related) of the modified FABQ and the TSK-11 in patients with shoulder pain.


Condition Intervention Phase
Shoulder Pain
Procedure: Cervicothoracic manipulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation

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

Primary Outcome Measures:
  • Global Rating of Change (GROC) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Numerical Pain Rating Scale [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Painfree Shoulder Range of Motion [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2006
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manipulation + Exercise Group
Cervicothoracic manipulation and ROM exercises
Procedure: Cervicothoracic manipulation
Thrust and non-thrust manipulation to the cervical and thoracic spine
Other Name: Mobilization

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 at right)
  • Age between 18-65 years old
  • Shoulder Pain and Disability Index (SPADI) score greater than 20 points (full description of this measure provided in self report measures section)

Exclusion criteria:

  • Medical red flags noted in the patient's Medical Screening Questionnaire(i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, weight loss, fever, prolonged history of steroid use, etc.)
  • Acute fractures in the shoulder region.
  • Acute severe trauma to the cervical (neck) or thoracic (upper back) regions in the last 6 weeks.
  • Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).
  • 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.
  • Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
  • 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.
  • Insufficient English language skills to complete all questionnaires as they have only been validated in English.
  • Inability to comply with treatment and follow-up schedule
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00835302

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Wardenburg Health Center
Boulder, Colorado, United States, 80030
Physiotherapy Associates
Greenwood Village, Colorado, United States
United States, Massachusetts
Newton Wellesley Hospital
Newton, Massachusetts, United States
United States, Minnesota
Groves Physical Therapy
St. Paul, Minnesota, United States
United States, New Hampshire
Concord Hospital
Concord, New Hampshire, United States
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00835302     History of Changes
Other Study ID Numbers: 08-0220, 1543340
Study First Received: February 2, 2009
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Cervical
Thoracic
Manipulation
Mobilization
Clinical prediction rule
Shoulder pain.

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

ClinicalTrials.gov processed this record on October 29, 2014