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Trial record 22 of 28 for:    Developmental Disabilities | ( Map: Minnesota, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00835302
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

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 or disease Intervention/treatment Phase
Shoulder Pain Procedure: Cervicothoracic manipulation Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Global Rating of Change (GROC) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Shoulder Pain and Disability Index (SPADI) [ Time Frame: 7 days ]
  2. Numerical Pain Rating Scale [ Time Frame: 7 days ]
  3. Painfree Shoulder Range of Motion [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00835302

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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT00835302     History of Changes
Other Study ID Numbers: 08-0220
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: February 2009
Keywords provided by University of Colorado, Denver:
Clinical prediction rule
Shoulder pain.
Additional relevant MeSH terms:
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Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms