Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization

Completed · Phase 1

Conditions studied: Neck Pain

In brief

Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.

Key facts

Study ID

NCT00504686

Run by

Franklin Pierce University

People needed

140

Starts

2007-01-01

Expected to finish

2008-12-01

Last updated by the study team

2009-02-03

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following inclusion criteria will be used to determine eligibility for this study:
• Primary complaint of neck pain with or without unilateral upper extremity symptoms
• Age between 18-60 years old
• NDI score greater than 10 points

You may not qualify if…

• The following exclusion criteria will be used to determine ineligibility for this study:
• Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
• History of whiplash injury within the past six weeks
• Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
• 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.
• 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 reflex)
• Diminished or absent sensation to pinprick in any upper extremity dermatome

Where it is running

• Concord Hospital — Concord, New Hampshire, United States

Full record on ClinicalTrials.gov

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