This study aims to compare whether or not there is a difference in the effectiveness of upper back(thoracic spine)mobilizations vs manipulations used in a population of patients with mechanical neck pain. We hypothesize that patients receiving a manipulative technique will experience better outcomes than patients receiving the mobilization techniques and these results will be evident at a 48-hour follow-up.

Condition	Intervention	Phase
Neck Pain	Procedure: spine mobilizations  Procedure: spine manipulation	Phase I

Further Study Details: 

Primary Outcomes: Pain Diagram and Scale; Neck Disability Scale; Global Rating of Change Scale
Secondary Outcomes: Side Effects Questionnaire
Expected Total Enrollment:  96

Patients with mechanical neck pain who meet our inclusion criteria, who do not meet our exclusion criteria will be offered an opportunity to participate in our study. They will be issued an informed consent detailing the study and will have time to decide whether or not to participate. Once they have enlisted in the study they will complete forms to assess there current functional level. The investigator will then perform a standard clinical exam on the upper quarter to include a comprehensive subjective examination, upper extremity strength, reflexes, sensory assessment, cervical range of motion, thoracic range of motion and pain assessment. Once the above data has been collected and the patient has meet the criteria for the study, a second investigator will then choose a randomized and sealed envelope which will indicate the treatment to be performed. The patient will either receive mobilization or manipulation to the thoracic spine. Mobilizations will be performed in prone over the spinous processes of T1-T6. Each one will be performed for 30 seconds each with force directed posterioanterior. The manipulation will be performed in supine with the patients arms crossed over there chest. The therapist will pull the patients arms downward to create spinal flexion down to the level where the manipulation will occur. The therapists manipulative hand will stabilize the lower vertebrae of the motion segment and there body will be used to push down through the patients arms to perform a high velocity, low amplitude thrust of the superior vertebrae. The manipulation will first be attempted in the upper thoracic spine, if a cavitation is heard on the first attempt they will move onto the middle thoracic area. If a cavitation is not heard they will attempt a second time before moving on to the next area. Both area will receive a maximum of two attempts. Once the manipulation of mobilization is performed the patient will be assigned one home exercise which includes rotation of the cervical spine in both directions for 10 reps, 3-4 times per day. The patient will return within 48 hours for final data collection which will include a global rating of change scale completed both by the therapist and the patient, pain diagram and scale, neck disability index, cervical and thoracic range of motion measurements, and a side effects questionnaire. The patient will then be discharged from the study and will continue with Physical Therapy as deemed appropriate at the time of examination.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Primary complaint of neck pain with duration of symptoms greater than 4 weeks
• Age between 18-60 years old

Exclusion Criteria:

• Red flags from the medical neck screening questionnaire to include tumor, fracture, metabolic disease, RA, osteoporosis, prolonged history of steroid use.
• History of whiplash injury
• Diagnosis of cervical spinal stenosis
• Bilateral upper extremity symptoms
• Evidence of central nervous system involvement to include hyperreflexia, sensory disturbances in the hand, instrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes
• Two or more positive neurological signs consistent with nerve root compression to include muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity muscle stretch reflex, diminished or absent sensation to pinprick in any upper extremity dermatome
• Prior surgery to the neck or thoracic spine
• Pending legal action regarding their neck pain

Please refer to this study by ClinicalTrials.gov identifier  NCT00128869

Paul E Glynn, DPT, OCS      617-243-6172    pglynn@partners.org
Joshu Cleland, DPT, OCS       joshcleland@comcast.net

California
      Sharp Rees-Stealy Medical Group, San Diego,  California,  92123,  United States; Recruiting
Colorado
      Centennial Physical Therapy-Colorado Sport and Spine Centers, Colorado Springs,  Colorado,  80919,  United States; Recruiting
Massachusetts
      Newton-Wellesley Hospital, Newton,  Massachusetts,  02462,  United States; Recruiting
Minnesota
      Groves Physical Therapy, Brooklyn Center,  Minnesota,  55430,  United States; Recruiting

Study chairs or principal investigators

Paul E Glynn, DPT, OCS,  Principal Investigator,  Newton-Wellesley Hospital   

Study ID Numbers:  NO5-368
Last Updated:  August 9, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00128869
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23