Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain

This study has been completed.
Sponsor:
Information provided by:
Newton-Wellesley Hospital
ClinicalTrials.gov Identifier:
NCT00128869
First received: August 9, 2005
Last updated: May 8, 2008
Last verified: May 2008
  Purpose

This study aims to compare whether or not there is a difference in the effectiveness of upper back (thoracic spine) mobilizations versus manipulations used in a population of patients with mechanical neck pain. The investigators 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 manipulations
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Newton-Wellesley Hospital:

Primary Outcome Measures:
  • Pain Diagram and Scale
  • Neck Disability Scale
  • Global Rating of Change Scale

Secondary Outcome Measures:
  • Side Effects Questionnaire

Estimated Enrollment: 96
Study Start Date: May 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with mechanical neck pain who meet the study's inclusion criteria, who do not meet the study's exclusion criteria will be offered an opportunity to participate in this 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 their 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 have been collected and the patient has met 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 patient's arms crossed over his/her chest. The therapist will pull the patient's arms downward to create spinal flexion down to the level where the manipulation will occur. The therapist's manipulative hand will stabilize the lower vertebrae of the motion segment and his/her body will be used to push down through the patient's 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 he/she will move onto the middle thoracic area. If a cavitation is not heard he/she will attempt a second time before moving on to the next area. Both areas will receive a maximum of two attempts. Once the manipulation or 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, rheumatoid arthritis (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, intrinsic 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 neck pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128869

Locations
United States, California
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
United States, Colorado
Centennial Physical Therapy-Colorado Sport and Spine Centers
Colorado Springs, Colorado, United States, 80919
United States, Massachusetts
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
United States, Minnesota
Groves Physical Therapy
Brooklyn Center, Minnesota, United States, 55430
Sponsors and Collaborators
Newton-Wellesley Hospital
Investigators
Principal Investigator: Paul E Glynn, DPT, OCS Newton-Wellesley Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00128869     History of Changes
Other Study ID Numbers: NO5-368
Study First Received: August 9, 2005
Last Updated: May 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Newton-Wellesley Hospital:
Manipulation
Mobilization
Neck Pain
Physical Therapy

Additional relevant MeSH terms:
Neck Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014