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

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
spine mobilizations
spine manipulations
Sponsored by
Newton-Wellesley Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Manipulation, Mobilization, Neck Pain, Physical Therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Rees-Stealy Medical Group
  • Centennial Physical Therapy-Colorado Sport and Spine Centers
  • Newton-Wellesley Hospital
  • Groves Physical Therapy

Outcomes

Primary Outcome Measures

Pain Diagram and Scale
Neck Disability Scale
Global Rating of Change Scale

Secondary Outcome Measures

Side Effects Questionnaire

Full Information

First Posted
August 9, 2005
Last Updated
May 8, 2008
Sponsor
Newton-Wellesley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00128869
Brief Title
Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain
Official Title
Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Newton-Wellesley Hospital

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Manipulation, Mobilization, Neck Pain, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
spine mobilizations
Intervention Type
Procedure
Intervention Name(s)
spine manipulations
Primary Outcome Measure Information:
Title
Pain Diagram and Scale
Title
Neck Disability Scale
Title
Global Rating of Change Scale
Secondary Outcome Measure Information:
Title
Side Effects Questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Glynn, DPT, OCS
Organizational Affiliation
Newton-Wellesley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Centennial Physical Therapy-Colorado Sport and Spine Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Groves Physical Therapy
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9122645
Citation
Norlander S, Aste-Norlander U, Nordgren B, Sahlstedt B. Mobility in the cervico-thoracic motion segment: an indicative factor of musculo-skeletal neck-shoulder pain. Scand J Rehabil Med. 1996 Dec;28(4):183-92.
Results Reference
background
PubMed Identifier
9271151
Citation
Norlander S, Gustavsson BA, Lindell J, Nordgren B. Reduced mobility in the cervico-thoracic motion segment--a risk factor for musculoskeletal neck-shoulder pain: a two-year prospective follow-up study. Scand J Rehabil Med. 1997 Sep;29(3):167-74.
Results Reference
background
PubMed Identifier
9825389
Citation
Norlander S, Nordgren B. Clinical symptoms related to musculoskeletal neck-shoulder pain and mobility in the cervico-thoracic spine. Scand J Rehabil Med. 1998 Dec;30(4):243-51. doi: 10.1080/003655098443995.
Results Reference
background
Citation
Flynn TW, Wainner RS, Whitman JM. Immediate effects of thoracic spine manipulation on cervical range of motion and pain. Journal or Manual and Manipulative Therapy. 9(3), 164-171. 2001
Results Reference
result
PubMed Identifier
15922233
Citation
Cleland JA, Childs JD, McRae M, Palmer JA, Stowell T. Immediate effects of thoracic manipulation in patients with neck pain: a randomized clinical trial. Man Ther. 2005 May;10(2):127-35. doi: 10.1016/j.math.2004.08.005.
Results Reference
result
Links:
URL
http://www.APTA.org
Description
American Physical Therapy Association Web Site
URL
http://aaompt.org
Description
American Academy of Orthopaedic Manual Physical Therapy web site

Learn more about this trial

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

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