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Manual Physical Therapy and Exercise for Mechanical Neck Disorders

Primary Purpose

Neck Pain, Radiculitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Manual Physical Therapy and Exercise
Minimal Intervention
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Cervical pain, Radicular pain, Manual therapy, Mobilization, Manipulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary complaint of neck pain, with or without unilateral upper extremity symptoms
  • age greater than 18
  • Neck Disability Index (NDI) score greater than or equal to 10 points
  • Composite Visual Analog Scale (VAS) score greater than or equal to 30mm
  • Eligible for military health care
  • Reside within one hour of the military treatment facilities
  • Possess sufficient English language skills to complete all questionnaires

Exclusion Criteria:

  • whiplash injury within the past 6 weeks
  • history of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
  • pending legal action regarding their neck pain
  • diagnosis of central cervical spinal stenosis
  • bilateral upper extremity symptoms
  • two positive neurological findings at the same nerve root level

Sites / Locations

  • Brooke Army Medical Center
  • Wilford Hall Medical Center

Outcomes

Primary Outcome Measures

Neck Disability Index
Visual analog scale for neck pain
Visual analog scale for upper extremity pain
Global rating of change

Secondary Outcome Measures

Treatment success rates based on GRC
Additional healthcare utilization

Full Information

First Posted
December 26, 2006
Last Updated
December 26, 2006
Sponsor
Brooke Army Medical Center
Collaborators
59th Medical Wing
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1. Study Identification

Unique Protocol Identification Number
NCT00416117
Brief Title
Manual Physical Therapy and Exercise for Mechanical Neck Disorders
Official Title
The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Brooke Army Medical Center
Collaborators
59th Medical Wing

4. Oversight

5. Study Description

Brief Summary
Mounting evidence does support the combined use of manual physical therapy (MPT)and exercise for patients with cervicogenic headache and mechanical neck pain. However, there is insufficient evidence to assess the effectiveness of MPT and exercise for patients with neck disorders with radicular symptoms. Our purpose for this study was to determine the effectiveness of a manual physical therapy and exercise program as compared to a minimal intervention approach in the treatment of patients with mechanical neck pain, with or without upper extremity symptoms.
Detailed Description
Prior to randomization, potential participants underwent a standardized history and examination of the cervical spine and upper quarter. We collected demographic information that included each patient's age; gender; medication use; imaging results; and the location, nature, and duration of symptoms. Self-report measures included the NDI and VAS pain scales. Physical exam measures included cervical range of motion measurements with a gravity inclinometer, passive accessory motion testing to assess cervical spine segmental mobility and pain provocation, an upper quarter neurological screening, and special tests commonly used to identify cervical impairments. Participants meeting all inclusion criteria were randomized into one of two treatment groups: 1) manual physical therapy and exercise (MTE) or 2) minimal intervention (MI). Patients in the MTE group received manual physical therapy interventions specifically targeted to impairments identified during the physical examination. Physical therapists chose manual interventions consisting of thrust and non-thrust joint manipulation/mobilization, muscle energy, and soft-tissue mobilization/stretching techniques that are commonly referenced and used in clinical practice. We provided all patients in the MTE group with a standard home exercise program of cervical retraction, deep neck flexor strengthening, and cervical rotation range of motion exercises. Patients in the MI group received a basic treatment plan consistent with general practitioner care. We provided all patients with a basic regimen of postural advice, encouragement to maintain neck motion and daily activity levels, cervical rotation range of motion exercise, and instructions to continue any prescribed medication use. Minimalist physical therapy treatments consisted of sub-therapeutic pulsed (10%) ultrasound at 0.1w/cm2 for 10 minutes applied to the cervical spine and cervical rotation range of motion exercises. We provided these treatments to maintain the patients' expectations for physical therapy treatment and subsequent improvement, and to standardize the therapist-patient interaction time The intervention period lasted 3 weeks with both groups receiving treatment twice weekly for up to 6 sessions. We standardized treatment time for both groups by using a one-hour initial evaluation and treatment session and thirty-minute follow-up treatment sessions. Patients did not have to complete all six visits if their symptoms had fully resolved. The treating therapist instructed and supervised all exercises to ensure proper patient technique and understanding. We collected outcome measure data at baseline and at the patient's 3-week, 6-week and 1-year follow-ups. All outcome measures were collected by physical therapists that were blinded to treatment group allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Radiculitis
Keywords
Neck pain, Cervical pain, Radicular pain, Manual therapy, Mobilization, Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Manual Physical Therapy and Exercise
Intervention Type
Procedure
Intervention Name(s)
Minimal Intervention
Primary Outcome Measure Information:
Title
Neck Disability Index
Title
Visual analog scale for neck pain
Title
Visual analog scale for upper extremity pain
Title
Global rating of change
Secondary Outcome Measure Information:
Title
Treatment success rates based on GRC
Title
Additional healthcare utilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary complaint of neck pain, with or without unilateral upper extremity symptoms age greater than 18 Neck Disability Index (NDI) score greater than or equal to 10 points Composite Visual Analog Scale (VAS) score greater than or equal to 30mm Eligible for military health care Reside within one hour of the military treatment facilities Possess sufficient English language skills to complete all questionnaires Exclusion Criteria: whiplash injury within the past 6 weeks history of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery pending legal action regarding their neck pain diagnosis of central cervical spinal stenosis bilateral upper extremity symptoms two positive neurological findings at the same nerve root level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Walker, PT, DSc
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18923311
Citation
Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e.
Results Reference
derived

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Manual Physical Therapy and Exercise for Mechanical Neck Disorders

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