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Manual Physical Therapy and Exercise for Mechanical Neck Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416117
Recruitment Status : Completed
First Posted : December 27, 2006
Last Update Posted : December 27, 2006
59th Medical Wing
Information provided by:
Brooke Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Neck Pain Radiculitis Procedure: Manual Physical Therapy and Exercise Procedure: Minimal Intervention Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial
Study Start Date : July 2001
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Neck Disability Index
  2. Visual analog scale for neck pain
  3. Visual analog scale for upper extremity pain
  4. Global rating of change

Secondary Outcome Measures :
  1. Treatment success rates based on GRC
  2. Additional healthcare utilization

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416117

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United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236
Sponsors and Collaborators
Brooke Army Medical Center
59th Medical Wing
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Principal Investigator: Michael J Walker, PT, DSc Brooke Army Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00416117    
Other Study ID Numbers: C.2001.123
First Posted: December 27, 2006    Key Record Dates
Last Update Posted: December 27, 2006
Last Verified: December 2006
Keywords provided by Brooke Army Medical Center:
Neck pain
Cervical pain
Radicular pain
Manual therapy
Additional relevant MeSH terms:
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Neck Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases