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Manual Physical Therapy and Exercise for Mechanical Neck Disorders

This study has been completed.
Sponsor:
Collaborator:
Wilford Hall Medical Center
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00416117
First received: December 26, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 Intervention Phase
Neck Pain
Radiculitis
Procedure: Manual Physical Therapy and Exercise
Procedure: Minimal Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

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

Estimated Enrollment: 100
Study Start Date: July 2001
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00416117

Locations
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
Wilford Hall Medical Center
Investigators
Principal Investigator: Michael J Walker, PT, DSc Brooke Army Medical Center
  More Information

No publications provided by Brooke Army Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00416117     History of Changes
Other Study ID Numbers: C.2001.123
Study First Received: December 26, 2006
Last Updated: December 26, 2006
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Neck pain
Cervical pain
Radicular pain
Manual therapy
Mobilization
Manipulation

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

ClinicalTrials.gov processed this record on November 25, 2014