Manual Physical Therapy and Exercise for Mechanical Neck Disorders

Sponsor

Brooke Army Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00416117

Collaborator

59th Medical Wing (U.S. Fed)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

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:

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2001

Study Completion Date :

Jun 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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