Manual Physical Therapy and Exercise for Mechanical Neck Disorders
|ClinicalTrials.gov Identifier: NCT00416117|
Recruitment Status : Completed
First Posted : December 27, 2006
Last Update Posted : December 27, 2006
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain Radiculitis||Procedure: Manual Physical Therapy and Exercise Procedure: Minimal Intervention||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial|
|Study Start Date :||July 2001|
|Estimated Study Completion Date :||June 2004|
- Neck Disability Index
- Visual analog scale for neck pain
- Visual analog scale for upper extremity pain
- Global rating of change
- Treatment success rates based on GRC
- Additional healthcare utilization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416117
|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|
|Principal Investigator:||Michael J Walker, PT, DSc||Brooke Army Medical Center|