Manual Physical Therapy and Exercise for Mechanical Neck Disorders

Neck Pain Clinical Trial

Official title:

The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416117
• Other study ID #: C.2001.123
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 26, 2006
• Last updated: December 26, 2006
• Start date: July 2001
• Est. completion date: June 2004

Study information

• Verified date: December 2006
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain
• Radiculitis

Intervention

Procedure:
• Manual Physical Therapy and Exercise

• Minimal Intervention

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index
Primary	Visual analog scale for neck pain
Primary	Visual analog scale for upper extremity pain
Primary	Global rating of change
Secondary	Treatment success rates based on GRC
Secondary	Additional healthcare utilization