Manual Physical Therapy and Exercise for Mechanical Neck Disorders

NCT00416117 | Completed Phase 2

• 1 other identifier: C.2001.123
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain; Radiculitis

Keywords

Neck pain; Cervical pain; Radicular pain; Manual therapy; Mobilization; Manipulation

Outcome Measures

Primary Outcomes (4)

• Neck Disability Index

• Visual analog scale for neck pain

• Visual analog scale for upper extremity pain

• Global rating of change

Secondary Outcomes (2)

• Treatment success rates based on GRC

• Additional healthcare utilization

Interventions

Manual Physical Therapy and Exercise PROCEDURE

Minimal Intervention PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• 59th Medical Wing: collaborator

Study Sites (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (1)

• Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e.

  PMID: 18923311 DERIVED

MeSH Terms

Conditions

Neck Pain; Radiculopathy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael J Walker, PT, DSc

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 26, 2006
• First Posted: December 27, 2006
• Study Start: July 1, 2001
• Study Completion: June 1, 2004
• Last Updated: December 27, 2006

Record last verified: 2006-12

Locations

US (2)