Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01092715
First received: March 23, 2010
Last updated: March 24, 2010
Last verified: March 2010

March 23, 2010
March 24, 2010
June 2003
June 2004   (final data collection date for primary outcome measure)
Neck Disability Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Neck Disability Index score (patient generated score from questionnaire)
Same as current
Complete list of historical versions of study NCT01092715 on ClinicalTrials.gov Archive Site
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Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain
A Comparison of Cervical Spine Mobilization and "Standard" Physical Therapy Intervention in the Treatment of Chronic Neck Pain, A Pilot Study

Neck pain is a common problem in our society, accounting for 20% of all chiropractic visits. Physical therapy interventions for chronic neck pain have been chosen based on the patient's symptoms and examination findings. These interventions include superficial and deep heat, massage, traction, manual therapy, and exercise programs. There is little controlled research addressing the efficacy of these therapies. Although many of these interventions provide some patients with pain relief and increased function, studies often utilize multiple interventions on the same subject such as heat, ultrasound, cervical traction, range of motion exercises, making interpretation of the results difficult. Much of the literature to date has focused on studies of subjects suffering from acute neck pain. Many of these studies suggest that subjects report decreased pain, decreased disability and increased cervical spine active range of motion. There are no controlled studies comparing the effects of spinal mobilization and standard physical therapy on subjects with chronic neck pain. The object of this study is two fold: 1) to determine the score variability of two neck disability questionnaires )both baseline and change scores) to be used in sample size calculations, and 2) to establish the ability to recruit, treat and follow sufficient numbers of subjects needed for a full clinical trial. The ability to predict outcomes of neck pain treatment will lead to more appropriate therapies and an avoidance of unnecessary treatments.

Background and Purpose: Chronic neck pain is a common problem. Studies of physical therapy for neck pain often utilize multiple interventions on the same subject making interpretation of the results difficult. The objectives of this study were two fold, 1) to establish the ability to recruit and treat subjects needed for a clinical trial of mobilization vs. massage for neck pain and 2) to estimate the variability of the Neck Disability Index (NDI) in a defined population of patients with neck pain and determine sample size for a trial. Subjects and

Methods: Subjects were randomized to either sedative massage (SM) to the neck and upper back or joint mobilization to the cervical spine (JM). All subjects also received moist heat and a home exercise program. Outcomes tracked for establishing trial feasibility included the number of referrals, number of referrals meeting inclusion criteria, number of subjects declining to participate and reasons for their refusal, acceptance rate of randomization, number of dropouts, and reasons for dropout. Descriptive statistics and baseline data were analyzed with means and standard deviations when appropriate. Groups were compared in regard to demographic and clinical characteristics only. The Neck Disability Index scores were calculated for pre-treatment, post-treatment, and change scores within each group.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Neck Pain
  • Procedure: Spinal mobilization
    Non thrust mobilization to the cervical spine
  • Procedure: Massage
    Sedative massage to cervical paraspinal muscles
  • Procedure: Neck exercises
    Range of motion exercises to include foraminal opening
  • Experimental: Mobilization
    Spinal mobilization and exercises
    Interventions:
    • Procedure: Spinal mobilization
    • Procedure: Neck exercises
  • Active Comparator: Massage
    Neck massage and exercises
    Interventions:
    • Procedure: Massage
    • Procedure: Neck exercises
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Neck pain of at least 12 weeks duration

Exclusion Criteria:

  • Signs and/or symptoms of cervical radiculopathy or myelopathy
  • Symptomatic shoulder pathology
  • History of cervical spine surgery
  • History of motor vehicle collision within the past three years
  • Recent neck or shoulder trauma
  • Fibromyalgia or generalized pain syndrome
  • History of cancer affecting the head or neck
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01092715
1423-02
No
Ralph Gay, MD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Timothy J Madson, PT Mayo Clinic
Study Director: Timothy J Madson, PT Mayo Clinic
Mayo Clinic
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP