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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
  Purpose

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.


Condition Intervention Phase
Neck Pain
Procedure: Spinal mobilization
Procedure: Massage
Procedure: Neck exercises
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Cervical Spine Mobilization and "Standard" Physical Therapy Intervention in the Treatment of Chronic Neck Pain, A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Neck Disability Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Neck Disability Index score (patient generated score from questionnaire)


Enrollment: 23
Study Start Date: June 2003
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mobilization
Spinal mobilization and exercises
Procedure: Spinal mobilization
Non thrust mobilization to the cervical spine
Procedure: Neck exercises
Range of motion exercises to include foraminal opening
Active Comparator: Massage
Neck massage and exercises
Procedure: Massage
Sedative massage to cervical paraspinal muscles
Procedure: Neck exercises
Range of motion exercises to include foraminal opening

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092715

Locations
United States, Minnesota
Mayo Clinic Dept of Physical Medicine & Rehabilitation
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Timothy J Madson, PT Mayo Clinic
Study Director: Timothy J Madson, PT Mayo Clinic
  More Information

No publications provided

Responsible Party: Ralph Gay, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01092715     History of Changes
Other Study ID Numbers: 1423-02
Study First Received: March 23, 2010
Last Updated: March 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Neck pain
Spinal manipulation
Massage

Additional relevant MeSH terms:
Neck Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014