Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092715
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : March 25, 2010
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Neck Pain Procedure: Spinal mobilization Procedure: Massage Procedure: Neck exercises Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Neck Disability Index [ Time Frame: 6 weeks ]
    Neck Disability Index score (patient generated score from questionnaire)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01092715

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

Responsible Party: Ralph Gay, MD, Mayo Clinic Identifier: NCT01092715     History of Changes
Other Study ID Numbers: 1423-02
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: March 2010

Keywords provided by Mayo Clinic:
Neck pain
Spinal manipulation

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