Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain

NCT ID: NCT01092715

Last Updated: 2010-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2004-06-30

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.

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mobilization

Spinal mobilization and exercises

Group Type: EXPERIMENTAL

Spinal mobilization

Intervention Type: PROCEDURE

Non thrust mobilization to the cervical spine

Neck exercises

Intervention Type: PROCEDURE

Range of motion exercises to include foraminal opening

Massage

Neck massage and exercises

Group Type: ACTIVE_COMPARATOR

Massage

Intervention Type: PROCEDURE

Sedative massage to cervical paraspinal muscles

Neck exercises

Intervention Type: PROCEDURE

Range of motion exercises to include foraminal opening

Interventions

Spinal mobilization

Non thrust mobilization to the cervical spine

Intervention Type: PROCEDURE

Massage

Sedative massage to cervical paraspinal muscles

Intervention Type: PROCEDURE

Neck exercises

Range of motion exercises to include foraminal opening

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Timothy J Madson, PT

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Timothy J Madson, PT

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

Mayo Clinic Dept of Physical Medicine & Rehabilitation

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

1423-02

Identifier Type: -

Identifier Source: org_study_id