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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Spinal mobilization; Procedure: Neck exercises; Procedure: Massage

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
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Dept of Physical Medicine & Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Neck exercises; Range of motion exercises to include foraminal opening; Procedure: Massage; Sedative massage to cervical paraspinal muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index	Neck Disability Index score (patient generated score from questionnaire)	6 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Timothy J Madson, PT, Mayo Clinic; Study Director: Timothy J Madson, PT, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (ACTUAL): June 1, 2004
• Study Completion (ACTUAL): June 1, 2004

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (ESTIMATE): March 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 25, 2010
• Last Update Submitted That Met QC Criteria: March 24, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Massage; Spinal manipulation; Neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 1423-02