A Phase 2 interventional study of Spinal mobilization and Massage in Neck Pain, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-03-25.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 23 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.
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Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria:
Spinal mobilization and exercises
Procedure: Spinal mobilization · Procedure: Neck exercises
Neck massage and exercises
Procedure: Massage · Procedure: Neck exercises
Non thrust mobilization to the cervical spine
Sedative massage to cervical paraspinal muscles
Range of motion exercises to include foraminal opening
Neck Disability Index
Neck Disability Index score (patient generated score from questionnaire)
Time frame: 6 weeks
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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