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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01092715
Enrollment
23
Registered
2010-03-25
Start date
2003-06-30
Completion date
2004-06-30
Last updated
2010-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

Neck pain, Spinal manipulation, Massage

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.

Interventions

Non thrust mobilization to the cervical spine

PROCEDUREMassage

Sedative massage to cervical paraspinal muscles

Range of motion exercises to include foraminal opening

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Neck Disability Index6 weeksNeck Disability Index score (patient generated score from questionnaire)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026