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Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Spinal mobilization
Massage
Neck exercises
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Spinal manipulation, Massage

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Dept of Physical Medicine & Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobilization

Massage

Arm Description

Spinal mobilization and exercises

Neck massage and exercises

Outcomes

Primary Outcome Measures

Neck Disability Index
Neck Disability Index score (patient generated score from questionnaire)

Secondary Outcome Measures

Full Information

First Posted
March 23, 2010
Last Updated
March 24, 2010
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01092715
Brief Title
Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain
Official Title
A Comparison of Cervical Spine Mobilization and "Standard" Physical Therapy Intervention in the Treatment of Chronic Neck Pain, A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, Spinal manipulation, Massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobilization
Arm Type
Experimental
Arm Description
Spinal mobilization and exercises
Arm Title
Massage
Arm Type
Active Comparator
Arm Description
Neck massage and exercises
Intervention Type
Procedure
Intervention Name(s)
Spinal mobilization
Intervention Description
Non thrust mobilization to the cervical spine
Intervention Type
Procedure
Intervention Name(s)
Massage
Intervention Description
Sedative massage to cervical paraspinal muscles
Intervention Type
Procedure
Intervention Name(s)
Neck exercises
Intervention Description
Range of motion exercises to include foraminal opening
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
Neck Disability Index score (patient generated score from questionnaire)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Madson, PT
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy J Madson, PT
Organizational Affiliation
Mayo Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Dept of Physical Medicine & Rehabilitation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain

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