- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01999283
Effect of Group Pilates and Yoga Exercise Classes for Chronic Cervical Pain (Pilates/Yoga)
November 25, 2013 updated by: Kim Dunleavy PhD, PT, OCS, Wayne State University
Effect of Group Pilates and Yoga Exercise Classes on Function, Range of Motion, Endurance, Postural Position, Medication Use and Balance in Adults With Chronic Cervical Pain
Exercise has been found to be effective in alleviating back and neck pain.
Two exercise methods which are available in the community in a group format are Yoga and Pilates.
While there is some research on the efficacy of these exercise methods for low back pain, there is no definitive research on the use of Yoga or Pilates group exercise for individuals with chronic cervical pain.This study investigated the effect of group Yoga and Pilates exercise compared to a wait-listed control group on impairments and function related to neck pain for individuals with chronic cervical pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Individuals reporting chronic mild to moderate neck pain for more than 3 months were assigned to a pilates, yoga or wait-listed control group.
The exercise group consisted of 12 one hour small group sessions instructed by experienced Physical Therapists with additional yoga or pilates training.
Participants were evaluated at baseline, 6 weeks, and 12 weeks.
Exercise participants also completed a follow up 6 weeks after completion.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Bloomfield Hills, Michigan, United States, 48301
- Equilibrium Studio
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Detroit, Michigan, United States, 48201
- Wayne State University
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Novi, Michigan, United States, 48374
- Oakland Physical Therapy
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Rochester, Michigan, United States, 48307
- Older Persons Commission
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to attend at 12 exercise class sessions (once a week for an hour)
- Stable moderate to severe neck pain (3/10- 8/10) present for > 3 months
- Able to get up and down off the floor
- Able to ambulate in the community without an assistive device
- Medically stable and cleared to participate in exercise
Exclusion Criteria:
- Neck Pain that is easily aggravated with exercise
- Neurological symptoms in the arms or legs (numbness, tingling, weakness)
- History of recent whiplash, spine surgery, diagnosed osteoporosis, cervical stenosis with leg symptoms
- Any medical conditions which does not allow active exercise
- Unable to make medical decisions independently or have memory problems
- Regularly attending Pilates or Yoga classes or individual sessions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Yoga Group Exercise
Yoga group exercise will be taught by a licensed Physical Therapist.
Groups consist of 4-8 individuals with 12 sessions once weekly over 12 weeks.
|
Yoga poses and postures modified to diminish stress on the cervical region and improve flexibility.
Breathing and mind-body focus to address stress-related discomfort.
A general Hatha yoga style will be used with components from Ashtanga Yoga.
Intensity and range of motion will be progressively increased as tolerated.
|
|
ACTIVE_COMPARATOR: Pilates Group Mat Exercise
Pilates mat exercise will be taught by a licensed Physical Therapist with additional Rehabilitation Pilates certification.
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The Pilates mat exercises focus on both spinal muscle activation and stability, progressive endurance of the stabilizing muscles with arm and leg challenges and dynamic mobility.
The exercises are progressed from more supported to anti-gravity position, slow increases in arm weights and flexibility.
|
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NO_INTERVENTION: Control
Wait Listed control group.
Participants complete the same testing and were offered the option of attending the exercise classes on completion.
The controls were not included in the exercise groups after completion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline Neck Disability Index
Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks
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Self reported Neck Disability Index questionnaire
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Baseline, 6 weeks, 12 weeks, 18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Number of days of pain medication use in the past week
Time Frame: Baseline, week 6, week 12
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Self report
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Baseline, week 6, week 12
|
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Change from baseline in Neck Pain Ratings (NPR) experienced on average over the past week
Time Frame: Baseline, week 6, week 12, week 18
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Average pain experienced over the past week (general, worst pain and experienced with functional activities - sustained positions, upper extremity movement, work, recreation)
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Baseline, week 6, week 12, week 18
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Change from baseline Cervical range of motion measurements
Time Frame: Baseline, week 6, week 12, week 18
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Measured with the Cervical Range of Motion instrument (CROM)
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Baseline, week 6, week 12, week 18
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Change from baseline differences between habitual and self corrected postural position
Time Frame: Baseline, week 6, week 12, week 18
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Sagittal plane position measured for Upper Cervical angle, forward head position, and thoracic width using the Cervical range of motion device.
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Baseline, week 6, week 12, week 18
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Change from baseline in time for the Timed up and go test
Time Frame: Baseline, week 6, week 12, week 18
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Time to stand from a chair and walk to a standardized distance, return and sit down
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Baseline, week 6, week 12, week 18
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Change from baseline Dynamic Gait Index score
Time Frame: Baselin, week 6, week 12, week 18
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Series of functional gait activities including walking, walking at different speeds, stepping over and around an obstacle, turning the head and tilting the head while walking scored by an observer.
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Baselin, week 6, week 12, week 18
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Change from baseline in Activities Balance Confidence Scale score
Time Frame: Baseline, week 6, week 12, week 18
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Self reported confidence in maintaining balance for functional activities.
|
Baseline, week 6, week 12, week 18
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with identified potential for adverse drug responses
Time Frame: Baseline
|
Descriptive analysis of number of participants with potential for adverse drug responses based on review of medication by Pharmacist
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Baseline
|
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Identification of frequency of types of medication use in individuals with chronic neck pain
Time Frame: Baseline
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Descriptive analysis of medication used both for pain relief and co-morbidities
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Baseline
|
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Frequency of types of potential adverse drug responses in patients with chronic mechanical neck pain
Time Frame: Baseline
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Identification of potential adverse drug responses by Pharmacist from medication review
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kim Dunleavy, PhD, PT, OCS, Wayne State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (ESTIMATE)
December 3, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
December 3, 2013
Last Update Submitted That Met QC Criteria
November 25, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WSUPT2013A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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