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Effect of Group Pilates and Yoga Exercise Classes for Chronic Cervical Pain (Pilates/Yoga)

Primary Purpose

Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Group Exercise
Pilates Group Mat Exercise
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Pain focused on measuring Cervical pain, yoga, pilates, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Equilibrium Studio
  • Wayne State University
  • Oakland Physical Therapy
  • Older Persons Commission

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Yoga Group Exercise

Pilates Group Mat Exercise

Control

Arm Description

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.

Pilates mat exercise will be taught by a licensed Physical Therapist with additional Rehabilitation Pilates certification.

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.

Outcomes

Primary Outcome Measures

Change from baseline Neck Disability Index
Self reported Neck Disability Index questionnaire

Secondary Outcome Measures

Change in Number of days of pain medication use in the past week
Self report
Change from baseline in Neck Pain Ratings (NPR) experienced on average over the past week
Average pain experienced over the past week (general, worst pain and experienced with functional activities - sustained positions, upper extremity movement, work, recreation)
Change from baseline Cervical range of motion measurements
Measured with the Cervical Range of Motion instrument (CROM)
Change from baseline differences between habitual and self corrected postural position
Sagittal plane position measured for Upper Cervical angle, forward head position, and thoracic width using the Cervical range of motion device.
Change from baseline in time for the Timed up and go test
Time to stand from a chair and walk to a standardized distance, return and sit down
Change from baseline Dynamic Gait Index score
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.
Change from baseline in Activities Balance Confidence Scale score
Self reported confidence in maintaining balance for functional activities.

Full Information

First Posted
November 19, 2013
Last Updated
November 25, 2013
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT01999283
Brief Title
Effect of Group Pilates and Yoga Exercise Classes for Chronic Cervical Pain
Acronym
Pilates/Yoga
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain
Keywords
Cervical pain, yoga, pilates, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pilates Group Mat Exercise
Arm Type
Active Comparator
Arm Description
Pilates mat exercise will be taught by a licensed Physical Therapist with additional Rehabilitation Pilates certification.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga Group Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates Group Mat Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Neck Disability Index
Description
Self reported Neck Disability Index questionnaire
Time Frame
Baseline, 6 weeks, 12 weeks, 18 weeks
Secondary Outcome Measure Information:
Title
Change in Number of days of pain medication use in the past week
Description
Self report
Time Frame
Baseline, week 6, week 12
Title
Change from baseline in Neck Pain Ratings (NPR) experienced on average over the past week
Description
Average pain experienced over the past week (general, worst pain and experienced with functional activities - sustained positions, upper extremity movement, work, recreation)
Time Frame
Baseline, week 6, week 12, week 18
Title
Change from baseline Cervical range of motion measurements
Description
Measured with the Cervical Range of Motion instrument (CROM)
Time Frame
Baseline, week 6, week 12, week 18
Title
Change from baseline differences between habitual and self corrected postural position
Description
Sagittal plane position measured for Upper Cervical angle, forward head position, and thoracic width using the Cervical range of motion device.
Time Frame
Baseline, week 6, week 12, week 18
Title
Change from baseline in time for the Timed up and go test
Description
Time to stand from a chair and walk to a standardized distance, return and sit down
Time Frame
Baseline, week 6, week 12, week 18
Title
Change from baseline Dynamic Gait Index score
Description
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.
Time Frame
Baselin, week 6, week 12, week 18
Title
Change from baseline in Activities Balance Confidence Scale score
Description
Self reported confidence in maintaining balance for functional activities.
Time Frame
Baseline, week 6, week 12, week 18
Other Pre-specified Outcome Measures:
Title
Number of participants with identified potential for adverse drug responses
Description
Descriptive analysis of number of participants with potential for adverse drug responses based on review of medication by Pharmacist
Time Frame
Baseline
Title
Identification of frequency of types of medication use in individuals with chronic neck pain
Description
Descriptive analysis of medication used both for pain relief and co-morbidities
Time Frame
Baseline
Title
Frequency of types of potential adverse drug responses in patients with chronic mechanical neck pain
Description
Identification of potential adverse drug responses by Pharmacist from medication review
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Dunleavy, PhD, PT, OCS
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Equilibrium Studio
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48301
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Oakland Physical Therapy
City
Novi
State/Province
Michigan
ZIP/Postal Code
48374
Country
United States
Facility Name
Older Persons Commission
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26435334
Citation
Dunleavy K, Kava K, Goldberg A, Malek MH, Talley SA, Tutag-Lehr V, Hildreth J. Comparative effectiveness of Pilates and yoga group exercise interventions for chronic mechanical neck pain: quasi-randomised parallel controlled study. Physiotherapy. 2016 Sep;102(3):236-42. doi: 10.1016/j.physio.2015.06.002. Epub 2015 Aug 13.
Results Reference
derived

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Effect of Group Pilates and Yoga Exercise Classes for Chronic Cervical Pain

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