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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01999283
Other study ID # WSUPT2013A
Secondary ID
Status Completed
Phase N/A
First received November 19, 2013
Last updated November 25, 2013
Start date July 2010
Est. completion date May 2013

Study information

Verified date November 2013
Source Wayne State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Yoga Group Exercise
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.
Pilates Group Mat Exercise
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.

Locations

Country Name City State
United States Equilibrium Studio Bloomfield Hills Michigan
United States Wayne State University Detroit Michigan
United States Oakland Physical Therapy Novi Michigan
United States Older Persons Commission Rochester Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants with identified potential for adverse drug responses Descriptive analysis of number of participants with potential for adverse drug responses based on review of medication by Pharmacist Baseline Yes
Other Identification of frequency of types of medication use in individuals with chronic neck pain Descriptive analysis of medication used both for pain relief and co-morbidities Baseline No
Other Frequency of types of potential adverse drug responses in patients with chronic mechanical neck pain Identification of potential adverse drug responses by Pharmacist from medication review Baseline Yes
Primary Change from baseline Neck Disability Index Self reported Neck Disability Index questionnaire Baseline, 6 weeks, 12 weeks, 18 weeks No
Secondary Change in Number of days of pain medication use in the past week Self report Baseline, week 6, week 12 No
Secondary 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) Baseline, week 6, week 12, week 18 No
Secondary Change from baseline Cervical range of motion measurements Measured with the Cervical Range of Motion instrument (CROM) Baseline, week 6, week 12, week 18 No
Secondary 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. Baseline, week 6, week 12, week 18 No
Secondary 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 Baseline, week 6, week 12, week 18 No
Secondary 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. Baselin, week 6, week 12, week 18 No
Secondary Change from baseline in Activities Balance Confidence Scale score Self reported confidence in maintaining balance for functional activities. Baseline, week 6, week 12, week 18 No
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