NCT01999283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
Last Updated

December 3, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

November 19, 2013

Last Update Submit

November 25, 2013

Conditions

Keywords

Cervical painyogapilatesexercise

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Neck Disability Index

    Self reported Neck Disability Index questionnaire

    Baseline, 6 weeks, 12 weeks, 18 weeks

Secondary Outcomes (7)

  • Change in Number of days of pain medication use in the past week

    Baseline, week 6, week 12

  • Change from baseline in Neck Pain Ratings (NPR) experienced on average over the past week

    Baseline, week 6, week 12, week 18

  • Change from baseline Cervical range of motion measurements

    Baseline, week 6, week 12, week 18

  • Change from baseline differences between habitual and self corrected postural position

    Baseline, week 6, week 12, week 18

  • Change from baseline in time for the Timed up and go test

    Baseline, week 6, week 12, week 18

  • +2 more secondary outcomes

Other Outcomes (3)

  • Number of participants with identified potential for adverse drug responses

    Baseline

  • Identification of frequency of types of medication use in individuals with chronic neck pain

    Baseline

  • Frequency of types of potential adverse drug responses in patients with chronic mechanical neck pain

    Baseline

Study Arms (3)

Yoga Group Exercise

ACTIVE COMPARATOR

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.

Other: Yoga Group Exercise

Pilates Group Mat Exercise

ACTIVE COMPARATOR

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

Other: Pilates Group Mat Exercise

Control

NO INTERVENTION

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.

Interventions

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.

Yoga Group 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.

Pilates Group Mat Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Equilibrium Studio

Bloomfield Hills, Michigan, 48301, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Oakland Physical Therapy

Novi, Michigan, 48374, United States

Location

Older Persons Commission

Rochester, Michigan, 48307, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Kim Dunleavy, PhD, PT, OCS

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Physical Therapy

Study Record Dates

First Submitted

November 19, 2013

First Posted

December 3, 2013

Study Start

July 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 3, 2013

Record last verified: 2013-11

Locations