Cervical PainPilates/YogaNCT01999283
Effect of Group Pilates and Yoga Exercise Classes for Chronic Cervical Pain
A study testing Yoga Group Exercise and Pilates Group Mat Exercise in people with Cervical Pain, run by Wayne State University at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Yoga Group Exercise and Pilates Group Mat Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Equilibrium Studio
Bloomfield Hills, Michigan, 48301
Wayne State University
Detroit, Michigan, 48201
Oakland Physical Therapy
Novi, Michigan, 48374
Older Persons Commission
Rochester, Michigan, 48307
About this study
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
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.
Read the 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.
- Conditions
- Cervical Pain
- Being tested
- Yoga Group Exercise, Pilates Group Mat Exercise
- Keywords
- Cervical pain, yoga, pilates, exercise
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Group ExerciseOther
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 ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Neck Disability Index
Self reported Neck Disability Index questionnaire
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (7)
Change in Number of days of pain medication use in the past week
Self report
Measured: Baseline, week 6, week 12
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)
Measured: Baseline, week 6, week 12, week 18
Change from baseline Cervical range of motion measurements
Measured with the Cervical Range of Motion instrument (CROM)
Measured: Baseline, week 6, week 12, week 18
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.
Measured: Baseline, week 6, week 12, week 18
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
Measured: Baseline, week 6, week 12, week 18
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.
Measured: Baselin, week 6, week 12, week 18
Change from baseline in Activities Balance Confidence Scale score
Self reported confidence in maintaining balance for functional activities.
Measured: Baseline, week 6, week 12, week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startJul 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Dunleavy PhD, PT, OCS, Wayne State University
- Investigators
- Kim Dunleavy, PhD, PT, OCS, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999283
- Sponsor's protocol ID
- WSUPT2013A
- Acronym
- Pilates/Yoga
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26435334
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01999283
- Acronym / sponsor ID
- Pilates/Yoga / WSUPT2013A
- Conditions
- Cervical Pain
- Keywords
- Cervical pain, yoga, pilates, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga Group Exercise | Active comparator | Other: Yoga Group ExerciseYoga 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 Group Mat Exercise | Active comparator | Other: Pilates Group Mat ExercisePilates mat exercise will be taught by a licensed Physical Therapist with additional Rehabilitation Pilates certification. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Group ExerciseYoga 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. | Other | Yoga Group Exercise |
| Pilates Group Mat ExerciseThe 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. | Other | Pilates Group Mat Exercise |
Primary outcome
Change from baseline Neck Disability Index
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks
Self reported Neck Disability Index questionnaire
7 secondary outcomes
Change in Number of days of pain medication use in the past week
Time frame: Baseline, week 6, week 12
Change from baseline in Neck Pain Ratings (NPR) experienced on average over the past week
Time frame: Baseline, week 6, week 12, week 18
Change from baseline Cervical range of motion measurements
Time frame: Baseline, week 6, week 12, week 18
Change from baseline differences between habitual and self corrected postural position
Time frame: Baseline, week 6, week 12, week 18
Change from baseline in time for the Timed up and go test
Time frame: Baseline, week 6, week 12, week 18
Change from baseline Dynamic Gait Index score
Time frame: Baselin, week 6, week 12, week 18
Change from baseline in Activities Balance Confidence Scale score
Time frame: Baseline, week 6, week 12, week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
- Derived from this study: PubMed 26435334Dunleavy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Dunleavy, PhD, PT, OCS principal investigator
Wayne State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Group Exercise and Pilates Group Mat Exercise in people with Cervical Pain, run by Wayne State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Neck Disability Index (time frame: Baseline, 6 weeks, 12 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01999283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.