- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02433821
Pilates to Treat Neck Pain
Effectiveness of Pilates to Treat Mechanical Neck Pain
The neck pain comes from disturbances related to the cervical spine, of multifactorial origin and is considered a frequent problem of disability.
Pilates is a physical conditioning method that has been widely used to improve posture and develop body awareness.
The aim of this study is to assess the impact of the Pilates method in the control of pain, function and quality of life in patients with chronic mechanical neck pain.
Methods: 64 patients with chronic mechanical neck pain will be selected and randomized into two groups: intervention and control. Both groups will be assessed for pain, function, quality of life and medication intake.
The intervention group will hold Pilates sessions for three months, with two sessions per week. The control group will continue with the usual drug treatment. Both groups will be instructed to use 750mg acetaminophen every 6 hours if there is pain, but consumption of the drug will be controlled.
Although the symptoms of neck pain are common in the population, no study has investigated the effects of the Pilates method as a possible treatment for neck pain. The hypothesis is that the Pilates method can offer benefits to these patients.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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SP
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Sao Paulo, SP, Brazil, 04329010
- Universidade Federal de São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People with diagnosis of chronic mechanical neck pain and symptoms of pain in the lower region of spine, between the occipital and the first thoracic vertebra, for more than three months.
- Pain between 3 and 8 on the numerical pain scale
- Age between 18 and 65
- Both genders
- Agree to take part in the study and sign the terms of agreement
Exclusion Criteria:
- Fibromyalgia
- Previous traumatic injuries in the spine
- Infections and inflammation in the spine cervical pain radiating to upper limbs
- The practice of physical activity started or altered in the last 3 months
- Visual deficiency not corrected by glasses, disturbance in the central nervous system, hearing deficiency making the use of the method impossible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilates Group
The group will realize 2 classes per week, lasting one our, of Pilates under supervision of a trained instructor.
The training program will last 3 months.
|
|
No Intervention: Control group
The patients will keep the drug treatment and will be keep in a waiting list.
After the 180 days of study the will be invited to realize the Pilates training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain
Time Frame: Baseline, after 45, 90 and 180 days
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Evaluated by visual analogue scale (VAS) from 0 to 10
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Baseline, after 45, 90 and 180 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in function
Time Frame: Baseline, after 45, 90 and 180 days
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Evaluated by the Neck Disability Index (score ranges from 0 to 50)
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Baseline, after 45, 90 and 180 days
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Change in Quality of life
Time Frame: Baseline, after 45, 90 and 180 days
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Evaluated by the short form 36 (SF-36) questionnaire
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Baseline, after 45, 90 and 180 days
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Change in medication intake
Time Frame: After 45, 90 and 180 days from baseline
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Patients fill out a specific form regarding the medication intake
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After 45, 90 and 180 days from baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jamil Natour, PHD, Federal University of São Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP_UNIFESP-0208/11
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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