Pilates to Treat Neck Pain
Primary Purpose
Mechanical Neck Pain
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Pilates
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Neck Pain focused on measuring Mechanical Neck Pain, Pain, Function, Quality of life, Pilates
Eligibility Criteria
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.
Sites / Locations
- Universidade Federal de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pilates Group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in pain
Evaluated by visual analogue scale (VAS) from 0 to 10
Secondary Outcome Measures
Change in function
Evaluated by the Neck Disability Index (score ranges from 0 to 50)
Change in Quality of life
Evaluated by the short form 36 (SF-36) questionnaire
Change in medication intake
Patients fill out a specific form regarding the medication intake
Full Information
NCT ID
NCT02433821
First Posted
April 8, 2013
Last Updated
April 29, 2015
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02433821
Brief Title
Pilates to Treat Neck Pain
Official Title
Effectiveness of Pilates to Treat Mechanical Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
Keywords
Mechanical Neck Pain, Pain, Function, Quality of life, Pilates
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilates Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates
Primary Outcome Measure Information:
Title
Change in pain
Description
Evaluated by visual analogue scale (VAS) from 0 to 10
Time Frame
Baseline, after 45, 90 and 180 days
Secondary Outcome Measure Information:
Title
Change in function
Description
Evaluated by the Neck Disability Index (score ranges from 0 to 50)
Time Frame
Baseline, after 45, 90 and 180 days
Title
Change in Quality of life
Description
Evaluated by the short form 36 (SF-36) questionnaire
Time Frame
Baseline, after 45, 90 and 180 days
Title
Change in medication intake
Description
Patients fill out a specific form regarding the medication intake
Time Frame
After 45, 90 and 180 days from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil Natour, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04329010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
29752907
Citation
de Araujo Cazotti L, Jones A, Roger-Silva D, Ribeiro LHC, Natour J. Effectiveness of the Pilates Method in the Treatment of Chronic Mechanical Neck Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1740-1746. doi: 10.1016/j.apmr.2018.04.018. Epub 2018 May 9.
Results Reference
derived
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Pilates to Treat Neck Pain
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