Pilates to Treat Neck Pain

April 29, 2015 updated by: Luciana de Araujo Cazotti, Federal University of São Paulo

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

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Sao Paulo, SP, Brazil, 04329010
        • Universidade Federal de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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
Evaluated by visual analogue scale (VAS) from 0 to 10
Baseline, after 45, 90 and 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in function
Time Frame: Baseline, after 45, 90 and 180 days
Evaluated by the Neck Disability Index (score ranges from 0 to 50)
Baseline, after 45, 90 and 180 days
Change in Quality of life
Time Frame: Baseline, after 45, 90 and 180 days
Evaluated by the short form 36 (SF-36) questionnaire
Baseline, after 45, 90 and 180 days
Change in medication intake
Time Frame: After 45, 90 and 180 days from baseline
Patients fill out a specific form regarding the medication intake
After 45, 90 and 180 days from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jamil Natour, PHD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

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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