NCT02433821

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

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

February 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

April 8, 2013

Last Update Submit

April 29, 2015

Conditions

Mechanical Neck Pain

Keywords

Mechanical Neck PainPainFunctionQuality of lifePilates

Outcome Measures

Primary Outcomes (1)

  • Change in pain

    Evaluated by visual analogue scale (VAS) from 0 to 10

    Baseline, after 45, 90 and 180 days

Secondary Outcomes (3)

  • Change in function

    Baseline, after 45, 90 and 180 days

  • Change in Quality of life

    Baseline, after 45, 90 and 180 days

  • Change in medication intake

    After 45, 90 and 180 days from baseline

Study Arms (2)

Pilates Group

EXPERIMENTAL

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.

Other: Pilates

Control group

NO INTERVENTION

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.

Interventions

PilatesOTHER
Pilates Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04329010, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 29752907DERIVED

MeSH Terms

Conditions

Pain

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Jamil Natour, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2013

First Posted

May 5, 2015

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

May 1, 2014

Last Updated

May 5, 2015

Record last verified: 2015-04

Locations

BR(1)