Pilates to Treat Neck Pain

Mechanical Neck Pain Clinical Trial

Official title:

Effectiveness of Pilates to Treat Mechanical Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433821
• Other study ID #: CEP_UNIFESP-0208/11
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2013
• Last updated: April 29, 2015
• Start date: February 2012
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Neck Pain
• Neck Pain

Intervention

Other:
• Pilates

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Evaluated by visual analogue scale (VAS) from 0 to 10	Baseline, after 45, 90 and 180 days	No
Secondary	Change in function	Evaluated by the Neck Disability Index (score ranges from 0 to 50)	Baseline, after 45, 90 and 180 days	No
Secondary	Change in Quality of life	Evaluated by the short form 36 (SF-36) questionnaire	Baseline, after 45, 90 and 180 days	No
Secondary	Change in medication intake	Patients fill out a specific form regarding the medication intake	After 45, 90 and 180 days from baseline	No