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Completed

NCT Number: NCT02433821

Pilates to Treat 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.

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Key information

Conditions

Mechanical Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Federal de Sao Paulo

São Paulo, 04329010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates

Other

Primary outcomes

  1. Change in pain

    Time frame: Baseline, after 45, 90 and 180 days

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

Secondary outcomes

  1. Change in function

    Time frame: Baseline, after 45, 90 and 180 days

    Evaluated by the Neck Disability Index (score ranges from 0 to 50)

  2. Change in Quality of life

    Time frame: Baseline, after 45, 90 and 180 days

    Evaluated by the short form 36 (SF-36) questionnaire

  3. Change in medication intake

    Time frame: After 45, 90 and 180 days from baseline

    Patients fill out a specific form regarding the medication intake

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effectiveness of Pilates to Treat Mechanical Neck Pain

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
May 5, 2015
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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