Clinical trial NCT02433821: Pilates to Treat Neck Pain
Official title: Effectiveness of Pilates to Treat Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mechanical Neck Pain
Keywords: Mechanical Neck Pain
Pain
Function
Quality of life
Pilates
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in pain
timeFrame: Baseline, after 45, 90 and 180 days
Secondary outcomes:
measure: Change in function
timeFrame: Baseline, after 45, 90 and 180 days
measure: Change in Quality of life
timeFrame: Baseline, after 45, 90 and 180 days
measure: Change in medication intake
timeFrame: After 45, 90 and 180 days from baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, PhD
role: STUDY_CHAIR
References:
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.