Mechanical Neck PainPhase 3NCT02433821
Pilates to Treat Neck Pain
A Phase 3 study testing Pilates in people with Mechanical Neck Pain, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Mechanical Neck Pain
- Being tested
- Pilates
- Keywords
- Mechanical Neck Pain, Pain, Function, Quality of life, Pilates
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Evaluated by visual analogue scale (VAS) from 0 to 10
Measured: Baseline, after 45, 90 and 180 days
Secondary outcomes (3)
Change in function
Evaluated by the Neck Disability Index (score ranges from 0 to 50)
Measured: Baseline, after 45, 90 and 180 days
Change in Quality of life
Evaluated by the short form 36 (SF-36) questionnaire
Measured: Baseline, after 45, 90 and 180 days
Change in medication intake
Patients fill out a specific form regarding the medication intake
Measured: After 45, 90 and 180 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana de Araujo Cazotti, Federal University of São Paulo
- Investigators
- Jamil Natour, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433821
- Sponsor's protocol ID
- CEP_UNIFESP-0208/11
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29752907
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pilates to Treat Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT02433821
- Acronym / sponsor ID
- CEP_UNIFESP-0208/11
- Conditions
- Mechanical Neck Pain
- Keywords
- Mechanical Neck Pain, Pain, Function, Quality of life, Pilates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: PilatesThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates | Other | Pilates Group |
Primary outcome
Change in pain
Time frame: Baseline, after 45, 90 and 180 days
Evaluated by visual analogue scale (VAS) from 0 to 10
3 secondary outcomes
Change in function
Time frame: Baseline, after 45, 90 and 180 days
Change in Quality of life
Time frame: Baseline, after 45, 90 and 180 days
Change in medication intake
Time frame: After 45, 90 and 180 days from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Derived from this study: PubMed 29752907de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamil Natour, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pilates in people with Mechanical Neck Pain, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain (time frame: Baseline, after 45, 90 and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.