- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03782584
Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain
November 20, 2020 updated by: Gonca Şahiner Pıçak, Dokuz Eylul University
The aim of this study is to investigate the effects of modified pilates exercises on neck pain, deep neck flexor muscles edurance, joint position sense and functionality in patients with chronic neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
50 individuals with Chronic Neck Pain not working will be included to our study.
We will evaluate pain (with visual analog scale), deep neck flexors' endurance (with cranio-cervical flexure test using the pressure stabilizing feedback device), cervical range of motion and cervical proprioception (wit cervical range of motion device).
Besides we will conduct a questionnaire (neck disability index) to get further knowledge about their functionality.
Participants will be randomly allocated 2 groups consisting of 25 participants and these 2 groups will receive different interventions.
Modified Pilates Exercise Group (MPEG) will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week in the presence of a physiotherapist.
The Control Group (KG) will receive daily routine advises to prevent neck pain and they will be asked about to apply these advises and not to make other changes in their life.
The evaluations will be repeated and analyzed 2 times, pre-treatment and 6 weeks after treatment , and the effectiveness of the modified pilates exercises will be examined in the chronic neck pain.
Our hypothesis is ''Modified pilates exercises have a positive effect on neck pain, range of motion, deep neck flexor muscles, joint position sense and function in patients with chronic neck pain.''
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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İzmir, Turkey
- Izmir University of Economics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having neck pain more than 3 months
- No physical therapy in last year
- No background with pilates exercises
- Being able to understand Turkish, treatment and evaluations.
- Being able to complete all the evaluations and treatment
Exclusion Criteria:
- Fracture or surgery background with shoulder, cervical area or other extremities.
- Any systemic musculoskeletal diseases
- Existing chest deformities or scoliosis
- Cervical hernia, neuropathy or whiplash.
- Pregnancy
- Having pain above 7 in VAS
- Any other pain that could prevent people from doing exercises
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Modified Pilates Exercise Group
they will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week.
|
modified exercises from original pilates exercises.
Other Names:
|
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OTHER: Control Group
they will be given daily life advises to prevent neck pain
|
they will be given daily life advises to prevent neck pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Evaluation
Time Frame: 6 weeks
|
This test will be measured by Visual Analog Scale (VAS) score.
VAS has 10-centimeter line corresponding to the amount of pain they experienced.
"0" means "no pain" and "10" means "pain as bad as possible".
|
6 weeks
|
|
Neck Disability Index
Time Frame: 6 weeks
|
Neck disability index is a survey that has 10 different sections including Pain intensity, personal care, weight lifting, reading, headache, concentration, work, driving, sleeping and resting activitie.
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6 weeks
|
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Posture Evaluation
Time Frame: 6 weeks
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Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.
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6 weeks
|
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Neck Range Of Motion
Time Frame: 6 weeks
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Range of motion will be measured by cervical range of motion device (CROM device)
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6 weeks
|
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Deep Neck Flexor Endurance
Time Frame: 6 weeks
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Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
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6 weeks
|
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Neck Position Sense
Time Frame: 6 weeks
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Joint position error of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by cervical range of motion device (CROM device).
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: sevgi sevi yeşilyaprak, PHD, 9 eylül university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2018
Primary Completion (ACTUAL)
August 30, 2018
Study Completion (ACTUAL)
November 30, 2018
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
December 18, 2018
First Posted (ACTUAL)
December 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 23, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEU.HSI.MSc-2015970022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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