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Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
modified pilates exercise
daily life advises
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring exercise, pilates, modified pilates, chronic neck pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Izmir University of Economics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Modified Pilates Exercise Group

Control Group

Arm Description

they will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week.

they will be given daily life advises to prevent neck pain

Outcomes

Primary Outcome Measures

Pain Evaluation
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".
Neck Disability Index
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.
Posture Evaluation
Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.
Neck Range Of Motion
Range of motion will be measured by cervical range of motion device (CROM device)
Deep Neck Flexor Endurance
Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
Neck Position Sense
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).

Secondary Outcome Measures

Full Information

First Posted
March 19, 2018
Last Updated
November 20, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03782584
Brief Title
Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain
Official Title
Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.''

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
exercise, pilates, modified pilates, chronic neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Pilates Exercise Group
Arm Type
Experimental
Arm Description
they will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week.
Arm Title
Control Group
Arm Type
Other
Arm Description
they will be given daily life advises to prevent neck pain
Intervention Type
Other
Intervention Name(s)
modified pilates exercise
Other Intervention Name(s)
daily routine advises
Intervention Description
modified exercises from original pilates exercises.
Intervention Type
Other
Intervention Name(s)
daily life advises
Intervention Description
they will be given daily life advises to prevent neck pain
Primary Outcome Measure Information:
Title
Pain Evaluation
Description
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".
Time Frame
6 weeks
Title
Neck Disability Index
Description
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.
Time Frame
6 weeks
Title
Posture Evaluation
Description
Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.
Time Frame
6 weeks
Title
Neck Range Of Motion
Description
Range of motion will be measured by cervical range of motion device (CROM device)
Time Frame
6 weeks
Title
Deep Neck Flexor Endurance
Description
Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
Time Frame
6 weeks
Title
Neck Position Sense
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sevgi sevi yeşilyaprak, PHD
Organizational Affiliation
9 eylül university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir University of Economics
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35857170
Citation
Sahiner Picak G, Yesilyaprak SS. Effects of clinical pilates exercises in patients with chronic nonspecific neck pain: a randomized clinical trial. Ir J Med Sci. 2023 Jun;192(3):1205-1214. doi: 10.1007/s11845-022-03101-y. Epub 2022 Jul 20.
Results Reference
derived

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Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain

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