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Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation

Primary Purpose

Sagital Cervical Disorientation

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
clinical pilates exercises
home exercises program
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sagital Cervical Disorientation focused on measuring clinical pilates, exercise, Sagital Cervical Disorientation, Disorientation, Forward Head Posture

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Neck pain at least for three months,
  • Anterior head translation of sagittal segmental alignment disorders,
  • Craniovertebral angle as <50 degree,
  • Desk-work minimum for 3 years,
  • Working with the computer daily at least for 5 hours,
  • Less severe physical activity level according to the International Physical Activity Questionnaire.

Exclusion Criteria:

  • Taken any physiotherapy program for the last 6 months due to neck or back pain complain,
  • Pain severe 3 cm or less according to the Visual Analog Scale (VAS),
  • Structural scoliosis,
  • Broken neck history
  • Rheumatic disorder that affects the neck,
  • Acute torticollis,
  • Vertebral column surgical history,
  • Spinal cord compression due to tumor or other reasons,
  • Neurological deficit,
  • Temporomandibular joint problem,
  • Taking any kind of pain killers except for basic analgesics.

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

clinical pilates exercises

Home exercises program

Arm Description

The experimental group will receive clinical pilates exercise training in group form for 3 weeks a week for 8 weeks. The training will be done 40-50 minutes per one day. The exercise session will be started with a 10 minute warming program, 30 minutes with the core stabilization training and the clinical pilates exercises with the postural alignment exercises will be applied and the exercise session will be ended with the 10 minutes cooling period.

For 8 weeks the member in comparison group will be ask to do the exercise program 3 days a week at home. This group will receive a program of stretching, strengthening, and posture exercises. All the exercises in the program will be illustrated on a descriptive form with images. In terms of the follow-up during 8-week duration, the individuals will be called frequently and in the interview by the end of the study.

Outcomes

Primary Outcome Measures

Postural Disorders
The evaluation of cervical and upper thoracic posture will be done through the lateral photography. A camera placed on the tripod will be placed 1,5 m away from the patient while standing in a standing position, and the lens of the camera corresponds to the shoulder of the person. Before the patients will be asked to be on their neutral position, they will be asked to move their heads forth and back for the three times and leave their two arms loose next to the body. Angular calculations will be done by attaching reflective markers to their anatomical points of T4 spinosus process, C7 spinosus process, tragus and eye canthus before the photography. Computer program (Markus Bader-MB Software Solutions, triangular screen ruler) will be used for the angular calculations (craniovertebral angle, head tilt angle, cervico-thoracic angle).

Secondary Outcome Measures

Cervical Joint Position Sense
In order to determine cervical joint position sense, the individual's head will be brought to the target position by the investigator and held for 2 seconds at this position. The individual will be ask to save this position into their minds as it will be remembered later on. Again initial position(0°) will be turned here 10 seconds waiting will be and then in the same position (target position) he or she will be asked to move forward slowly and wait for 2 seconds in the same location. The angular difference between result value and target value will be recorded by reading from the baseline inclinometer. 30 seconds break will be given between measurements (flexion, extension, lateral flexion and rotation). The target position determined for the evaluation of joint position sense of neck flexion and extension is determined as 30°, for left-right lateral flexion is 20° and 30° for left-right rotation. All the tests will be done both eyes open and closed.
Normal Motion of Cervical Joint
The cervical normal joint movement will be evaluated by baseline bubble inclinometer. The validity and reliability of the device has been proven and; the active cervical normal joint movements (flexion, extension, left-right lateral flexion, left-right rotation) will be measured.. During sitting, in order to prevent regional movement, the body will be stabilized to the chair with the help of stabilization belt. For each movement, 3 measurements will be done and the best value will be used for the data analysis.
Muscle Strength
Hand Held Dynamometer (HHD) will be used for isometric muscle strength measurement of neck muscles. Cervical flexor, extensor, left and right lateral flexors' isometric muscle strength will be evaluated by the dynamometer.Stabilizer Pressure Biofeedback device will be used for muscle strength measurement of M.Longus Kolli, M.Longus Capitis, M. Rectus Capitis Lateralis and M. Rectus Capitis Anterior which are defined as deep cervical flexor muscles.
muscle endurance
With the aim of measuring the endurance of neck flexor muscles, the individuals will be asked to lie in the supine position as hands on the abdomen and knees in 90 degrees flexion. 0.5 kg of weight will be placed to the forehead of the patient with the help of a band put above the ears. First the patients will be asked to make cervical retraction and then make a cervical flexion in 10 degrees and the flexion degree will be determined with the help of goniometer.For the evaluation of neck extensor muscle endurance, the individuals will be asked to come up to the chest line and hang their head from the bed while the arms are lying on the side of the body beside the body. There will be weights placed above the ears; 2 kg for women and 4 kg for men.
Neck pain
The pain intensity during relaxing and activity of the individuals will be evaluated through VAS. As its validity and reliability has been proven previously the VAS; is the scale which defines the pain intensity on 10 cm line on a horizontal line a "0"= no pain, "10"=severe pain. The individuals will be asked to sign the point on the line which refers to the pain intensity they feel and the distance between "0" point and the signed point will be measured and the numeric value will be recorded as the pain intensity of the individual.
disability scale
The first questionnaire - Neck Disability Index- prepared for the neck pain and functional disability can be defined as the adapted version of Oswestry Back Pain Disability Questionnaire applied to the cervical region. The Neck Disability Index evaluates the disability occurred in daily life as a result of neck pain. The Neck Disability Index is composed of 10 items; 4 with subjective symptoms (pain level, head ache, concentration, sleeping) and 6 with daily life activities (personal care, weight lifting, reading, work life, car driving, spare time activities). The pointing is done from 0 to 5.
muscle shortness
The sternal and clavicular part of Pectoralis major muscle, M. Pectoralis minor, Adductor and internal rotator (M. Teres major, M. Latissimus dorsi, M. Rhomboideus major and minor) muscle shortness will be evaluated by using a ruler.

Full Information

First Posted
November 9, 2017
Last Updated
July 25, 2018
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT03352921
Brief Title
Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation
Official Title
Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean 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 compare the effects of clinical pilates exercises and home exercise program on postural disorders, pain intensity, normal range of motion, muscle strength, endurance, muscle shortness, joint position sense and functional status in desk workers with sagittal cervical disorientation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sagital Cervical Disorientation
Keywords
clinical pilates, exercise, Sagital Cervical Disorientation, Disorientation, Forward Head Posture

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
clinical pilates exercises
Arm Type
Experimental
Arm Description
The experimental group will receive clinical pilates exercise training in group form for 3 weeks a week for 8 weeks. The training will be done 40-50 minutes per one day. The exercise session will be started with a 10 minute warming program, 30 minutes with the core stabilization training and the clinical pilates exercises with the postural alignment exercises will be applied and the exercise session will be ended with the 10 minutes cooling period.
Arm Title
Home exercises program
Arm Type
Active Comparator
Arm Description
For 8 weeks the member in comparison group will be ask to do the exercise program 3 days a week at home. This group will receive a program of stretching, strengthening, and posture exercises. All the exercises in the program will be illustrated on a descriptive form with images. In terms of the follow-up during 8-week duration, the individuals will be called frequently and in the interview by the end of the study.
Intervention Type
Other
Intervention Name(s)
clinical pilates exercises
Other Intervention Name(s)
exercise program
Intervention Description
servikal, deep flexor muscles, posture exercsises
Intervention Type
Other
Intervention Name(s)
home exercises program
Other Intervention Name(s)
classical exercises
Intervention Description
stretching, strengthening, and posture exercises to reduce functional disability, to relieve the pain and to provide postural straightening.
Primary Outcome Measure Information:
Title
Postural Disorders
Description
The evaluation of cervical and upper thoracic posture will be done through the lateral photography. A camera placed on the tripod will be placed 1,5 m away from the patient while standing in a standing position, and the lens of the camera corresponds to the shoulder of the person. Before the patients will be asked to be on their neutral position, they will be asked to move their heads forth and back for the three times and leave their two arms loose next to the body. Angular calculations will be done by attaching reflective markers to their anatomical points of T4 spinosus process, C7 spinosus process, tragus and eye canthus before the photography. Computer program (Markus Bader-MB Software Solutions, triangular screen ruler) will be used for the angular calculations (craniovertebral angle, head tilt angle, cervico-thoracic angle).
Time Frame
eigth weeks
Secondary Outcome Measure Information:
Title
Cervical Joint Position Sense
Description
In order to determine cervical joint position sense, the individual's head will be brought to the target position by the investigator and held for 2 seconds at this position. The individual will be ask to save this position into their minds as it will be remembered later on. Again initial position(0°) will be turned here 10 seconds waiting will be and then in the same position (target position) he or she will be asked to move forward slowly and wait for 2 seconds in the same location. The angular difference between result value and target value will be recorded by reading from the baseline inclinometer. 30 seconds break will be given between measurements (flexion, extension, lateral flexion and rotation). The target position determined for the evaluation of joint position sense of neck flexion and extension is determined as 30°, for left-right lateral flexion is 20° and 30° for left-right rotation. All the tests will be done both eyes open and closed.
Time Frame
8 weeks
Title
Normal Motion of Cervical Joint
Description
The cervical normal joint movement will be evaluated by baseline bubble inclinometer. The validity and reliability of the device has been proven and; the active cervical normal joint movements (flexion, extension, left-right lateral flexion, left-right rotation) will be measured.. During sitting, in order to prevent regional movement, the body will be stabilized to the chair with the help of stabilization belt. For each movement, 3 measurements will be done and the best value will be used for the data analysis.
Time Frame
8 weeks
Title
Muscle Strength
Description
Hand Held Dynamometer (HHD) will be used for isometric muscle strength measurement of neck muscles. Cervical flexor, extensor, left and right lateral flexors' isometric muscle strength will be evaluated by the dynamometer.Stabilizer Pressure Biofeedback device will be used for muscle strength measurement of M.Longus Kolli, M.Longus Capitis, M. Rectus Capitis Lateralis and M. Rectus Capitis Anterior which are defined as deep cervical flexor muscles.
Time Frame
8 weeks
Title
muscle endurance
Description
With the aim of measuring the endurance of neck flexor muscles, the individuals will be asked to lie in the supine position as hands on the abdomen and knees in 90 degrees flexion. 0.5 kg of weight will be placed to the forehead of the patient with the help of a band put above the ears. First the patients will be asked to make cervical retraction and then make a cervical flexion in 10 degrees and the flexion degree will be determined with the help of goniometer.For the evaluation of neck extensor muscle endurance, the individuals will be asked to come up to the chest line and hang their head from the bed while the arms are lying on the side of the body beside the body. There will be weights placed above the ears; 2 kg for women and 4 kg for men.
Time Frame
8 weeks
Title
Neck pain
Description
The pain intensity during relaxing and activity of the individuals will be evaluated through VAS. As its validity and reliability has been proven previously the VAS; is the scale which defines the pain intensity on 10 cm line on a horizontal line a "0"= no pain, "10"=severe pain. The individuals will be asked to sign the point on the line which refers to the pain intensity they feel and the distance between "0" point and the signed point will be measured and the numeric value will be recorded as the pain intensity of the individual.
Time Frame
8 weeks
Title
disability scale
Description
The first questionnaire - Neck Disability Index- prepared for the neck pain and functional disability can be defined as the adapted version of Oswestry Back Pain Disability Questionnaire applied to the cervical region. The Neck Disability Index evaluates the disability occurred in daily life as a result of neck pain. The Neck Disability Index is composed of 10 items; 4 with subjective symptoms (pain level, head ache, concentration, sleeping) and 6 with daily life activities (personal care, weight lifting, reading, work life, car driving, spare time activities). The pointing is done from 0 to 5.
Time Frame
8 weeks
Title
muscle shortness
Description
The sternal and clavicular part of Pectoralis major muscle, M. Pectoralis minor, Adductor and internal rotator (M. Teres major, M. Latissimus dorsi, M. Rhomboideus major and minor) muscle shortness will be evaluated by using a ruler.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Neck pain at least for three months, Anterior head translation of sagittal segmental alignment disorders, Craniovertebral angle as <50 degree, Desk-work minimum for 3 years, Working with the computer daily at least for 5 hours, Less severe physical activity level according to the International Physical Activity Questionnaire. Exclusion Criteria: Taken any physiotherapy program for the last 6 months due to neck or back pain complain, Pain severe 3 cm or less according to the Visual Analog Scale (VAS), Structural scoliosis, Broken neck history Rheumatic disorder that affects the neck, Acute torticollis, Vertebral column surgical history, Spinal cord compression due to tumor or other reasons, Neurological deficit, Temporomandibular joint problem, Taking any kind of pain killers except for basic analgesics.
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33706543
Citation
Hurer C, Angin E, Tuzun EH. Effectiveness of clinical Pilates and home exercises in sagittal cervical disorientation: randomized controlled study. J Comp Eff Res. 2021 Apr;10(5):365-380. doi: 10.2217/cer-2020-0186. Epub 2021 Mar 12.
Results Reference
derived

Learn more about this trial

Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation

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