Sagital Cervical DisorientationNCT03352921
Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation
A study testing clinical pilates exercises and home exercises program in people with Sagital Cervical Disorientation, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sagital Cervical Disorientation
- What is being tested?
- clinical pilates exercises and home exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Dec 2017to 1 Jun 2018
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sagital Cervical Disorientation
- Being tested
- clinical pilates exercises, home exercises program
- Keywords
- clinical pilates, exercise, Sagital Cervical Disorientation, Disorientation, Forward Head Posture
- Medical subject headings
- Motor Activity, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical pilates exercisesOther
Also called exercise program
servikal, deep flexor muscles, posture exercsises
home exercises programOther
Also called classical exercises
stretching, strengthening, and posture exercises to reduce functional disability, to relieve the pain and to provide postural straightening.
| Study group | Role | What they receive |
|---|---|---|
| clinical pilates exercises | Experimental | 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. Receives: Other: clinical pilates exercises |
| Home exercises program | Active comparator | 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. Receives: Other: home exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: eigth weeks
Secondary outcomes (7)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Dec 2017
- Primary completion1 Feb 2018
- Study completion1 Jun 2018
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 Sagital Cervical DisorientationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemaliye Hürer, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352921
- Sponsor's protocol ID
- EMU
- Status last verified
- Jul 2018
- First submitted
- 9 Nov 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33706543
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation
- ClinicalTrials.gov ID
- NCT03352921
- Acronym / sponsor ID
- EMU
- Conditions
- Sagital Cervical Disorientation
- Keywords
- clinical pilates, exercise, Sagital Cervical Disorientation, Disorientation, Forward Head Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 24 Nov 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical pilates exercises | Experimental | Other: clinical pilates exercisesThe 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. |
| Home exercises program | Active comparator | Other: home exercises programFor 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
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 |
|---|---|---|
| clinical pilates exercisesAlso: exercise programservikal, deep flexor muscles, posture exercsises | Other | clinical pilates exercises |
| home exercises programAlso: classical exercisesstretching, strengthening, and posture exercises to reduce functional disability, to relieve the pain and to provide postural straightening. | Other | Home exercises program |
Primary outcome
Postural Disorders
Time frame: eigth weeks
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).
7 secondary outcomes
Cervical Joint Position Sense
Time frame: 8 weeks
Normal Motion of Cervical Joint
Time frame: 8 weeks
Muscle Strength
Time frame: 8 weeks
muscle endurance
Time frame: 8 weeks
Neck pain
Time frame: 8 weeks
disability scale
Time frame: 8 weeks
muscle shortness
Time frame: 8 weeks
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 26 Jul 2018.
- Derived from this study: PubMed 33706543Hurer 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.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical pilates exercises and home exercises program in people with Sagital Cervical Disorientation, run by Eastern Mediterranean University at 1 site in Cyprus.
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 6 inclusion and 11 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 26 Jul 2018. 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 Cyprus. 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.
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?
Postural Disorders (time frame: eigth weeks). 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 NCT03352921, 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 26 Jul 2018.