Neck PainNCT03782584
Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain
A study testing modified pilates exercise and daily life advises in people with Neck Pain, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- modified pilates exercise and daily life advises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 30 Nov 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.''
- Conditions
- Neck Pain
- Being tested
- modified pilates exercise, daily life advises
- Keywords
- exercise, pilates, modified pilates, chronic neck pain
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified pilates exerciseOther
Also called daily routine advises
modified exercises from original pilates exercises.
daily life advisesOther
they will be given daily life advises to prevent neck pain
| Study group | Role | What they receive |
|---|---|---|
| Modified Pilates Exercise Group | Experimental | they will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week. Receives: Other: modified pilates exercise |
| Control Group | Other | they will be given daily life advises to prevent neck pain Receives: Other: daily life advises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 6 weeks
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.
Measured: 6 weeks
Posture Evaluation
Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.
Measured: 6 weeks
Neck Range Of Motion
Range of motion will be measured by cervical range of motion device (CROM device)
Measured: 6 weeks
Deep Neck Flexor Endurance
Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
Measured: 6 weeks
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Apr 2018
- Primary completion30 Aug 2018
- Study completion30 Nov 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Şahiner Pıçak, Dokuz Eylul University
- Investigators
- sevgi sevi yeşilyaprak, PHD, Principal investigator, 9 eylül university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782584
- Sponsor's protocol ID
- DEU.HSI.MSc-2015970022
- Status last verified
- Dec 2018
- First submitted
- 19 Mar 2018
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35857170
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03782584
- Acronym / sponsor ID
- DEU.HSI.MSc-2015970022
- Conditions
- Neck Pain
- Keywords
- exercise, pilates, modified pilates, chronic neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 20 Dec 2018 (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 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.''
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Pilates Exercise Group | Experimental | Other: modified pilates exercisethey will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week. |
| Control Group | Other | Other: daily life advisesthey will be given daily life advises to prevent neck pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| modified pilates exerciseAlso: daily routine advisesmodified exercises from original pilates exercises. | Other | Modified Pilates Exercise Group |
| daily life advisesthey will be given daily life advises to prevent neck pain | Other | Control Group |
Primary outcome
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".
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.
Posture Evaluation
Time frame: 6 weeks
Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.
Neck Range Of Motion
Time frame: 6 weeks
Range of motion will be measured by cervical range of motion device (CROM device)
Deep Neck Flexor Endurance
Time frame: 6 weeks
Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
Neck Position Sense
Time frame: 6 weeks
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).
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 23 Nov 2020.
- Derived from this study: PubMed 35857170Sahiner 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.
- Individual participant dataSharing planned: No
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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.
sevgi sevi yeşilyaprak, PHD principal investigator
9 eylül university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified pilates exercise and daily life advises in people with Neck Pain, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 7 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 23 Nov 2020. 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 Turkey (Türkiye). 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?
Pain Evaluation (time frame: 6 weeks). The study lists 6 primary outcomes in all. 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 NCT03782584, 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 23 Nov 2020.