SpondyloarthritisNCT04483648
Cervical Stabilization Exercises in Patients With Spondyloarthritis
A study testing Exercise in people with Spondyloarthritis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in spondyloarthritis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed as axial spondyloarthritis according to ASAS criteria
- Being able to understand and follow the exercise commands
- Willingness to participate in the study
Who cannot join
- Trauma history related to cervical region
- A completed ankylosis in cervical region
- Surgery history related to cervical region
- Any vestibular disorders
- Upper extremity involvement other than axial spondyloarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cervical Stabilization Exercises on Cervical Position Error in Patients With Spondyloarthritis: A Randomized Controlled Trial
The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in spondyloarthritis patients.
Read the detailed description
The position sense and kinesthesia are defined as proprioception. In other words, proprioception allows being aware of positions of the body parts in the space. Muscles, tendons, joint capsules are source of proprioception.
Possible damage to these structures due to inflammation may cause diminished proprioception sense. Decreased proprioception was shown for cervical region in axial spondyloarthritis patients in a recent study.
Different exercise programs may help increasing proprioception. Therefore, the aim of the present study is investigate the effects of cervical stabilization exercises on cervical proprioception accuracy.
- Conditions
- Spondyloarthritis
- Being tested
- Exercise
- Keywords
- Arthritis, Exercise, Proprioception
- Medical subject headings
- Spondylarthritis, Arthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Home exercises were performed three times in a week for six weeks. Home exercises included range of motion exercises, coordination exercises and strengthening exercises. Repeats and durations of the exercises increased every week to provide progression.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | A progressive home-based cervical stabilization exercise program was delivered by sending messages and video instructions via a freeware and cross-platform messaging service (WhatsApp Messenger) in a weekly basis. Receives: Other: Exercise |
| Control Group | No intervention | Patients in control group did not receive any exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cervical Proprioception Accuracy
Cervical position error method was used to determine the cervical proprioception accuracy. Cervical position error was evaluated in flexion, extension, rotation and lateral flexion directions and was calculated using a special formula. The results were analyzed as angles.
Measured: At baseline and six weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Sep 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Bayraktar, Izmir Katip Celebi University
- Investigators
- Deniz Bayraktar, PT, PhD, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483648
- Sponsor's protocol ID
- SpAJPE
- Status last verified
- Feb 2023
- First submitted
- 21 Jul 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be sent upon a reasonable request.
Publications
Sieper J, Braun J, Dougados M, Baeten D. Axial spondyloarthritis. Nat Rev Dis Primers. 2015 Jul 9;1:15013. doi: 10.1038/nrdp.2015.13.
PubMed 27188328Swinkels A, Dolan P. Spinal position sense and disease progression in ankylosing spondylitis: a longitudinal study. Spine (Phila Pa 1976). 2004 Jun 1;29(11):1240-5. doi: 10.1097/00007632-200406010-00014.
PubMed 15167664Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.
PubMed 25703454Armstrong B, McNair P, Taylor D. Head and neck position sense. Sports Med. 2008;38(2):101-17. doi: 10.2165/00007256-200838020-00002.
PubMed 18201114Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.
PubMed 18180194Alahmari K, Reddy RS, Silvian P, Ahmad I, Nagaraj V, Mahtab M. Intra- and inter-rater reliability of neutral head position and target head position tests in patients with and without neck pain. Braz J Phys Ther. 2017 Jul-Aug;21(4):259-267. doi: 10.1016/j.bjpt.2017.05.003. Epub 2017 May 19.
PubMed 28558952Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.
PubMed 17143898
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Stabilization Exercises on Cervical Position Error in Patients With Spondyloarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04483648
- Acronym / sponsor ID
- SpAJPE
- Conditions
- Spondyloarthritis
- Keywords
- Arthritis, Exercise, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Jul 2020 (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 effectiveness of cervical stabilization exercises on cervical positioning error in spondyloarthritis patients.
Detailed description
The position sense and kinesthesia are defined as proprioception. In other words, proprioception allows being aware of positions of the body parts in the space. Muscles, tendons, joint capsules are source of proprioception.
Possible damage to these structures due to inflammation may cause diminished proprioception sense. Decreased proprioception was shown for cervical region in axial spondyloarthritis patients in a recent study.
Different exercise programs may help increasing proprioception. Therefore, the aim of the present study is investigate the effects of cervical stabilization exercises on cervical proprioception accuracy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: ExerciseA progressive home-based cervical stabilization exercise program was delivered by sending messages and video instructions via a freeware and cross-platform messaging service (WhatsApp Messenger) in a weekly basis. |
| Control Group | No intervention | –Patients in control group did not receive any exercise intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed as axial spondyloarthritis according to ASAS criteria
- Being able to understand and follow the exercise commands
- Willingness to participate in the study
Key exclusion criteria (5 listed)
- Trauma history related to cervical region
- A completed ankylosis in cervical region
- Surgery history related to cervical region
- Any vestibular disorders
- Upper extremity involvement other than axial spondyloarthritis
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 |
|---|---|---|
| ExerciseHome exercises were performed three times in a week for six weeks. Home exercises included range of motion exercises, coordination exercises and strengthening exercises. Repeats and durations of the exercises increased every week to provide progression. | Other | Exercise Group |
Primary outcome
Change in Cervical Proprioception Accuracy
Time frame: At baseline and six weeks later
Cervical position error method was used to determine the cervical proprioception accuracy. Cervical position error was evaluated in flexion, extension, rotation and lateral flexion directions and was calculated using a special formula. The results were analyzed as angles.
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 3 Feb 2023.
- Background: PubMed 27188328Sieper J, Braun J, Dougados M, Baeten D. Axial spondyloarthritis. Nat Rev Dis Primers. 2015 Jul 9;1:15013. doi: 10.1038/nrdp.2015.13.
- Background: PubMed 15167664Swinkels A, Dolan P. Spinal position sense and disease progression in ankylosing spondylitis: a longitudinal study. Spine (Phila Pa 1976). 2004 Jun 1;29(11):1240-5. doi: 10.1097/00007632-200406010-00014.
- Background: PubMed 25703454Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.
- Background: PubMed 18201114Armstrong B, McNair P, Taylor D. Head and neck position sense. Sports Med. 2008;38(2):101-17. doi: 10.2165/00007256-200838020-00002.
- Background: PubMed 18180194Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.
- Background: PubMed 28558952Alahmari K, Reddy RS, Silvian P, Ahmad I, Nagaraj V, Mahtab M. Intra- and inter-rater reliability of neutral head position and target head position tests in patients with and without neck pain. Braz J Phys Ther. 2017 Jul-Aug;21(4):259-267. doi: 10.1016/j.bjpt.2017.05.003. Epub 2017 May 19.
- Background: PubMed 17143898Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.
- Individual participant dataSharing planned: Yes. Data will be sent upon a reasonable request.
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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.
Deniz Bayraktar, PT, PhD principal investigator
Izmir Katip Celebi 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 Exercise in people with Spondyloarthritis, run by Izmir Katip Celebi 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 3 inclusion and 5 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 3 Feb 2023. 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?
Change in Cervical Proprioception Accuracy (time frame: At baseline and six weeks later). 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 NCT04483648, which also lists 7 linked publications.
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 3 Feb 2023.