Rheumatoid ArthritisNCT04948775
Cervical Stabilization Exercises in Patients With Rheumatoid Arthritis
A study testing Cervical stabilization exercises in people with Rheumatoid Arthritis, 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 rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Cervical stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2020to 15 Jun 2023
- 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
- Having been diagnosed with RA according to the ACR 2010 Criteria
- Being between 18 and 65 years old
- To be able to understand the given commands
Who cannot join
- Refusing to participate in the study
- History of trauma involving the neck
- Having an orthopedic disorder concerning the neck
- History of spine surgery
- Having a disease that affects vestibular system
- Upper extremity involvement due to a disorder other than RA
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cervical Stabilization Exercises on Cervical Proprioception, Functional Status and Quality of Life in Patients With Rheumatoid Arthritis
The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in rheumatoid arthritis.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, recurrent polyarthritis of the synovial joints. Although the prevalence of the disease shows ethnic differences, the average prevelance of the disease is 1%, and the female/male ratio is 2.5-3/1. The average age of onset is between 30-50 years. Common cervical involvement in RA patients was first described by Garrod in 1890. The most common inflammatory arthritis involving the cervical vertebra is RA. Thoracic and lumbar spine involvement is less common compared to cervical spine involvement in the disease.
Proprioceptive sense is defined as a type of specialized sensory model that includes joint movement (kinesthesia) and position sense. Mechanoreceptors located in different structures such as muscle, tendon, joint capsule and skin in both axial joints and peripheral joints provide the perception of joint position and movement. The sense of proprioception provides dynamic joint stability and various movement skills without the need for conscious planning. It also prevents premature joint degeneration by preventing uncontrolled load on the joints. The cervical proprioceptive system consists of mechanoreceptors of the cervical intervertebral joints, neck muscles and vertebral ligaments, muscle spindles localized in the deep muscles of the cervical spine, and sensitive fibers connecting the neurons in posterior horn of the spinal cord to the neck proprioceptors. Cervical vertebrae, unlike the thoracic and lumbar regions, has an additional importance due to the abundance of mechanoreceptors that provide reflex connections and proprioceptive input with the vestibular central and central nervous systems. In previous studies, it has been shown that the sense of cervical proprioception is impaired in patients with chronic neck pain due to traumatic and degenerative causes. It has been shown that cervical proprioceptive sensory dysfunction in RA causes, vestibular symptoms, changes in contol of eye movements and postural disorders in cervical paravertebral muscles.
No study investigating the effect of exercise on cervical proprioception in RA patients was found in the literature. The aim of this study was to determine the effects of cervical stabilization exercises on cervical proprioception in RA patients. The secondary aim of the present study is to evaluate the effects of cervical stabilization exercises on the functional status and quality of life in patients with RA.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Cervical stabilization exercises
- Keywords
- Proprioception, Exercise, Neck, Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical stabilization exercisesOther
A progressive home-based cervical stabilization exercise program which is aimed to train deep stabilizer muscles of the cervical spine and improve coordination between superficial and deep cervical muscles will be performed by the patients for 6 weeks. Exercises are going to be delivered by sending messages and video instructions via a freeware and crossplatform messaging service (WhatsApp Messenger) in a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Cervical Stabilization Exercise Group Receives: Other: Cervical stabilization exercises |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cervical Reposition Error
Cervical reposition error method will be used to determine the cervical proprioception accuracy. Cervical reposition error will be evaluated in flexion, extension, rotation and lateral flexion directions and will be calculated using a special formula.
Measured: At baseline and 6 weeks later
Secondary outcomes (3)
Change in Functional Status
Neck Disability Index, which is a self-report tool and has 10 items, will be used to evalutae the functional status of the neck.
Measured: At baseline and 6 weeks later
Change in Physical Performance
Neck flexor muscles endurance test and neck extansor muscles endurance test will be used to investigate physical performance.
Measured: At baseline and 6 weeks later
Change in Disease Related Quality of Life
RAQoL (30 items, self-report) and HAQ (20 items, self-report) will be employed to evaluate the disease related quality of life.
Measured: At baseline and 6 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start28 Nov 2020
- Primary completion30 Apr 2021
- Study completion15 Jun 2023
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 Rheumatoid ArthritisStudies 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
- 26 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
- NCT04948775
- Sponsor's protocol ID
- RACSE
- Status last verified
- Apr 2024
- First submitted
- 28 Jun 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon a reasonable request.
Publications
Harris ED Jr. Rheumatoid arthritis. Pathophysiology and implications for therapy. N Engl J Med. 1990 May 3;322(18):1277-89. doi: 10.1056/NEJM199005033221805. No abstract available.
PubMed 2271017Gillick JL, Wainwright J, Das K. Rheumatoid Arthritis and the Cervical Spine: A Review on the Role of Surgery. Int J Rheumatol. 2015;2015:252456. doi: 10.1155/2015/252456. Epub 2015 Aug 17.
PubMed 26351458Heywood AW, Meyers OL. Rheumatoid arthritis of the thoracic and lumbar spine. J Bone Joint Surg Br. 1986 May;68(3):362-8. doi: 10.1302/0301-620X.68B3.3733796.
PubMed 3733796Roijezon 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 18180194Gulcemal MO, Sarac DC, Alp G, Duran G, Gucenmez S, Solmaz D, Akar S, Bayraktar D. Effects of video-based cervical stabilization home exercises in patients with rheumatoid arthritis: a randomized controlled pilot study. Z Rheumatol. 2024 Dec;83(Suppl 3):352-358. doi: 10.1007/s00393-024-01543-6. Epub 2024 Jul 1.
PubMed 38953936
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Stabilization Exercises on Cervical Proprioception, Functional Status and Quality of Life in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04948775
- Acronym / sponsor ID
- RACSE
- Conditions
- Rheumatoid Arthritis
- Keywords
- Proprioception, Exercise, Neck, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 28 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 2 Jul 2021 (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 rheumatoid arthritis.
Detailed description
Rheumatoid arthritis (RA) is a chronic, recurrent polyarthritis of the synovial joints. Although the prevalence of the disease shows ethnic differences, the average prevelance of the disease is 1%, and the female/male ratio is 2.5-3/1. The average age of onset is between 30-50 years. Common cervical involvement in RA patients was first described by Garrod in 1890. The most common inflammatory arthritis involving the cervical vertebra is RA. Thoracic and lumbar spine involvement is less common compared to cervical spine involvement in the disease.
Proprioceptive sense is defined as a type of specialized sensory model that includes joint movement (kinesthesia) and position sense. Mechanoreceptors located in different structures such as muscle, tendon, joint capsule and skin in both axial joints and peripheral joints provide the perception of joint position and movement. The sense of proprioception provides dynamic joint stability and various movement skills without the need for conscious planning. It also prevents premature joint degeneration by preventing uncontrolled load on the joints. The cervical proprioceptive system consists of mechanoreceptors of the cervical intervertebral joints, neck muscles and vertebral ligaments, muscle spindles localized in the deep muscles of the cervical spine, and sensitive fibers connecting the neurons in posterior horn of the spinal cord to the neck proprioceptors. Cervical vertebrae, unlike the thoracic and lumbar regions, has an additional importance due to the abundance of mechanoreceptors that provide reflex connections and proprioceptive input with the vestibular central and central nervous systems. In previous studies, it has been shown that the sense of cervical proprioception is impaired in patients with chronic neck pain due to traumatic and degenerative causes. It has been shown that cervical proprioceptive sensory dysfunction in RA causes, vestibular symptoms, changes in contol of eye movements and postural disorders in cervical paravertebral muscles.
No study investigating the effect of exercise on cervical proprioception in RA patients was found in the literature. The aim of this study was to determine the effects of cervical stabilization exercises on cervical proprioception in RA patients. The secondary aim of the present study is to evaluate the effects of cervical stabilization exercises on the functional status and quality of life in patients with RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Cervical stabilization exercisesCervical Stabilization Exercise Group |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having been diagnosed with RA according to the ACR 2010 Criteria
- Being between 18 and 65 years old
- To be able to understand the given commands
Key exclusion criteria (7 listed)
- Refusing to participate in the study
- History of trauma involving the neck
- Having an orthopedic disorder concerning the neck
- History of spine surgery
- Having a disease that affects vestibular system
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 |
|---|---|---|
| Cervical stabilization exercisesA progressive home-based cervical stabilization exercise program which is aimed to train deep stabilizer muscles of the cervical spine and improve coordination between superficial and deep cervical muscles will be performed by the patients for 6 weeks. Exercises are going to be delivered by sending messages and video instructions via a freeware and crossplatform messaging service (WhatsApp Messenger) in a weekly basis. | Other | Intervention Group |
Primary outcome
Change in Cervical Reposition Error
Time frame: At baseline and 6 weeks later
Cervical reposition error method will be used to determine the cervical proprioception accuracy. Cervical reposition error will be evaluated in flexion, extension, rotation and lateral flexion directions and will be calculated using a special formula.
3 secondary outcomes
Change in Functional Status
Time frame: At baseline and 6 weeks later
Change in Physical Performance
Time frame: At baseline and 6 weeks later
Change in Disease Related Quality of Life
Time frame: At baseline and 6 week later
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 10 Apr 2024.
- Background: PubMed 2271017Harris ED Jr. Rheumatoid arthritis. Pathophysiology and implications for therapy. N Engl J Med. 1990 May 3;322(18):1277-89. doi: 10.1056/NEJM199005033221805. No abstract available.
- Background: PubMed 26351458Gillick JL, Wainwright J, Das K. Rheumatoid Arthritis and the Cervical Spine: A Review on the Role of Surgery. Int J Rheumatol. 2015;2015:252456. doi: 10.1155/2015/252456. Epub 2015 Aug 17.
- Background: PubMed 3733796Heywood AW, Meyers OL. Rheumatoid arthritis of the thoracic and lumbar spine. J Bone Joint Surg Br. 1986 May;68(3):362-8. doi: 10.1302/0301-620X.68B3.3733796.
- 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.
- Derived from this study: PubMed 38953936Gulcemal MO, Sarac DC, Alp G, Duran G, Gucenmez S, Solmaz D, Akar S, Bayraktar D. Effects of video-based cervical stabilization home exercises in patients with rheumatoid arthritis: a randomized controlled pilot study. Z Rheumatol. 2024 Dec;83(Suppl 3):352-358. doi: 10.1007/s00393-024-01543-6. Epub 2024 Jul 1.
- Individual participant dataSharing planned: Yes. Data will be available upon a reasonable request.
Related trials for Rheumatoid Arthritis
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
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 Cervical stabilization exercises in people with Rheumatoid Arthritis, 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 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 10 Apr 2024. 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 Reposition Error (time frame: At baseline and 6 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 NCT04948775, 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 10 Apr 2024.