Cervical Stabilization Exercises in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervical stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Proprioception, Exercise, Neck, Arthritis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Izmir Katip Celebi UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Cervical Stabilization Exercise Group
Control Group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in Physical Performance
Neck flexor muscles endurance test and neck extansor muscles endurance test will be used to investigate physical performance.
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.
Full Information
NCT ID
NCT04948775
First Posted
June 28, 2021
Last Updated
January 31, 2023
Sponsor
Izmir Katip Celebi University
1. Study Identification
Unique Protocol Identification Number
NCT04948775
Brief Title
Cervical Stabilization Exercises in Patients With Rheumatoid Arthritis
Official Title
Effect of Cervical Stabilization Exercises on Cervical Proprioception, Functional Status and Quality of Life in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Proprioception, Exercise, Neck, Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Cervical Stabilization Exercise Group
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group
Intervention Type
Other
Intervention Name(s)
Cervical stabilization exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cervical Reposition Error
Description
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.
Time Frame
At baseline and 6 weeks later
Secondary Outcome Measure Information:
Title
Change in Functional Status
Description
Neck Disability Index, which is a self-report tool and has 10 items, will be used to evalutae the functional status of the neck.
Time Frame
At baseline and 6 weeks later
Title
Change in Physical Performance
Description
Neck flexor muscles endurance test and neck extansor muscles endurance test will be used to investigate physical performance.
Time Frame
At baseline and 6 weeks later
Title
Change in Disease Related Quality of Life
Description
RAQoL (30 items, self-report) and HAQ (20 items, self-report) will be employed to evaluate the disease related quality of life.
Time Frame
At baseline and 6 week later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Bayraktar, PT, PhD
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Katip Celebi University
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Bayraktar, PhD
Phone
+90 232 329 35 35
Ext
4833
Email
ptdenislav@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available upon a reasonable request.
IPD Sharing Time Frame
Data will be available from September 2023 to December 2043.
IPD Sharing Access Criteria
Data will be send for academical purposes (for conducting a meta-analysis and/or systematic review)
Citations:
PubMed Identifier
2271017
Citation
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. Erratum In: N Engl J Med 1990 Oct 4;323(14):996.
Results Reference
background
PubMed Identifier
26351458
Citation
Gillick 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.
Results Reference
background
PubMed Identifier
3733796
Citation
Heywood 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.
Results Reference
background
PubMed Identifier
25703454
Citation
Roijezon 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.
Results Reference
background
PubMed Identifier
18201114
Citation
Armstrong B, McNair P, Taylor D. Head and neck position sense. Sports Med. 2008;38(2):101-17. doi: 10.2165/00007256-200838020-00002.
Results Reference
background
PubMed Identifier
18180194
Citation
Treleaven 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.
Results Reference
background
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Cervical Stabilization Exercises in Patients With Rheumatoid Arthritis
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