Cervical Stabilization Exercises in Patients With Rheumatoid Arthritis

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04948775
Collaborator
(none)
50
1
2
3.1
16.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cervical stabilization exercises
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Cervical Stabilization Exercises on Cervical Proprioception, Functional Status and Quality of Life in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Jun 28, 2021
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

A progressive home-based cervical stabilization exercise program is going to be delivered by sending messages and video instructions via a freeware and crossplatform messaging service (WhatsApp Messenger) in a weekly basis. Home exercises are going to be prescribed three times in a week for six weeks. Repeats and durations of the exercises are going to be increased every week to provide progression.

Other: Cervical stabilization exercises
Cervical stabilization exercises are aimed to train deep stabilizer muscles of the cervical spine and improve coordination between superficial and deep cervical muscles. These exercises have been increasingly used in recent years. These exercises require patients to control neutral spinal alignment with stabilizer muscle activations in various conditions, beginning with gentle craniocervical nods and proceeding through increased levels of extremity loading.

No Intervention: Control Group

Patients in control group are not going to receive any exercise intervention.

Outcome Measures

Primary Outcome Measures

  1. Change in Cervical Proprioception Accuracy [Baseline to 6 weeks]

    Cervical position error method will be used to determine the cervical proprioception accuracy. Cervical position error will be evaluated in flexion, extension, rotation and lateral flexion directions and will be calculated using a special formula. The results will be analyzed as angles.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Izmir Katip Celebi University İzmir Turkey

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Deniz Bayraktar, Assistant Professor, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT04948775
Other Study ID Numbers:
  • RACSE
First Posted:
Jul 2, 2021
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Deniz Bayraktar, Assistant Professor, Izmir Katip Celebi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 2, 2021