Cervical Stabilization Exercises in Patients With Rheumatoid Arthritis

April 8, 2024 updated by: Deniz Bayraktar, Izmir Katip Celebi University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Izmir Katip Celebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Intervention Group
Cervical Stabilization Exercise Group
Other: Cervical stabilization exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and 6 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Status
Time Frame: At baseline and 6 weeks later
Neck Disability Index, which is a self-report tool and has 10 items, will be used to evalutae the functional status of the neck.
At baseline and 6 weeks later
Change in Physical Performance
Time Frame: At baseline and 6 weeks later
Neck flexor muscles endurance test and neck extansor muscles endurance test will be used to investigate physical performance.
At baseline and 6 weeks later
Change in Disease Related Quality of Life
Time Frame: At baseline and 6 week later
RAQoL (30 items, self-report) and HAQ (20 items, self-report) will be employed to evaluate the disease related quality of life.
At baseline and 6 week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Principal Investigator: Deniz Bayraktar, PT, PhD, Izmir Katip Celebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RACSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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