NCT04948775

Brief Summary

The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

June 28, 2021

Last Update Submit

April 8, 2024

Conditions

Keywords

ProprioceptionExerciseNeckArthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline and 6 weeks later

Secondary Outcomes (3)

  • Change in Functional Status

    At baseline and 6 weeks later

  • Change in Physical Performance

    At baseline and 6 weeks later

  • Change in Disease Related Quality of Life

    At baseline and 6 week later

Study Arms (2)

Intervention Group

EXPERIMENTAL

Cervical Stabilization Exercise Group

Other: Cervical stabilization exercises

Control Group

NO INTERVENTION

Control Group

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 2271017BACKGROUND
  • 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.

    PMID: 26351458BACKGROUND
  • 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.

    PMID: 3733796BACKGROUND
  • 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.

    PMID: 25703454BACKGROUND
  • Armstrong B, McNair P, Taylor D. Head and neck position sense. Sports Med. 2008;38(2):101-17. doi: 10.2165/00007256-200838020-00002.

    PMID: 18201114BACKGROUND
  • 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.

    PMID: 18180194BACKGROUND
  • Gulcemal 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.

MeSH Terms

Conditions

Arthritis, RheumatoidMotor ActivityArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Deniz Bayraktar, PT, PhD

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 2, 2021

Study Start

November 28, 2020

Primary Completion

April 30, 2021

Study Completion

June 15, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Data will be available upon a reasonable request.

Time Frame
Data will be available from September 2023 to December 2043.
Access Criteria
Data will be send for academical purposes (for conducting a meta-analysis and/or systematic review)

Locations