The Effects of Manual Therapy on Balance and Cervical Proprioception

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04794647
Collaborator
(none)
60
3
2
19.4
20
1

Study Details

Study Description

Brief Summary

Introduction: Neck pain causes disturbances in both proprioception and balance. The aim of the present study is to determine the effect of mobilization applied to the cervical region on static/dynamic balance and cervical proprioception in patients with nonspecific neck pain (NSNP).

Materials and Methods: ... patients were randomly allovated into two groups. Both grups received conventional physiotherapy program (hot pack with transcutaneous electrical nerve stimulation); additionally, the experimental group received mobilization, and the control group received placebo mobilization twice a week for 3 weeks. Before and 3 weeks later, static/dynamic balance, cervical proprioception, cervical mobility and pain were evaluated respectively with Kinesthetic Skill Training System 3000 device, joint position error test, Cervical Joint Range of Motion Device, Visual Analogue Scale.

Condition or Disease Intervention/Treatment Phase
  • Other: Cervical mobilization
  • Other: Placebo mobilization
N/A

Detailed Description

Nonspecific neck pain (NSNP) is one of the most common causes of neck pain and it occurs as a result of postural or mechanical causes without a specific musculoskeletal pathology or injury history. Neck pain leads to a decrease in the activity of the deep cervical muscle which contains a large amount of muscle spindles, with an increase in the activity of the superficial cervical muscle. Depending on the pain, chemical changes occur in the cervical receptors and differentiation in sensitivity of the muscle spindle is observed. These changes in the structures of the cervical region predispose to deterioration in the sense of proprioception, which is an important component of balance. The disruption in proprioceptive abilities causes sensori-motor defects, muscle inhibition, muscle atrophy, and muscle fatigue. Changing cervical afferent information can affect proprioception as well as balance. Both the presence of neck pain and disruptions in the proprioceptive sense may reflect negatively on balance and postural control. In a study comparing patients with neck pain with asymptomatic individuals, increases in postural sway were found in patients with neck pain, and it was stated that the increased sway was associated with the dysfunction of the postural control system.

In the light of these informations, treatment approaches that can positively contribute to proprioception and balance gain importance in patients with NSNP. Although manual therapy is used both to reduce pain, and to increase cervical mobility in patients with NSNP, the number of studies investigating the effects of manual therapy on balance and proprioception is quite insufficient.

It was thought that mobilization applied to the cervical region can improve cervical proprioception and mobility, reduce pain and contribute positively to balance. The purpose of this study is to examine the effect of mobilization applications on the balance and cervical proprioception in patients with NSNP.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, controlled and double blind clinical trialrandomized, controlled and double blind clinical trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Manual Therapy Applied to the Cervical Region on Balance and Proprioception in Patients With Nonspesific Neck Pain: A Randomised Placebo Controlled Study
Actual Study Start Date :
Jan 2, 2020
Anticipated Primary Completion Date :
Aug 12, 2021
Anticipated Study Completion Date :
Aug 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: cervical mobilization

'Rotation mobilization' was applied to the symptomatic segment / segments after the detailed evaluation (symptom localization tests, cervical region safety tests, joint play tests, pain provocation/alleviation tests) in accordance with the Kaltenborn-Evjenth system in cervical region. Five series of 45-s mobilizations were performed with 15 s of rest. Each patient received 6 treatment sessions over a period of 3 week.

Other: Cervical mobilization
A kind of manual therapy tecnique applied to the cervical region
Other Names:
  • Manual therapy
  • Placebo Comparator: placebo mobilization

    Placebo mobilization was applied to the cervical region in the same position and the same grip with the mobilization group. The physiotherapist put her hand on a randomly selected faset without any pushing or pulling, The duration of placebo mobilization was the same as the duration of the other group. Each patient received 6 treatment sessions over a period of 3 week.

    Other: Placebo mobilization
    It was applied to the randomly selected cervical faset without any pushing or pulling in the same position and the same grip with cervical mobilization.

    Outcome Measures

    Primary Outcome Measures

    1. Balance [baseline-3rd week]

      Balance measured with the Kinesthetic Ability Training System 3000 (Med-Fit Systems Inc., Fallbrook, C.A., USA) for static and dynamic balance. The increase in the balance index indicates a deterioration in balance, while the decrease in the index represents an improvement in stability.

    2. Cervical proprioception [baseline-3rd week]

      Cervical joint position error test was conducted using the CROM device in transverse plane (right and left rotation). A travel eye mask was used to blindfold the patient. The examiner held the patient's head and moved slowly to the target head position, which is 50% of the maximum cervical range of motion. When patient reached actively the target position that memorized, the difference between the target position and the position obtained was recorded. Each direction of testing was performed three times and the mean error of these trials was used in the analysis.

    Secondary Outcome Measures

    1. Cervical mobility [baseline-3rd week]

      Active cervical range of motion was measured with the CROM device (Cervical Range of Motion-Perfomance Attainment Associates, St. Paul, MN, 55117, United States) for each direction (flexion, extension, right and left lateral flexion, right and left rotation). It is an inclinometer system that utilizes gravity and magnetic effects.

    2. Cervical pain [baseline-3rd week]

      The visual analog scale (VAS) was used to assess patient's pain intensity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • to be diagnosed with NSNP by a physiatrist

    • to be in the age range of 18-60 years

    • to have pain affected by neck movements

    • to have restriction of cervical region in at least the last three weeks

    Exclusion Criteria:
    • Neurological or orthopedic disease that may affect balance / proprioception

    • presence of neurological / inflammatory symptoms

    • presence of cervical instability

    • to have trauma / cervical surgery / severe osteoporosis

    • to use of drugs that may affect balance (antidepressants, anticonvulsants, antihistamines, sedatives, betahistine)

    • to have visual / vestibular disorder

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University Faculty of Medicine Ankara Turkey 06500
    2 Gazi Univercity Ankara Turkey 06560
    3 Gazi University Ankara Turkey

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Study Chair: Nevin Atalay Güzel, Prof., Gazi Univercity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zafer Günendi, Prof., Gazi University
    ClinicalTrials.gov Identifier:
    NCT04794647
    Other Study ID Numbers:
    • 24074710-604.01.01
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Aug 12, 2021
    Last Verified:
    Aug 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 Zafer Günendi, Prof., Gazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2021