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The Effects of Manual Therapy on Balance and Cervical Proprioception

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervical mobilization
Placebo mobilization
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Mobilization, Balance, Pain, Mobility, Joint position sense.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gazi University Faculty of MedicineRecruiting
  • Gazi Univercity
  • Gazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

cervical mobilization

placebo mobilization

Arm Description

'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.

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.

Outcomes

Primary Outcome Measures

Balance
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.
Cervical proprioception
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

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

Full Information

First Posted
March 9, 2021
Last Updated
August 11, 2021
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04794647
Brief Title
The Effects of Manual Therapy on Balance and Cervical Proprioception
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
August 12, 2021 (Anticipated)
Study Completion Date
August 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Mobilization, Balance, Pain, Mobility, Joint position sense.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled and double blind clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cervical mobilization
Arm Type
Experimental
Arm Description
'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.
Arm Title
placebo mobilization
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical mobilization
Other Intervention Name(s)
Manual therapy
Intervention Description
A kind of manual therapy tecnique applied to the cervical region
Intervention Type
Other
Intervention Name(s)
Placebo mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
baseline-3rd week
Title
Cervical proprioception
Description
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.
Time Frame
baseline-3rd week
Secondary Outcome Measure Information:
Title
Cervical mobility
Description
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.
Time Frame
baseline-3rd week
Title
Cervical pain
Description
The visual analog scale (VAS) was used to assess patient's pain intensity.
Time Frame
baseline-3rd week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zafer Günendi, Prof.
Phone
+90 532 383 91 53
Email
zafergunendi@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nagihan Acet, Phd.
Phone
+90 532 205 26 05
Email
nagihan.acet@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevin Atalay Güzel, Prof.
Organizational Affiliation
Gazi Univercity
Official's Role
Study Chair
Facility Information:
Facility Name
Gazi University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagihan Acet, PhD
Facility Name
Gazi Univercity
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gazi University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effects of Manual Therapy on Balance and Cervical Proprioception

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