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Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage group
Connective tissue massage group
Mobilization group
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be between the ages of 18-65. To participate in the study voluntarily. Having a complaint of neck pain for at least 3 months. Exclusion Criteria: To have undergone cervical spine surgery Having cervical fracture and/or joint subluxation/dislocation Severe degenerative arthritis Having a neurological disease (Parkinson's disease, poliomyelitis, etc.) or an -inflammatory rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, etc.) Presence of malignancy Having cord compression and signs Severe radiculopathy or myelopathy Positive vertebrobasilar artery test, Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Massage group

    Connective tissue massage group

    Mobilization group

    Arm Description

    Massage group will be applied classic massage+cervical stabilisation exercises

    Connective tissue group will be applied connective tissue massage+cervical stabilisation exercises

    Mobilization group will be applied cervical mobilization techniques+cervical stabilisation exercises

    Outcomes

    Primary Outcome Measures

    Pain Intensity
    Pain intensity will be assessed with the Visual Analogue Scale (a 100 mm long horizontal line). Patient will be asked to score the pain he/she feels out of 10. The beginning of the figure is "0 "no pain", ending in "10 "there is unbearable pain".

    Secondary Outcome Measures

    Pressure Pain Threshold
    Pressure Pain Threshold will be assessed with a digital algometer device. The device that objectively measures the pain threshold will be used for the evaluation. The probe of the device will be pressed on the trapezius muscle. The first pain threshold felt will be recorded.
    Cervical Range of Motion
    Cervical range of motion will be evaluated with a goniometer in the sitting position. Neck flexion, extension, right-left lateral flexion and right-left rotation ranges of motion will be recorded
    Balance
    Balance will be evaluated with the Biodex Balance System Device. The individual is placed on a platform of the device that evaluates the ability to keep the centre of gravity on the support surface. Changes in the centre of gravity of the individual standing on this platform will be recorded with this device in static and dynamic, with eyes open and closed.
    Functional Status
    Functional Status will be assessed with Neck Disability Index. This index consists of 10 items. Each item was scored from 0 (no disability) to 5 (complete disability). The total score ranged from 0 (no disability) to 50 (total disability). As the score increased, disability increased and as the score decreased, disability decreased.
    Life quality
    Life quality will be assessed with Short Form-36 questionnaire. The questionnaire consists of 36 items. Scoring is done over 100 points and the scores are between 0 and 100 points for each sub-parameter. "0" is calculated as the worst value and "100" as the best value.

    Full Information

    First Posted
    March 3, 2023
    Last Updated
    March 3, 2023
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05769179
    Brief Title
    Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain
    Official Title
    Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 30, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    March 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of the study was to compare the effects of different manual therapy approaches on pain, cervical range of motion, balance, functional status and life quality in patients with chronic neck pain.
    Detailed Description
    Various physiotherapy and rehabilitation methods are applied in the treatment of patients with chronic neck pain. Clinical practice guidelines for individuals with chronic neck pain recommend both manual therapy and exercise therapy among conservative treatments. Manual therapy are methods that can be safely applied to soft tissues and joints. Both manual therapy and exercise applications have been shown to have positive effects on neck pain and function. Some studies in the literature have also shown that manual therapy methods have positive effects on balance. However, no study examining the effects of different manual therapy (classical massage, connective tissue massage, manual joint techniques) approaches applied to individuals with chronic neck pain on pain, cervical range of motion, balance, functional status and quality of life was found in the literature.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Massage group
    Arm Type
    Experimental
    Arm Description
    Massage group will be applied classic massage+cervical stabilisation exercises
    Arm Title
    Connective tissue massage group
    Arm Type
    Experimental
    Arm Description
    Connective tissue group will be applied connective tissue massage+cervical stabilisation exercises
    Arm Title
    Mobilization group
    Arm Type
    Experimental
    Arm Description
    Mobilization group will be applied cervical mobilization techniques+cervical stabilisation exercises
    Intervention Type
    Other
    Intervention Name(s)
    Massage group
    Intervention Description
    Massage group will be applied classic massage and cervical stabilisation exercises 3 days a week for 4 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Connective tissue massage group
    Intervention Description
    Connective tissue massage group will be applied connective tissue massage and cervical stabilisation exercises 3 days a week for 4 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Mobilization group
    Intervention Description
    Mobilization group will be applied cervical mobilization techniques and cervical stabilisation exercises 3 days a week for 4 weeks
    Primary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Pain intensity will be assessed with the Visual Analogue Scale (a 100 mm long horizontal line). Patient will be asked to score the pain he/she feels out of 10. The beginning of the figure is "0 "no pain", ending in "10 "there is unbearable pain".
    Time Frame
    change from baseline at 4 weeks
    Secondary Outcome Measure Information:
    Title
    Pressure Pain Threshold
    Description
    Pressure Pain Threshold will be assessed with a digital algometer device. The device that objectively measures the pain threshold will be used for the evaluation. The probe of the device will be pressed on the trapezius muscle. The first pain threshold felt will be recorded.
    Time Frame
    change from baseline at 4 weeks
    Title
    Cervical Range of Motion
    Description
    Cervical range of motion will be evaluated with a goniometer in the sitting position. Neck flexion, extension, right-left lateral flexion and right-left rotation ranges of motion will be recorded
    Time Frame
    change from baseline at 4 weeks
    Title
    Balance
    Description
    Balance will be evaluated with the Biodex Balance System Device. The individual is placed on a platform of the device that evaluates the ability to keep the centre of gravity on the support surface. Changes in the centre of gravity of the individual standing on this platform will be recorded with this device in static and dynamic, with eyes open and closed.
    Time Frame
    change from baseline at 4 weeks
    Title
    Functional Status
    Description
    Functional Status will be assessed with Neck Disability Index. This index consists of 10 items. Each item was scored from 0 (no disability) to 5 (complete disability). The total score ranged from 0 (no disability) to 50 (total disability). As the score increased, disability increased and as the score decreased, disability decreased.
    Time Frame
    change from baseline at 4 weeks
    Title
    Life quality
    Description
    Life quality will be assessed with Short Form-36 questionnaire. The questionnaire consists of 36 items. Scoring is done over 100 points and the scores are between 0 and 100 points for each sub-parameter. "0" is calculated as the worst value and "100" as the best value.
    Time Frame
    change from baseline at 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be between the ages of 18-65. To participate in the study voluntarily. Having a complaint of neck pain for at least 3 months. Exclusion Criteria: To have undergone cervical spine surgery Having cervical fracture and/or joint subluxation/dislocation Severe degenerative arthritis Having a neurological disease (Parkinson's disease, poliomyelitis, etc.) or an -inflammatory rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, etc.) Presence of malignancy Having cord compression and signs Severe radiculopathy or myelopathy Positive vertebrobasilar artery test, Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyda Toprak Celenay
    Phone
    +90312 906 1000
    Email
    sydtoprak@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyda Toprak Celenay
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Comparison of Different Manual Therapy Approaches in Patients With Chronic Neck Pain

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