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Effect of Exercise and Manuel Therapy Methods on Pain, Posture, Daily Living in People With Cervical Pathologies

Primary Purpose

Musculoskeletal Disorder of the Neck

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscle Energy Technic
Deep Friction Massage
Exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Disorder of the Neck focused on measuring neck pain, physiotherapy, rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • clinical diagnosis of cervical disorder (for example; chronic neck pain, cervical disc herniation)
  • must have pain at least three months.

Exclusion Criteria:

  • History of structural scoliosis
  • History of surgery
  • History of metabolic, neurologic and metastatic diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Muscle energy technic

    Deep Friction Massage

    exercise

    Arm Description

    post isometric relaxation technics were used as muscle energy technics.

    Painful areas palpated and deep friction massage was applied.

    Physiotherapist guided Spinal stabilization exercises were applied.

    Outcomes

    Primary Outcome Measures

    change in pain sensitivity
    pressure pain threshold (PPT) was measured with digital algometer. Pressure pain threshold which identifies minimum levels increasing mechanical stimulus is gold standard method for measuring pain sensitivity. PPT was measured from cervical vertebrae's spinous process and muscle belly's. Algometer range was set 0 kgF to 12kgF. Higher values represent increased pressure sensation.

    Secondary Outcome Measures

    change in Light touch sensation
    Semmes weinstein monofilaments were used to determine light touch sensation. It has twenty different evaluator size. Evaluator size was started 2.83 point and higher values represent worse outcome. Upper extremity dermatomes were tested.
    change in upper extremity disability
    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was used.The questionnaire has 34 item which each item scored 1 to 5 points. All responses summed and averaged.This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 100 scale. Minimum score is "0" and total score is "100". higher values represent a worse outcome.
    change in posture
    Posture was assessed with global postural system. This computer generated system has two cameras and lets three different plane postural assessment. the assessments and postural deviation calculate with computer programme.
    change in perceived life quality
    perceived quality of life was assessed with nottingham health profile. the questionnaire has 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100. higher values represent better life quality.
    change in functional disability
    Neck Disability Index (NDI) was used.NDI total scores ranged from 0 (no disability) to 50 (severe disability) which have ten items assessing perceived neck pain during daily living activities such as lifting, reading, driving, sleeping and recreational activities.

    Full Information

    First Posted
    July 18, 2018
    Last Updated
    August 8, 2018
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03622944
    Brief Title
    Effect of Exercise and Manuel Therapy Methods on Pain, Posture, Daily Living in People With Cervical Pathologies
    Official Title
    Servikal bölge Patolojisi Olan Bireylerde Egzersiz ve Manuel Terapi yöntemlerinin ağrı, postür ve yaşam Kalitesi üzerindeki etkinliğinin Belirlenmesi
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    March 1, 2016 (Actual)
    Study Completion Date
    October 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to determine the effect of exercise and two different manual therapy methods on pain, quality of life and posture in people with neck pain.
    Detailed Description
    Deep friction massage will use on cervical regions in first group, muscle energy technic will use second group and cervical stabilization exercise will use as an third group. For all groups, pain intensity, Quality of life and posture will assess.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Musculoskeletal Disorder of the Neck
    Keywords
    neck pain, physiotherapy, rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Muscle energy technic
    Arm Type
    Active Comparator
    Arm Description
    post isometric relaxation technics were used as muscle energy technics.
    Arm Title
    Deep Friction Massage
    Arm Type
    Active Comparator
    Arm Description
    Painful areas palpated and deep friction massage was applied.
    Arm Title
    exercise
    Arm Type
    Active Comparator
    Arm Description
    Physiotherapist guided Spinal stabilization exercises were applied.
    Intervention Type
    Procedure
    Intervention Name(s)
    Muscle Energy Technic
    Intervention Description
    post isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks.
    Intervention Type
    Procedure
    Intervention Name(s)
    Deep Friction Massage
    Intervention Description
    deep friction massage was applied to cervical region included tendons, muscles and soft tissue.
    Intervention Type
    Procedure
    Intervention Name(s)
    Exercise
    Intervention Description
    spinal stabilization exercise were applied three sessions in a week totally six weeks.
    Primary Outcome Measure Information:
    Title
    change in pain sensitivity
    Description
    pressure pain threshold (PPT) was measured with digital algometer. Pressure pain threshold which identifies minimum levels increasing mechanical stimulus is gold standard method for measuring pain sensitivity. PPT was measured from cervical vertebrae's spinous process and muscle belly's. Algometer range was set 0 kgF to 12kgF. Higher values represent increased pressure sensation.
    Time Frame
    change from baseline PPT at six weeks
    Secondary Outcome Measure Information:
    Title
    change in Light touch sensation
    Description
    Semmes weinstein monofilaments were used to determine light touch sensation. It has twenty different evaluator size. Evaluator size was started 2.83 point and higher values represent worse outcome. Upper extremity dermatomes were tested.
    Time Frame
    change from baseline light touch sensation at six weeks
    Title
    change in upper extremity disability
    Description
    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was used.The questionnaire has 34 item which each item scored 1 to 5 points. All responses summed and averaged.This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 100 scale. Minimum score is "0" and total score is "100". higher values represent a worse outcome.
    Time Frame
    Change from baseline disability at six weeks .
    Title
    change in posture
    Description
    Posture was assessed with global postural system. This computer generated system has two cameras and lets three different plane postural assessment. the assessments and postural deviation calculate with computer programme.
    Time Frame
    change from baseline posture at six weeks
    Title
    change in perceived life quality
    Description
    perceived quality of life was assessed with nottingham health profile. the questionnaire has 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100. higher values represent better life quality.
    Time Frame
    change from baseline life quality at six weeks
    Title
    change in functional disability
    Description
    Neck Disability Index (NDI) was used.NDI total scores ranged from 0 (no disability) to 50 (severe disability) which have ten items assessing perceived neck pain during daily living activities such as lifting, reading, driving, sleeping and recreational activities.
    Time Frame
    change from baseline functional disability at six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of cervical disorder (for example; chronic neck pain, cervical disc herniation) must have pain at least three months. Exclusion Criteria: History of structural scoliosis History of surgery History of metabolic, neurologic and metastatic diseases.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aynur Demirel, PhD
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24694684
    Citation
    Rihn JA, Radcliff K, Hipp J, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. Radiographic variables that may predict clinical outcomes in cervical disk replacement surgery. J Spinal Disord Tech. 2015 Apr;28(3):106-13. doi: 10.1097/BSD.0b013e31826a0c84.
    Results Reference
    result
    PubMed Identifier
    20359958
    Citation
    Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1.
    Results Reference
    result
    PubMed Identifier
    11374522
    Citation
    Persson LC, Lilja A. Pain, coping, emotional state and physical function in patients with chronic radicular neck pain. A comparison between patients treated with surgery, physiotherapy or neck collar--a blinded, prospective randomized study. Disabil Rehabil. 2001 May 20;23(8):325-35. doi: 10.1080/09638280010005567.
    Results Reference
    result
    PubMed Identifier
    22851876
    Citation
    Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
    Results Reference
    result

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    Effect of Exercise and Manuel Therapy Methods on Pain, Posture, Daily Living in People With Cervical Pathologies

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