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Passive Vertebral Mobilization and Propriocemptive Neuromuscular Techniques in Mechanical Neck Pain

Primary Purpose

Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Passive Vertebral Mobilization
PNF exercise
Routine Physiotherapy
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Neck Pain focused on measuring Mechanical Neck Pain, Passive Vertebral Mobilization, Proprioceptive Neuromuscular Techniques (PNF), Quality of Life, Disability, Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with mechanical neck pain having limited range of motion and muscle spasm and difficulty function between 18 to 60 years of age

Exclusion Criteria:

  • Patients diagnosed with rheumatoid arthritis, Ankylosing spondylitis or other systemic disease
  • Patients with cancer of the cervical spine
  • Patients with history of fracture of spine
  • Patients with any congenital anomaly of Cervical spine
  • Patients having whiplash disorder with in last four weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    PVM group

    PNF group

    RPT(Routine Physiotherapy) group

    Arm Description

    This group included 30 participants. Passive vertebral mobilization was given along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care

    This group included 30 participants. PNF exercise in the form of diagonal pattern neck movements was along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care

    This group included 30 participants.Routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale (PAIN)
    changes from baseline. Visual Analog Scale (VAS) is a 10 cm horizontal line, with 0 presenting No pain and 10 representing Worst Pain.
    ROM of Cervical spine (Flexion)
    changes from baseline
    ROM of Cervical spine (Extension)
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    ROM of Cervical spine (rotation rightward)
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    ROM of Cervical spine (rotation leftward)
    changes from baseline. Bubble inclinometer was used to measure ROM in sitting position
    ROM of Cervical spine (Side bending Right)
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    ROM of Cervical spine (Side bending Left)
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    Neck Flexors Muscle endurance
    changes from baseline. Neck Flexion holding time in supine lying position was measured in seconds with the help of stop watch.
    NDI (neck Disability Index)
    changes from baseline NDI is self rated index to measure pain and disability due to neck pain. Neck disability index consists of 10 questions addressing functional activities. There are 6 potential responses for each item, ranging from no disability (0) to total disability (5).The NDI is scored from 0 to 50 with higher score indication greater disability.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2019
    Last Updated
    March 10, 2021
    Sponsor
    Isra University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813680
    Brief Title
    Passive Vertebral Mobilization and Propriocemptive Neuromuscular Techniques in Mechanical Neck Pain
    Official Title
    Comparison Between Passive Vertebral Mobilization and Proprioceptive Neuromuscular Techniques in Managing Pain and Disability in Patients With Mechanical Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 20, 2015 (Actual)
    Primary Completion Date
    September 30, 2017 (Actual)
    Study Completion Date
    March 22, 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was conducted to determine the effectiveness of Passive Vertebral Mobilization (PVM) and Proprioceptive Neuromuscular Techniques (PNF) in reducing pain, disability and improving quality of life in patients with Mechanical Neck Pain.
    Detailed Description
    Neck Pain is very common and is now considered a public health issue. It poses significant health and economic burden, being a frequent cause of disability. A significant proportion of direct health care costs associated with neck disorders are attributable to visits to health care providers, to sick leave, and to the related loss of productive capacity. Mechanical neck pain affects between 45-54% of people in the general population .This can result in severe pain and disability. Mechanical neck pain described as a reduction in the mobility of cervical spinal segment is often the focus of manipulative physical therapy interventions. Most neck pain is not attributed to diseases but rather caused by muscular and postural condition. The cervical pain is a mechanical problem .It is therefore sense that a mechanical treatment works better than pharmacological treatment. Cervical spine often impairs flexibility of key muscles related to cervical spine . Stretching exercise is beneficial for increasing flexibility as well as muscle performance. The normal function of cervical spine is complex and requires a large variety of activities to be coordinated in order for an individual to perform daily activities with the least amount of strain and potential injury. When the dysfunction develops in the cervical spine, a chain reaction may develop which can affect the whole neck and even the entire body. Commonly used approaches to treatment include rest, therapeutic massage, application of physical agents like heat, cold, TENS, and ultrasonic various types of mobilizations, manipulations (by physical therapists, chiropractors, osteopaths and others), therapeutic exercises, postural care and off course medication and surgical interventions. However, studies of their effectiveness have generally been short-term and inconclusive. The aim of the study is to compare which treatment either Passive Vertebral Mobilization or Proprioceptive Neuromuscular Facilitation, whether itself or in combination, is more effective and beneficial in the treatment of mechanical neck pain. Several studies have been reported to determine the effectiveness of manual therapy/ passive vertebral mobilization but with largely inconclusive results. However there are few studies if any to compare PNF exercise with PVM in terms of their effectiveness. PNF are simple and requiring low level expertise as compare to PVM.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mechanical Neck Pain
    Keywords
    Mechanical Neck Pain, Passive Vertebral Mobilization, Proprioceptive Neuromuscular Techniques (PNF), Quality of Life, Disability, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Control Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PVM group
    Arm Type
    Active Comparator
    Arm Description
    This group included 30 participants. Passive vertebral mobilization was given along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care
    Arm Title
    PNF group
    Arm Type
    Active Comparator
    Arm Description
    This group included 30 participants. PNF exercise in the form of diagonal pattern neck movements was along with routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care
    Arm Title
    RPT(Routine Physiotherapy) group
    Arm Type
    Active Comparator
    Arm Description
    This group included 30 participants.Routine physiotherapy comprising TENS, Hotpack/IRR, Isometric neck exercise and postural care.
    Intervention Type
    Other
    Intervention Name(s)
    Passive Vertebral Mobilization
    Other Intervention Name(s)
    Spinal mobilization
    Intervention Description
    Posteroanterior glides was given to cervical spine using Maitland method along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
    Intervention Type
    Other
    Intervention Name(s)
    PNF exercise
    Other Intervention Name(s)
    Proprioceptive Neuromuscular Facilitation
    Intervention Description
    The subjects was given PNF exercises comprising PNF diagonal patterns for neck along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
    Intervention Type
    Other
    Intervention Name(s)
    Routine Physiotherapy
    Other Intervention Name(s)
    Routine Physical therapy (RPT)
    Intervention Description
    Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale (PAIN)
    Description
    changes from baseline. Visual Analog Scale (VAS) is a 10 cm horizontal line, with 0 presenting No pain and 10 representing Worst Pain.
    Time Frame
    4 weeks
    Title
    ROM of Cervical spine (Flexion)
    Description
    changes from baseline
    Time Frame
    4 weeks
    Title
    ROM of Cervical spine (Extension)
    Description
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    Time Frame
    4 weeks
    Title
    ROM of Cervical spine (rotation rightward)
    Description
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    Time Frame
    4 weeks
    Title
    ROM of Cervical spine (rotation leftward)
    Description
    changes from baseline. Bubble inclinometer was used to measure ROM in sitting position
    Time Frame
    4 weeks
    Title
    ROM of Cervical spine (Side bending Right)
    Description
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    Time Frame
    4 weeks
    Title
    ROM of Cervical spine (Side bending Left)
    Description
    changes from baseline.Bubble inclinometer was used to measure ROM in sitting position
    Time Frame
    4 weeks
    Title
    Neck Flexors Muscle endurance
    Description
    changes from baseline. Neck Flexion holding time in supine lying position was measured in seconds with the help of stop watch.
    Time Frame
    4 weeks
    Title
    NDI (neck Disability Index)
    Description
    changes from baseline NDI is self rated index to measure pain and disability due to neck pain. Neck disability index consists of 10 questions addressing functional activities. There are 6 potential responses for each item, ranging from no disability (0) to total disability (5).The NDI is scored from 0 to 50 with higher score indication greater disability.
    Time Frame
    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: Patients with mechanical neck pain having limited range of motion and muscle spasm and difficulty function between 18 to 60 years of age Exclusion Criteria: Patients diagnosed with rheumatoid arthritis, Ankylosing spondylitis or other systemic disease Patients with cancer of the cervical spine Patients with history of fracture of spine Patients with any congenital anomaly of Cervical spine Patients having whiplash disorder with in last four weeks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muhammad Ashfaq
    Organizational Affiliation
    Isra University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35710215
    Citation
    Ashfaq M, Babur MN, Malick WH, Hussain MA, Awan WA. Comparative effectiveness of proprioceptive neuromuscular facilitation and passive vertebral mobilization for neck disability in patients with mechanical neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2022 Jul;31:16-21. doi: 10.1016/j.jbmt.2022.02.009. Epub 2022 Mar 18.
    Results Reference
    derived

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    Passive Vertebral Mobilization and Propriocemptive Neuromuscular Techniques in Mechanical Neck Pain

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