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Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soft Tissue Mobilization with Neural Mobilization
Soft Tissue Mobilization without Neural Mobilization
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical radiculopathy,, Soft tissue mobilization,, Neural mobilization

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with age 18 to 55years
  • Patients having pain more than 3months
  • Radiating pain in one of the upper limb
  • Spurling's test positive

Exclusion Criteria:

  • Traumatic injury of upper limb or cervical spine
  • Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
  • Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
  • Circulatory disturbance of upper extremity
  • Known history of high level of spinal cord injury and malignancy
  • Thoracic Outlet syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Soft Tissues mobilization with Neural mobilization

    Soft Tissues mobilization without Neural mobilization

    Arm Description

    Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques and Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session)

    Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session)

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Pain intensity in one of the upper limb is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.

    Secondary Outcome Measures

    Recurrence of pain and Neck disability
    Neck disability index scale used to measure ability to manage neck pain in everyday life in terms of: Pain intensity, Personal care, Lifting, Reading, Headaches, and Concentration. In which "0" shows disability and "5" shows normal.
    Neck Range of Motion
    Range of motion of the cervical spine and upper extremity (any of the upper limb) measured by Goniometer. Values deviated from standard values are considered as abnormal. The DASH Outcome Measure is scored as: the disability/symptom section (30 items, scored 1-5) where "1" shows No difficulty and "5" shows maximal difficulty

    Full Information

    First Posted
    August 27, 2018
    Last Updated
    August 28, 2018
    Sponsor
    Isra University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03652831
    Brief Title
    Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
    Official Title
    Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2018 (Anticipated)
    Primary Completion Date
    February 2019 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    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 will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization.
    Detailed Description
    soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently. Soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance. Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Radiculopathy
    Keywords
    Cervical radiculopathy,, Soft tissue mobilization,, Neural mobilization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects will be assigned randomly into two groups: Soft tissue mobilization with neural mobilization and Soft tissue mobilization without Neural mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Soft tissue mobilization with Neural mobilization group. Later on odd and even numbered subjects will be included in specific group.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Soft Tissues mobilization with Neural mobilization
    Arm Type
    Active Comparator
    Arm Description
    Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques and Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session)
    Arm Title
    Soft Tissues mobilization without Neural mobilization
    Arm Type
    Active Comparator
    Arm Description
    Soft Tissue Mobilization with Neural mobilization group will be assessed by spurling test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Post Isometric Relaxation Techniques. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session)
    Intervention Type
    Other
    Intervention Name(s)
    Soft Tissue Mobilization with Neural Mobilization
    Intervention Description
    Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time. Hot Pack for 10mints Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minute. Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session)
    Intervention Type
    Other
    Intervention Name(s)
    Soft Tissue Mobilization without Neural Mobilization
    Intervention Description
    Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time. Hot Pack for 10mints Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minutes Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session)
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Pain intensity in one of the upper limb is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.
    Time Frame
    4weeks
    Secondary Outcome Measure Information:
    Title
    Recurrence of pain and Neck disability
    Description
    Neck disability index scale used to measure ability to manage neck pain in everyday life in terms of: Pain intensity, Personal care, Lifting, Reading, Headaches, and Concentration. In which "0" shows disability and "5" shows normal.
    Time Frame
    4weeks
    Title
    Neck Range of Motion
    Description
    Range of motion of the cervical spine and upper extremity (any of the upper limb) measured by Goniometer. Values deviated from standard values are considered as abnormal. The DASH Outcome Measure is scored as: the disability/symptom section (30 items, scored 1-5) where "1" shows No difficulty and "5" shows maximal difficulty
    Time Frame
    4weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with age 18 to 55years Patients having pain more than 3months Radiating pain in one of the upper limb Spurling's test positive Exclusion Criteria: Traumatic injury of upper limb or cervical spine Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc) Patient asymptomatic for pain but symptomatic for tingling and paraesthesia Circulatory disturbance of upper extremity Known history of high level of spinal cord injury and malignancy Thoracic Outlet syndrome
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noor Ul Ain, Mphil-OPT
    Phone
    0333-5292822
    Email
    Noorabid2015@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Waqar Ahmed Awan, Ph D Rehab
    Phone
    03335348846
    Email
    wawan01@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy

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