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Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy (SNAG&MCT)

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sustained Natural Apophyseal Glides
Mechanical Cervical Traction
Sponsored by
Obafemi Awolowo 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, Sustained Natural Apophyseal Glides, Mechanical Cervical Traction, Pain Intensity, Neck Disability

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects diagnosed with neck pain of mechanical origin of not less than 3 months. Subjects without pathology affecting the neck and upper limb(s).

-

Exclusion Criteria:(i) Participants with history of vertebro-basilary artery insufficiency. Patient with history of cervical surgery or arthroplasty

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    SNAGS Group

    MCT Group

    Arm Description

    Subjects in SNAGS group were treated with application of sustained natural apophyseal glides, twice weekly for six weeks

    subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks

    Outcomes

    Primary Outcome Measures

    Visual analogue scale
    Visual analogue scale is a scale with 10 points indicating the severity of pain. o indicate no pain and 10 indicate excruciating pain. 5 indicate moderate pain. Patient is asked to point to the scale indicating the perception of his or her pain intensity

    Secondary Outcome Measures

    Neck disability index
    It has 10 sections with 5 questions on each section asking patient on what he can do. Patient circles one choice that is most appropriate to him. These are added together and percentage are found. If 9 are filled out of 10 it will be 9 multiplied by 5 making 45. The total score divided by 45 multiply by 100 will be the percentage of disability. If the percentage is high, the disability is high and if the percentage is low the disability is low

    Full Information

    First Posted
    November 28, 2017
    Last Updated
    December 4, 2017
    Sponsor
    Obafemi Awolowo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03362567
    Brief Title
    Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy
    Acronym
    SNAG&MCT
    Official Title
    Comparative Effects of Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 28, 2016 (Actual)
    Primary Completion Date
    April 15, 2017 (Actual)
    Study Completion Date
    April 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Obafemi Awolowo 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
    Sustained natural apophyseal glides (SNAGS), is a form of manual therapy, involved a combination of a sustained facet glide with active motion, followed by overpressure. Natural apophseal glides (NAGS), a modification of SNAGS, involves a mid to end-range facet joint mobilisation applied anterocranially or posterioanteriorly along the plane of treatment, combined with a small amount of manual traction which increases movement within the spine, and decreases symptomatic pain . A study reported that Natural Apophyseal Glides (NAGS) and Sustained Natural Apophyseal Glides (SNAGS) demonstrated significant effects in reducing pain and disability in subjects with chronic neck pain . This technique, SNAGS, is however an evolving manual therapy techniques which its effectiveness has not been thoroughly investigated in cervical radiculopathy treatment raised author's curiosity to compare and document efficacy of SNAGS with cervical traction in Nigeria since comparative studies evaluating SNAGS and manual cervical traction relative efficacies among Nigerians are yet to be documented if at all available. Consequently, the quest is to look for a quicker and a better way of relieving cervical radiculopathy in this environment . The more reason why we have to compare it with a conventional mechanical traction.
    Detailed Description
    This is a Quasi experimental study. Participants will be patients with radiculopathy receiving treatment at the Usman Danfodio University Teaching Hospital Sokoto Nigeria. Ethical approval will be obtained from Institute of Public Health of the Obafemi Awolowo University Ile-Ife, Nigeria, and a copy will be taken to the site of the study. The purpose and protocol for the study will be explained to the participants, after their informed consent have been obtained. The sample size will be determined using N= 4σ2 (Zcrit+Zpwr)2/ D2 where N is the total sample size, σ is the assumed SD of each group (assumed to be equal for the groups), which is assumed to be 16.63 from previous study; Zcrit is the standard normal deviate corresponding to the selected significance criterion, i.e 0.05(95% = 1,960), Zpwr is the standard normal deviate corresponding to the selected statistical power (i.e. 0.80 = 0.842), and D is the minimum expected difference among the three means, and D =18 from a previous study. Therefore, N obtained will be 41.22. Fifty two participants are proposed for this study (making 26 participants for each group) in order to give room for attrition. The 52 participants will be allocated to two groups (Groups A and B) using permuted block randomization. Subjects in group A will receive (i) Sustained Natural Apophyzeal Glides: Each subject in this group will be in sitting position facing the wall bar. The therapist will place on thumb reinforced over the spinous process of the implicated cervical vertebra. The therapist will then push upon the implicated spinous process. The pressure will be sustained for 60 seconds. Six repetitions will be carried out and maintained on each visit twice in a week for 6 weeks. Subjects in group B will receive over -the -door mechanical cervical traction in sitting position using position 10% of each patient's body weight for 15 minutes on each visit, twice in a week for 6 weeks. Pain intensity will be measured using visual analogue scale, cervical range of motions will be measured using inclinometer, functional disabilities will be measured using neck disabilities index questionnaires. The out come measures will be applied three times: pre-treatment, 3rd week and 6th week within the treatment period. The data obtained will be analysed using descriptive and inferential statistics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Radiculopathy
    Keywords
    Cervical Radiculopathy, Sustained Natural Apophyseal Glides, Mechanical Cervical Traction, Pain Intensity, Neck Disability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study involved 47 patients with cervical radiculopathy which were purposively recruited from the Physiotherapy Department Outpatient Clinic of Usmanu Danfodio University Teaching Hospital, Sokoto for the study. Subjects were randomly allocated to Sustained Natural Apophyseal Glides (SNAGS)and Mechanical Cervical Traction (MCT) group. All the subjects were treated using cryotherapy for seven minutes. Subjects in SNAGS group were then treated with sustained natural apophyseal glides, twice weekly for six weeks while subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks. Visual analogue scale, neck disability index questionnaires and inclinometer were used to assess pain intensity, disability and cervical range of motion respectively at the beginning, 3rd and 6th week of treatment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SNAGS Group
    Arm Type
    Experimental
    Arm Description
    Subjects in SNAGS group were treated with application of sustained natural apophyseal glides, twice weekly for six weeks
    Arm Title
    MCT Group
    Arm Type
    Experimental
    Arm Description
    subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks
    Intervention Type
    Other
    Intervention Name(s)
    Sustained Natural Apophyseal Glides
    Other Intervention Name(s)
    SNAGS
    Intervention Description
    Subjects in SNAGS group were treated with sustained natural apophyseal glides, twice weekly for six weeks
    Intervention Type
    Other
    Intervention Name(s)
    Mechanical Cervical Traction
    Other Intervention Name(s)
    MCT
    Intervention Description
    subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks
    Primary Outcome Measure Information:
    Title
    Visual analogue scale
    Description
    Visual analogue scale is a scale with 10 points indicating the severity of pain. o indicate no pain and 10 indicate excruciating pain. 5 indicate moderate pain. Patient is asked to point to the scale indicating the perception of his or her pain intensity
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Neck disability index
    Description
    It has 10 sections with 5 questions on each section asking patient on what he can do. Patient circles one choice that is most appropriate to him. These are added together and percentage are found. If 9 are filled out of 10 it will be 9 multiplied by 5 making 45. The total score divided by 45 multiply by 100 will be the percentage of disability. If the percentage is high, the disability is high and if the percentage is low the disability is low
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects diagnosed with neck pain of mechanical origin of not less than 3 months. Subjects without pathology affecting the neck and upper limb(s). - Exclusion Criteria:(i) Participants with history of vertebro-basilary artery insufficiency. Patient with history of cervical surgery or arthroplasty -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adesola O Ojoawo, Phd
    Organizational Affiliation
    Obafemi Awolowo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25097535
    Citation
    Ali A, Shakil-Ur-Rehman S, Sibtain F. The efficacy of Sustained Natural Apophyseal Glides with and without Isometric Exercise Training in Non-specific Neck Pain. Pak J Med Sci. 2014 Jul;30(4):872-4.
    Results Reference
    background

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    Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy

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