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SNAGs in Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound Therapy, SNAGs
Sponsored by
Raj Nursing and Paramedical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  • Age group between 20- 45 years.
  • Both Gender male and female.
  • Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy.
  • Pain reported on VAS score ˃3 in neck region.
  • Patients agree to sign written consent form.

Exclusion Criteria Patients were excluded if they were diagnosed with following conditions for ˃6 months:

  • T.B, carcinoma, heart disease, osteoporosis.
  • Neural disorders due to PIVD.
  • Any trauma or localized infection in neck region.
  • Upper MND, cervical stenosis, metabolic diseases in bone and joint.
  • Hyper flexibility
  • Open sores,
  • Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants.
  • Psychiatric diseases such as phobia/obsession, depression.
  • Allergy to hot pack
  • Patients with history of surgery in cervical spine region with in a year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Mean and standard deviations of age and height between group A and B

    Between group comparison of VAS, NDI and ROM

    Arm Description

    100 subjects with a mean age of 30.82±6.75 (group A, 31.42±6.67; group B, 30.82±6.82) ranging from 20 to 45 years, with a mean height of 165.52±7.85 (group A, 164.92±7.79; group B, 166.12±7.87) centimeters

    VAS, NDI and Neck ROM between two groups were compared at pretest (0 day) and posttest (end of two weeks)

    Outcomes

    Primary Outcome Measures

    Visual analog scale
    Visual analog scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line. On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity.
    Neck Range of motion
    Range of motion of the cervical spine measured by bubble inclinometer. It consists of a 360-degree scale with a fluid filled circular tube containing a small air bubble. It is a gravity dependent Goniometer, which uses the gravity's effect on fluid level to measure joint position and motion.

    Secondary Outcome Measures

    Neck disability Index
    Neck disability Index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored ranging from 0 (no pain or disability) to 5 (severe pain and disability); and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

    Full Information

    First Posted
    October 30, 2020
    Last Updated
    November 5, 2020
    Sponsor
    Raj Nursing and Paramedical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04617288
    Brief Title
    SNAGs in Mechanical Neck Pain
    Official Title
    Efficacy of SNAGs in the Management of Mechanical Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 10, 2015 (Actual)
    Primary Completion Date
    August 25, 2015 (Actual)
    Study Completion Date
    August 25, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Raj Nursing and Paramedical College

    4. Oversight

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

    5. Study Description

    Brief Summary
    Neck pain is second largest cause of disability worldwide. Chronic neck pain prevalence is 14% which is somewhat higher in females as compared to males. In India reported prevalence is 6%. Therapeutically, neck pain is managed by physiotherapists using rest, stretching and strengthening exercises, educating patient, and intense proprioception and positional exercises.
    Detailed Description
    To determine the evidences for the efficacy of SNAGs in the Management of Mechanical Neck Pain. 100 patients [Age group 25-45 yrs] who were diagnosed with neck pain, with onset ˃1-3 months (chronic) were randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound. Subjects in-group A that received conventional Physiotherapy plus SNAGs showed greater Improvement in pain and range of motion compared with the conventional Physiotherapy plus ultrasound group on 2nd week compared with pretreatment. The result of study suggests that both SNAGs and Ultrasound groups improves the symptoms of neck pain. Ultrasound group improved the pain symptoms but was too small to reach satisfactory outcome for patients. Based on these results conventional Physiotherapy plus SNAGs should be the treatment of choice for neck pain rather than conventional Physiotherapy plus Ultrasound .

    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
    Model Description
    Participants randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mean and standard deviations of age and height between group A and B
    Arm Type
    Experimental
    Arm Description
    100 subjects with a mean age of 30.82±6.75 (group A, 31.42±6.67; group B, 30.82±6.82) ranging from 20 to 45 years, with a mean height of 165.52±7.85 (group A, 164.92±7.79; group B, 166.12±7.87) centimeters
    Arm Title
    Between group comparison of VAS, NDI and ROM
    Arm Type
    Experimental
    Arm Description
    VAS, NDI and Neck ROM between two groups were compared at pretest (0 day) and posttest (end of two weeks)
    Intervention Type
    Other
    Intervention Name(s)
    Ultrasound Therapy, SNAGs
    Other Intervention Name(s)
    Hot Pack, Exercise
    Primary Outcome Measure Information:
    Title
    Visual analog scale
    Description
    Visual analog scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line. On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity.
    Time Frame
    2 weeks
    Title
    Neck Range of motion
    Description
    Range of motion of the cervical spine measured by bubble inclinometer. It consists of a 360-degree scale with a fluid filled circular tube containing a small air bubble. It is a gravity dependent Goniometer, which uses the gravity's effect on fluid level to measure joint position and motion.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Neck disability Index
    Description
    Neck disability Index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored ranging from 0 (no pain or disability) to 5 (severe pain and disability); and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria Age group between 20- 45 years. Both Gender male and female. Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy. Pain reported on VAS score ˃3 in neck region. Patients agree to sign written consent form. Exclusion Criteria Patients were excluded if they were diagnosed with following conditions for ˃6 months: T.B, carcinoma, heart disease, osteoporosis. Neural disorders due to PIVD. Any trauma or localized infection in neck region. Upper MND, cervical stenosis, metabolic diseases in bone and joint. Hyper flexibility Open sores, Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants. Psychiatric diseases such as phobia/obsession, depression. Allergy to hot pack Patients with history of surgery in cervical spine region with in a year.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    SNAGs in Mechanical Neck Pain

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