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Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome

Primary Purpose

Chronic Pain, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
soft tissue mobilization
neck isometric strengthening exercises
Sponsored by
Health Education Research Foundation (HERF)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Assessment, Neck pain, Pain measurements, Patient outcome assessment, Treatment outcome

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria

:• Age above 30 and below 75 years

  • Patients having local neck pain included
  • Female included
  • With chronic neck syndrome (> month)

Exclusion Criteria:

  • Age below 30 and more than 75 years
  • Patients having radiating pain excluded
  • Male excluded.
  • With acute neck syndrome (< 3 month)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental Group(Group A)

    Control group (Group B)

    Arm Description

    Experimental Group received soft tissue mobilization with neck isometric strengthening exercises.

    Control group received neck isometric strengthening exercises alone.

    Outcomes

    Primary Outcome Measures

    Numerical pain rating scale (NPRS)
    NPRS was used to assess the pain intensity. The 11-point numeric scale ranging from 0-10; 0 means no pain while 10 means worst possible pain.
    Neck disability index (NDI)
    NDI was used to assess the neck-related disability. Of the 50 score, 0-4 means no disability while 35-50 means severe disability.
    Neck range of motion
    Goniometer was used to measure the range of motion of neck.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 26, 2021
    Last Updated
    January 27, 2022
    Sponsor
    Health Education Research Foundation (HERF)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05227963
    Brief Title
    Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome
    Official Title
    Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 4, 2016 (Actual)
    Primary Completion Date
    May 10, 2016 (Actual)
    Study Completion Date
    August 20, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Health Education Research Foundation (HERF)

    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
    A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.
    Detailed Description
    The experimental group received STM and neck isometric strengthening exercises, whereas the control group received neck isometrics strengthening exercises only. Numeric Pain Rating Scale (NPRS) was used to assess the pain intensity, while Neck Disability Index (NDI) was used to assess the neck-related disability. The data was collected pre-, during, and post-intervention. Repeated measure analysis of variance (RM ANOVA) was used to analyze within the group changes, while independent t-test was used to analyze the differences between the groups. Data were analyzed by using SPSS version 21. This study describes the comparative effectiveness of STM when used as adjunct to strengthening exercises and when strengthening exercises are used alone for the management of TNS. According to the results of this study, STM in combination with neck isometric strengthening exercises as well as exercises alone were effective for managing neck pain and functional disability when a comparison was made within the groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain, Neck Pain
    Keywords
    Assessment, Neck pain, Pain measurements, Patient outcome assessment, Treatment outcome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    The randomized control study was conducted in two groups,one was experimental group received soft tissue mobilization and other was control group received strengthening exercises with supportive treatment for both groups.
    Masking
    Investigator
    Masking Description
    Non-probability convenient sampling technique was used to recruit the sample through lottery method into two groups.
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group(Group A)
    Arm Type
    Experimental
    Arm Description
    Experimental Group received soft tissue mobilization with neck isometric strengthening exercises.
    Arm Title
    Control group (Group B)
    Arm Type
    Other
    Arm Description
    Control group received neck isometric strengthening exercises alone.
    Intervention Type
    Other
    Intervention Name(s)
    soft tissue mobilization
    Intervention Description
    In this group, each participants received 45-minutes long session that includes 25-minutes of soft tissue mobilization and 20-minutes of neck isometric strengthening exercises. In each session, patient was seated on chair and sustained pressure, direct oscillation, perpendicular mobilization, parallel mobilization, and friction massage was applied on the neck musculature for a minute followed by a release for 30 seconds. This protocol was repeated three times in each session. Each session was repeated four-times a week for two-weeks (a total eight sessions).
    Intervention Type
    Other
    Intervention Name(s)
    neck isometric strengthening exercises
    Intervention Description
    In this group, each participant received 20-minutes long session. Each session started in seated position and participants were asked to perform flexion, extension, side bending and rotation against resistance. During flexion movement, therapist placed hand on forehead and asked patient to move the neck forward, while in extension, therapist hand was placed at back of the head and patient had to move neck in backward direction. However, in side bending and rotation- therapist hand was placed at lateral side of the head and asked patient to side bend the neck and look at shoulder in the same direction respectively. Each session was repeated four-times a week for two-weeks (a total eight sessions).
    Primary Outcome Measure Information:
    Title
    Numerical pain rating scale (NPRS)
    Description
    NPRS was used to assess the pain intensity. The 11-point numeric scale ranging from 0-10; 0 means no pain while 10 means worst possible pain.
    Time Frame
    upto 2 weeks
    Title
    Neck disability index (NDI)
    Description
    NDI was used to assess the neck-related disability. Of the 50 score, 0-4 means no disability while 35-50 means severe disability.
    Time Frame
    upto 2 weeks.
    Title
    Neck range of motion
    Description
    Goniometer was used to measure the range of motion of neck.
    Time Frame
    upto 2 weeks .

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria :• Age above 30 and below 75 years Patients having local neck pain included Female included With chronic neck syndrome (> month) Exclusion Criteria: Age below 30 and more than 75 years Patients having radiating pain excluded Male excluded. With acute neck syndrome (< 3 month)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome

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