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
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
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
NCT ID
NCT05227963
First Posted
October 26, 2021
Last Updated
January 27, 2022
Sponsor
Health Education Research Foundation (HERF)
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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