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Effects of Garston Tool and Neuromuscular Reeducation in Cervical Headache

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Garston tool
Neuromuscular Re-education
Sponsored by
Health Education Research Foundation (HERF)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: Minimum 20years- Maximum 50 years (Male/Female) Unilateral pain Neck stiffness and ROM restrictions Pain exacerbated by posture and neck movements Pain effecting QOL Positive flexion-rotation test Exclusion Criteria: Headache not of cervical origin Congenital condition of cervical spine Headache with autonomic involvement, dizziness or visual impairment Inability to tolerate the flexion rotation test Conditions contraindicated for graston technique

Sites / Locations

  • Nazma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Graston Tool

Neuromuscular Re-Education

Arm Description

Graston instrument, 20 strokes per minute proximal to distal and 20 strokes per minute distal to proximal for a period of 3 minutes was given over the painful area. GT group protocol included the use application of IASTM along with the application of ice therapy at the end of the session. The assessment of patients was done at the initial and last visit before the completion of the treatment program. Three treatment sessions per week were given to each patient for a total of four weeks.

General stretching and strengthening exercises for the neck muscles. The protocol of treatment for the NMR group included the use of the Neuromuscular re-education soft tissue mobilization technique (NMR) followed by active movements of the patient.

Outcomes

Primary Outcome Measures

Change from Baseline in pain on 10 points on Numeric Pain Rating Scale at 4th week
The Numeric Pain Rating Scale, is a validated, self reported tool assessing average pain intensity over period of last 24 hours. Possible pain ranges from 0( No pain) to 10 (Worst pain). Change= (Week 4 Score - Baseline Score )
Change from Baseline in pain on 27 items on Headache Disability Index at 4th week
Headache Disability Index is a 27 items questionnaire that identify the limitations experienced due to headache. It includes questions to identify the frequency ranges from one per month, more than one but less than four per months, more than one per week and intensity of headache ranges from mild to moderate and to severe.
Change from Baseline in pain on 10 items on Neck Disability Index at 4th week
Neck Pain Disability Index is a 10 items questionnaire that identify the functional status of patients based on their conditions. it includes questions related to pain, personal care, reading, lifting, headaches, driving, sleeping , work, focus and leisure.

Secondary Outcome Measures

Full Information

First Posted
December 23, 2022
Last Updated
May 8, 2023
Sponsor
Health Education Research Foundation (HERF)
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1. Study Identification

Unique Protocol Identification Number
NCT05849545
Brief Title
Effects of Garston Tool and Neuromuscular Reeducation in Cervical Headache
Official Title
Comparing the Effects of the Graston Tool and Neuromuscular Reeducation in Reducing Cervical Headache.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Yes

5. Study Description

Brief Summary
Patients suffering from Cervicogenic headache have restricted range of motion and pain which in turn causes functional disability and reduced quality of life. The aim of this research was to determine the effects of Graston technique to improve range of motion, function, and reduction of pain and in patients having Cervicogenic headache
Detailed Description
A randomized controlled trial in which Graston Technique and Neuromuscular Re-education technique would be applied on patients presenting with cervicogenic headaches by using different tools and the changes would be examined pre and post intervention. The participants fulfilling inclusion criteria would be randomly allocated to two groups. Both groups received different protocols and will be assessed on data collection tool on their first and last visit using Goniometer, Headache Disability Index (HDI), Neck pain Disability Index (NDI) and Numeric Pain Rating Scale (NPRS). Participants of both groups will be pre-tested before the application of interventional techniques and post-tested after the application of respective intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Graston Tool
Arm Type
Experimental
Arm Description
Graston instrument, 20 strokes per minute proximal to distal and 20 strokes per minute distal to proximal for a period of 3 minutes was given over the painful area. GT group protocol included the use application of IASTM along with the application of ice therapy at the end of the session. The assessment of patients was done at the initial and last visit before the completion of the treatment program. Three treatment sessions per week were given to each patient for a total of four weeks.
Arm Title
Neuromuscular Re-Education
Arm Type
Active Comparator
Arm Description
General stretching and strengthening exercises for the neck muscles. The protocol of treatment for the NMR group included the use of the Neuromuscular re-education soft tissue mobilization technique (NMR) followed by active movements of the patient.
Intervention Type
Device
Intervention Name(s)
Garston tool
Other Intervention Name(s)
Neuromuscular Re-education
Intervention Description
GT group protocol included the use application of IASTM along with the application of ice therapy at the end of the session. Using the Graston instrument, 20 strokes per minute proximal to distal and 20 strokes per minute distal to proximal for a period of 3 minutes were given over the painful area. Baseline values were recorded for demographics evaluation and episodes of pain onsets. The assessment of patients was done at the initial and last visit before the completion of the treatment program. Three treatment sessions per week were given to each patient for a total of four weeks.
Intervention Type
Procedure
Intervention Name(s)
Neuromuscular Re-education
Intervention Description
General stretching and strengthening exercises for the neck muscles. The protocol of treatment for the NMR group included the use of the Neuromuscular re-education soft tissue mobilization technique (NMR) followed by active movements of the patient.
Primary Outcome Measure Information:
Title
Change from Baseline in pain on 10 points on Numeric Pain Rating Scale at 4th week
Description
The Numeric Pain Rating Scale, is a validated, self reported tool assessing average pain intensity over period of last 24 hours. Possible pain ranges from 0( No pain) to 10 (Worst pain). Change= (Week 4 Score - Baseline Score )
Time Frame
Baseline and 4th week
Title
Change from Baseline in pain on 27 items on Headache Disability Index at 4th week
Description
Headache Disability Index is a 27 items questionnaire that identify the limitations experienced due to headache. It includes questions to identify the frequency ranges from one per month, more than one but less than four per months, more than one per week and intensity of headache ranges from mild to moderate and to severe.
Time Frame
Baseline and 4th week
Title
Change from Baseline in pain on 10 items on Neck Disability Index at 4th week
Description
Neck Pain Disability Index is a 10 items questionnaire that identify the functional status of patients based on their conditions. it includes questions related to pain, personal care, reading, lifting, headaches, driving, sleeping , work, focus and leisure.
Time Frame
Baseline and 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: Minimum 20years- Maximum 50 years (Male/Female) Unilateral pain Neck stiffness and ROM restrictions Pain exacerbated by posture and neck movements Pain effecting QOL Positive flexion-rotation test Exclusion Criteria: Headache not of cervical origin Congenital condition of cervical spine Headache with autonomic involvement, dizziness or visual impairment Inability to tolerate the flexion rotation test Conditions contraindicated for graston technique
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazma Namroz
Organizational Affiliation
Riphah International Univeristy, Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nazma
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
there is a plan
Citations:
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23771276
Citation
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Effects of Garston Tool and Neuromuscular Reeducation in Cervical Headache

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