Effects of Garston Tool and Neuromuscular Reeducation in Cervical Headache

May 8, 2023 updated by: Health Education Research Foundation (HERF)

Comparing the Effects of the Graston Tool and Neuromuscular Reeducation in Reducing Cervical Headache.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 46000
        • Nazma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Graston Tool
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.
Device: Garston tool
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.
Other Names:
  • Neuromuscular Re-education
Active Comparator: Neuromuscular Re-Education
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.
Procedure: Neuromuscular Re-education
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in pain on 10 points on Numeric Pain Rating Scale at 4th week
Time Frame: Baseline and 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 )
Baseline and 4th week
Change from Baseline in pain on 27 items on Headache Disability Index at 4th week
Time Frame: Baseline and 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.
Baseline and 4th week
Change from Baseline in pain on 10 items on Neck Disability Index at 4th week
Time Frame: Baseline and 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.
Baseline and 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Health Education Research Foundation (HERF)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nazma Namroz, Riphah International Univeristy, Islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Jaweria Syed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

there is a plan

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings