- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05849545
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
|
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.
|
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
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.
Investigators
- 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
- Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.
- Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
- Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.
- Racicki S, Gerwin S, Diclaudio S, Reinmann S, Donaldson M. Conservative physical therapy management for the treatment of cervicogenic headache: a systematic review. J Man Manip Ther. 2013 May;21(2):113-24. doi: 10.1179/2042618612Y.0000000025.
- Biondi DM. Cervicogenic headache: a review of diagnostic and treatment strategies. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):16S-22S.
- Portillo-Soto A, Eberman LE, Demchak TJ, Peebles C. Comparison of blood flow changes with soft tissue mobilization and massage therapy. J Altern Complement Med. 2014 Dec;20(12):932-6. doi: 10.1089/acm.2014.0160.
- Elsocht G, Delaunaij T, Van Durme M, Van Hautegem E. Cervicogenic Headache.
- Fredriksen TA, Antonaci F, Sjaastad O. Cervicogenic headache: too important to be left un-diagnosed. J Headache Pain. 2015;16:6. doi: 10.1186/1129-2377-16-6. Epub 2015 Jan 20.
- Warren 1. Hammer M D, DABCO. Functional Soft-Tissue Examination and Treatment by Manual Methods 2007 2007.
- Stow R. Instrument-assisted soft tissue mobilization. International journal of athletic therapy and training. 2011;16(3):5-8.
- Hall TM, Robinson KW, Fujinawa O, Akasaka K, Pyne EA. Intertester reliability and diagnostic validity of the cervical flexion-rotation test. J Manipulative Physiol Ther. 2008 May;31(4):293-300. doi: 10.1016/j.jmpt.2008.03.012.
- Sandmark H, Nisell R. Validity of five common manual neck pain provoking tests. Scand J Rehabil Med. 1995 Sep;27(3):131-6.
- Schoensee SK, Jensen G, Nicholson G, Gossman M, Katholi C. The effect of mobilization on cervical headaches. J Orthop Sports Phys Ther. 1995 Apr;21(4):184-96. doi: 10.2519/jospt.1995.21.4.184.
- Boyer S, Novack J, Madsen L, Kingma J, Schrader J, Docherty C. The Immediate Effects of Graston Technique© on Hamstring Flexibility Compared to a Control. Journal of Athletic Training. 2017;52(6):S94.
- Barger KM. Compressive versus decompressive soft tissue therapy on acute hamstring flexibility and pain in male athletes with perceived hamstring tightness: Oklahoma State University; 2016.
- Cheatham SW, Lee M, Cain M, Baker R. The efficacy of instrument assisted soft tissue mobilization: a systematic review. J Can Chiropr Assoc. 2016 Sep;60(3):200-211.
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)
March 10, 2021
Primary Completion (Actual)
July 15, 2021
Study Completion (Actual)
July 15, 2021
Study Registration Dates
First Submitted
December 23, 2022
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 9, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Cervicogenic Headache
-
Meltem UzunCompletedExercise | Therapeutics | Headache, CervicogenicTurkey
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosCompletedCervicogenic HeadachesUnited States
-
Des Moines UniversityCompleted
-
Hungarian University of Sports ScienceCairo UniversityCompleted
-
Foundation University IslamabadRecruiting
-
Cairo UniversityNot yet recruiting
-
University of LahoreCompletedCervicogenic HeadachePakistan
-
Istanbul Medipol University HospitalIstanbul Kent UniversityCompletedCervicogenic Headache | Cervicogenic HeadachesTurkey (Türkiye)
-
Ankara City Hospital BilkentRecruitingCervicogenic Headache | Third Occipital NerveTurkey (Türkiye)
-
Hong Kong Baptist UniversityActive, not recruiting
Clinical Trials on Garston tool
-
Cairo UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisUniversity of OxfordCompletedRandomized Controlled TrialUnited Kingdom, France
-
University of California, San FranciscoCompleted
-
VA Office of Research and DevelopmentRecruitingTotal Knee ArthroplastyUnited States
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedAirway Morbidity | Anesthesia Insertion ComplicationTaiwan
-
Sun JingfengRecruiting
-
ZipongoUnknown
-
Walter Reed National Military Medical CenterUniversity of Wisconsin, MilwaukeeCompletedHypertension | Cardiovascular Disease | Diabetes Mellitus | Osteoarthritis | Chronic Disease | Hyperlipidemia | COPDUnited States
-
Unity Health TorontoCompletedSocial Determinants of Health | Social Isolation | Poverty | Social MarginalizationCanada
-
Aarhus University HospitalUnknownPaediatric Early Warning SystemDenmark