Cervicogenic HeadacheNCT05849545
Effects of Garston Tool and Neuromuscular Reeducation in Cervical Headache
A study testing Garston tool and Neuromuscular Re-education in people with Cervicogenic Headache, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Garston tool and Neuromuscular Re-education
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Garston tool, Neuromuscular Re-education
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garston toolDevice
Also called Neuromuscular Re-education
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.
Neuromuscular Re-educationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Graston Tool | Experimental | 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. Receives: Device: Garston tool |
| Neuromuscular Re-Education | Active comparator | 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. Receives: Procedure: Neuromuscular Re-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: Baseline and 4th week
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.
Measured: Baseline and 4th week
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.
Measured: Baseline and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start10 Mar 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazma Namroz, Principal investigator, Riphah International Univeristy, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849545
- Sponsor's protocol ID
- Jaweria Syed
- Status last verified
- May 2023
- First submitted
- 23 Dec 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan
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.
PubMed 23771276Elsocht G, Delaunaij T, Van Durme M, Van Hautegem E. Cervicogenic Headache.
Biondi DM. Cervicogenic headache: a review of diagnostic and treatment strategies. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):16S-22S.
PubMed 15928349Bogduk 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.
PubMed 11403743Fredriksen 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.
PubMed 25604994Warren 1. Hammer M D, DABCO. Functional Soft-Tissue Examination and Treatment by Manual Methods 2007 2007.
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.
PubMed 25420037Stow 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.
PubMed 18486750Sandmark H, Nisell R. Validity of five common manual neck pain provoking tests. Scand J Rehabil Med. 1995 Sep;27(3):131-6.
PubMed 8602474Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.
PubMed 22034615Racicki 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.
PubMed 24421621Schoensee 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.
PubMed 7773270Dunning 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.
PubMed 26852024Boyer 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of the Graston Tool and Neuromuscular Reeducation in Reducing Cervical Headache.
- ClinicalTrials.gov ID
- NCT05849545
- Acronym / sponsor ID
- Jaweria Syed
- Conditions
- Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graston Tool | Experimental | Device: Garston toolGraston 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. |
| Neuromuscular Re-Education | Active comparator | Procedure: Neuromuscular Re-educationGeneral 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garston toolAlso: Neuromuscular Re-educationGT 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. | Device | Graston Tool |
| Neuromuscular Re-educationGeneral 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 or surgery | Neuromuscular Re-Education |
Primary outcome
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 )
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 23771276Headache 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.
- BackgroundElsocht G, Delaunaij T, Van Durme M, Van Hautegem E. Cervicogenic Headache.
- Background: PubMed 15928349Biondi DM. Cervicogenic headache: a review of diagnostic and treatment strategies. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):16S-22S.
- Background: PubMed 11403743Bogduk 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.
- Background: PubMed 25604994Fredriksen 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.
- BackgroundWarren 1. Hammer M D, DABCO. Functional Soft-Tissue Examination and Treatment by Manual Methods 2007 2007.
- Background: PubMed 25420037Portillo-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.
- BackgroundStow R. Instrument-assisted soft tissue mobilization. International journal of athletic therapy and training. 2011;16(3):5-8.
- Background: PubMed 18486750Hall 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.
- Background: PubMed 8602474Sandmark H, Nisell R. Validity of five common manual neck pain provoking tests. Scand J Rehabil Med. 1995 Sep;27(3):131-6.
- Background: PubMed 22034615Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.
- Background: PubMed 24421621Racicki 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.
- Individual participant dataSharing planned: Yes. there is a plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazma Namroz principal investigator
Riphah International Univeristy, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garston tool and Neuromuscular Re-education in people with Cervicogenic Headache, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in pain on 10 points on Numeric Pain Rating Scale at 4th week (time frame: Baseline and 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05849545, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.