Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100588
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-10-20
Brief Title:
The Classification and Treatment of Myofascial Headache a Cross-sectional Study and Randomized Controlled Trial
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
The Classification of Myofascial Headache a Cross-sectional Study the Added Value of Dry Needling in the Treatment of Myofascial Headache a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPHAS_RCT
Brief Summary:
This project comprises two studies a cross-sectional study and a randomized controlled trial
1 The goal of the cross-sectional study is to compare multiple outcome parameters in different headache types tension type TTH cervicogenic CGH and myofascial headache MFH as drafted by the International Classification of Headache Disorders ICHD Not only will these types be compared against each other they will also be compared to healthy controls HC
The main research questions are
Are the criteria drafted by the International Classification of Headache Disorders ICHD discriminative for MFH
Are there differences between the headache types and healthy controls in pain disability scores range of motion ROM muscle strength muscle elasticity and hyperalgesia pain pressure threshold PPT
Participants will
Fill out questionnaires about their pain and disability
Be clinically investigated by a physiotherapist anamnesis inspection examination of movement and structures of the neck and head
Undergo a testing battery including neck ROM neck muscle strength elasticity and PPT measurement of the C2 processus spinosus the bilateral upper trapezius muscle and the tibialis anterior muscle of the dominant leg
2 The goal of this randomized controlled study is to investigate the additional effect of dry needling in the treatment of MFH patients as compared to a treatment consisting of manual techniques only The main question it aims to answer is
Does manual therapy combined with dry needling provide an additional effect on pain disability and functional outcomes in MFH patients as compared to manual therapy alone
After the baseline test see part 1 participants with MFH will be randomly divided to receive 4 sessions over 4 weeks of MT or MT DN Hereafter the baseline test is repeated at 1 week and 3 months post-treatment
1 The goal of the cross-sectional study is to compare multiple outcome parameters in different headache types tension type TTH cervicogenic CGH and myofascial headache MFH as drafted by the International Classification of Headache Disorders ICHD Not only will these types be compared against each other they will also be compared to healthy controls HC
The main research questions are
Are the criteria drafted by the International Classification of Headache Disorders ICHD discriminative for MFH
Are there differences between the headache types and healthy controls in pain disability scores range of motion ROM muscle strength muscle elasticity and hyperalgesia pain pressure threshold PPT
Participants will
Fill out questionnaires about their pain and disability
Be clinically investigated by a physiotherapist anamnesis inspection examination of movement and structures of the neck and head
Undergo a testing battery including neck ROM neck muscle strength elasticity and PPT measurement of the C2 processus spinosus the bilateral upper trapezius muscle and the tibialis anterior muscle of the dominant leg
2 The goal of this randomized controlled study is to investigate the additional effect of dry needling in the treatment of MFH patients as compared to a treatment consisting of manual techniques only The main question it aims to answer is
Does manual therapy combined with dry needling provide an additional effect on pain disability and functional outcomes in MFH patients as compared to manual therapy alone
After the baseline test see part 1 participants with MFH will be randomly divided to receive 4 sessions over 4 weeks of MT or MT DN Hereafter the baseline test is repeated at 1 week and 3 months post-treatment
Detailed Description:
Although tension-type headache TTH and cervicogenic headache CGH are classified as two distinct headache types according to the International Classification of Headache Disorders ICHD there are many cases in which overlap between these two types exists and for whom clinical diagnosis can be challenging Peripheral activation or sensitization of myofascial nociceptors is suggested as a potential mechanism in both categories and as a consequence the ICHD 3rd edition - 2018 has recently drafted an alternative diagnosis headache attributed to cervical myofascial pain MFH However clear clinical criteria for this diagnosis are currently lacking
By subjecting CGH TT MFH and HC 34 participants of each to the ICHD criteria and a clinical investigation we will look at similarities and differences and the ability of the criteria to differentiate the headache types
Among the several proposed approaches for the treatment of myofascial pain dry needling DN has received particular attention in the last decades DN is defined as a skilled intervention using a thin needle which is inserted into a painful point in the muscle also referred to as a trigger point Although previous studies have indicated that DN may be an effective intervention in the treatment of TTH and CGH little is known about its additional effect on MFH
Therefore 50 MFH patients will be recruited Participants are included based on online questionnaires a clinical examination of the neck and the ICHD criteria All participants will receive information and have to sign an informed consent form Participants will be subjected to baseline assessment which involves measurements of pain scores NPRS hyperalgesia PPT by algometry ROM EasyAngle device and neck muscle strength measurement EasyForce device and neck muscle elasticity measurement using Shear Wave Elastography SWE Then participants will be randomly allocated to either a manual therapy group or a manual therapy dry needling group 4 sessions of therapy will be given over 4 weeks time
1 week and 3 months after the treatment sessions the baseline measurements will be repeated After 6 and 12 months patients will complete questionnaires from home which will give information about pain disability scores
By subjecting CGH TT MFH and HC 34 participants of each to the ICHD criteria and a clinical investigation we will look at similarities and differences and the ability of the criteria to differentiate the headache types
Among the several proposed approaches for the treatment of myofascial pain dry needling DN has received particular attention in the last decades DN is defined as a skilled intervention using a thin needle which is inserted into a painful point in the muscle also referred to as a trigger point Although previous studies have indicated that DN may be an effective intervention in the treatment of TTH and CGH little is known about its additional effect on MFH
Therefore 50 MFH patients will be recruited Participants are included based on online questionnaires a clinical examination of the neck and the ICHD criteria All participants will receive information and have to sign an informed consent form Participants will be subjected to baseline assessment which involves measurements of pain scores NPRS hyperalgesia PPT by algometry ROM EasyAngle device and neck muscle strength measurement EasyForce device and neck muscle elasticity measurement using Shear Wave Elastography SWE Then participants will be randomly allocated to either a manual therapy group or a manual therapy dry needling group 4 sessions of therapy will be given over 4 weeks time
1 week and 3 months after the treatment sessions the baseline measurements will be repeated After 6 and 12 months patients will complete questionnaires from home which will give information about pain disability scores
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None