Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03171337
Status:
UNKNOWN
Last Update Posted:
2017-06-05
First Post:
2017-05-04
Brief Title:
The Efficacy of Acupuncture and Fus Subcutaneous Needling FSN in Treating Chronic Tension-type Headache by fMRI
Sponsor:
Jiang Xumei
Organization:
South China Normal University
Study Overview
Official Title:
To Explore the Cerebral Function Efficacy of Acupuncture and Fus Subcutaneous Needling FSN in the Treatment of Chronic Tension-type Headache by Means of fMRI a Single-blinded Randomized Controlled Trials
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Epidemiological studies show a one-year prevalence of 30-60 for episodic tension-type headache TTH and 2-3 for chronic TTH CTTH Many TTH patients seek acupuncture treatment worldwide and CTTH is one of the most commonly treated FSN has been used to treat CTTH recently the curative effect of it was especially good for CTTH accompanying pericranial tenderness Nonetheless the effectiveness of acupuncture and FSN for CTTH remains controversial Several research results showed that symptoms of TTH improve after acupuncture treatment but these improvements were more subjective than objective measures So the aim of this study is to determine the cerebral function efficacy of acupuncture and FSN in the treatment of CTTH using Headache impact test questionnaire HIT-6 VAS to evaluate the subjective symptom and fMRI to detect the objective cerebral function changes
Intervention device acupuncture Fus subcutaneous placebo sham acupuncture
Intervention device acupuncture Fus subcutaneous placebo sham acupuncture
Detailed Description:
Tension-type headache TTH is the most prevalent type of primary headache Unlike migraine however there have been no significant treatment advances for chronic TTH in the past few decades probably due to the limited understanding of its pathophysiology compared with that of migraine The objective of the present study is to investigate the cerebral function imaging changes in patients with chronic tension headache trough comparing that in healthy people focus on the regional homogeneity ReHo of ROIs of brain In addition the effect of acupuncture and Fus subcutaneous needing FSN on the cerebral function will also be studied This is a clinical trial study randomized in parallel single-blinded assessor and with a sham placebo control
The study will be carried out in the Traditional therapy center Guangdong Hospital of Traditional Chinese Medicine Patients will be collected according to the inclusion criteria conform to diagnose criterion for headache ICHD-3 with age between 18 and 45 years old Healthy people will be collected too according to the inclusion criteria for healthy people with age matching with the patients The participants will respond to questionnaires at the beginning and end of the first fifth and last therapeutic intervention and their fMRI of brain will be acquired The therapeutic intervention will include 8 acupuncture sessions 8 FSN sessions and 8 placebo sham acupuncture sessions twice per week for 4 weeks The measurements taken will be impact of headache on daily life severity of headache emotional problem of headache the cerebral function of ROIs by means of fMRI of headache and so on
Through these interventions it is hoped that patients will present an improvement in their pain presentation quality of life and emotional problem as well as cerebral function imaging in certain region of brain Evidence for these hypotheses will provide the cerebral function effect mechanism of acupuncture and FSN to CTTH and some evidence in the research will perhaps support that acupuncture and FSN are two type minimally-invasive treatment methods with few side-effects and low cost
The study will be carried out in the Traditional therapy center Guangdong Hospital of Traditional Chinese Medicine Patients will be collected according to the inclusion criteria conform to diagnose criterion for headache ICHD-3 with age between 18 and 45 years old Healthy people will be collected too according to the inclusion criteria for healthy people with age matching with the patients The participants will respond to questionnaires at the beginning and end of the first fifth and last therapeutic intervention and their fMRI of brain will be acquired The therapeutic intervention will include 8 acupuncture sessions 8 FSN sessions and 8 placebo sham acupuncture sessions twice per week for 4 weeks The measurements taken will be impact of headache on daily life severity of headache emotional problem of headache the cerebral function of ROIs by means of fMRI of headache and so on
Through these interventions it is hoped that patients will present an improvement in their pain presentation quality of life and emotional problem as well as cerebral function imaging in certain region of brain Evidence for these hypotheses will provide the cerebral function effect mechanism of acupuncture and FSN to CTTH and some evidence in the research will perhaps support that acupuncture and FSN are two type minimally-invasive treatment methods with few side-effects and low cost
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?:
False
Is an FDA AA801 Violation?:
None