| CTRI Number |
CTRI/2024/06/068503 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Single point acupuncture treatment for acute headache |
|
Scientific Title of Study
|
Effect of single point acupuncture for headache in acute care: a single centre, prospective randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavan B Mulimani |
| Designation |
Student |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Acupuncture and Meridian studies, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9380876052 |
| Fax |
|
| Email |
pavansdpbp1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Professor, Dean |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Acupuncture and Meridian studies, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
09449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan B Mulimani |
| Designation |
Student |
| Affiliation |
SDM college of naturopathy and yogic sciences |
| Address |
Department of Acupuncture and Meridian studies, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9380876052 |
| Fax |
|
| Email |
pavansdpbp1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
|
|
Primary Sponsor
|
| Name |
Dr Pavan B Mulimani |
| Address |
Department of Acupuncture and Meridian studies, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady, Karnataka 574240 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pavan B Mulimani |
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
Department of Natural
Therapeutics, Shanthivana,
Dharmasthala
Dakshina Kannada
KARNATAKA |
09380876052
pavansdpbp1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshawara College of Naturopathy and Yogic sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R51||Headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham acupuncture |
Patients in the control group will be receiving predefined distant non-acupuncture points bilaterally and superficially using fine needles. Physicians avoided “de qi†and manual stimulation of the needles. |
| Intervention |
Single point acupuncture |
Acupuncture patients will be treated at “LI-10†point bilaterally. We instructed physicians to achieve “de qi†(an irradiating feeling considered to be indicative of effective needling) if possible and to stimulate needles manually at least once during each session.
‘LI-10’ acupuncture point location: 2 t-sun below the Quchi (LI 11)
Duration: 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Met current International Headache Society (IHS) and International Classification of Headache Disorders (ICHD-2) criteria for migraine (with or without aura) at time of entry into the study
2) Who reported an average of at least two headaches per month are eligible.
|
|
| ExclusionCriteria |
| Details |
1) Participants who are taking more than three medications (including over-the-counter) specifically for migraine at the time of interview, or
2) Had failed triptan therapy in the past.
3) History of any current co-morbid illness.
4) Onset of headache disorder less than one year before or at age 50 or older
5) Pregnancy
6) Malignancy
7) Cluster headache (IHS code 3)
8) Suspicion that headache disorder had specific aetiology (IHS code 5-11)
9) Cranial neuralgias (IHS code 12); and
10) Acupuncture treatment in the previous 12 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale (VAS) |
Baseline and immediately after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Migraine and tension-type headache give rise to notable health, clinically, migraine
is characterised by hemicranial throbbing pain, which may or may not be
accompanied by vomiting, nausea, photophobia (heightened sensitivity to light),
phonophobia (heightened sensitivity to sound), and temporary neurological
symptoms Tension-type headache is essentially defined as bilateral headache of a
pressing or tightening quality without a known medical cause. Tension-type
headache is classified as episodic if it occurs on less than 15 days a month
and as chronic if it occurs more often Hence due to the adverse effects of the drug’s taken people are opting
for non-pharmacological interventions, any action that does not use medication
and is intended to improve an individual’s health is referred to as
non-pharmacologic interventions (NPI). This includes complementary and
alternative medicine (CAM) techniques, which have become more and more common
among headache sufferers in recent years, non-pharmacological
treatments are typically well tolerated and can be helpful in helping patients
control their pain. A expanding array of
non-pharmacological therapeutic modalities have demonstrated encouraging efficacy, such as
acupuncture, psychotherapy, physiotherapy and non-invasive or invasive
neuromodulation.
Acupuncture is one of
the NPI, which is chosen widely due to its high efficacy and less side effects.
The World Health Organization
defines acupuncture (zhen) in their 2007 as: “the insertion of needles
into humans or animals for remedial purposes or its methodsâ€. (19) Anecdotal
studies have shown that acupuncture can be helpful in managing the headache. So,
the present study was designed to assess the influence of single point
acupuncture on headache. |