| CTRI Number |
CTRI/2025/12/098498 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective Non Randomized Single Arm Interventional Multi Dimensional Outcome DM Thesis Exploratory] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analgesic Efficacy and Multi-Dimensional Outcomes of Bilateral Ultrasound
Guided Cervical Vagus Nerve Hydrodilatation in Fibromyalgia Patients: An
Exploratory Single Arm Study |
|
Scientific Title of Study
|
Analgesic Efficacy and MultiDimensional Outcomes of Bilateral Ultrasound
Guided Cervical Vagal Nerve Hydrodilatation in Fibromyalgia Patients An
Exploratory Single Arm Study |
| Trial Acronym |
TRFMPOCUSGGBLCVCNX5DWHD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maj Dr Vivek PD Retd |
| Designation |
Senior Resident Academic |
| Affiliation |
AIIMS Rishikesh |
| Address |
PG Student in DM Pain Medicine
Jan 2025 to 2028 Batch
AIIMS Rishikesh
Veerabhadra Road
Dehradun Distt
Uttarakhand
Bharath ie India
AV Nest
Geeta Jindal Niwas
1st Flr
Plot No 247
Galli No 11
Nirmal Block B
Visthapith Colony
Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
7795999169 |
| Fax |
9986532392 |
| Email |
dr.vpd.expressclinics@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maj Dr Vivek PD Retd |
| Designation |
Senior Resident Academic |
| Affiliation |
AIIMS Rishikesh |
| Address |
PG Student in DM Pain Medicine
Jan 2025 to 2028 Batch
AIIMS Rishikesh
Veerabhadra Road
Dehradun Distt
Uttarakhand
Bharath ie India
AV Nest
Geeta Jindal Niwas
1st Flr
Plot No 247
Galli No 11
Nirmal Block B
Visthapith Colony
Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
7795999169 |
| Fax |
9986532392 |
| Email |
dr.vpd.expressclinics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Division of Pain Medicine
Dept of Anaesthesiology
Jan 2025 to 2028 Batch
AIIMS Rishikesh
Veerabhadra Road
Dehradun Distt
Uttarakhand
Bharath ie India
Division of Pain Medicine
Dept of Anaesthesiology
Jan 2025 to 2028 Batch
AIIMS Rishikesh
Veerabhadra Road
Dehradun Distt
Uttarakhand
Bharath ie India
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9654162941 |
| Fax |
7795999169 |
| Email |
praveenrt64@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh
Veerabhadra Road
Dehradun Distt
Uttarakhand
Bharath ie India
PIN 249201 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Maj Dr Vivek PD Retd |
Pain Clinic OPD and OT |
AIIMS Rishikesh
Veerabhadra Road
Dehradun Distt
Uttarakhand
Bharath ie India
Dehradun
UTTARANCHAL |
7795999169
9986532392
dr.vpd.expressclinics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Comparator as it is a Single Arm Study |
Only Before and After Intervention Timeline Data Points Mentioned for Primary and Secondary Outcome Variables |
| Intervention |
Point of Care Ultrasound Guided Bilateral Cervical Vagus Nerves 5 Percent Dextrose Water Hydrodilatation |
20 ml of Sterile 5 Percent Dextrose Water Injected through 22 G Sterile Hypodermic Needle under Point of Care Ultrasound Guidance around the Carotid Sheaths at around C6 Vertebral Level to Hydrodilate the Vagus Nerves on each Side as a Chemical NeuroModulatory Intervention to Restore the Parasympathetic Balance in Dual Drug PharmacoTherapy Resistant Fibromyalgia Patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed as Fibromyalgia as per 2016 ACR Revised Preliminary Clinical Criteria for FM
2 Already on Dual-Drug Therapy of Duloxetine at least 40 mg per Day and Pregabalin at least 150 mg per Day for at least 3 months continued in the same Dosages during the duration of the Study
3 Pre-Intervention Baseline WPI greater than or equal to 7
4 Pre-Intervention Baseline SSS greater than or equal to 7
5 Pre-Intervention Baseline ODI greater than or equal to 50 percent
6 Pre-Intervention Baseline PHQ-9 greater than or equal to 10
7 Undergoing Pre-Intervention Baseline as well as Day 30 not exceeding day 90 Post-intervention for Heart Rate Variability Based Autonomic Function Tests |
|
| ExclusionCriteria |
| Details |
1 Patients on Anti Platelet Anti Coagulant Medication
2 Patients with any of these known Co Morbidities Uncontrolled Severe Cardiovascular Disease e.g. Severe Uncontrolled Systemic Hypertension greater than or equal to 180 90 mmHg NIBP Cardiac Dys Rhythmias with or without Implantable Pacemakers Cardioverter Defibrillators Severe Valvular heart Diseases any Causes of reduced Cardiac Ejection Fraction less than 40 percent any other Cardiovascular Disease Dysfunction qualifying as American Society of Anesthesiologists Physical Status Classification PS III or IV 3 or 4
3 Patients with Diagnosed Coagulopathy s
4 Women with Confirmed Pregnancy
5 Patients with a known observed Allergy to Ultrasound Conducting Jelly Rarely so |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Magnitude of Interval Change from pre-intervention Baseline in WPI at Days 30, 60 &
90 Post-Intervention. |
Pre Intervention and at Days 30,60 & 90 Post-Intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Magnitude of Interval Change in from pre-intervention Baseline SSS at Days 30, 60 &
90 Post-Intervention. |
Pre-Intervention & Days 30, 60 & 90 Post-Intervention. |
Magnitude of Interval Change from pre-intervention Baseline in ODI at Days 30, 60 &
90 Post-Intervention. |
Pre-Intervention & Days 30, 60 & 90 Post-Intervention. |
Magnitude of Interval Change from pre-intervention Baseline in PHQ-9 Score for
Severity of Clinical Depression at Days 30, 60 & 90 Post-Intervention. |
Pre-Intervention & Days 30, 60 & 90 Post-Intervention. |
Magnitude of Interval Change from pre-intervention Baseline in each of the Heart Rate Variability Based Tests of Autonomic Functions at Days 30, 60 & 90 post-
Intervention. |
Pre-Intervention & Days 30, 60 & 90 Post-Intervention. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.vpd.expressclinics@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 28-02-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Fibromyalgia FM is a complex multifactorial disorder characterized primarily by Chronic Widespread Pain cWSP predominantly Musculoskeletal in Origin alongside a constellation of other Symptoms including Fatigue Sleep Disturbances Cognitive Dysfunction Anxiety and Depression the latter constellation frequently described as Fibro Fog that significantly reduce Quality of Life QoL
Pharmacological Therapies for fibromyalgia with moderate evidence include Duloxetine Milnacipran and Pregabalin which provide short to mediumterm pain relief while Antidepressants and CNS Depressants show smaller benefits
Conservative Approaches such as Cognitive Behavioural Therapy Multimodal Exercise Programs Including Aquatic and Combined Exercises Manual Therapy and Patient Education have Strong Evidence for reducing Pain and Disability in the Short
Medium and Long Term Interventional Methods like transcutaneous electrical Nerve Stimulation and Magnetic Field Therapy show promise for ShortTerm pain reduction but lack robust Long Term Data
Hypotheses supporting repeated Trancutaneous Vagus Nerve Stimulation tVNS Sessions normalize Autonomic Imbalance reduce Chronic MultiSite Pain and improve Visceral Symptoms by restoring Vagal Control over Nociceptive and ImmuneInflammatory Systems hence offering a promising NeuroModulatory Intervention NMI targeting Autonomic Dysfunction in Fibromyalgia
Peripheral Nerve PN HydroDissection HD with Dextrose 5 percent wv in Water D5W of Peripheral Nerves is increasingly utilized particularly in Entrapment Neuropathies like Carpal Tunnel Syndrome CTS
However Recently the FIRST CASE of Therapeutic HydroDissection HD of the Bilateral Vagus Nerves in the Carotid Sheath under Point of Care Ultrasound guidance POCUSG with D5W WITHOUT Local Anesthetic LA for Chronic Widespread Pain cWSP in a Patient with Fibromyalgia FM demonstrated favorable Outcomes in reducing MultiSite Pain as well as in reducing Depressive and Autonomic Symptoms
In our Current Proposed Study we hypothesize that this Novel Intervention ie Bilateral Ultrasound Guided Cervical Vagal Nerve Hydrodilatation is a beneficial adjunct to the Current Standard Of Care Dual Drug Pharmacotherapy and is deemed to be Clinically and Procedurally Safe due to being devoid of Local Anaesthetic use around the Hydrodissection of Bilateral Vagus Nerves and by Virtue of being performed under POCUS Guidance respectively
We also hypothesize it to be an efficacious not only in reducing Chronic Widespread Pain of Fibromyalgia but also enhance MultiDimensional NeuroModulatory Outcomes of reducing Clinical Depression and improving Parasympathetic Cardiovascular Autonomous Functioning as studied by Pre and Post Intervention Scores of WPI SSS ODI PHQ9 as well as Heart Rate Variability Based Autonomic Function Tests in Patients of Dual Drug Resistant Fibromyalgia ie Duloxetine least 40 mg per Day and Pregabalin at least 150 mg per Day consumed for at least past 3 months with a Preintervention WPI greater than or equal to 7 as well as SSS greater than or equal to 7 and ODI greater than or equal to 50 percent
We purport that the Results of the Study shall add to a justified Advancement to an emerging Scientific Discipline of Pain Medicine in a relatively recent DifficulttoTreat Disease Complex ie Fibromyalgia |