| CTRI Number |
CTRI/2025/06/089030 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on local Magnesium sulphate injection for neck pain |
|
Scientific Title of Study
|
Efficacy of magnesium sulphate in myofascial trigger point injections in chronic neck pain - A randomised 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 Binayak Sahu |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room no. 5011, 5th floor, Academic block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9348999752 |
| Fax |
|
| Email |
19binayak19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhruv Jain |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room no. 5008B, 5th floor, Academic block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
7042129423 |
| Fax |
|
| Email |
dhruvjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhruv Jain |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room no. 5008B, 5th floor, Academic block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
7042129423 |
| Fax |
|
| Email |
dhruvjn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi, Ansari Nagar East, Pin-110029, India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi |
| Address |
Ansari Nagar East,New Delhi , Pin.110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Binayak Sahu |
AIIMS, New Delhi |
Pain clinic, 4th floor, Rajkumari Amrit Kaur OPD, AIIMS, New Delhi
South
DELHI |
9348999752
19binayak19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M791||Myalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trigger point injection with magnesium and ropivacaine |
1ml injectate of 250 mg magnesium sulphate (500mg/ml) and 0.25% ropivacaine will be injected in the trigger point of neck muscle under ultrasound guidance untill twitch is seen in muscle fibre or reproduction of pain occurs. |
| Comparator Agent |
Trigger point injection with only ropivacaine |
1ml injectate of 0.25% ropivacaine will be injected in the trigger point of neck muscle under ultrasound guidance untill twitch is seen in muscle fibre or reproduction of pain occurs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Neck pain more than 3 months
2.Age more than 18years
3.Definitive diagnosis of myofascial pain syndrome of neck muscles with identification of trigger points defined by presence of one or more taut bands in muscle, focal tenderness within these taut bands, local or referred pain on palpation or gentle snapping palpation elicits a twitch response. |
|
| ExclusionCriteria |
| Details |
1.Patients not giving consent
2.Any painful conditions of neck and back muscles other than myofascial pain syndrome like fibromyalgia, spondylosis, cervical radiculopathy, vertrebrobasilar insufficiency
3.Known allergy to local anaesthetics or magnesium sulphate
4.History of prior invasive procedure in neck muscle |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Rating Scale for pain |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Rating Scale for pain |
14days and 1month |
| Neck movement using goniometer |
1month and 3 months |
| Pain pressure threshold using algometer |
1month and 3months |
| Neck disability index |
1month and 3 months |
| Patient satisfaction score |
1month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Myofascial pain syndrome is a common problem for chronic neck and back pain in general population. Different treatment modalities like Dry needling, Trigger point injections, Transcutaneous Electrical Nerve Stimulation exists, but among these Trigger Point Injections is widely accepted method. In trigger point iInjections Local anaesthetics, Steroids, Botulinum toxins has been used previously. Recent study shows Magnesium as a new promising alternative. Moreover, Magnesium Sulphate is cheaper, easily available and have lesser side effects when used as an injectate in Trigger Point Injection. Magnesium can be beneficial as it acts as a vasodilator which leads to wash away accumulated toxins like prostaglandin, bradykinin etc. It also acts as muscle relaxant and inhibits pre-synaptic Acetylcholine release from neuromuscular junction and sympathetic junction Therefore, our study aims to prove that Magnesium Sulphate can be used as an alternative injectate in Trigger Point Injection. |