| CTRI Number |
CTRI/2024/11/076992 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nerve excerises with topical magnesium in neck pain |
|
Scientific Title of Study
|
The impact Of Neural Mobilization And Topical Magnesium On Anxiety, Depression, Sleep Quality And Functional Activities Of Daily Living In Middle Aged Adults With Cervical Radiculopathy: A 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 |
Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
B 512A, Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
B 512A, Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syeda Safiya Noor |
| Designation |
Research Scholar |
| Affiliation |
Galgotias University |
| Address |
E005, Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8130709841 |
| Fax |
|
| Email |
jyoti.sharma@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Room No. C-102, Galgotias University, Plot No. 02, Sector 17-A, Y amuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Galgotias University, Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida,Gautam Buddh Nagar, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Jyoti Sharma |
Galgotias University |
Room No. E003, Department of Physiotherapy, School of Allied Health Sciences, Galgotias
University, Plot No. 02,
Sector 17-A, Yamuna
Expressway, Greater
Noida, 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9717161626
jsharmaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hot pack and neural mobilisation |
The subjects will be given hot packs for 10 minutes as a warm up before the treatment.
Neural mobilization (NM) using a slider technique in a smooth and rhythmic manner.
Preparation: Upper Limb Tension Test 1 was used to position the patient.
Slider Technique: Alternation of elbow extension (loading the median nerve) and wrist flexion (unloading the median nerve), with elbow flexion (unloading) and wrist extension (loading).
Neural mobilization: will be given 15 minutes 3 times/week for 8 weeks. Each mobilization will be of 60 seconds. Rest period of 30 seconds.
|
| Intervention |
Topical magnesium and neural mobilisation |
The subjects will be given hot packs for 10 minutes as a warm up before the treatment.
Neural mobilization (NM) using a slider technique in a smooth and rhythmic manner.
Preparation: Upper Limb Tension Test 1 was used to position the patient.
Slider Technique: Alternation of elbow extension (loading the median nerve) and wrist flexion (unloading the median nerve), with elbow flexion (unloading) and wrist extension (loading).
Neural mobilization: will be given 15 minutes 3 times/week for 8 weeks. Each mobilization will be of 60 seconds. Rest period of 30 seconds.
Followed by magnesium supplementation using pure magnesium Spray 5 sprays at both wrist (each side), 5 spray at back of the neck. 2 times/week, thrice weekly for 8 weeks. Detailed instructions on dosage and administration will be provided to participants. Participants will be instructed to adhere strictly to the supplementation regimen
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Cervical radiculopathy: Persistent symptoms for at least 3 months.
Positive ULTT (Upper limb tension test)
No allergic reaction to patch test.
|
|
| ExclusionCriteria |
| Details |
Individuals with severe cardiovascular disorders, renal impairment, Diabetes type II or other medical conditions where magnesium supplementation may pose a risk.
Participants with known allergies or sensitivities to magnesium or any components of the transdermal lotion.
Individuals currently taking medications or supplements that may interact with magnesium, affecting its absorption or efficacy.
Pregnant or lactating individuals due to potential risks to the developing fetus or nursing infant.
Any history of recent trauma or surgery before the study initiation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Upper limb tension test (ULTT): is a clinical assessment used to evaluate neural tension or irritation in the upper extremity. It involves a series of movements to stretch the nerves of the arm and assess symptoms like pain, tingling, or numbness, which may indicate nerve involvement. The test is often used to diagnose conditions such as cervical radiculopathy or carpal tunnel syndrome. In this there are 4 test ULTT1, ULTT2A, ULTT2B and ULTT3 out these if 3 of 4 comes positive then we can rule out cervical radiculopathy.
2. Neck Disability Index (NDI): its measure the impact of cervical radiculopathy. Scores range from 0 to 5 for each of the 10 items. The top score is 50. A percentage score can be created by multiplying the acquired score by two. On rare occasions, a respondent will omit to answer a particular question. The average of all other items is then added to the completed items.
|
Baseline, 3 weeks and follow up after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression, Anxiety and Stress Scale - 21 Items (DASS-21), 2. Pittsburgh Sleep Quality Index (PSQI), Cervical Radiculopathy Impact Scale (CRIS) |
Baseline, 3 weeks and follow up after 6 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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-identiļ¬cation.
- 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 who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jsharmaphysio@gmail.com].
- For how long will this data be available start date provided 05-06-2025 and end date provided 24-06-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - na
|
|
Brief Summary
|
Cervical
radiculopathy (CR) is a debilitating illness that adversely affects a person’s
ability to function physically, mentally, and socially. The complicated
presentation of cervical radiculopathy (CR) is linked to a greater reliance on
healthcare services. An objective loss of sensory and/or motor function
resulting from a conduction impairment to a spinal nerve or its root is known
as CR. This can happen with or without discomfort. . Radiculopathy-related pain
is referred to as painful radiculopathy, and if there are documented poor sensory
symptoms, it may meet the criteria for definitive neuropathic pain. Magnesium works as an analgesic by inhibiting the postsynaptic
N-methyl-d-aspartate (NMDA) receptors spinal neurons in the dorsal horn of the
spinal cord. The physiological blockage of the calcium channels of the NMDA
receptor can be restored by magnesium delivery. Magnesium treatment is thought
to have an antinociceptive effect by using this process to reduce central
sensitization, wind-up, and diminish dorsal horn neuron activity A randomized
controlled trial study aim to analyze the effect of neural mobilization and topical magnesium on
anxiety, depression, sleep quality and functional activities of daily living on
cervical radiculopathy among middle age adults. |