| CTRI Number |
CTRI/2025/06/088574 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Topical Magnesium Spray and Elastic Band Exercises to Improve the Quality of Life in Adults with Radiating Back Pain. |
|
Scientific Title of Study
|
Effect of Transdermal Magnesium and Moderate Intensity TheraBand Training on Pressure, Pain Threshold, Disability and Quality of Life Among Adults with Sciatic Pain: 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 |
Sakshi Vats |
| Designation |
PhD Scholar |
| Affiliation |
GALGOTIAS University |
| Address |
School of Allied Health Sciences, Block B, Room No.325 Galgotias University, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9992357385 |
| Fax |
|
| Email |
sakshivats186@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Vats |
| Designation |
PhD Scholar |
| Affiliation |
GALGOTIAS University |
| Address |
School of Allied Health Sciences, Block B, Room No. 325, Galgotias University, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9992357385 |
| Fax |
|
| Email |
sakshivats186@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Vats |
| Designation |
PhD Scholar |
| Affiliation |
GALGOTIAS University |
| Address |
School of Allied Health Sciences, Block B, Room No. 325, Galgotias University, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9992357385 |
| Fax |
|
| Email |
sakshivats186@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sakshi Vats |
| Address |
Galgotias University, Noida, Uttar Pradesh, 203201 |
| 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 Savita Kataria |
Amar Jyoti Rehabilitation and Research Centre |
Amar Jyoti Charitable Trust, Karkardooma, Delhi, 110092
East
DELHI |
9810081074
savitakpc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCHOOL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Patients in control group will receive TheraBand exercises along with placebo transdermal magnesium spray. Each exercise consists of 15-20 repetitions × 3 sets, with 3 sessions/week for 8 weeks. |
| Intervention |
Experimental Group (Transdermal Magnesium spray + TheraBand Exercises) |
Transdermal magnesium spray:
Patient will be in prone lying position; therapist will spray the magnesium spray over the course of sciatic nerve. A total number of 10 sprays will be applied over the whole nerve route.
TheraBand exercises
1. Hamstring stretching: Patient will be in supine lying position with the band around the sole of the foot by holding the both ends of TheraBand in both the hands after that patient will be asked to lift the leg by gently pull on the TheraBand to increase the stretch by keeping the leg straight. Patient will hold this stretch for 30-45 seconds/ 10-12 repetitions/ 3 sets.
2. Hip abduction: Patient will be in standing position then therapist will attach the band to a stable anchor point, such a door handle. Patient will stand with feet shoulder-width apart and wrap the band around ankle. By keeping feet together, patient move legs out to the sides and then back to the midline of body. Repeat this movement for 10-12 times with a hold of 30-45 seconds/ 3 sets.
3. Hip flexion: Patient will be in standing position then therapist will attach one end of the band with the patient ankle and other band will be tie to the anchor or fixed object behind the patient. Then patient will ask to move leg in forward direction to create the hip flexion. Patient will perform the exercise for 10-12 times in a set for 3 sets with a hold of 30-45 seconds.
4. Lumbar extension: Patient will Sit on floor with knees straight and one end of the band looped around the feet. Grasp the other end of the band at chest level. By Keeping back straight and upright, lean backward away from feet without arch the back, hold the position then slowly return to original position. Patient will ask to repeat the exercise for 10-12 times in a set of 3 sets with a hold 0f 30-45 seconds.
5. Trunk rotation: Anchor the band at patient’s chest height, grab it in both hands, and step away from the anchor sideways. Patient will extend arms out in front and twist torso until arms are straight out to the side (away from the anchor). Reverse the motion and perform on both sides. This motion will be repeat for 10-12 times on each side for 3 sets with a hold of 30-45 seconds.
Treatment session is given to patient 3 times a week for 8 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
18-40 Years
Sciatica Pain
Bilateral/Unilateral
Disc herniation
|
|
| ExclusionCriteria |
| Details |
Surgical Intervention
Spinal Infection
Spinal Tumor
Spinal Fracture
Known Mg Deficiency
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pin Rating Scale
Roland Morris Disability Questionnaire
SF-36
|
Numeric Pin Rating Scale (Baseline, 8th week)
Roland Morris Disability Questionnaire (Baseline, 8th week)
SF-36
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Electrolyte Level |
Baseline, 8th week |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 3 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| 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="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
|
Introduction: Sciatic pain, commonly known as sciatica, is a prevalent condition characterized by radiating pain along the sciatic nerve pathway, significantly affecting an individual’s quality of life due to discomfort, numbness, and muscle weakness. Aim: To study the effect of transdermal magnesium and moderate intensity TheraBand training on quality of life among adults with sciatic pain. Cost-effective, non-invasive methods of treating sciatic pain are becoming more and more necessary. Investigating the synergistic effects of transdermal magnesium and moderate-intensity TheraBand training may provide an innovative approach to promote integrative pain management techniques by enhancing quality of life, lowering disability, and improving pressure pain threshold in impacted individuals. Material and Methods: A two-group pretest-post-test randomised clinical trial will be conducted in recognised hospitals in Delhi using simple random sampling from February 2025 to February 2026. Two groups will be formed, each consisting of 56 subjects. Group A will serve as the experimental group receive a transdermal magnesium spray and TheraBand exercises. Group B, the control group, will receive sham transdermal magnesium spray and TheraBand exercises, both groups will be treated for 3 days in a week for 8 weeks. The paired t-test will be employed to assess subjective parameters within the same group, while the unpaired t-test will be used for intergroup comparisons, establishing a significance level of <0.05. This integrated approach addresses both biochemical and functional aspects, offering comprehensive rehabilitation benefits.
|