| CTRI Number |
CTRI/2025/01/079404 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Epsom salt on low back pain |
|
Scientific Title of Study
|
Effect of Epsom salt application on pressure pain threshold and surface electromyographic activity on non-specific low back pain |
| 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 T K Mithila |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic Sciences, Ujire, near siddavana, Belthangady
near siddavana, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
09481326780 |
| Fax |
|
| Email |
mithilapammi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha K J |
| Designation |
Professor, Dean |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic Sciences, Ujire, near siddavana, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
09480401646 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T K Mithila |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic Sciences, Ujire, near siddavana, Belthangady
Dakshina Kannada
KARNATAKA
562127
India |
| Phone |
09481326780 |
| Fax |
|
| Email |
mithilapammi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic Sciences, Ujire, near siddavana, Belthangady, Dakshina Kannada, Karnataka, India, 574240 |
|
|
Primary Sponsor
|
| Name |
Dr T K Mithila |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic Sciences, Ujire, near siddavana, Belthangady, Dakshina Kannada, Karnataka, India, 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 T K Mithila |
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital |
Department of Natural Therapeutics, Shanthivana, Dharmasthala, Belthangady, India, 574240
Dakshina Kannada
KARNATAKA |
9481326780
mithilapammi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic Sciences, Ujire |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Epsom salt application with Naturopathy and Yogic interventions) |
Epsom salt application over low back pain
Duration: 20 minutes everyday for 10 days.
Naturopathy interventions includes hydrotheraoy (enema, neutral douche, under water massage, neutral spinal bath, revuslisve compress, reclining steam bath, cold circular jet bath)
Duration: 20 - 30 minutes
Yogic intervention includes
Loosening exercise: 16 minutes
Standing asanas: 6 minutes
Supine asanas: 8 minutes
Sitting series: 6 minutes
Prone series: 6 minutes
Pranayama: 10 minutes
Relaxation techniques: 8 minutes. |
| Comparator Agent |
Group B (Naturopathy and Yogic interventions) |
Naturopathy interventions includes hydrotheraoy (enema, neutral douche, under water massage, neutral spinal bath, revuslisve compress, reclining steam bath, cold circular jet bath)
Duration: 20 - 30 minutes
Yogic intervention includes
Loosening exercise: 16 minutes
Standing asanas: 6 minutes
Supine asanas: 8 minutes
Sitting series: 6 minutes
Prone series: 6 minutes
Pranayama: 10 minutes
Relaxation techniques: 8 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) The pain is derived from somatic referred pain or non-radicular pain
2) Voluntary participation in this study
3) Patients having lower back pain for more than 3 months |
|
| ExclusionCriteria |
| Details |
1) Specific low back pain (tumors, infections, metabolic diseases, rheumatoid arthritis, fractures)
2) Spinal deformity (spondylolisthesis, isthmic fissure, or scoliosis)
3) Extraspinal diseases (e.g., vascular, genitourinary diseases)
4) History of lumbar spine surgery
5) Using any medications that could affect the balance
6) Patients altered sensitive to pressure
7) Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pressure Pain Threshold
2) Surface Electromyography |
Baseline and after 10 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Visual Analog scale
2) Oswestry Disability Index (ODI) Questionnaire
3) Roland Morris Disability Questionnaire |
Baseline and after 10 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
06/02/2025 |
| 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
|
Non-specific low back
pain (nLBP) refers to the pain in the lumbosacral spine that lasts longer than
three months without a known anatomical or neurophysiological explanation. It
can have a mechanical, musculoskeletal, or multifactorial basis. Thus, non-specific LBP is a significant clinical
and financial burden as well as a significant public health issue. A systematic review and meta-analysis for the
prevalence of LBP in 2022 reported the pooled point, annual, and lifetime
prevalence of LBP in India was 48% (95% CI 40-56%); 51% (95% CI45-58%), and 66%
(95% CI 56-75%), respectively. In clinical and experimental research, pressure
pain thresholds (PPTs) are typically employed to assess the sensitivity of deep
muscle tissue. The fourth most common mineral in the body is
magnesium. The skeleton contains more than 60% of the magnesium in the body,
with the remaining portion being located in the cells, where it is necessary
for cell division and energy metabolism. Magnesium functions as a cofactor in
numerous metalloenzymes mechanistically. Topical magnesium administration has been linked
to a reduction in inflammatory skin problems based on anecdotal data and a few
published reports.
So, the
present study was designed to assess the effect of Epsom salt application on
the PPT and sEMG activity among non-specific low back pain.
The aim of
the present study is to assess
the effect of Epsom salt application
on pressure pain threshold and surface electromyographic activity on non-specific
low back pain.
Objectives 1) To quantify the effect of Epsom salt application on change in
pressure pain threshold among non-specific low back pain. 2) To quantify the
changes in electromyographic activity after Epsom salt application among non-specific
low back pain. 3) To quantify the
changes in pain and functional activity using Oswestry Disability Index (ODI),
and Roland and Morris (RMQ) questionnaires.
|