| CTRI Number |
CTRI/2025/07/091257 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of low back pain with multiple ayurveda procedures |
|
Scientific Title of Study
|
Efficacy of multimodal approach in the management of chronic mechanical low back pain (katishoolaa) - 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 |
Dr Suman Raichandani |
| Designation |
PG Scholar |
| Affiliation |
KAHER shri B M K Ayurveda Mahavidyalaya |
| Address |
Room number 8
Department of Shalyatantra
KAHER shri B M K Ayurveda Mahavidyalaya Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
7999112699 |
| Fax |
|
| Email |
suman16051996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh S Killedar |
| Designation |
Associate Professor |
| Affiliation |
KAHER shri B M K Ayurveda Mahavidyalaya |
| Address |
Room number 8
Department of Shalyatantra
KAHER shri B M K Ayurveda Mahavidyalaya Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9035987505 |
| Fax |
|
| Email |
drramesh39@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh S Killedar |
| Designation |
Associate Professor |
| Affiliation |
KAHER shri B M K Ayurveda Mahavidyalaya |
| Address |
Room number 8
Department of Shalyatantra
KAHER shri B M K Ayurveda Mahavidyalaya Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9035987505 |
| Fax |
|
| Email |
drramesh39@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India
Pin code 590003
|
|
|
Primary Sponsor
|
| Name |
Dr Suman Raichandani |
| Address |
PG Scholar
Department of Shalyatantra
KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India
Pin code 590003 |
| 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 Suman Raichandani |
KAHER shri B M K Ayurveda Mahavidyalaya Belagavi Karnataka India 590003 |
Department of Shalyatantra
Division General Shalya OPD
Room number 8
Belgaum
KARNATAKA |
07999112699
suman16051996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for research on human subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: PRUSHTHA-GRAHAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रविस्रावणम् | (Procedure Reference: Su.Sh. 08/16, Procedure details: 1 ALABU RAKTMOKSHANA / WET CUPPING PROCEDURE - 20 minutes for 2 times i.e. day 0 and day 7
2 yoga asanas/postures for 35 minutes daily for a period of 14 days
Alabu Raktamokshana Procedure
1 Poorvakarma
Yavagu paan before the raktmokshana procedure will be done.
Under all aseptic precautions, abhyanga with Mahanarayana taila will be done followed by nadi sweda for 10 minutes
2 Pradhan karma the following steps will be followed during each cupping therapy which will last for a duration of 20 minutes
A Primary sucking Four acrylic cups of size one will be utilized for the interventions and the air inside the cup will be removed by hand suction using a manual suction pump The cup adheres to the skin and will be left there for two to three minutes
B Scarification Using a sterile lancet and the multiple superficial incisions approach superficial skin incisions will be produced In order to ensure enough blood flow the incisions will be made equally spaced and neither excessively deep nor too superficial The cups will be placed bilaterally on the lower back parallel to the L1 through L5 vertebrae and spaced 3 cm apart
C Bloodletting Using the previously mentioned technique the cup will be reapplied to the skin until it was full with capillary vessel blood Re-scarification will not be done the cups will be left in place for three to five minutes
Paschata karma
Removal and dressing: After removing the cups, the bleeding location will be cleansed and dressing will be done. Vitals of the patient will be monitored.
2. YOGA Asana
Yoga postures for chronic low back pain for a period of 14 days daily once will be carried out.
Standing - Shithilikarana Vyayama - 6 min
Supine - Pavanamuktasana - 7 min
Sitting on Heel - Shashankasana - 7 min
Standing - Ardhakati Chakrasana - 3 min
Standing - Utthita Parsvakonasana -3 min
Standing - Parivrtta Trikonasana - 3 min
Long Sitting - Vakrasana - 3 min
Sitting - Vibhagiya Pranayama
Supine - Shavasana - 5 min.
)
(1) Medicine Name: Trayodashang guggulu, Reference: Bhaishajya Ratnavali Vaatvyadhi Adhikar 151-162, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 14 Days(2) Medicine Name: Mahanarayana taila , Reference: Bhaishajya Ratnavali Vaatvyadhi Adhikar 98- 101 1/2, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Duration: 14 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Multimodal therapy (Medicine and Physiotherapy) | 1 Oral medicine Acetaminophen 500 mg orally twice a day for 14 days
2 Standardized Interferential therapy with a frequency of 3.85kHz; 140Hz constant and pulse duration 130μs with 15 minutes duration for 7 days
3 Hot pack therapy will be used for 15 minutes for 7 days
4 Spinal mobility and core stability exercises such as bridging trunk rotation cat-camel exercise and back extension will be performed ten repetitions a day for a period of fourteen days |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients between age group 20 to 60 years irrespective of gender religion occupation
and socio economic status
2 Patients fulfilling diagnostic criteria
3 Patients with complaints of low backache for more than 12 weeks
4 Patients who are able to undertake a 2 minute Walk Distance test
5 Pain intensity more than 3 and less than 8 on a 0 to 10 numerical pain rating scale |
|
| ExclusionCriteria |
| Details |
1 Evidence of central nervous system involvement including symptoms of cauda equina syndrome or the presence of pathological reflexes in the physical examination
2 Recent within the past 2 weeks epidural steroid injection for LBP and/or leg pain
3 Pregnant and lactating females
4 Patients with history of low back pain due to tumors infections congenital disease
radiculopathy or fractures neurological diseases like multiple sclerosis transverse
myelitis and previous spine surgery
5 Psychiatric disorders such as depression or others liver and renal dysfunction history
medication for cardiac failure and a history of cerebrovascular accident or myocardial
infarction within 6 months before the day of agreement to enter the trial
6 Suspicion of serious pathology based on red flags noted in the general medical screening
Red flags include progressive motor or sensory loss urinary retention or overflow
incontinence history of cancer recent invasive spinal procedure and significant trauma
relative to age |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Pain assessed by Numeric Pain Rating Scale and Visual analogue scale
2 Heaviness at back region
3 Stiffness at back region
4 Numbness at back region
5 Modified Oswestry Low
Back Pain Disability score
6 Range of Motion at the
Lumbar spine by goniometry
7 Modified Scobers test |
Day 0 Day 7 Day 14 Day 21 Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Timed up and go test
2 Roland and morris disability questionnaire |
Day 0 Day 7 Day 14 Day 21 Day 30 |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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 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
|
Millions of people worldwide suffer from the widespread and incapacitating ailment
known as chronic mechanical low back pain. Because it causes severe pain, disability, and a
decline in the quality of life for people who are affected, it presents as a serious worldwide health
burden. There were 619 million LBP sufferers globally in 2020; by 2050, that figure is predicted
to rise to 843 million. As a complex symptom, LBP is linked to a lower quality of life for
those who experience it. Among other symptoms, it causes negative social relationships, work
absenteeism, functional impairment, fear of movement, stress, anxiety, and depression. The
burden of low back pain is greatly increased by lifestyle variables like smoking, being
overweight, not exercising, and getting little sleep. The main reason why a person with
chronic LBP seek medical attention is because they have trouble carrying out everyday
functioning tasks. People with LBP are treated with a variety of therapies to address their
range of motion limitations, pain symptoms, and perceptions of their disability. These therapies
include pharmaceutical management, manual therapy, therapeutic exercise, patient education
regarding lifestyle modifications, and modalities like electrical stimulation, ultrasound, heat, and
cryotherapy. Because of their affordability and effectiveness in managing chronic pain,
medication-based treatments are acknowledged as first-line
treatments. The most effective therapeutic options are opioids and NSAIDs. Their long-term
effectiveness and possible adverse effects, such as organ damage, ulcers, tiredness and dizziness,
may raise questions, though. This method is only feasible and safe in the short term due to the
possible adverse effects of medication and the possibility of opiate addiction. Over half of
people with LBP experience a return of symptoms, necessitating expensive operations or a reliance on pain medication for symptom management. The long-term effects of current therapies
are also variable. As a result, more successful interventions are required. According to Ayurveda, low back pain is associated with cluster disorders of vata vyadhi,
specifically Katigraha, Gridrasi, and Khalli, which have particular common symptoms including
pain , stiffness , and suptata. According to Vata vyadhi, pain is a
common symptom. Sneha, Sveda, Samshodana, Agnikarma, Raktamokshana, Lepa, Basti and
others are included in the Samanya Chikitsa Sutra for Vata Vyadhi. When it comes to
symptoms like Suptata, Kandu, Chimchimayana, Sthambha, and Grathita with ruja and
avagadatara rakta dosha conditions, Alabu is especially recommended. Because the principle
of blood evacuation is comparable in cupping therapy and Alabu Chikitsa, the therapy is called
Modified Alabu Chikitsa. Cupping therapy is regarded as an alternate or additional form of
treatment. Researchers have proposed the clinical value and acceptability of cupping therapy in
the treatment of LBP, as interest in this pain management technique continues to grow. Yoga
has been shown in prior clinical trials to improve back-related impairment and self-efficacy in
individuals with CLBP. Traditional recommendations for the treatment of Vaat vyadhi include
formulas such as Mahanaryana taila for local application and Trayodashang guggulu.
Multimodal approach is necessary to provide a complete care for the patient and is the need of
hour. Hence the integrative approach is planned to evaluate the efficacy of wet cupping therapy,
yoga and medications in the management of chronic Low Back Pain. |