| CTRI Number |
CTRI/2023/11/060057 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Pranic Healing] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pranic Healing on chronic lower backache |
|
Scientific Title of Study
|
A double-arm Randomised Controlled Pilot trial investigating the comparative impact of complementary Pranic healing and Conventional Therapy for chronic low backache |
| 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 Rakesh Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Dr Rakesh Sharma
College of Nursing
AIIMS Rishikesh
College of Nursing
Dehradun
UTTARANCHAL
249410
India |
| Phone |
9639553333 |
| Fax |
|
| Email |
rakesh553333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Dr Rakesh Sharma
College of Nursing
AIIMS Rishikesh
College of Nursing
Dehradun
UTTARANCHAL
249410
India |
| Phone |
9639553333 |
| Fax |
|
| Email |
rakesh553333@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Dr Rakesh Sharma
College of Nursing
AIIMS Rishikesh
College of Nursing
Dehradun
UTTARANCHAL
249410
India |
| Phone |
9639553333 |
| Fax |
|
| Email |
rakesh553333@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self funded |
| Address |
Dr Rakesh Sharma, College Of Nursing, AIIMS, Virbhadra Marg Pashulok, Rishikesh Dehradun UTTARANCHAL 249203 India Dehradun UTTARANCHAL 249203 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 Rakesh Sharma |
AIIMS Rishikesh Hospital |
Building No. 44, Level-1,Block-B,
Orthopedic Department OPD, Room No-08,
AIIMS Rishikesh Hospital.
Dehradun
UTTARANCHAL |
9639553333
rakesh553333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
1.Analgesics, non-steroidal anti-inflammatory drugs: Tab Diclofenac (75mg) + Paracetamol (350mg); Two times in a day for five days, orally.
2.Physiotherapy: Back aching exercise, Extension exercise; 2 times in a day.
3.Supportive therapy: Tab Calcium Citrate Malate; 500mg, orally, two times in a day for three months
|
| Intervention |
conventional Therapy + Pranic Healing |
Conventional Therapy:
1.Analgesics, non-steroidal anti-inflammatory drugs: Tab Diclofenac (75mg) + Paracetamol (350mg); Two times in a day for five days, orally.
2.Physiotherapy: Back aching exercise, Extension exercise; 2 times in a day.
3.Supportive therapy: Tab Calcium Citrate Malate; 500mg, orally, two times in a day for three months,
Pranic Healing:
Pranic healing is a no touch, no drug therapy based on Pranic Healing (PH), which is a traditional no-touch healing technique based on balancing the body’s energy centres or chakras.
The steps of pranic healing are as follows:
Principles in healing is to remove all the painful, diseased, trouble-causing energies from the entire aura (Pranamayakosha/energy body) and the affected part of the body, chakra or organ and energize the cleansed part with fresh prana or life force to facilitate the healing process. The steps in healing are:
1.Preparation for Healing with preparation of healer, client and the healing area.
2.Diagnosing the problem of the client by sensing the Pranamayakosha with scanning to find out which part of the body, aura, chakras, organs affected as per clients’ complaints.
3.Cleansing: Cleansing is a process to remove all the painful, diseased, trouble-causing energies from the entire aura and the affected part of the body or chakra or organ.
There are 2 methods.
a) Aura cleansing (General Cleaning) to cleanse the entire aura,
b) Localized cleaning is cleaning of the affected part & chakras cleansing.
4. Healers should receive the energy/fresh prana with hand method, through pranayama and through prayer.
5. Recharging / Energizing the cleansed chakras, organs and the affected part of the body with healthy, fresh energy.
6. Rescanning the treated part to confirm the normalcy of energy status.
7. Stabilize / Sealing the affected part to prevent energy leakage from the treated part.
8. Release/disconnect the energy link between the healer and the client to facilitate to enhance further healing.
9. Do Thanksgiving for completion of the healing.
In case of low backache, emphasis is given on treating the spine, affected part, chakras like Front and back solar plexus chakras, mÅ«lÄdhÄra chakra.
The healing will be done by a certified Yogic healer using the principles of energy healing.
The participants will be asked to sit on a chair with their eyes closed during the 30-minute session.
Method of intervention: physical in person healing.
Frequency: 30 mins each session for 2 times a week.
Follow up: It will be done every 1 month till 3 months for a total of 1 baseline and 3 follow-up data collection
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
I. Patients with no radiculopathy features
II. Patient with chronic low backache for more than 3 months
|
|
| ExclusionCriteria |
| Details |
I. Patient with infective, neoplastic, traumatic etiology of lower backache
II. Patients who don’t consent for the study
III. Patients with indication for invasive procedures for pain relief as per expert.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain perception score of patients |
Baseline, 1 month, 2 months and 3 months
To compare the pain perception score of patients among complimentary pranic healing and Conventional therapy arms using Visual analogue scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the functional improvement in lower backache following the individual therapies using Rolando Morris Disability questionnaire and Oswestry Disability Index |
Frequency: 30 mins each session for 2 times a week
Follow up: It will be done every 1 months till 3 months for a total of 1 baseline and 3 follow up data collection
|
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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 1 |
|
Date of First Enrollment (India)
|
30/11/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
|
Chronic low backache is defined as pain that
continues for 12 weeks or longer, even after an initial injury or underlying
cause of acute low backache has been treated. It is a common ailment across
the world with an estimated prevalence of 4.2% in individuals aged between 24
and 39 years old and 19.6% in those aged between 20 and 59 which increases
linearly from the third decade of life on, until the 60 years of age, being
more prevalent in women.
Comprehensive pain management of chronic low
backache relies on the use of pharmacotherapy, physical therapy, and a
multidisciplinary approach to treatment. Recent studies have shown a benefit
for traditional adjunctive therapies and interdisciplinary treatment.
A few traditional adjunctive therapies which have
been applied for management of chronic low backache include energy therapies
like Biofield therapy which includes Pranic Healing = also called as Yoga
based biofield therapy (also known as yogic healing in India).
Biofield therapies are noninvasive therapies in
which the practitioner explicitly works with a client’s biofield (interacting
fields of energy and information that surround living systems) to stimulate
healing responses in patients.10 This biofield is also known as pranamaya
kosha as mentioned as
Taittiriya-Upanishad.
Pranic healing (PH), standardized and taught by
Master Chao Kok Sui (Chao, 1993) from the Philippines is a procedure of
manipulating this pranic energy body which is felt and or seen as an aura or
energy field around the physical body has shown to be effective in management
of Chronic lower backache, colorectal cancer pain and fibromyalgia.
Yogic healing is a similar to Pranic healing and
work simultaneously at all koshas. As a biofield therapy with no current
evidence to show its efficacy for chronic low backache pain relief.
Hence, the current randomized controlled pilot
trial is thus being undertaken to investigate the effect of complementary Pranic healing in lowering the intensity of
chronic low backache compared to only conventional therapy.
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