| CTRI Number |
CTRI/2024/04/065293 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy Other (Specify) [Physiotherapy with Yoga] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of alternative therapies on pain, anxiety, quality of sleep, ADLs and quality of life in patients with bilateral chronic leg pain. |
|
Scientific Title of Study
|
Effects of exercises and yoga asanas on pain, anxiety, quality of sleep, activities of daily living and quality of life in patients with pain in both the legs. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms. Antara Bishnu |
| Designation |
Research Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004 Department of Physiotherapy, School of Allied Health sciences, Manav Rachna International Institute of Research and Studies, Faridabad-Haryana, 121004 Faridabad HARYANA 121004 India |
| Phone |
7047600267 |
| Fax |
|
| Email |
bishnuantara@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004 Department of Physiotherapy, School of Allied Health sciences, Manav Rachna International Institute of Research and Studies, Faridabad-Haryana, 121004 Faridabad HARYANA 121004 India |
| Phone |
7042637002 |
| Fax |
|
| Email |
priyankasethi.sahs@mriu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004 Department of Physiotherapy, School of Allied Health sciences, Manav Rachna International Institute of Research and Studies, Faridabad-Haryana, 121004 Faridabad HARYANA 121004 India |
| Phone |
7042637002 |
| Fax |
|
| Email |
priyankasethi.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MS. ANTARA BISHNU |
| Address |
SONATORE PARA, R N T ROAD, PS- SURI, PO- SURI, DIST- BIRBHUM, WB, 731101. |
| 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 |
| MS ANTARA BISHNU |
Manav Rachna International Institute of Research and Studies |
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004 Faridabad HARYANA |
7047600267
bishnuantara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE AT THE SCHOOL OF ALLIED HEALTH SCIENCES, MRIIRS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G258||Other specified extrapyramidal andmovement disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparator Agent Group A -– Physiotherapy with affirmation training for six weeks. |
Exercise protocol design for restless leg syndrome targeting gastrocnemius medialis and gastrocnemius lateralis muscle for both leg along with affirmation training. |
| Intervention |
Comparator Agent Group B - consisted Yoga with affirmation training for six weeks. |
Utkatasana yoga asana along with affirmation. |
| Comparator Agent |
Group C- Physiotherapy with affirmation and Yoga with affirmation both applied on alternate days for six weeks |
Group A and group B protocol would be given to the patient on alternate days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria Inclusion Criteria
1. Age between of 20-45 years.
2. Newly diagnosed with IRLSSG SCALE (mild- moderate)
3. Having pain more than 3 months (VAS score; 3-8)
4. Both the genders.
- Untreated with any medication.
- Disturbed sleep
- Reflecting worse QoL (lower score of SF-36)
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Diagnostic case of psychosomatic or psychotic disorder.
2. Any history of sensory loss.
3. Recent history of musculoskeletal or neurological impairments or any neuromuscular disease.
4. Any history of sensory loss.
5. No medical complain including BP, Diabetes, renal failure, cardiac pacemaker, pregnancy any other physiological problem.
6. Abnormal NCS findings.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
1. Pain, anxiety and Sleep
|
Day-0
Day-42
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Activities of Daily Living
2. Quality of Life |
Day-0
Day-42 |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
15/04/2024 |
| 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)
|
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
|
The study protocol
was approved by the research ethical committee of School of Allied Health Sciences,
Manav Rachna International Institute of Research and Studies. The study will be
done in accordance with the national ethical guidelines for biomedical and health
research involving human participants- Indian Council of Medical Research (ICMR)
guidelines (revised-2017) and guidelines of Helsinki declaration 2013. All the
participants will be made to sign the written informed consent prior to the
participation into the study. The participants will be taken from outpatient
department and education campus of Manna Rachna International Institute of Research
and Studies, Faridabad, Haryana. Following
identification of the participants through inclusion and exclusion criteria, a
total of 42 subjects will be enrolled for the study. The sampling using
randomization (Coin and toss method) will be done and the participants will be
assigned alternatively into three groups with 14 participants in each group. The interventional
Group-A will be treated with Physiotherapy exercises and affirmations; Interventional
Group-B will get treated yoga asana with
affirmation training and comparator Group-C will be treated with
physiotherapy with affirmation and yoga with affirmation on alternate day
basis. The overall treatment will be offered in all the three groups will be
for six weeks. The Group A and B will get intervention on alternate days while
Group C will get alternate therapy proposed in Group A and Group B on alternate
days for all the six weeks respectively. The subjects will be assessed at Day-0
for baseline data which will be the pre assessment data and finally at Day-42 for the final post
intervention assessment.
|