| CTRI Number |
CTRI/2022/06/043363 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga Therapy in Post-operative Myofascial Pain in Breast Cancer Patients |
|
Scientific Title of Study
|
Effect of Yoga Therapy in Management of Post-operative Myofascial Pain in Breast Cancer Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashwant Kashyap |
| Designation |
Assistant Professor Medical Oncology |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Dept of Medical Oncology, B Block Basement, All India Institute of Medical Sciences, Raipur, GE Road, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
y2k2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer (Yoga & Naturopathy) |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Dept of Yoga & Naturopathy, First floor AYUSH Building, All India Institute of Medical Sciences, Raipur, GE Road, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8076431586 |
| Fax |
|
| Email |
dr.vikrampai@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer (Yoga & Naturopathy) |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Dept of Yoga & Naturopathy, First floor AYUSH Building, All India Institute of Medical Sciences, Raipur, GE Road, Tatibandh, Raipur
CHHATTISGARH
492099
India |
| Phone |
8076431586 |
| Fax |
|
| Email |
dr.vikrampai@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur, GE Road, Tatibandh, Raipur |
| Central Council for Research in Yoga & Naturopathy, 61-65, Institutional Area, Janakpuri, New Delhi - 110058 (India)
Ph 0112852043 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Yoga Naturopathy |
| Address |
61-65, Institutional Area, Janakpuri, New Delhi - 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Vikram Pai |
All India Institute of Medical Sciences Raipur |
Dept of Yoga & Naturopathy, First Floor, AYUSH Building, AIIMS, Raipur, GE Road, Tatibandh
Raipur
CHHATTISGARH |
8076431586
dr.vikrampai@aiimsraipur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (2) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (3) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (4) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (5) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (6) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (7) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (8) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (9) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
35 Min Yoga Protocol |
Yoga protocol comprising Loosening exercises, Yoga postures, Breathing practices and Guided relaxation techniques.
Duration of Intervention for each subject is 4 weeks |
| Comparator Agent |
Control |
Only standard care for Breast cancer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patients Diagnosed with any myofascial pain syndrome Those with a history of breast conservation or simple mastectomy within last six months.
First time primary diagnosis of breast cancer (grades I to IIIA), Neck and shoulder/axillary pain that began after the breast cancer surgery.
Asymmetric shoulder pain (NRS on painful side : NRS on non painful side > 2:1) Acute or Chronic myofascial pain syndrome with severe intensity i.e NRS > 4/10. Patients with pain at least 4 days in a week. Patients without neurological pain, as in DN4 score less than 4. Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study. Patients who read, understood and signed the Free and Clarified Consent Term
|
|
| ExclusionCriteria |
| Details |
Other medical conditions (i.e, arthritis) like periarthritis of shoulder joint,frozen shoulder, cervical disc herniation etc. Recurrent cancer
Previous diagnosis of fibromyalgia syndrome. Patients with major depression, according to DSM-IV criteria. History of bipolar mood disorder, panic syndrome or psychosis. Intermittent pain history. Patients with another pain syndrome in shoulders. Patients who had contraindications (for example, symptoms consistent with severe disk disease) or autoimmune disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Intensity of Pain by neumarical rating scale (NRS)
2. Shoulder Pain and Disability Index (SPADI)
3. Pressure Pain threshold by algometer
|
Baseline on Day 1, 1 week, on the day of suture removal, after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Resting Heart rate variability (HRV):
2.National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NCCN-FACT FBSI-16) Questionnaire
3.Neutrophil lymphocyte ratio
|
Baseline on Day 1, 1 week, on the day of suture removal, after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2022 |
| Date of Study Completion (India) |
17/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/10/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain after breast
cancer surgery is a major problem and women undergoing mastectomy and breast
reconstruction experience postoperative pain syndromes in approximately
one-half of all cases.The cause of pain following breast cancer
surgery can be as a result of extensive tissue damage, brachial plexus injury
following axillary dissection, vascular injury, infection, axillary web
syndrome, lymphedema, etc. Yoga
interventions have demonstrated positive effects on behavioral symptoms related
to fatigue, including depressed mood, pain and physical function..Various
components of yoga program such as asanas, meditation, pranayama and relaxation
have been used in these studies. Yoga has also demonstrated its utility in
other chronic pain syndromes such as fibromyalgia in non-cancer populations. The aim of this study is to evaluate the effect of Yoga Therapy in Management
of Post-operative Myofascial Pain in Breast Cancer Patients.Each patient who is eligible to take part will be randomly allocated to Test or control group. Both groups will receive standard care in the form of surgery, chemotherapy, radiotherapy and physiotherapy as adviced by the oncologist. Yoga group will undergo 35 min Yoga protocol along with standard care for 4 weeks. Both groups will be assessed after 4 weeks to see the improvements.
|