| CTRI Number |
CTRI/2022/09/045230 [Registered on: 05/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the Effect of Cupping Therapy versus Myofascial Release in Mechanical Low Back Pain |
|
Scientific Title of Study
|
Efficacy of Cupping Therapy versus Myofascial Release in Mechanical Low Back Pain: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunal |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
9034420555 |
| Fax |
|
| Email |
kunalsetia52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Physiotherapy Research Lab, Maharishi Markandeshwar Institute of Physiotherapy, Maharishi Markandeshwar deemed to be University, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Kunal |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sunita Sharma |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kunal |
Maharishi Markandeshwar Hospital Department of Musculoskeletal Physiotherapy |
Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA |
9034420555
kunalsetia52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cupping Therapy |
In Group A manual suction pump and four Plastic cups, estimate one will be utilized for the interventions. The cups will be applied to the lower back, parallel to L1 to L5 vertebrae, with a 3-cm distance between them, bilaterally. With 4 cups to the lower back with manual suction pump for 15 minutes three days a week for 2 weeks. |
| Comparator Agent |
Myofascial Release |
Group B was given Myofascial Release (MFR) three days a week for 2 weeks for 15 minutes. The myofascial convention included a selection of three techniques:
1. Longitudinal sliding of lumbar paravertebral muscles
2. Myofascial release of the thoracolumbar fascia
3. Myofascial release of quadratus lumborum. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 25 to 55 years
2. Both males and females
3. Low Back Pain ≥ 2-3 weeks
4. Low Back pain without neurological deficit
5. No previous treatment with cupping therapy for low back pain
|
|
| ExclusionCriteria |
| Details |
1. Radiating Pain with neurological deficit
2. Previous history of any injury, trauma, fracture, surgery, infection, tumor in lumbar spine
3. Pregnancy
4. Recent motor vehicle accident including lumbar spine
5. Osteoporosis
6. Contraindication to cupping therapy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Modified Oswestry Low Back Disability Index Questionnaire (MODI) |
3 times for 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Numeric Pain Rating Scale (NPRS) |
3 times for 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/09/2022 |
| Date of Study Completion (India) |
15/03/2023 |
| Date of First Enrollment (Global) |
05/09/2022 |
| Date of Study Completion (Global) |
15/03/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
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
|
Ethical Statement:
Ethical approval of this study will be taken from the student project committee and ethical committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. Study will be done in accordance with Helsinki declaration revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participants, 2017.
Recruitment and Intervention: The objective of the study is to find out the efficacy of Cupping Therapy versus Myofascial Release in Mechanical Low Back Pain patients on pain intensity and low back disability. Participants will be chosen from a group of 25–55-year-old who had been suffering from low back pain for at least 2-3 weeks. Each subject’s complete demographic information, including name, age, gender, weight, and height, will be recorded. For 2 weeks, treatment will be provided thrice a week. The Numeric Pain Rating Scale is used to assess pain intensity, and the Modified Oswestry Low Back Disability Index Questionnaire is used to assess disability, and baseline measures will be done after the 1st and 2nd week of the intervention.
|