| CTRI Number |
CTRI/2024/11/076825 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| 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
|
Effectiveness of interferential therapy versus muscle energy technique on patients with low back pain |
|
Scientific Title of Study
|
To compare the effects of interferential therapy(IFT) versus muscle energy technique with conventional physiotherapy protocol on quadratus lumborum in adults with non-specific low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srishti Gupta |
| Designation |
MPT student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area, sitapura, tonk road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7290956971 |
| Fax |
|
| Email |
srishti2005@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Room No. 14 physiotherapy OPD, Basement, Mahatma Gandhi hospital, mahatma Gandhi university of medical sciences and technology, RIICO institutional area, Sitapura Tonk road Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saleem Akhtar Naqvi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Room No. 14 physiotherapy OPD, Basement, Mahatma Gandhi hospital, mahatma Gandhi university of medical sciences and technology, RIICO institutional area, Sitapura Tonk road Jaipur
RAJASTHAN
302022
India |
| Phone |
9680154007 |
| Fax |
|
| Email |
physio.sallu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and technology, RIICO institutional area, Sitapura Tonk road Jaipur, Rajasthan, India 302022 |
|
|
Primary Sponsor
|
| Name |
Srishti Gupta |
| Address |
State Bank Colony, Nadrai Gate, kasganj, Kasganj, Uttar Pradesh,India 207123 |
| 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 Saleem Akhtar Naqvi |
Mahatma Gandhi Hospital, Jaipur |
Room No. 14 Physiotherapy OPD, Basement, Mahatma Gandhi Hospital, Jaipur.
Jaipur
RAJASTHAN |
9680154007
physio.sallu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Interferential therapy along with conventional physiotherapy protocol |
Interferential therapy with conventional physiotherapy protocol will be given for 6
sessions per week. Also, 10-15 min hot pack will be applied. Interferential therapy
(IFT) using standardized parameters (carrier frequency - 3.85 kHz and pulse
duration-130µs) with quadripolar application will be given for duration of
15 minutes. Total duration 2 weeks |
| Intervention |
Muscle energy technique with conventional physiotherapy |
muscle energy technique for 3-5 repetitions.
The patients will be given Muscle energy technique with conventional physiotherapy
protocol (Strengthening exercise, hot pack)
for 6 session per week (total 12 sessions).Total duration 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who will have duration of pain for less than 6weeks.
2. Participants with non specific and postural low back pain.
3.Participants with lumbar pain and pain at the attachments of quadratus
lumborum
4. Participants with restricted with either right or left side bending.
5.Participants willing to participate in the study.
6. Subjects with tightness of quadratus lumborum. |
|
| ExclusionCriteria |
| Details |
1.Participants who will have duration of pain more than 6 weeks.
2.Participants suffering from specific low back pain like prolapse
intervertebral discs with instability or any radicular symptoms, lumbar
spondylosis, lumbar canal stenosis, spondylolisthesis, sensory deficits,
malignancies and tuberculosis, osteoporosis, psychiatric disorders, pain relief patches/injections/ slow releasing hormonal capsule, fracture or
dislocation , haematomas or abscesses.
3.Contraindication of interferential therapy such as cardiac pacemakers,
thrombosis, recent hemorrhage, pregnancy, fever, tumors or with any
metallic implants.
4. History of spinal surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain- Visual Analogue Scale
2.Modified Oswestry low back pain questionnaire |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Oswestry low back pain questionnaire |
1 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
29/11/2024 |
| 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 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
|
50 Samples will be divided into two groups of 25 individual in each group, and will
be studied 2 weeks on the basis of inclusion criteria. Group A- Muscle energy technique with conventional physiotherapy
protocol.(Strengthening exercise, hot pack)
muscle energy technique for 3-5 repetitions.
The patients will be given Muscle energy technique with conventional physiotherapy
protocol for 6 session per week(total 12 sessions) Group B- Interferential therapy along with conventional physiotherapy protocol.
Interferential therapy with conventional physiotherapy protocol will be given for 6
sessions per week. Also, 10-15 min hot pack will be applied5
. Interferential therapy
(IFT) using standardized parameters (carrier frequency - 3.85 kHz and pulse
duration-130µs) with quadripolar application will be given for duration of
15 minutes. |