| CTRI Number |
CTRI/2024/11/077354 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Interferential Therapy on Reducing Pain Score in Low back pain Patients. |
|
Scientific Title of Study
|
Effectiveness of different frequency of interferential therapy on reducing pain score among low back pain patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Vishwa |
| Designation |
Undergraduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
New Block G, Ground Floor, Room Number One, Rehabilitation OPD,
No 1 Ramachandra Nagar,
Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116
Chennai
TAMIL NADU
600069
India |
| Phone |
868084053 |
| Fax |
|
| Email |
t0121092@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research Institute
Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Summer Research Founder Chancellor |
| Address |
Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research Institute
Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu,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 K Soundararajan |
Sri Ramachandra Hospital |
New Block
Physiotherapy OPD,
ground Floor, Room No
1, Faculty of
Physiotherapy,Sri
Ramachandra Institute
of Higher Education
and Research[Deemed
to be university],Porur,
Chennai-600116,Tamil
Nadu,India
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9551163416
soundararajan.k@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Project, Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai-600116,Tamil Nadu,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Quadripolar Constant AMF. Quadripolar Constant Amplitude Modulation Frequency (AMF) without vector Interferential Therapy involves the use of four electrodes to create an interference pattern within the tissues |
| Intervention |
Intervention A Group |
Bipolar Constant Amplitude Modulation Frequency (AMF). Bipolar Constant Amplitude Modulation Frequency (AMF) Interferential Therapy involves the use of two medium-frequency currents that are slightly out of phase to produce a low-frequency effect for therapeutic purposes |
| Intervention |
Intervention B Group |
Quadripolar Constant AMF with vector. Quadripolar Constant Amplitude Modulation Frequency (AMF) with vector 90 degree Interferential Therapy involves the use of four electrodes to create an interference pattern within the tissues |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient Diagnosed with Low Back Pain . |
|
| ExclusionCriteria |
| Details |
Pregnant women,
Tumor,
Cognitive unstable,
Patients with associated neurological problems,
Pain Score more than 4 in VAS . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analouge Scale base line |
at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index |
at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week |
| Lumbar Range of Motion |
at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week |
| Lumbar Muscle endurance |
at baseline, at the end of 2nd week, at the end of 4th week, at the end of 6th week, at the end of 8th week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2024 |
| 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) |
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
|
|
Brief Summary
|
BACKGROUND:
Interferential Therapy (IFT) is a widely known and practiced modality in
outpatient physiotherapy
as a mainstay of pain management of low back disorders. Interferential Therapy
is the application of two medium-frequency
currents to produce a low-frequency effect. It is based on the principle of
Interference, because of which beat frequency
is produced. Low Back Pain describes a wide range of pain due to Inflammation
and degenerative origin that results in functional
impairment. As stated previously, IFT being the widely accepted treatment modality for Pain management, its parameters have
been scarcely explored and studied for research purposes.
In this context, limited literature evidence regarding the parameters for
clinical application is available.
OBJECTIVE: To evaluate the
effectiveness of IFT by comparing it with chosen parameters and the overall
patient satisfaction with the outcome of treatment.
MATERIAL AND METHOD: An
Experimental Clinical Trial study design. 120 Subjects will be recruited from the
Sri Ramachandra Physical Rehabilitation Centre OPD. Subjects are stratified and
randomly assigned to 3 groups: bipolar constant amplitude modulation frequency
(AMF), quadripolar constant AMF with vector, and control. 40 patients per group (single
blinding) age 25 TO 45 years with LOW BACK pain. The study population comprises
those who have been diagnosed
with Low back Disorders. Interferential Therapy shall be delivered to all
groups to tolerance intensity and at high AMF. Pain is monitored and measured
before and after treatment on all sessions using a Visual Analogue Scale and
patient-perceived effect scale. Patients shall follow up for 3 days.
Socio-demographic details are also collected along with informed consent. At
the end of 3rd day, the patients are asked to fill out a Physical Therapy
Patient Satisfaction Questionnaire that indicates their satisfaction following
treatment.
ANTICIPATED OUTCOME: i)
Frequency 80-100 Hz would be a more effective choice of frequency for Low back pain
control. ii) Patients belonging to the intervention group may have more
significant satisfaction than patients belonging to the control group. iii)
Patients belonging to the intervention group with chosen parameters would have
a significant improvement in terms of relief of symptoms. Also, the satisfaction
index would be higher among the patients in experimental group than the control
group.
|