| CTRI Number |
CTRI/2024/07/070786 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| 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
|
A clinical study to compare the effects of interferential therapy and microcurrent on low back pain of unknown origin |
|
Scientific Title of Study
|
Comparative Efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with Chronic Non Specific Low Back Pain a randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohini Kusum Lakra |
| Designation |
Post Graduate Student |
| Affiliation |
|
| Address |
Room Number 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), BT Road, Bonhooghly,
Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
7033598852 |
| Fax |
|
| Email |
rohinilakra7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bibhuti Sarkar |
| Designation |
I/C- Lecturer (PT) |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room Number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
8820692556 |
| Fax |
|
| Email |
sarkarb1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohini Kusum Lakra |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room Number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
7033598852 |
| Fax |
|
| Email |
rohinilakra7@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute
for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly,
Kolkata 700090 |
|
|
Primary Sponsor
|
| Name |
Rohini Kusum Lakra |
| Address |
National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata 700090 |
| 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 |
| Rohini Kusum Lakra |
National Institute for Locomotor Disabilities (Divyangjan) |
Room Number 117,
Department of
Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), BT
Road, Bonhooghly,
Kolkata West Bengal
Pin Code - 700090
North Twentyfour
Parganas
WEST BENGAL
North Twentyfour Parganas
WEST BENGAL |
7033598852
rohinilakra7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute for Locomotor Disabilities (Divyangjan) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interferential Therapy |
The intervention group will get 10 minutes of interferential therapy with Carrier Frequency of 4 KHz in a Quadripolar technique with Supervised Exercise Program. Interferential Therapy and Supervised Exercise will be given for 10 sessions(5 sessions per week for 2 weeks) Patient will perform the home exercise program once a day in home during 2 weeks of treatment period. |
| Comparator Agent |
Microcurrent |
The comparator group will get 20 minutes of Microcurrent with Current of 100 μA pulsed direct current in an alternating positive ramped square waveform with Supervised Exercise Program. Interferential Therapy and Supervised Exercise will be given for 10 sessions(5 sessions per week for 2 weeks) Patient will perform the home exercise program once a day in home during 2 weeks of treatment period. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects age between 20 to 45 years.3
2. Both male and female subjects.
3. Pain in the area between 12th ribs and L5 vertebra.2
4. Subjects with Low Back Pain duration of more than 3 months.6
5. Pain intensity according to Numerical Pain Rating Scale (NPRS) from 3-8. |
|
| ExclusionCriteria |
| Details |
1. Cases of unilateral or bilateral radiating pain (Radiculopathy, Sciatica).2
2. Musculoskeletal conditions like scoliosis, spondylosis, spondylolisthesis, limb length discrepancy etc.3,5
3. History of trauma, fracture of spine, lower limb, spinal surgery and metal implant etc.
4. Diagnosed cases of carcinoma, renal disorder, vascular disease and infectious disease of spine like TB.5
5. Rheumatological disorders like Rheumatoid arthritis, Ankylosing spondylitis etc.
6. Neurological conditions like Spinal cord injury, Developmental disorders and congenital diseases like spina bifida etc.
7. Cases with implanted pacemaker / cardiac disorders.
8. Pregnancy and other diagnosed gynaecological disorders etc.3
9. Localised skin infections / lesions in lumbar spine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain intensity [Numerical Pain Rating Scale (NPRS)].
2. Lumbar Flexion-Extension ROM [Modified -Modified Schober’s Test (MMST)].
3. Function [Oswestry Disability Index (ODI)]. |
2 times – on day 0 and after 2 weeks of
intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
PURPOSE OF THE STUDY:
There are many studies available on the efficacy of Interferential Therapy on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain. However very few studies have been conducted on Microcurrent in the treatment of chronic non- specific low back pain. To the best of our knowledge there are no studies available which compared the efficacy of Interferential Therapy and Microcurrent in chronic non- specific low back pain. So, the purpose of this study is to compare the efficacy of Interferential Therapy and Microcurrent along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain.
AIM: To find out the comparative efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain.
OBJECTIVES: 1. To find out the efficacy of Interferential Therapy along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain.
2. To find out the efficacy of Microcurrent along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain. 3. To compare the efficacy of Interferential Therapy along with Supervised Exercise and Microcurrent along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain.
HYPOTHESIS: NULL HYPOTHESIS (H0): There is no statistically significant difference between the efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain. ALTERNATIVE HYPOTHESIS (H1): There is statistically significant difference between the efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain.
PROCEDURE:After obtaining the Approval from the Institutional Ethical Committee (IEC), all the subjects with Low Back Pain referred from the Assessment Clinic of National Institute for Locomotor Disabilities (Divyangjan) [NILD] will be approached, assessed and screened according to inclusion and exclusion criteria. Subjects meeting the exclusion criteria will not be included. Those meeting the inclusion criteria will be explained in detail about the aim and procedure of the study in their most communicable language. Written informed consent in their preferred language will be taken from the subjects agreeing to participate. The subjects will be divided into two groups with a minimum of 17 subjects in each group, by block randomization method. The demographic data and outcome measures for Pain using the ‘Numerical Pain Rating Scale, Range of Motion by ‘Modified- Modified Schober’s test’ and Function by ‘Oswestry Disability Index’ will be collected at baseline as pre intervention data and at the end of 10 sessions as post intervention data. Group - A: All the subjects in Group A (n = 17) will be treated with Interferential Therapy for 10 minutes followed by Supervised Exercise Program for 10 sessions. Group - B: All the subjects in Group B (n = 17) will be treated with Microcurrent for 20 minutes followed by Supervised Exercise Program for 10 sessions. Home Exercise Program and Ergonomic Care will be explained to all the subjects in both groups. Rescue medications duly prescribed by physician will be continued along with the Physiotherapeutic approach in both the groups during the study.
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