| CTRI Number |
CTRI/2022/05/042523 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
12/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
An RCT comparing Effectiveness of Percutaneous Electrical Nerve Stimulation Versus Trigger Point Dry Needling In Tibiofemoral Osteoarthritis |
|
Scientific Title of Study
|
“Effectiveness of Percutaneous Electrical Nerve Stimulation Versus Trigger Point Dry Needling In Tibiofemoral Osteoarthritis: A Randomized Controlled Trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhanjan Das |
| Designation |
Research Scholar |
| Affiliation |
Garden City University |
| Address |
Room No 307 Department of Physiotherapy School of Health
Sciences Garden City University 16 KM Old Madras Road TC Palya,
KR Puram Bangalore
Bangalore
Bangalore
KARNATAKA
560049
India |
| Phone |
8967549104 |
| Fax |
|
| Email |
subhanjan181318@gcu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prema Kulkarni |
| Designation |
Assistant Professor |
| Affiliation |
Garden City University |
| Address |
Room No 307 Department of Physiotherapy School of Health
Sciences Garden City University 16 KM Old Madras Road TC Palya,
KR Puram Bangalore
Bangalore
Bangalore
KARNATAKA
560049
India |
| Phone |
08967549104 |
| Fax |
|
| Email |
kulkarniprema9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prema Kulkarni |
| Designation |
Assistant Professor |
| Affiliation |
Garden City University |
| Address |
Room No 307 Department of Physiotherapy School of Health
Sciences Garden City University 16 KM Old Madras Road TC Palya,
KR Puram Bangalore
Bangalore
KARNATAKA
560049
India |
| Phone |
08967549104 |
| Fax |
|
| Email |
kulkarniprema9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Subhanjan Das |
| Address |
Research Scholar Department of Physiotherapy Room No 307
Garden City University 16th KM Old Madras Road Bangalore 36 |
| 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 |
| Subhanjan Das |
Clinical facilities attached with Garden City University |
Physiotherapy Clinic by
Garden City University
Room No 307
Department of Physiotherapy
GCU University Campus
TC Palya 16th KM Old
Madras Road
Bangalore 36
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8967549104
subhanjan181318@gcu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of PhD research proposals, Garden City University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Percutaneous Electrical Nerve
Stimulation |
Delivery of therapeutic current
(TENS) via thin solid needles
placed through the skin.
Frequency: Twice a week
Duration: Six Week
Self exercise is performed by the patient.
|
| Comparator Agent |
TENS |
TENS is applied to the patient. Frequency: Twice a week.
Duration: Six weeks
Self exercises are performed by the patient |
| Intervention |
Trigger point Dry Needling |
Solid sterile needles are
inserted to myofascial triger
points using clean field methods
and withdrawn after seconds to
minutes. No medicine is
delivered. Frequency: Twice a
Week Duration: Six week
Self Exercise is performed by the patient. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild to moderate2 clinically diagnosed primary tibiofemoral OA as per ACR criteria6
2. Patients of both sexes
3. Age 50 – 65 years1
4. Chronic pain in the knee >3 months19
5. Unilateral symptoms
6. Ability to walk without support for 6 meters.
|
|
| ExclusionCriteria |
| Details |
1. History of surgery of the painful knee.
2. History of severe or permanent injury/pathology (other than osteoarthritis) in the lower limb.
3. History of surgery of the lower limb in the preceding six months 19
4. Had received physiotherapy, manual therapy or any other local therapy that can affect the treatment efficacy or outcome in the preceding 2 months 19
5. Peripheral neuropathy or sensory loss around the treatment area.
6. Those who had received oral steroids, opiate treatment in the past 6 months 34
7. Patients with contraindications and concerns related to dry needling as listed out in 2013 APTA resource manual of dry needling. 11
8. Acute exacerbations
9. Malignancy or severe systemic disease |
|
|
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
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee injury and osteoarthritis outcome score (KOOS) |
Pre intervention: Day 1 before therapy
Post intervention: 6 weeks
Follow up: 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PPT via algometer.
Pressure Pain Threshold of fixed points will be
measured |
Pre intervention: Day 1 before therapy
Post intervention: 6 weeks
Follow up: 4 Weeks |
PPT via algometer.
Pressure Pain Threshold of fixed points will be
measured |
Pre intervention: Day 1 before therapy
Post intervention: Day 14
Follow up: 4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
16/05/2022 |
| 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
|
Will be published once completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed research will be a comparative interventional study to investigate the effectiveness of 3 different types of physiotherapeutic interventions, Namely, Percutaneous Electrical Nerve Stimulations (PENS), Dry Needling, and conventional physiotherapy of TENS (The control group) with common use of exercise in all three groups in the treatment of osteoarthritis knee. Outcome Measures: The primary outcome measure is KOOS score, the secondary outcome measures are the Pressure Pain Threshold (PPT) measured with an algometer. Further secondary outcome measures may be added. Pre, post, and 4 weeks follow-up will be taken. |