| CTRI Number |
CTRI/2021/06/034213 [Registered on: 14/06/2021] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Exercises and Electrical Stimulation in Patients with Knee Osteoarthritis |
|
Scientific Title of Study
|
Effect of Neuromuscular Exercises and Neuromuscular Electrical Stimulation in Patients with Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shabnam Joshi |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy,Guru Jambheshwar University of Science and Technology, Hisar |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti |
| Designation |
Research Scholar & Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9416665373 |
| Fax |
|
| Email |
jyotisabharwal35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti |
| Designation |
Research Scholar & Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9416665373 |
| Fax |
|
| Email |
jyotisabharwal35@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jyoti, Research Scholar,Department of Physiotherapy,Guru Jambheshwar University of Science and Technology, Hisar |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar |
| Type of Sponsor |
Other [ University ] |
|
|
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 |
| Jyoti |
Guru Jambheshwar University of Science and Technology, Hisar |
OPD, Room Number 07 ,Department of Physiotherapy
Hisar
HARYANA |
9416665373
jyotisabharwal35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Conventional treatment includes general knee exercises with hot packs for thrice a week for six weeks |
| Intervention |
Neuromuscular Electrical Stimulation |
Neuromuscular electrical stimulation with conventional treatment for thrice a week for six weeks |
| Intervention |
Neuromuscular Exercises |
Neuromuscular Exercises with conventional treatment for thrice a week for six weeks |
| Intervention |
Neuromuscular Exercises and Neuromuscular Electrical Stimulation |
Neuromuscular Exercises and Neuromuscular Electrical Stimulation with conventional treatment for thrice a week for six weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling American College of Rheumatology (ACR) criteria for knee osteoarthritis
2.Grade II and III knee osteoarthritis as per Kellgren and Lawrence grading system
|
|
| ExclusionCriteria |
| Details |
1.History of inflammatory and infectious conditions of knee joint
2.Patients with history of surgery around knee joint
3.History of trauma in knee joint
4.Any muscular, joint and neurological conditions affecting lower extremity
5.Unable to walk unaided
6.Currently undertaking any exercise program for knee OA
7.Any contraindication to electrical stimulation (eg. epilepsy)
8.Presence of any skin disorders around knee
9.Any condition or reason restricting the participation of the patient in the study
10.Unwilling and uncooperative patients
11.Patients who have been referred for joint replacement
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Visual Analogue Scale
2.Knee Injury and Osteoarthritis Outcome Score
3.Community balance and mobility scale
4.Dynamic Gait test
5.Range of Motion (ROM)
|
At the baseline
At the end of 6 weeks
After follow up of 4 weeks weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed up and go test |
At the baseline
At the end of 6 weeks
After follow up of 4 weeks. |
|
|
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)
|
16/06/2021 |
| 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="1"
Months="1"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Knee OA is a prevalent arthritic condition which leads to reduced physical function and pain leading to poor quality of life.exercises are a vital part of physiotherapy intervention in the management of knee osteoarthritis. Neuromuscular exercises are individualized and goal-based exercise program that address the functional instability and impaired muscle function for the lower extremities. Neuromuscular exercises typically involve multiple joints and muscle groups performed in functional weight-bearing positions. Emphasis is on the quality and efficiency of movement, as well as alignment of the trunk and lower limb joints. The neuromuscular training method is based on biomechanical and neuromuscular principles and aims to improve sensorimotor control and achieve compensatory functional stability.One emerging method of quadriceps muscle strengthening and rehabilitation in knee OA patients is the use of neuromuscular electrical stimulation therapy . This therapy entails the use of low-level electrical impulses that cause involuntary contractions in the targeted muscles through stimulating surface electrodes directly applied to the desired muscle group. Neuromuscular electrical stimulation (NMES) may be an alternative, low cost, efficient, and less painful treatment approach than voluntary knee exercises for patients with knee OA. NMES is considered an efficient technique for quadriceps strengthening and also known to improve muscle architecture. Therefore, use of combination of the electrical impulses applied via neuromuscular electrical stimulation and unique exercise strategies such as neuromuscular exercises may improve both the clinical and functional outcomes in patients of knee osteoarthritis. |