| CTRI Number |
CTRI/2023/01/049164 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
17/01/2023 |
| 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
|
Efficacy of Floss Band Technique along with conventional approach in management of Knee Osteoarthritis.
|
|
Scientific Title of Study
|
Efficacy of floss band technique along with conventional approach in management of 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 |
Akansha Yadav |
| Designation |
Student |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity University Sector 125, Noida, Uttar Pradesh
Amity University Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
7303905245 |
| Fax |
|
| Email |
akansha.yadav4@s.amity.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity University Sector 125, Noida, Uttar Pradesh
Amity University Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity University Sector 125, Noida, Uttar Pradesh
Amity University Sector 125, Noida, Uttar Pradesh
Balrampur
UTTAR PRADESH
201303
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
|
Source of Monetary or Material Support
|
| Dr. Vimals Physiotherapy and Sports Injury Clinic.
20 August kranti marg block A gulmohar park new delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Vimal Sharma |
Dr. Vimals Physiotherapy and Sports Injury Clinic |
August Kranti Marg, Block A, Gulmohar Park, New Delhi, 110049
South
DELHI |
8860075117
info@drvimal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amity Institute of Physiotherapy NTCC Committee |
Approved |
| Dr Vimals Physiotherapy and Sports Injury Clinic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy exercises for knee osteoarthritis. |
Knee extensions (15 reps 3 sets 10 secs)
Quadriceps Isometrics (15 reps 3 sets 10 secs)
Straight Leg Raise (15 reps 3 sets 10 secs)
Towel Press(Quadriceps) (15 reps 3 sets 10 secs)
Towel Press (Hamstring) (15 reps 3 sets 10 secs)
Abductor Strengthening (15 reps 3 sets 10 secs)
Adductor Strengthening (15 reps 3 sets 10 secs)
VMO Strengthening (15 reps 3 sets 10 secs)
Total No. of sessions per week: 3 sessions
Total duration of treatment: 4 weeks |
| Intervention |
Floss band exercises with convention physiotherapy for knee osteoarthritis. |
Knee extensions (15 reps 3 sets 10 secs)
Quadriceps Isometrics(15 reps 3 sets 10 secs)
Straight Leg Raise (15 reps 3 sets 10 secs)
Towel Press (Quadriceps) (15 reps 3 sets 10 secs)
Towel Press (Hamstring) (15 reps 3 sets 10 secs)
Abductor Strengthening (15 reps 3 sets 10 secs)
Adductor Strengthening (15 reps 3 sets 10 secs)
Sitting Knee Extension with floss band (8-10 reps 1 set)
Prone Knee flexion with floss band (8-10 reps 1 set)
Mini Squats with floss band (8-10 reps 1 set)
Hams Bridge with floss band (8-10 reps 1 set)
Split Squat with floss band (8-10 reps 1 set)
Total number of session per week: 3 sessions
Total duration of treatment: 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Females diagnosed with Osteoarthritis showing Grade 2 and 3 Osteoarthritis according to Kellgren and Lawrence scale in x-ray
2.Age group of 50 to 65 years
3.Individuals with Normal and Overweight Body Mass Index (BMI)
4.No analgesic taken during the treatment period
|
|
| ExclusionCriteria |
| Details |
1.Any Previous Surgical Procedure of knee
2.Knee pain visual numeric scale (VAS) less than 1 or greater than 8
3.Any other condition of knee
4.Traumatic injuries of knee
5.Fractures
6.Vascular disorders
7.Known Rheumatic diseases
8.Underweight and obese females
9.Known pregnancy |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Flexibility |
at 0 weeks
at 2 weeks
at 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle strength- Lower Limb (1 Repetition Maximum), Quality of life- WHOQOL-BREF |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/01/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Pain and decreased range of motion are the main problems faced by individuals suffering from knee osteoarthritis. The beneficial effect of many pain reducing electrical modalities combined with manual therapy has been confirmed several times in order to achieve best therapeutic results. There have been studies about 20 min session of floss band intervention showing an acute effect of floss band but there have been not much findings about effect of using floss band in such musculoskeletal condition of knee osteoarthritis and there are not much studies about the long term effect of using a floss band technique in these individuals. Therefore, this study will aim to know the efficacy and long-term effect of using floss band technique in cases of knee osteoarthritis.
Aim: To determine the effect of using a floss band with exercises for treatment of patients knee osteoarthritis on pain, flexibility, muscle strength and quality of life. Objectives: · To determine the efficacy of floss band technique on pain in knee osteoarthritis. · To determine the efficacy of floss band technique on flexibility in knee osteoarthritis. · To determine the efficacy of floss band technique on muscle strength. · To determine the efficacy of floss band technique on quality of life in knee osteoarthritis · To compare the effect of two different treatment interventions (Floss band with exercises and conventional physiotherapy treatment) in patient having knee osteoarthritis.
There will 40 patients included in the study and those will be further divided into 2 groups . Group A-20 further divided into A1 that will have 10 patients with normal BMI and will receive conventional physiotherapy treatment for knee OA and A2 will have 10 patients with overweight BMI and will receive conventional physiotherapy treatment for knee OA. Group B- 20 further divided into B1 that will have 10 patients with normal BMI and will receive conservative physiotherapy treatment with floss band exercises for knee OA and B2 will have 10 patients with overweight BMI each will receive conservative physiotherapy treatment with floss band exercises for knee OA. |