| CTRI Number |
CTRI/2023/09/057590 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Mulligan rotational taping on pain, knee range of motion, foot posture and gait parameters in knee osteoarthritis- A Randomised Control Trial |
|
Scientific Title of Study
|
Efficacy of Mulligan rotational taping on pain, knee range of motion, foot posture and gait parameters in individuals with medial compartment knee osteoarthritis- A Randomised Control 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 |
Dr Aditee Mangaonkar PT |
| Designation |
Postgraduate student, Musculoskeletal physiotherapy |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy, Pune |
| Address |
11/12 Thube park, Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy,
Shivajinagar,
Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9623626773 |
| Fax |
|
| Email |
aditeemangaonkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
Head of Department, Musculoskeletal physiotherapy |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy, Pune |
| Address |
11/12 Thube park, Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy,
Shivajinagar,
Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
Head of Department, Musculoskeletal physiotherapy |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy, Pune |
| Address |
11/12 Thube park, Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy,
Shivajinagar,
Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institue For Orthopaedics and Rehabilitation College of Physiotherapy, Pune |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Pune |
| Address |
11/12 Thube park, Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy,
Shivajinagar,
Pune- 411005 |
| 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 Aditee Mangaonkar PT |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Pune |
11/12 Thube park, Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy,
Shivajinagar,
Pune- 411005
Pune
MAHARASHTRA |
9623626773
aditeemangaonkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopaedics and Rehabilitation |
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 |
Mulligan rotational taping |
Duration: 6 days. An inelastic tape over a underwrap tape will be applied to the leg, starting from the fibular head, by giving a rotational glide and ending at the posterior aspect of the femur distally, to correct the positional fault in the tibiofemoral joint |
| Comparator Agent |
placebo taping |
Duration: 6 days. An inelastic tape will be applied to the leg, starting from the fibular head, without giving a rotational glide and ending at the posterior aspect of the femur distally. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients referred to the physiotherapy department.
2.Patients between age group 50-70 diagnosed radiographically with primary knee Osteoarthritis.
3.Patients diagnosed with stage 2 and 3 on Kellgren-Lawrence scale.
4.Patients with pain intensity on VAS 4 to 8 |
|
| ExclusionCriteria |
| Details |
1.Patients having any history of trauma to the lower limb in the past 1 year.
2.Patients with any surgical history for the spine or lower limb in the past 1 year.
3.Patients with uncontrolled systemic diseases like Diabetes Mellitus.
4.Patients with any neurological and cardiovascular impairments.
5.Patients with predominant Lateral tibiofemoral compartment or patellofemoral compartment osteoarthritis.
6.Patients with contraindications to manual therapy.
7.Patients having allergic reactions to the tape or having any skin disorders.
8.Patients with BMI > 30kg/m2
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain- using Visual analogue scale
Range of motion- using universal goniometer
Foot posture- using FPI_6
Gait parameters- using mobile application |
Pre-intervention & 1 week after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plantar pressure using Podiatech foot plates |
Pre-intervention & 1 week after the intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/09/2023 |
| Date of Study Completion (India) |
30/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Aim of the study is to understand the efficacy of Mulligan rotational taping on outcomes like pain, knee range of motion, foot posture and gait parameters in individuals with medial compartment knee osteoarthritis. Subjects after fulfulling the selection criteria, will be stratified according to the Kellgren-Lawrence grading system of Osteoarthritis of knee including grade 2 and 3. They will be then randomly allocated to experimental and control group. Outcome measures will be assessed prior to intervention. The experimental group will be given intervention i.e. Mulligan rotational tape and the control group will be applied a placebo tape. Duration of intervention is 1 week, following which outcomes will be re-assessed after removal of the tape. Pain will be assessed using Visual Analogue scale, Knee range of motion using universal goniometer, Foot posture using FPI-6 index and gait parameters will be assessed using a portable mobile application called Equilibrium having gait sensor technology developed by Vayu technology. The study hypothesises that Mulligan rotational taping will be effective than placebo taping in improving the pain, knee range of motion, foot posture and gait parameters in medial compartment knee osteoarthritis. |