| CTRI Number |
CTRI/2022/11/047459 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Immediate Effect of Positional Release Technique In Patients With Knee Osteoarthritis. |
|
Scientific Title of Study
|
Immediate Effect of Positional Release Technique On Pain Pressure Threshold, Range Of Motion And Proprioception In Patients With Knee Osteoarthritis- An Experimental Study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apurva Deolankar |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM
Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9764681433 |
| Fax |
|
| Email |
apurvadeolankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Garg |
| Designation |
Associate professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM
Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9027612715 |
| Fax |
|
| Email |
gargkapil9855@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrApurva Deolankar |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM
Institute of Physiotherapy N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9764681433 |
| Fax |
|
| Email |
apurvadeolankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM INSTITUTE OF PHYSIOTHERAPY , N-6 Cidco, Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM INSTITUTE OF PHYSIOTHERAPY |
| Address |
N6 Cidco, Aurangabad 431003 |
| 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 Apurva Deolankar |
MGM Medical College and Hospital |
Department of Musculoskeletal Physiotherapy, C building, OPD NO 1
Aurangabad
MAHARASHTRA |
9764681433
apurvadeolankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institute of Physiotherapy Institutional Ethics Committee |
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 |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Postional Release Technique and Conventional Physiotherapy |
This group will be given positional release technique along with conventional physiotherapy. The total duration for the intervention will be 15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who had medically or clinically diagnosed with knee osteoarthritis (ACR clinical/radiographic classification criteria of knee Osteoarthritis)
2. Stage I and II of Kellgren and Lawrence classification of osteoarthritis
3. Presence of at least two latent or active trigger point in quadriceps muscle.
|
|
| ExclusionCriteria |
| Details |
1.Any recent lower limb trauma and surgery
2.Any knee deformity
3.Any systemic Diseases
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain Pressure Threshold
2. Range of Motion.
3. Procproception. |
Pre- treatment- 5 minutes
Post- treatment- 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="71"
Sample Size from India="71"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/11/2022 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2023 |
|
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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [apurvadeolankar@gmail.com].
- For how long will this data be available start date provided 25-11-2023 and end date provided 25-10-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Objectives:
1. To determine the immediate effect on Pain pressure threshold by Positional Release Technique on Quadriceps muscle in patients with knee osteoarthritis.
2. To determine the immediate effect on Range of motion by Positional Release Technique on Quadriceps muscle in patients with knee osteoarthritis
3. To determine the immediate effect of proprioception by Positional Release Technique on Quadriceps muscle in patients with knee osteoarthritis.
Study design: Single group, A Pre-Post Experimental study
Study setting: Tertiary Care Hospital, Aurangabad
Procedure: Patients with knee osteoarthritis of age of 45- 70 years will be included in the study. Eligible participants will be included in the study and before collection of the data, informed written consent will be obtained. Proprioception will be assessment in standing position by a digital inclinometer, asked to actively squat until the affected leg reach the target position and maintain the position for 10 sec. The range of motion assessed by Goniometer. The trigger points will be palpated and assessed by pressure algometer. The intervention will be given to the participants. Pain pressure threshold, range of motion and proprioception for post treatment data.
Intervention: Patient in supine position. The therapist stands beside the affected leg and assess active and latent trigger points by pressure algometer of quadriceps muscle. The patient will be asked to place the leg on the therapist’s hand for support and the therapist hold the leg below knee in a slightly flexed at hip joint to maintain the quadriceps muscle in position in shortened state. The therapist’s other hand again palpates the trigger point by palpation and gentle compression is applied by the thumb over the trigger points and the pressure will be hold for 90 sec then the patient leg is brought into neutral position again. The same procedure is repeated three times with rest interval of 1 minute after each compression.
Conventional physiotherapy: Patient will be given Moist pack along with static quads, static hams, dynamic quadriceps, straight leg raise, hamstring stretch.
|