| CTRI Number |
CTRI/2026/01/101761 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| 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
|
Comparison Of Maitland Mobilisation With Two Different Physiotherapy Treatment Approaches for Pain, Function and Quality of Life in Postmenopausal Women with Bilateral Knee Osteoarthritis |
|
Scientific Title of Study
|
A Comparative Study Of Maitland Mobilisation Combined With Multimodal Physiotherapy Approaches On Pain, Function and Quality of life In Postmenopausal Women With Bilateral Knee Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sehajleen Kaur |
| Designation |
Postgraduate Student |
| Affiliation |
Khalsa College, Amritsar |
| Address |
P.G. Department of Physiotherapy, Khalsa College, Amritsar
Amritsar
PUNJAB
143002
India |
| Phone |
8264337330 |
| Fax |
|
| Email |
sehajsethi018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rishamdeep Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Khalsa College, Amritsar |
| Address |
P.G. Department of Physiotherapy, Khalsa College, Amritsar
Amritsar
PUNJAB
143002
India |
| Phone |
9855972227 |
| Fax |
|
| Email |
risham3650@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishamdeep Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Khalsa College, Amritsar |
| Address |
P.G. Department of Physiotherapy, Khalsa College, Amritsar
PUNJAB
143002
India |
| Phone |
9855972227 |
| Fax |
|
| Email |
risham3650@gmail.com |
|
|
Source of Monetary or Material Support
|
| Outpatient Department Of Physiotherapy , Khalsa College ,Amritsar-143002, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Sehajleen Kaur |
| Address |
P.G. Department of Physiotherapy, Khalsa College, Amritsar-143002, Punjab, India |
| Type of Sponsor |
Other [(Principal Investigator of this study)] |
|
|
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 |
| Sehajleen Kaur |
Khalsa College, Amritsar |
Outpatient Department of Physiotherapy, Khalsa College, Amritsar
Amritsar
PUNJAB |
8264337330
sehajsethi018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College Ethical Committee |
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 |
| Intervention |
Maitland Mobilisation with Interferential current therapy, Multiple-angle isometrics and Step-up and Step down exercise |
Participants will receive Maitland mobilisation grade II and III applied to tibiofemoral (anteroposterior and posteroanterior) and patellofemoral (caudal and cephalic) joint at 2-3 oscillations per second for 1-2 minutes per glide, Interferential current therapy for 20 minutes, Multiple-angle isometrics is administered as 3 sets of 10 repetitions at each of the three (30°,60°,90°) angles and Step-up and Step-down exercise initiating from 5 repetitions and progressing to 10 repetitions and additional weight. The protocol will be carried out for 3 sessions per week for a total of 4 weeks. |
| Comparator Agent |
Maitland Mobilisation with Therapeutic Ultrasound, Isometrics and Dynamic Quads |
Participants will receive Maitland mobilisation grade II and III applied to tibiofemoral (anteroposterior and posteroanterior) and patellofemoral (caudal and cephalic) joint at 2-3 oscillations per second for 1-2 minutes per glide, Therapeutic Ultrasound for 5 minutes at frequency of 1MHz and an intensity of 0.8 W/cm², Isometrics include Supine Straight Leg Raise, Lateral Leg Abduction for hold of 10 seconds and 10 repetitions and Seated Adductor Squeeze for hold of 10 seconds and 20 repetitions and Dynamic Quads initiating from 5 repetitions and progressing to 10 repetitions and additional resistance. The protocol will be carried out for 3 sessions per week for a total of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Postmenopausal women
2. Radiologically diagnosed bilateral knee osteoarthritis (Kellgren-Lawrence grade II -III) (Radiograph obtained within six months of the outset of the study)
3. Persistent knee pain present for more than 3 months
|
|
| ExclusionCriteria |
| Details |
1. History of knee surgery or intra-articular injection within the last 6 months
2. Advanced Osteoarthritis (Kellgren -Lawrence grade IV)
3. Neurological disorders affecting gait or balance
4. Rheumatoid arthritis
5. Acute trauma, fracture or ligamentous injury of the lower limb
6. Concurrent participation in another physiotherapy or exercise trial
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numeric Rating Scale
2. Western Ontario and McMaster Universities Osteoarthritis Index
3. World Health Organization Quality of Life – BREF (Brief Version) |
1. Baseline and Post-intervention (4 weeks)
2. Baseline and Post-intervention (4 weeks)
3. Baseline and Post-intervention (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Universal Goniometer
2. Manual Muscle Testing |
1. Baseline and Post-intervention (4 weeks)
2. Baseline and Post-intervention (4 weeks)
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/02/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- 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 [sehajsethi018@gmail.com].
- For how long will this data be available start date provided 20-01-2026 and end date provided 03-08-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Osteoarthritis of the knee is a degenerative joint disorder, particularly prevalent among postmenopausal women due to age related and hormonal changes. It is characterized by pain, reduced range of motion, muscle weakness, functional limitation, and impaired quality of life. Postmenopausal women are at increased risk of knee osteoarthritis due to estrogen deficiency, often resulting in bilateral involvement, chronic pain, functional limitations, and reduced quality of life. The present study is designed as a randomized parallel group clinical trial involving 60 postmenopausal women with bilateral knee osteoarthritis. Participants will be randomly allocated into two groups . The intervention group will receive Maitland mobilization combined with interferential current therapy, multiple-angle isometrics and step-up and step-down exercise. The comparator group will receive Maitland mobilization combined with therapeutic ultrasound, isometrics and dynamic quadriceps exercise. The primary outcome measures will include pain intensity assessed using the Numeric Rating Scale (NRS), functional status assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). The secondary outcome measures will include knee joint range of motion assessed using a goniometer and muscle strength assessed using Manual Muscle Testing (MMT). Outcome assessments will be conducted at baseline and at the end of the intervention period. The results of this study are expected to provide comparative evidence on the effectiveness of different physiotherapy treatment combinations in reducing pain, improving functional independence and overall quality of life of postmenopausal women suffering from bilateral knee osteoarthritis thereby enhancing clinical effectiveness and promoting better long-term management strategies. |