| CTRI Number |
CTRI/2024/09/073634 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
"This study will be exploring how Mind-Body Techniques Can Improve Sleep, Reduce Pain, and decrease disability in patients with Knee Osteoarthritis"
|
|
Scientific Title of Study
|
Effect Of Mind-Body Technique on Sleep Quality, Pain and Disability in Knee Osteoarthritis Patients- A Randomized Controlled 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 |
Gayatri Chandak |
| Designation |
PG Student |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, No.3, MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7558239299 |
| Fax |
|
| Email |
chandakg19.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rinkle Malani |
| Designation |
Director and Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, No.3, MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9370312412 |
| Fax |
|
| Email |
rinkle.malani@mgmsop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinkle Malani |
| Designation |
Director and Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, No.3, MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9370312412 |
| Fax |
|
| Email |
rinkle.malani@mgmsop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 Gayatri Chandak |
MGM School of Physiotherapy |
Department of Musculoskeletal Physiotherapy, No.3, MGM School of Physiotherapy, C-Building, N-6, CIDCO, Chhatrapati Sambhajinagar, 431001 Maharashtra, India
Aurangabad
MAHARASHTRA |
7558239299
chandakg19.7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guidelines based Physiotherapy Treatment |
Guidelines based physiotherapy treatment (4)
-
1. Isometric strengthening - Isometrics for quadriceps, hamstrings, glutes and hip
adductors with10 seconds hold and 1 set of 10 repetitions for 3 days/week for 4 weeks.
In 1st week 1 set, in 2nd and 3rd week 2 sets, 4th week 3 sets will be prescribed.
2. Stretching exercises – Stretching for hamstrings, quadriceps and calf muscles with 3
repetitions for 30 seconds hold.
3. Strengthening exercise – Strengthening for quadriceps, hamstrings, glutes maximus,
glutes medius and Iliopsoas with 10 seconds hold, 10 repetitions, 3 days/week for 4
weeks. Strengthening exercises involved the utilization of sandbag starting from ½ kg
progressed to 1 kg.
In 1
st week 1 set, in 2nd and 3rd week 2 sets, 4th week 3 sets will be prescribed.
Mini squatting of 1 set in 1st week without holds, in 2nd
-3
rd week with 5secs hold and in 4th
week with 10 secs hold.
4. Aerobic exercise – before starting aerobic exercises subjects will be asked to perform
warm and cool down for 5 minutes.
In warm and cool down sessions participants were asked to perform heel raise, ankle toe
movements, trunk rotations, gastrocenimius-soleus hamstrings stretches, breathing exercise.
1. Static cycling starting from 5 minutes and progressing to 15 minutes by 4th week.
2. Retro walking starting for 2 minutes and progressing to 10 minutes by 4th week.
Home exercise programmeIsometrics, strengthening exercises, stretching exercises two times/week when not
coming to therapy sessions.
Regular walking for 15 minutes and progressing to 30 minutes by end of 4th week. |
| Intervention |
Mind-Body technique |
Mind Body technique -
The intervention was modelled on the 6-week Mindfulness-Based program. These techniques
take regular activities such as sitting, walking, and lying down and transform them into
meditation through directed breathing and mindful awareness of thoughts and sensations. The
methods used included Pilates, body scan, sitting practice, walking meditation, and mindful
stretching. Each session included time for mindfulness meditation and time for discussion of
the themes brought up during the 6-week programme.
Pilates -
In total there will be 18 sessions, thrice a week for 6 weeks. Pilates training will be provided
by the therapist. Each session will be 50 minutes long including 10 minutes of warm up
exercises, 20 minutes of pilates exercises, 10 minutes of cool down exercises
1st WEEK Spine stretch
Spine twist
Saw 3 times (trying to reach as
far as possible)
3 times from each side
3 times from each side
2nd WEEK
1st week exercises +
Side kick
Bridging
3 times from each side
5 repetitions
3rd WEEK
2nd week exercises +
One leg kick
One leg circle
6 times from each side
5 times from each side
4th WEEK
3rd week exercises +
Double leg kick
Swimming
5 repetitions
3 x 10 seconds hold (from
each side)
5th WEEK
4th week exercises +
Side bend
Leg pull front
10 repetitions
3 times from each side
6th WEEK
5th week exercises +
One leg stretch
Side bend
5 times from each side
3 times from each sid |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having knee pain since 3 months, aged between 40-60 years, both male and female.
Patients having knee pain more than 3 score on NPRS scale.
Orthopaedician diagnosed knee osteoarthritis with Kellgren and Lawrence scale upto grade 3.
Patients having score 4 on Pittsburgh sleep quality scale.
|
|
| ExclusionCriteria |
| Details |
OA of any other joint
Previous hip or knee surgery.
Received intra-articular injection within 6 months.
Received physiotherapy treatment for knee pain in past 6 months.
Impaired lower limb function due to stiff knee.
Genu valgum, genu varum or any other lower limb deformity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS
Pittsburgh Sleep Quality Index (PSQI)
WOMAC
TSK |
NPRS: Baseline and at end of every week till 6 weeks
Pittsburgh Sleep Quality Index (PSQI): Baseline and at end of every week till 6 weeks
WOMAC: Baseline and at end of every week till 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TSK |
TSK: Baseline and at end of every week till 6 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/09/2024 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
AIM: To study the effect of mind body technique on sleep quality in OA patients.
OBJECTIVES:
PRIMARY OBJECTIVE:
To study the effect of mind body technique on sleep quality in knee OA patients.
To study the effect of mind body technique on pain in knee OA patients.
To study the effect of mind body technique on disability in knee OA patients.
SECONDARY OBJECTIVE:
To study the effect of mind body technique on fear of fall in knee OA patients. |