| CTRI Number |
CTRI/2021/09/036762 [Registered on: 23/09/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2022 |
| 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
|
Comparative Effect Of Pilates And Bruegger’s Exercises Along With Low Level Laser Therapy For Individuals With Forward Head Posture Associated Temporomandibular Joint Dysfunction. |
|
Scientific Title of Study
|
Comparative Effect Of Pilates And Bruegger’s Exercises In Conjunction With Low Level Laser Therapy For Individuals With Forward Head Posture Associated Tmj Dysfunction - A Two Arm Parallel Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauri Satish Malode |
| Designation |
PG student (MPT Orthopaedics) |
| Affiliation |
KAHER Institute of physiotherapy. |
| Address |
KAHER Institute of physiotherapy,Department of Orthopedic Physiotherapy, JNMC campus, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7057746317 |
| Fax |
|
| Email |
gaurismalode3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
MPT , PhD Orthopaedic Physiotherapy |
| Affiliation |
KAHER Institute of physiotherapy. |
| Address |
KAHER Institute of physiotherapy, JNMC campus, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7057746317 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Gauri Satish Malode |
| Designation |
PG student (MPT Orthopaedics) |
| Affiliation |
KAHER Institute of physiotherapy. |
| Address |
KAHER Institute of physiotherapy,Department of Orthopaedic Physiotherapy, JNMC campus, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7057746317 |
| Fax |
|
| Email |
gaurismalode3@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER INSTITUTE OF PHYSIOTHERAPY,Department of Orthopedic Physiotherapy, JNMC Campus, Nehru Nagar ,Belgaum, Karnataka. |
|
|
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 |
| Gauri Malode |
KLE Hospital and Research center |
KLE HOSPITAL AND RESEARCH CENTRE,DEPARTMENT OF ORTHOPEDIC PHYSIOTHERAPY, NEHRU NAGAR, BELGAUM
Belgaum
KARNATAKA |
7057746317
gaurismalode3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICS COMMITTEE of KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BRUEGGER’S EXERCISES Along with LOW LEVEL LASER THERAPY |
Bruegger’s
exercise will be started with 10 s hold and progressed to 30 s hold by the end of 3
weeks with 5 s of increment every 2 sessions. Exercises will be given for 3weeks
on alternate days.
The rest time will be 30 s which was constant throughout. The exercise will be
repeated 15 times per session.
LOW LEVEL LASER THERAPY-
A 635nm wavelength diode laser will be used with 200mW in a continuous mode, using a handpiece with a cylindrical applicator with a diameter
of 8mm in contact mode, with a power density of 400mW/cm2, delivering 8 J/cm2
on each application point, over a period of 20 sec. |
| Intervention |
PILATES ALONG WITH LOW LEVEL LASER THERAPY |
Protocol will start with Pilates Beginner exercises and progressed to intermediate and advance level. Participants will be encouraged to perform exercises in 2 sets of 10 repetitions per day. Pilates exercises will be given for 3 weeks on alternate days.
LOW LEVEL LASER THERAPY-
A 635nm wavelength diode laser will be used with 200mW in a continuous mode, using a handpiece with a cylindrical applicator with a diameter
of 8mm in contact mode, with a power density of 400mW/cm2, delivering 8 J/cm2
on each application point, over a period of 20 sec. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants with TMD-related pain for the past 3 months.
Forward head posture in association with TMJ dysfunction.
Craniovertebral angle <44°. |
|
| ExclusionCriteria |
| Details |
Participants with neck injuries, intervertebral disc hernias, spondylolisthesis.
Who will not report pain (myofascial pain) after the clinical examination RDC
axis I.
Who will be under another type of treatment for TMD (e.g., occlusal splints,
pharmacological drugs, or head and neck surgery).
Participants with a neurological or a psychiatric disorder (evaluated by axis II of
RDC/TMD). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VISUAL ANALOGUE SCALE
RANGE OF MOTION - TMJ
MANDIBULAR FUNCTION IMPAIREMENT QUESTIONNAIRE
CRANIOVERTEBRAL ANGLE – “ON PROTRACTORâ€
APPLICATION |
At baseline and after 3 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participant selection will be done as per the Inclusion and exclusion criteria.The purpose and procedure of the study will be explained to the participants. All the covid-19 precautionary measures according to ICMR will be taken. A brief demographic data and baseline outcome measures (CRANIOVERTEBRAL ANGLE, VISUAL ANALOGUE SCALE, RANGE OF MOTION, MANDIBULAR FUNCTION IMPAIREMENT QUESTIONNAIRE) will be obtained from the participants. Participants will be divided into two groups using envelope method. Intervention sessions will be carried out in KLE Hospital and Research Center Belagavi. Group A will be given Pilates Exercise along with low level LASER therapy and Group B will be given Bruegger’s exercise along with low level LASER therapy. Post intervention (i.e 3 weeks later), the CVA, pain, function and ROM of TMJ will be recorded. |