| CTRI Number |
CTRI/2021/12/038877 [Registered on: 23/12/2021] Trial Registered Prospectively |
| Last Modified On: |
22/12/2021 |
| 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
|
Use of "VIMS JAW CLAMP" mouth opening device in Oral Cancer patients. |
|
Scientific Title of Study
|
Effectiveness of "VIMS JAW CLAMP" along with Physiotherapy treatment in patient with trismus secondary to Head and Neck Cancer- A Randomized Control Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddiqui Misbah Nadeem |
| Designation |
MPT First year Musculoskeletal sciences |
| Affiliation |
D.V.V.P.Fs College of Physiotherapy |
| Address |
Dept. Of Musculoskeletal Sciences,
D.V.V.Ps College of Physiotherapy , Basement, Block 1, Oppo. Govt. Milk Dairy, M.I.D.C. Ahmednagar- 414111
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9075439620 |
| Fax |
|
| Email |
misbahsid95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Anap |
| Designation |
H.O.D and Professor |
| Affiliation |
D.V.V.P.Fs College of Physiotherapy |
| Address |
Dept. Of Musculoskeletal Sciences,
D.V.V.Ps College of Physiotherapy , Basement, Block 1, Oppo. Govt. Milk Dairy, M.I.D.C., Ahmednagar- 414111
Ahmadnagar
MAHARASHTRA
414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Anap |
| Designation |
H.O.D and Professor |
| Affiliation |
D.V.V.P.Fs College of Physiotherapy |
| Address |
Dept. Of Musculoskeletal Sciences,
D.V.V.Ps College of Physiotherapy , Basement, Block 1, Oppo. Govt. Milk Dairy, M.I.D.C., Ahmednagar- 414111
Ahmadnagar
MAHARASHTRA
414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
|
Source of Monetary or Material Support
|
| D.V.V.P.Fs College of Physiotherapy, opp Govt Milk Dairy, MIDC Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
Oppo. Govt. Milk Dairy, M.I.D.C., Ahmednagar- 414111 |
| 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 |
| Misbah Siddiqui |
D.V.V.P.Fs College of Physiotherapy |
Department of Musculo
skeletalsciences,
Opp.Govt. Milk Dairy,
M.I.D.C, Ahmednagar-
414111
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
9075439620
misbahsid95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapy |
Treatment given for 5 sessions per week for 2 weeks. time duration of each session 30 mins.
MET technique for Jaw opening 5 sec hold - 5 repetitions ,
A) Warm up :
The following movements of jaw should be performed 10 times without the device
1) Maximum mouth opening -10 repititions
2) Laterotrusion – 10 repetition on each side
3) Protrusion.- 10 repetitions
B) Active Resisted Exercises :
Five repetitions of active resisted exercise with self-applied manual resistance for the following
movements
1) Jaw opening-10 repetitions
2) Laterotrusion -10 repetition
3) Jaw closing – 10 repetitions
C) Neck Exercise:
Following neck movements with 10 repetitions of each
1)Flexion
2)Extension
3)Side Flexion
4)Rotation |
| Intervention |
Physiotherapy along with " VIMS JAW CLAMP" |
Treatment given for 5 sessions per week for 2 weeks. Time duration of each session 30 mins.
MET technique for Jaw opening 5 sec hold - 5 reps,
Warm up :
The following movements of jaw should be performed 10 times without the device
1) Maximum mouth opening -10 repetitions
2) Laterotrusion – 10 repetition on each side
3) Protrusion.- 10 repetitions
B) Passive Stretching :
Done using VIMS jaw mobilizing device, 30 seconds (if possible), repeated five times.
C) Active Resisted Exercises :
Five repetitions of active resisted exercise with self-applied manual resistance for the following
movements
1) Jaw opening-10 repetitions
2) Laterotrusion -10 repetition
3) Jaw closing – 10 repetitions
Neck Exercise:
Following neck movements with 10 repetitions of each
1)Flexion
2)Extension
3)Side Flexion
4)Rotation
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants diagnosed with trismus secondary to head and neck cancer.
2.Participants undergoing radiation therapy or after Radiation therapy treatment.
3.Participants who underwent only the excision of mass.
4.Participants with a mouth opening of <35mm.
|
|
| ExclusionCriteria |
| Details |
1.Participant with active malignancy.
2.Edentulism
3.Poor general Health
4.History of Previous maxillofacial trauma.
5.Participant who underwent Segmental or Hemi-mandibulectomy.
6.TMJ diseases other than malignancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maximal Interincisal Opening (MIO)
Gothenburg Trismus questionnaire (GTQ)
Neck Disability Index (NDI) |
Pre treatment,
after 2 weeks
post 1 week follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
31/12/2021 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to find out effectiveness of “ VIMS JAW CLAMP †in adjunct to physiotherapy treatment in patients with trismus secondary to Head and Neck Cancer as compared to physiotherapy alone- A Randomized Control Trial. 34 participants having trismus secondary to head and neck cancer will be recruited based on the inclusion criteria and then divided into two groups . Experimental group will be given MET for mouth opening , Active jaw exercises along with passive stretching provided by " VIMS JAW CLAMP" and neck exercises. Control group will be given MET for mouth opening , Active jaw exercises and neck exercises. The intervention will be given for two weeks. The outcomes will be taken at baseline, immediately after 2 weeks and after 1 week and the data will be analyzed statistically. |