| CTRI Number |
CTRI/2024/05/067131 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How effective are diclofenac patches on the skin for treating pain from Myofascial pain dysfunction syndrome? |
|
Scientific Title of Study
|
Efficacy of transdermal diclofenac patches in management of pain associated with Myofascial pain dysfunction syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshini M |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya Dental College,
Yenepoya University,
Derlakatte,
Mangalore,
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9787838428 |
| Fax |
|
| Email |
harshinimanoharan6498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena K M |
| Designation |
Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya Dental College,
Yenepoya University,
Derlakatte,
Mangalore,
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845010856 |
| Fax |
|
| Email |
veenaomr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshini M |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya Dental College,
Yenepoya University,
Derlakatte,
Mangalore,
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9787838428 |
| Fax |
|
| Email |
harshinimanoharan6498@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Dental college,Yenepoya university |
|
|
Primary Sponsor
|
| Name |
Harshini M |
| Address |
Yenepoya Dental college,
Yenepoya University,
DEerlakatte,
Mangalore-575018 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Harshini M |
Yenepoya Dental college |
Department of Oral medicine and radiology,Ground floor,Room no 1
Dakshina Kannada
KARNATAKA |
9787838428
harshinimanoharan6498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral diclofenac |
VAS score will be assesed pre-treatment.Patients from Group B will be prescribed with oral diclofenac tablets (50 mg) twice daily for 6 days.On 7th day, patients will be recalled and examined. Visual Analog score (VAS) will be re-assessed to evaluate the reduction in the pain score |
| Intervention |
Transdermal Diclofenac patches |
The study will be conducted in the department of Oral Medicine and Radiology, Yenepoya Dental college and hospital after getting ethical clearance from the institutional ethical committee .Detailed history will be elicited and clinical examination will be carried out.Patients diagnosed with MPDS according to the diagnostic criteria proposed by Laskin and meets the inclusion and exclusion criteria will be included in the study.Each sample of the selected group will be informed about the study in patient’s known language and informed consent will be obtained. The total of 20 patients will be included in the study and will be divided into two groups, 10 patients in each group -Group A (Transdermal diclofenac group) and Group B (Oral diclofenac group).Visual Analog score (VAS) will be assessed in both the groups pre-treatment Patients from Group A will be prescribed with transdermal diclofenac patches (100 mg). Patients will be advised to apply the transdermal patches over the masseter muscle for atleast 12 hours/day and change the old patch with the new one everyday on the same site for 6 days.On 7th day, patients will be recalled and examined. Visual Analog score (VAS) will be re-assessed to evaluate the reduction in the pain score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who were clinically diagnosed with MPDS according to Laskin’s criteria
2.Systemically healthy individuals
3.Patients who are conscious and co-operative and are able to give the Visual Analog Score (VAS)
|
|
| ExclusionCriteria |
| Details |
Patients with:
1.Missing teeth
2.Grossly decayed teeth
3.Allergy to diclofenac or any other NSAIDs
4.Any systemic and connective tissue disorders
5.Undergoing treatment with other NSAIDs or any other analgesics during the study period
6.Gastritis
7.Pregnant women
8.Trauma/Malignancy of the maxillofacial region
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain will be assessed using Visual analog score |
Reduction in pain will be assessed using Visual analog score at baseline and 7th day after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy in Management of pain |
Reduction in pain score will be assessed for determining the efficacy at baseline & 7th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Transdermal diclofenac patches are as effective as oral diclofenac in management of pain associated with myofascial pain dysfunction syndrome.So,the aim of the study is to evaluate the reduction in pain score with oral and transdermal diclofenac patches and compare their efficacy in management of pain associated with Myofascial pain dysfunction syndrome. |