CTRI Number |
CTRI/2023/07/054716 [Registered on: 04/07/2023] Trial Registered Prospectively |
Last Modified On: |
12/06/2023 |
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
|
Soft tissue manipulation in patients with restricted mouth opening. |
Scientific Title of Study
|
Effectiveness of soft tissue manipulation on function & muscle activity of superficial masseter and anterior temporalis in patients with oral submucous fibrosis. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rohan Kumar Sahu |
Designation |
Master of Physiotherapy |
Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi markandwshwar deemed to be university, Mullana- Ambala Haryana. Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi markandwshwar deemed to be university, Mullana- Ambala Haryana. Ambala HARYANA 133207 India |
Phone |
7582927554 |
Fax |
|
Email |
rohansahu512@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr Manu Goyal |
Designation |
Principal |
Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi markandwshwar deemed to be university, Mullana- Ambala Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi markandwshwar deemed to be university, Mullana- Ambala Ambala HARYANA 133207 India |
Phone |
8307715320 |
Fax |
|
Email |
manugoyal1111@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Rohan Kumar Sahu |
Designation |
Master of Physiotherapy |
Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi markandwshwar deemed to be university, Mullana- Ambala Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi markandwshwar deemed to be university, Mullana- Ambala Ambala HARYANA 133207 India |
Phone |
7582927554 |
Fax |
|
Email |
rohansahu512@gmail.com |
|
Source of Monetary or Material Support
|
This study will be conducted at musculoskeletal physiotherapy research lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana,- Ambala, Haryana, India. |
|
Primary Sponsor
|
Name |
Rohan Kumar Sahu |
Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
Name |
Address |
Prof Dr Manu Goyal |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana-Ambala Haryana. |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Rohan Kumar Sahu |
Musculoskeletal Physiotherapy Research lab MMIPR Mullana Ambala. |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana,- Ambala, Haryana, India. Ambala HARYANA |
7582927554
rohansahu512@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee MMISR Mullana Ambala Haryana |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Intralesional medications. |
Intralesional injections of 2ml Hydrocortisone + 2 ml of Hyaluronidase + 2 ml of LA (2% Lignocaine + 1:80000 Adrenaline) time duration will be once a week for 6 weeks. |
Intervention |
Soft tissue manipulation and intralesional injections |
Group 1 (Soft tissue manipulation + intralesional medications)
Group 2 (Intralesional medications)
Soft Tissue Manipulation (MFR + TMJ Distraction)
Time Duration twice in a week for 6 weeks
time duration in each session 40 to 45 minutes.
Intralesional medications
Intralesional injections of 2 ml
Hydrocortisone + 2 ml of Hyaluronidase + 2 ml of LA (2% Lignocaine + 1:80000 Adrenaline)
Time duration will be once a week for 6 weeks.
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
Individuals with OSMF.
Both male and female participants
|
|
ExclusionCriteria |
Details |
Patients with infections and inflammatory causes responsible for trismus.
Trauma to the maxillofacial skeleton.
Dermatomyositis
Scleroderma.
Gingivitis and periodontitis.
Parafunctional habits.
Patients who are unable to give consent.
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Mouth Opening Function |
Baseline
3 weeks
6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
NPRS |
Baseline
3 weeks
6 weeks |
EMG |
Baseline
3 weeks
6 weeks |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
19/07/2023 |
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="0" 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
|
Oral submucous fibrosis (OSMF) is a sneaky, long-lasting, and potentially cancerous condition of the oral cavity. Submucosal fibrosis, which affects the majority of the oral cavity, and increasing trismus from tight lips, cheeks, pharynx, and upper third of esophagus that causes dysphagia and a burning feeling in the mouth are the disease’s hallmarks. Symptoms of oral submucous fibrosis include pain, ulceration, and a burning sensation in the oral mucosa. Estimates place India’s prevalence at 1.2-4.6% in women and 0.2-2.3% in men. Micronutrient deficits, an excessive consumption of areca nuts, and capsaicin in chillies are etiological variables. The purpose of current study will to determine the effect of soft tissue manipulation and to know the function and muscle activity of superficial masseter and anterior temporalis muscle. It will be the two group pre-test post-test experimental design. The patients of Oral Submucous Fibrosis will be recruited based on inclusion and exclusion criteria. The patients will be randomly allocated to two groups, group 1 and 2. The experimental group (group 1) will receive soft tissue manipulation + intralesional medication, while the clinical group (group 2) will receive only intralesional medication. The patients of group 1 (experimental group) will be treated with intralesional medication once in a week for 6 weeks, along with soft tissue manipulation for twice a week for half an hour each session. After 2 weeks of treatment, a temporo-mandibular joint distraction and compression technique will also add which increased the treatment time to 35 min. Assessment will take at baseline, after 3 weeks and after 6 weeks. The patients of group 2 (clinical group) will be intervened by only intralesional medication. This study will help clinicians to incorporate soft tissue manipulation as a part of their treatment plan in patients with Oral Submucous Fibrosis. The estimated sample size will be calculated by conducting a pilot study. The collected data will be analyzed by using SPSS 20.0 version. Data analysis will be done with the help of Shapiro Wilk /Kolmogorov Smirnov test. Parametric/Non-parametric tests will be used accordingly. For within the group analysis, paired t-test/ Wilcoxon Signed Rank test will be used. For between group analysis, independent t-test/Mann-Whitney U test will be used. |