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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  
Status 
Not Applicable 
 
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.

 
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