Effectiveness of Electro-Acupuncture as an Alternative Therapy among Oral Sub-Mucous Fibrosis patients- A Randomised Controlled Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr S Priyanka
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 1) To evaluate pain score 0-10, mouth opening and burning sensation of mouth score 0-10
Overview
Brief Summary
This study is a randomised controlled trial comparing the effectiveness of electro-acupuncture therapy in reducing pain, improving mouth opening and reducing burning sensation among 50 oral sub-mucous fibrosis patients along with conventional treatment in India.
The primary outcome measures will be:
- To evaluate the effectiveness of electro-acupuncture therapy in reducing pain, improving mouth opening and reducing burning sensation of mouth in patients with grade I to grade III oral sub-mucous fibrosis along with conventional treatment.
2. To compare the effect of electro-acupuncture intervention along with conventional treatment and only conventional treatment.
The secondary outcomes will be:
1. To compare the effectiveness of pain and mouth opening between Grade I, Grade II and Grade III oral sub-mucous fibrosis patients in experimental and control group.
- To assess the patient acceptance and satisfaction of electro-acupuncture as an alternate therapy.
NULL HYPOTHESIS:
1. There is NO difference in pain, mouth opening and burning sensation amongst patients who receive electro-acupuncture therapy along with conventional treatment for Grade I to Grade III Oral Sub-Mucous Fibrosis.
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Electro-acupuncture therapy along with conventional treatment is NOT effective in comparison with conventional treatment in patients with Grade I to Grade III Oral Sub-Mucous Fibrosis.
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There is NO significant difference in pain and mouth opening among Grade I, Grade II, and Grade III Oral Sub-Mucous Fibrosis patients between the experimental and control groups.
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Electro-acupuncture does NOT lead to significant levels of patient acceptance and satisfaction in the treatment of Grade I to Grade III oral sub-mucous fibrosis patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Oral sub-mucous fibrosis patients suffer from severe burning sensations, dry mouth, pain, taste disorders, tongue mobility limitations less than 35mm, trismus, dysphagia, and altered tone.
Exclusion Criteria
- •A history of bleeding disorder, acupuncture treatment, pregnant or lactating women and subjects with wounds/ tumour in the area of needling.
Outcomes
Primary Outcomes
1) To evaluate pain score 0-10, mouth opening and burning sensation of mouth score 0-10
Time Frame: Every week for 1month and at the end of 2nd month
2) To compare the effect of electro-acupuncture intervention along with conventional treatment and only conventional treatment.
Time Frame: Every week for 1month and at the end of 2nd month
Secondary Outcomes
- To compare the effectiveness of pain and mouth opening between Grade I, Grade II and Grade III oral sub-mucous fibrosis patients in experimental and control group.(2months)
- To assess the patient acceptance score 0-10 and satisfaction score 0-10 of electro-acupuncture as an alternate therapy.(At the end of 1st month)
Investigators
Dr S Priyanka
Shri Dharmasthala Manjunatheshwara College Of Dental Sciences And Hospital