Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorHamad Medical Corporation
About this trial
Cupping therapy is an ancient complementary medicine therapy. It was a cornerstone in many ancient healing systems, including Traditional Chinese Medicine, Unani Medicine, Traditional Korean Medicine, and Islamic Medicine. Previous pilot randomized controlled trials reported promising effects of adding cupping therapy in the management of tinnitus and hearing loss. This trial aims to evaluate the safety and efficacy of wet cupping as a complementary treatment in the management of chronic subjective tinnitus with or without hearing loss. Materials and Methods: The study participants will be 142 patients suffering from subjective and continuous tinnitus aged from 21 to 65 years. Participants will be randomly assigned into an interventional group (71) or a control group (71). This study is a randomized controlled study. All participants will read and sign the informed consent. Intention to treat and changes in the Tinnitus Handicap Inventory (THI) between groups will be the primary outcome. Hearing Level (HL) and adverse events related to wet cupping will be the secondary outcomes. Data will be collected on required forms. Statistical analysis will also be performed. Descriptive analysis will also be represented, showing the demographic information. This clinical trial is a large clinical trial which will be based on a previously conducted pilot trial at Hamad Medical Corporation (HMC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 21 to 65 years old.
Primary subjective tinnitus with or without hearing loss for more than 6 months.
Tinnitus significantly impacting quality of life, as measured by the Tinnitus Handicap Inventory (THI).
Disqualifiers
Objective, acute or intermittent tinnitus.
History of Ménière's disease.
Tinnitus induced by cerebellopontine angle tumors.
Cardiovascular disease, or a serious medical or mental illness.
Trial design
Design model
Parallel
Treatments tested in this trial
Wet Cupping Therapy plus Usual care
Other interventionwet cupping therapy will be done by a licensed cupping therapist on 2 points post-auricular and bilateral) plus usual care
usual care only
Other interventionUsual medical care (Treatment includes (Patients with hearing loss: Hearing aid option with masker plus or minus Amitriptyline, while patients without hearing loss will receive Amitriptyline) according to ENT department at HMC guidelines.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tinnitus Handicap Inventory (THI)
A 25-item instrument designed to evaluate the handicap experienced by an individual due to tinnitus.
Time frame
The scale will be performed at baseline, and end of treatment at 8 weeksSecondary outcomes
1
Hearing Level (HL) :
Hearing level (HL) is measured in decibels (dB HL) using an audiogram
Time frame
The scale will be performed at baseline, and end of treatment at 8 weeks2
Adverse events.
Time frame
Adverse events will be checked up to 8 weeks from baseline.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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