Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus

June 30, 2026 updated by: Hamad Medical Corporation

Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus: A Randomized Controlled Study

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Wet Cupping therapy (WCT): One of the complementary and integrative medicine healing practices, which uses cups with superficial scarifications of the selected points on the skin.

Tinnitus was defined as the perception of a sound without an associated known stimulus consciously.

In spite of several work and research studies, the pathophysiology of Tinnitus is still unclear. Tinnitus is one of the major audiological symptoms. Despite its huge personal and presumed economic impact, there are only limited therapeutic options available. The reason for this deficiency lies in the very nature of the disease as it is deeply connected to elementary plasticity of auditory processing in the central nervous system. Furthermore, tinnitus with unknown causes was classified as subjective tinnitus, and if tinnitus duration was more than six months, it was classified as chronic tinnitus. One of the major challenges in tinnitus is to explore the pathophysiological causes to find an appropriate effective treatment.

Cupping therapy is an integrative and complementary medicine practice. Cupping therapy types were numerous, and there was a published classification of cupping therapy types. Wet cupping therapy is one of the technical types of cupping therapy. Wet cupping was practiced by applying cups on selected body points. Superficial scarifications should be performed by using a sterile surgical blade after removing the cups. The cups should be re-applied again. Cupping therapy showed promising and significant effects in the management of various diseases such as: headache, migraine, neck pain, low back pain, and knee osteoarthritis. A previous case report and a pilot study were conducted to evaluate the safety and efficacy of cupping therapy in the management of tinnitus and dizziness. The promising effects and the wide safety profile of wet cupping therapy were reported in this study. Furthermore, wet cupping therapy reduced the discomfort of tinnitus and dizziness. Evidently, cupping therapy was reported to have a wide safety profile as shown in previous published systematic reviews.

Tinnitus Handicap Inventory (THI) uses validated tinnitus questionnaires, is a self-administered test that is used to help determine the degree of distress suffered by the tinnitus patient. It is widely used in medical offices and in clinical trials to determine the effectiveness of a given therapy. The purpose of this questionnaire is to identify difficulties that may be experienced because of tinnitus, focused instead on the impact of tinnitus on a person's activities of daily living. The THI is the most recent, most reliable, and most widely used of several questionnaires developed over the last 20 years.

Hearing Level shows the audible threshold for standardized frequencies as measured by an audiometer. It will measure the intensity in decibels at certain frequencies measured in hertz.

The hypothesis of this condition is that wet cupping therapy has a significant effect as a complementary therapy for the management of subjective and continuous tinnitus.

Cupping reported effects that can be of benefit for tinnitus patients include increasing microcirculation in the area treated, reducing pro-inflammatory cytokines (IL-6, TNF-α), increasing anti-inflammatory lipids, and a neuromodulation effect.

This clinical trial is a large clinical trial design which will be based on a previously conducted pilot trial at Hamad Medical Corporation (HMC). The previously published pilot trial was the first world pilot clinical trial in this field which was conducted IN HMC, and to continue our work, this trial is a leading clinical trial which will improve the knowledge regarding the use of integrative medicine in the field of ear pathologies. It will provide the first evidence about the effectiveness and safety of using cupping therapy as an integrative therapy for the management of chronic subjective tinnitus. It is the first step of a long way to collect and provide evidence regarding the use of cupping therapy for the management of tinnitus.

Study objectives

  1. To examine the effect of wet cupping therapy as an integrative therapy on perceived tinnitus handicap severity among adults with subjective tinnitus.
  2. To evaluate the safety of wet cupping therapy as an integrative therapy treatment for subjective tinnitus.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • History of central nervous system disease.
  • Patient with anemia or cardiovascular diseases.
  • Current pregnancy or breast-feeding.
  • Patients with a lack of willingness or availability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Control group receive the usual medical care only treatment for tinnitus. Treatment includes (Patients with hearing loss: Hearing aid option with masker plus or minus Amitriptyline, while patients without hearing loss will receive Amitriptyline)
Other: usual care only
Usual 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.
Experimental: Intervention Group

wet cupping therapy will be done by a licensed cupping therapist on 2 points post-auricular and bilateral) (in the depression between the origins of the Sternocleidomastoid and Trapezius muscles, at the junction of the occipital and nuchal regions). The duration of applying cups (5 minutes, then scarification of the site then re-applying for another 5 minutes). Total duration of the session is 15 minutes. 2 cups will be applied at 2 sites as mentioned above. Size of cups is about 1.5 inch (3.8 cm) in diameter. There is no removal of hair. The expected blood volume is about (5 to 15 ml).

The procedure repeated every 4 weeks for 3 sessions. They also receive usual 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 Hamad
Other: Wet Cupping Therapy plus Usual care
wet cupping therapy will be done by a licensed cupping therapist on 2 points post-auricular and bilateral) plus usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI)
Time Frame: The scale will be performed at baseline, and end of treatment at 8 weeks
A 25-item instrument designed to evaluate the handicap experienced by an individual due to tinnitus.
The scale will be performed at baseline, and end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Level (HL) :
Time Frame: The scale will be performed at baseline, and end of treatment at 8 weeks
Hearing level (HL) is measured in decibels (dB HL) using an audiogram
The scale will be performed at baseline, and end of treatment at 8 weeks
Adverse events.
Time Frame: Adverse events will be checked up to 8 weeks from baseline.
Adverse events will be checked up to 8 weeks from baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-25-546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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