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Tinnitus, SubjectiveNCT07685171

Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus

A study of Tinnitus, Subjective and Cupping Therapy, run by Hamad Medical Corporation.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Tinnitus, Subjective, Cupping Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
No sites listed yet
Study dates
Jul 2026to Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zainab Al Musleh, PHD contact

+97455886124

Zalmusleh@hamad.qa

Ikbel Cheriaa, MSN contact

+97466157410

ICheriaa@hamad.qa

About this study

Official title: 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).

Read the 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.
Being tested
Wet Cupping Therapy plus Usual care, usual care only
Keywords
Subjective tinnitus, Wet Cupping Therapy, Integrative medecine
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wet Cupping Therapy plus Usual careOther

    wet cupping therapy will be done by a licensed cupping therapist on 2 points post-auricular and bilateral) plus usual care

  • usual care onlyOther

    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.

Study groups in NCT07685171
Study groupRoleWhat they receive
Control groupActive comparatorControl 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)
Receives: Other: usual care only
Intervention GroupExperimentalwet 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
Receives: Other: Wet Cupping Therapy plus Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinnitus Handicap Inventory (THI)

    A 25-item instrument designed to evaluate the handicap experienced by an individual due to tinnitus.

    Measured: The scale will be performed at baseline, and end of treatment at 8 weeks

Secondary outcomes (2)
  1. Hearing Level (HL) :

    Hearing level (HL) is measured in decibels (dB HL) using an audiogram

    Measured: The scale will be performed at baseline, and end of treatment at 8 weeks

  2. Adverse events.

    Measured: Adverse events will be checked up to 8 weeks from baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJan 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
We followed SPIRIT guideline Two groups (Study arms), Interventional Group (Usual care plus wet cupping therapy -71participants) and Control Group (usual care only-71participants). Participants are assigned to one of the two study arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group is randomized using stratified permuted block randomization method to ensure balanced allocation by age group and gender. The randomization sequence will be generated using computerized random number generation software (SPSS ver. 29), with block sizes of 4 to maintain allocation unpredictability. A biostatistician independent of the research team will generate the randomization sequence.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07685171
Sponsor's protocol ID
MRC-01-25-546
Status last verified
Feb 2026
First submitted
24 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Al-Bedah, A. M., Shaban, T., Suhaibani, A., Gazzaffi, I., Khalil, M., & Qureshi, N. A. (2016). Safety of cupping therapy in studies conducted in twenty one century: a review of literature. British Journal of Medicine and Medical Research, 15(8), 1-12.

  • Almusleh ZA, El Ansari W. Integrating Cupping Therapy in the Management of Sudden Sensorineural Hearing Loss: A Case Report. Cureus. 2020 Feb 20;12(2):e7063. doi: 10.7759/cureus.7063.

    PubMed 32226665
  • Kim, T. H., Kim, K. H., Choi, J. Y., & Lee, M. S. (2014). Adverse events related to cupping therapy in studies conducted in Korea: a systematic review. European Journal of Integrative Medicine, 6(4), 434-440

  • Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325.

    PubMed 25273878
  • Haider HF, Bojic T, Ribeiro SF, Paco J, Hall DA, Szczepek AJ. Pathophysiology of Subjective Tinnitus: Triggers and Maintenance. Front Neurosci. 2018 Nov 27;12:866. doi: 10.3389/fnins.2018.00866. eCollection 2018.

    PubMed 30538616
  • Aboushanab TS, AlSanad S. Cupping Therapy: An Overview from a Modern Medicine Perspective. J Acupunct Meridian Stud. 2018 Jun;11(3):83-87. doi: 10.1016/j.jams.2018.02.001. Epub 2018 Feb 7.

    PubMed 29436369
  • Al Bedah AM, Khalil MK, Posadzki P, Sohaibani I, Aboushanab TS, AlQaed M, Ali GI. Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials. J Altern Complement Med. 2016 Oct;22(10):768-777. doi: 10.1089/acm.2016.0193. Epub 2016 Aug 24.

    PubMed 27557333
  • Almusleh Z, Sulaiteen MA, Hadi KA, Hassan E, Ali A, Charalil J. Integrating cupping therapy in the management of tinnitus and dizziness: a pilot study. TMR Non-Drug Ther. 2021;4(2):11. doi:10.53388/TMRND20210529032

Questions about this trial

What is this clinical trial studying?

A study of Tinnitus, Subjective and Cupping Therapy, run by Hamad Medical Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zainab Al Musleh, PHD (+97455886124, Zalmusleh@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tinnitus Handicap Inventory (THI) (time frame: The scale will be performed at baseline, and end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07685171, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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