Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus

NCT07685171 | Not Yet Recruiting DMC

• 1 other identifier: MRC-01-25-546
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Tinnitus, Subjective; Cupping Therapy

Keywords

Subjective tinnitus; Wet Cupping Therapy; Integrative medecine

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Inventory (THI)

  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 Outcomes (2)

• Hearing Level (HL) :

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

• Adverse events.

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Intervention Group

EXPERIMENTAL

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

Interventions

Wet Cupping Therapy plus Usual care OTHER

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

Intervention Group

usual care only OTHER

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.

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  PMID: 32226665 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25273878 BACKGROUND

• 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.

  PMID: 30538616 BACKGROUND

• 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.

  PMID: 29436369 BACKGROUND

• 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.

  PMID: 27557333 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zainab Al Musleh, PHD

CONTACT

+97455886124; Zalmusleh@hamad.qa

Ikbel Cheriaa, MSN

CONTACT

+97466157410; ICheriaa@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Data analysts will be blinded to treatment assignment until statistical analysis completion * Independent statisticians will conduct all analyses using coded group identifiers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share