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Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus

30 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

142

Fase

  • Non applicabile

Contatti e Sedi

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Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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)
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.
Sperimentale: 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

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tinnitus Handicap Inventory (THI)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hearing Level (HL) :
Lasso di tempo: 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.
Lasso di tempo: Adverse events will be checked up to 8 weeks from baseline.
Adverse events will be checked up to 8 weeks from baseline.

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

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Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 gennaio 2029

Completamento dello studio (Stimato)

1 luglio 2029

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2026

Ultimo verificato

1 febbraio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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