Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus
Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus: A Randomized Controlled Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
- To examine the effect of wet cupping therapy as an integrative therapy on perceived tinnitus handicap severity among adults with subjective tinnitus.
- To evaluate the safety of wet cupping therapy as an integrative therapy treatment for subjective tinnitus.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zainab Al Musleh, PHD
- Numéro de téléphone: +97455886124
- E-mail: Zalmusleh@hamad.qa
Sauvegarde des contacts de l'étude
- Nom: Ikbel Cheriaa, MSN
- Numéro de téléphone: +97466157410
- E-mail: ICheriaa@hamad.qa
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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)
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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.
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Expérimental: 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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tinnitus Handicap Inventory (THI)
Délai: The scale will be performed at baseline, and end of treatment at 8 weeks
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A 25-item instrument designed to evaluate the handicap experienced by an individual due to tinnitus.
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The scale will be performed at baseline, and end of treatment at 8 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hearing Level (HL) :
Délai: 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
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The scale will be performed at baseline, and end of treatment at 8 weeks
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Adverse events.
Délai: Adverse events will be checked up to 8 weeks from baseline.
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Adverse events will be checked up to 8 weeks from baseline.
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
Dates d'enregistrement des études
Dates principales de l'étude
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Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
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Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MRC-01-25-546
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