Tinnitus
Conditions
Keywords
Tinnitus, acupuncture
Brief summary
This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.
Detailed description
This is a multicentre, randomised, controlled clinical trial with blinded participants, outcome assessment and statistician. The total trial period will be 14 weeks, including two weeks of baseline assessment, four weeks of treatment, and eight weeks of follow-up. A total of 180 patients with acute primary tinnitus will be randomized in a 1:1:1 ratio to receive 10 sessions of manual acupuncture, 10 sessions of sham acupuncture, or usual care alone over 4 weeks. Informed consent will be obtained from each patient before randomization.
Interventions
OTHERManual acupuncture
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the remaining weeks.
OTHERSham acupuncture
Ten manual acupuncture sessions will be delivered over 4 weeks, with treatment frequency decreasing from 3 sessions per week for the first 2 weeks to 2 sessions per week for the last 2 weeks.
BEHAVIORALUsaual care
Health education and standard evaluation related to tinnitus
Sponsors
Dan Bing
Hubei Xinhua Hospital
Wuhan No.1 Hospital
The Third People's Hospital of Hubei Province
Taihe Hospital
Qianjiang Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are blinded to intervention condition (manual avupuncture or sham acupuncture). Outcome assessors and data analysts are blinded to group allocation. Given the nature of acupuncture manipulation, acupuncturists in this trial are not blinded. However, acupuncturists does not take part in outcome assessments.
Intervention model description
Participants are assigned 1:1:1 to three parallel arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-65 years, male or female; 2. Primary complaint is persistent tinnitus (unilateral or bilateral); 3. Meet the diagnostic criteria for primary tinnitus according to the 2014 Clinical Practice Guideline developed by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF); 4. Had continuous tinnitus ≥2 weeks and \<6 months; 5. Tinnitus should be bothersome, with a screening THI score 28-76; 6. Acupuncture naive; 7. Able to provide written informed consent.
Exclusion criteria
1. Objective tinnitus; 2. Pulsatile tinnitus; 3. Diagnosed as secondary tinnitus as evaluated by audiologists and clinicians(Menière's disease, temporomandibular joint disorder or other diseases); 4. Had evidence of conductive hearing loss (confirmed by abnormal otoscopy or tympanogram); 5. Had contraindications for acupuncture, including curent pregnant, severe anemia, coagulation disorders, etc; 6. Having difficulties in expressing their symptoms clearly( severe mental disorders or cognitive impairment); 7. Currently suffering from other serious acute or chronic organic diseases, such as cerebrovascular, cardiovascular, liver, kidney, hematological diseases, infectious diseases, or malignant tumors; 8. Has received intratympanic injection, postauricular injection, corticosteroids, or other medications for tinnitus treatment (includingTraditional Chinese Medicine or proprietary Chinese medicines) within the past 2 weeks or at baseline; 9. Participated in other clinical trials, particularly those closely related to tinnitus treatment, such as sound therapy; 10. have a strong desire for medication treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Handicap Inventory (THI, 0-100) | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | 25-item measure of tinnitus-related handicap; total score 0-100, higher scores indicate greater handicap. In details, 0-16 points indicate no handicap; 18-36 points indicate mild handicap;38-56 points indicate moderate handicap; 58-76 points indicate severe handicap and \>76 points indicate catastrophic handicap. |
| Tinnitus Functional Index (TFI, 0-100) | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | 25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective response rate of THI | End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization. | Effective response rate of THI is defined as the proportion of patients with a THI score decrease of ≥7 points. |
| Effective response rate of TFI. | End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization. | Effective response rate of TFI is defined as the proportion of patients with a TFI score decrease of ≥13 points. |
| Visual Analogue Scale (VAS) for aural fullness | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness. |
| Visual Analogue Scale (VAS) for tinnitus | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness". |
| The Pittsburgh Sleep Quality Index (PSQI) | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | The pittsburgh Sleep Qual-ityIndex (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. It has 19 questions which can be grouped into seven categories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep dis-turbances, use of sleeping medication, and daytime dysfunction.The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality. |
| The Zung Self-Rating Depression Scale(SDS) | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression. |
| The Zung Self-Rating Anxiety Scale(SAS) | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety. |
| World Health Organization Quality of Life-BREF questionnaire(WHOQOL-BREF) | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | Quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), yielding domain scores and an overall score (0-100; higher scores indicate better quality of life). |
| Patient-Doctor Relationship Questionnaire (PDRQ-9) | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | Patient-Doctor Relationship Questionnaire (PDRQ-9) is to assess patient-doctor relationship. |
| Adverse Events | Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10) | Adverse events assessed each acupuncture treatment visit using a acupuncture adverse events questionnaire recording presence and severity of side effects (e.g., subcutaneous hemorrhage, minor bleeding) related to acupuncture, plus event frequency. |
| Assessment of blinding | At 12 weeks after randomization | At the end of the study, we will determine the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin. |
| Acupuncture expectancy scale(AES) | Baseline visit, and end of treatment at 4 weeks after randomization,. | The Acupuncture Expectancy Scale (AES) will be completed by participants in the verum and sham acupuncture groups at baseline and at the end of treatment (4 weeks after randomization). The questionnaire will not be administered to the usual care group. |
| Massachusetts General Hospital Acupuncture Sensation Scale(MASS) | Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10) | The Massachusetts General Hospital Acupuncture Sensation Scale, which includes twelve specific descriptors-soreness, aching, deep pressure, heaviness, fullness or distension, tingling, numbness, sharp pain, dull pain, warmth, cold, and throbbing-as well as an open field for patients to describe the sensation in their own words, will be administered following a brief explanation of de qi sensations by the acupuncturist to participants in the verum acupuncture and sham acupuncture groups, while the usual care group will not receive this questionnaire. |
| Auditory Sensitivity Scale | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. | Auditory Sensitivity Scale is a self-report questionnaire consisting of general questions on tinnitus and sound intolerance, along with 25 items rated on different scoring scales (e.g., 0/2/5, 0/1/2, 0/10), and provides a severity classification based on the total score: 31-55 for mild, 56-80 for moderate, 81-100 for severe, and 101-126 for very severe. |
Countries
China
Contacts
CONTACTDan Bing, PhD
PRINCIPAL_INVESTIGATORDan Bing, PhD
Tongji Hospital
Outcome results
None listed