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| Name | Class |
|---|---|
| Hubei Xinhua Hospital | OTHER |
| Wuhan No.1 Hospital | OTHER |
| The Third People's Hospital of Hubei Province | OTHER |
| Taihe Hospital |
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This clinical trial aims to assess the efficacy of manual acupuncture for patients with acute primary tinnitus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual acupuncture group | Experimental | Ten sessions of 30 minute manual acupuncture are deivered during a four-week treatment period. |
|
| Sham acupuncture | Sham Comparator | Ten sessions of 30 minute sham acupuncture are deivered during 4 weeks. |
|
| Usual care | Other | Health education and guidance related to tinnitus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual acupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Handicap Inventory (THI, 0-100) | 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. | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. |
| Tinnitus Functional Index (TFI, 0-100) | 25-item self-report measure of tinnitus-related functional impact; total score 0-100, higher scores indicate greater impairment. | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Effective response rate of THI | Effective response rate of THI is defined as the proportion of patients with a THI score decrease of ≥7 points. | End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization. |
| Effective response rate of TFI. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-item short version of the Big Five Inventory (BFI-10) | Personality is assessed by a10-item short version of the Big Five Inventory (BFI-10). | Baseline visit(before randomization) |
| Pure-Tone Audiometry(PTA) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Bing, PhD | Contact | 86+13971058388 | didibing1981@aliyun.com | |
| Dan Bing, PhD | Contact | 86-13971058388 | didibing1981@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Bing, PhD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, | Wuhan | Hubei | 430030 | China |
IPD after de-identification can be shared on individual request to the principal investigator at didibing1981@aliyun.com
IPD and supporting information will be available within 2 years after publication of the results.
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| OTHER |
| Qianjiang Central Hospital | UNKNOWN |
Participants are assigned 1:1:1 to three parallel arms.
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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.
| Sham acupuncture | Other | 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. |
|
| Usaual care | Behavioral | Health education and standard evaluation related to tinnitus |
|
Effective response rate of TFI is defined as the proportion of patients with a TFI score decrease of ≥13 points. |
| End of treatment at 4 weeks after randomization, 8 weeks after randomization and 12 weeks after randomization. |
| Visual Analogue Scale (VAS) for aural fullness | We will use a 10-mm Visual Analogue Scale (VAS) (0 = no tinnitus, 10 = the most loud of tinnitus) to assess aural fullness. | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. |
| Visual Analogue Scale (VAS) for tinnitus | The VAS will be used to assess the intensity of tinnitus. 0 indicates "no aural fullness", and 10 indicates "the most severe aural fullness". | 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 Quality Index (PSQI) | 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. | 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) | The Zung Self-Rating Depression Scale(SDS) will be adopted to assess depression. | 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) | The Zung Self-Rating Anxiety Scale(SAS) will be adopted to assess anxiety. | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. |
| World Health Organization Quality of Life-BREF questionnaire(WHOQOL-BREF) | 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). | 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) | Patient-Doctor Relationship Questionnaire (PDRQ-9) is to assess patient-doctor relationship. | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. |
| Adverse Events | 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. | Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10) |
| Assessment of blinding | 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. | At 12 weeks after randomization |
| Acupuncture expectancy scale(AES) | 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. | Baseline visit, and end of treatment at 4 weeks after randomization,. |
| Massachusetts General Hospital Acupuncture Sensation Scale(MASS) | 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. | Up to 4 weeks (manual acupuncture/sham acupuncture sessions 1-10) |
| Auditory Sensitivity Scale | 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. | Baseline visit, end of treatment at 4 weeks after randomization, post-treatment at 8 weeks after randomization and 12 weeks after randomization. |
Pure tone audiometry is conducted under standard soundproof conditions using the Hughson-Westlake method to obtain the air conduction threshold (bone conduction threshold is only used for diagnosis, to determine whether there is conductive hearing loss, and to assist in the screening process; statistical analysis only uses the air conduction threshold). The standard test frequencies range from 0.25 to 8 kHz. If conditions permit, extended high frequencies (Extended High Frequency, EHF; ≥ 9-16 kHz) are added, and necessary masking is performed in accordance with the norms.
| Baseline visit(before randomization) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |