## Protocol Section
### Identification Module
**NCT ID:** NCT06433895

**Brief Title:** Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus

**Official Title:** Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial

#### Organization Study ID Info
**ID:** E2-21-1003
#### Organization
**Class:** OTHER
**Full Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-25

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

**Investigator Full Name:** Tuğba Atan, MD

**Investigator Title:** Assoc. Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.

**Detailed Description:** Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. It results from complex interactions between the somatosensory and auditory systems, which involve the musculoskeletal system rather than the ear. The temporomandibular joint, craniocervical junction, cervical vertebrae and neck and shoulder muscles, in particular the sternocleidomastoid (SCM) muscle, upper trapezius and levator scapula, are anatomical regions that can cause somatic tinnitus.

Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.

### Conditions Module

**Conditions:**

- Tinnitus, Subjective

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period. Additionally, patients in the manual therapy group will receive manual therapy on a weekly basis for a total of six sessions.

**Intervention Names:**

- Other: Manual Therapy

- Other: Exercise

**Label:** Manual therapy + Exercise group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period.

**Intervention Names:**

- Other: Exercise

**Label:** Exercise group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Manual therapy + Exercise group

**Description:** Manual Therapy

**Name:** Manual Therapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Exercise group

- Manual therapy + Exercise group

**Description:** Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation

**Name:** Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The severity of tinnitus will be graded using a 10 cm visual analogue scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely severe tinnitus).

**Measure:** Visual Analogue Scale for Tinnitus (VAS-tinnitus)

**Time Frame:** baseline- 6 week

#### Secondary Outcomes

**Description:** Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain.

**Measure:** Visual Analogue Scale for cervical pain (VAS-Cervical)

**Time Frame:** baseline- 6 week

**Description:** The THI contains a total of 25 items with functional (11 items), emotional (9 items) and catastrophic (5 items) subscales. Each item is rated 0 (not affected), 2 (sometimes affected) or 4 (always affected). The total score ranges from 0 to 100, with higher scores indicating higher levels of disability of perceived tinnitus.

**Measure:** Tinnitus Handicap Index (THI)

**Time Frame:** baseline- 6 week

**Description:** The NDI is designed to assess self-reported neck functional status. The questionnaire consists of 10 items related to pain, activities of daily living, weight lifting, reading, headache, concentration, working status, driving, sleep and recreation and is rated on a 6-point Likert scale ranging from 0 (no disability) to 50 (major disability). Higher scores represent greater disability. The NDI has been found to be reliable and valid for cervical disorders.

**Measure:** Neck disability index (NDI)

**Time Frame:** baseline- 6 week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patients aged ≥ 18 and ≤ 65 years Patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus

1. Neck pain
2. Cervical joint range of motion limitation (especially rotation)
3. Modulation of tinnitus in relation to head and neck movements and posture
4. Tenderness in the cervico-occipital muscles Patients reporting cervical pain between \>2 and \<7 on a visual analogue scale (VAS) on most days of the last month Patients with stable medical and psychological status Patients willing to participate in the study

Exclusion Criteria:

Patients with objective tinnitus Patients with subjective tinnitus with hearing loss Patients with Meniere's disease Patients with a history of vertigo Patients with middle ear pathologies Patients with a history of intracranial pathology Patients with a history of whiplash injury Patients with a history of cervical spinal surgery Patients with a history of active infection, malignancy, inflammatory rheumatic disease or fibromyalgia Pregnancy Patients who have undergone any exercise or physiotherapy programme for the cervical region in the last 3 months

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Contacts:**

***Contact 1:***

- **Email:** tubaatan@gmail.com

- **Name:** Tuğba Atan

- **Phone:** +90 312 2911000

- **Phone Ext:** 1414

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006311

- Term: Hearing Disorders

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16769

- Name: Tinnitus

- Relevance: HIGH

- As Found: Tinnitus

- ID: M9400

- Name: Hearing Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014012

- Term: Tinnitus

### Misc Info Module

- Version Holder: 2024-05-31
