Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus

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

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Other: Manual Therapy; Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

Objective tinnitus Subjective tinnitus with hearing loss Meniere's disease History of vertigo Middle ear pathologies History of intracranial pathology History of whiplash injury History of cervical spinal surgery 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual therapy + Exercise group; 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.	Other: Manual Therapy; Manual Therapy; Other: Exercise; Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation
Active Comparator: Exercise group; 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.	Other: Exercise; Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for Tinnitus (VAS-tinnitus)	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).	baseline- week 3 - week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for cervical pain (VAS-Cervical)	Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain.	baseline- week 3 - week 6
Tinnitus Handicap Index (THI)	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.	baseline- week 3 - week 6
Neck disability index (NDI)	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.	baseline- week 3 - week 6
Cervical range of motion (ROM)	Cervical range of motion (ROM)	baseline -week 3- week 6
Manual muscle testing (MMT)	MMT for assessing strength of cervical flexors, extensors, lateral flexors, and rotators	baseline - week 3 -week 6
Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis	Myofascial trigger point of the SCM, upper trapezius, levator scapulae, splenius capitis	baseline- week 3- week 6
Tinnitus provocation with ROM	Tinnitus provocation with ROM	Baseline- week 3- week 6
Tinnitus provocation with MMT	Tinnitus provocation with MMT	Baseline- week 3- week 6
Tinnitus provocation with myofascial trigger point palpation	Tinnitus provocation with myofascial trigger point palpation	Baseline- week 3- week 6
SF-36 quality of life scores	SF-36 is a widely validated and reliable generic measure of health-related quality of life, covering eight domains: physical functioning, role limitations due to physical and emotional problems, pain, general health, vitality, social functioning, and mental health. Each subscale score ranges from 0 (worst) to 100 (best)	Baseline- week 3- week 6

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2024
• Primary Completion (Actual): June 25, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Exercise; Musculoskeletal Manipulations
• Other Study ID Numbers: E2-21-1003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No