NCT06433895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

May 23, 2024

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Visual Analogue Scale for cervical pain (VAS-Cervical)

    baseline- week 3 - week 6

  • Tinnitus Handicap Index (THI)

    baseline- week 3 - week 6

  • Neck disability index (NDI)

    baseline- week 3 - week 6

  • Cervical range of motion (ROM)

    baseline -week 3- week 6

  • Manual muscle testing (MMT)

    baseline - week 3 -week 6

  • +5 more secondary outcomes

Study Arms (2)

Manual therapy + Exercise group

EXPERIMENTAL

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 TherapyOther: Exercise

Exercise group

ACTIVE COMPARATOR

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

Interventions

Manual Therapy

Manual therapy + Exercise group

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

Exercise groupManual therapy + Exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 18 and ≤ 65 years Patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus
  • Neck pain
  • Cervical joint range of motion limitation (especially rotation)
  • Modulation of tinnitus in relation to head and neck movements and posture
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Atan D, Atan T, Cakir Agca BN, Guzelkucuk U. Effectiveness of manual therapy in the treatment of somatic tinnitus: a randomized controlled trial. Physiother Theory Pract. 2026 Mar 21:1-11. doi: 10.1080/09593985.2026.2647791. Online ahead of print.

MeSH Terms

Conditions

Tinnitus

Interventions

Musculoskeletal ManipulationsExercise

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 30, 2024

Study Start

May 25, 2024

Primary Completion

June 25, 2025

Study Completion

June 25, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations