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NCT Number: NCT04696588

Neck Kinesiotherapy and Massage in Tinnitus Treatment

The primary aim of this study is to investigate the effectiveness of cervical spine kinesiotherapy and massage in tinnitus treatment. Furthermore, we investigate if there is a link between cervical spine range of motion and cervical muscles tension and tinnitus.

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Key information

Conditions

Subjective Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otolaryngology, Laryngological Oncology, Audiology and Phoniatrics, Teaching Hospital of Medical university of Lodz, Poland

Lodz, Lodz, Zeromskiego 113 Street, 90-549, Poland

About this study

The study is planned with power of 80%. A total of 118 adult patients with subjective tinnitus are divided into two groups: Kinesiotherapy group (n=59) and Waiting list group (n=59).Kinesiotherapy group receives a complex set of cervical spine exercises and neck massage for consecutive 10 working days (entire treatment takes two weeks). Each visit lasts around 30 minutes. Patients from kinesiotherapy group will fill the outcome measures on the following time points: (a) Time point 0 - baseline (b) Time point 1- Two weeks after the baseline

(c) Time point 2- Four weeks after the baseline. Individuals from waiting list group are enrolled on a waiting list and do not receive any treatment. They undergo assessment at three time points corresponding to Kinesiotherapy group i.e Time point 0, Time point 1 and Time point 2.

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Adult patients with subjective tinnitus experienced in the ears or in the head (temporary and constant tinnitus) with and without sensorineural hearing loss.

Exclusion criteria

  • Other tinnitus treatment in last 6 months,
  • Objective tinnitus,
  • External and middle ear pathology,
  • Acute infections, conditions with fever
  • Bleedings or risk of bleeding
  • Severe respiratory and circulatory insufficiency
  • vasculitis, thrombophlebitis,
  • Pregnancy
  • Acute arthritis and periarticular soft tissues inflammation in the cervical region,
  • Severe pains in different locations,
  • Advanced osteoporosis
  • Uniformed services.
  • Cervical spine instability, cervical disc herniation, cervical radiculopathy.
  • Status post cervical spine surgery.
  • Status post lumbar puncture, status post computed tomography with contrast.
  • Lack of cooperation between the patient and the therapist, cognitive impairment.
  • Atherosclerosis, vertebrobasilar insufficiency.

Treatment and study plan

Complex set of kinesiotherapy of cervical spine and delicate massage

Other

Intervention:- A complex neck therapy.Treatment comprises 10 sessions performed on consecutive working days, includes four parts.

  • Active exercises of the neck, 5 minutes, first demonstrated by the physiotherapist and next the patient performs them under supervision, 5 repetitions of each of the following: cervical flexion, rotation to the left and to the right, side bending to the left and to the right, torsion to left and right.
  • Massage of cervical interspinales muscles performed by therapist 3 minutes.
  • Post Isometric Relaxation (PIR) performed by physiotherapist. 15 minutes.
  • Active neck exercises - the same as mentioned in step 1. 5 minutes. Total duration of one treatment session is around 30 minutes.

Primary outcomes

  1. Tinnitus Functional Index (TFI), a Polish validated version (Wrzosek et al., 2016).

    Time frame: Time point 0: Baseline, Time point 1: 2 weeks after baseline, Time point 2: 4 weeks after baseline

    The Tinnitus Functional Index is a comprehensive scale, assessing tinnitus severity, comprising 25 questions. It has eight subscales: intrusiveness, sense of control, cognitive, sleep, auditory, relaxation, quality of life, and emotion. Patients can mark their response on a scale starting from zero (0) to maximum response (10). Maximum possible score of TFI is 250 if the respondent were to mark all 25 TFI items at the maximum value of 10. High scores on TFI scale are interpreted as increased severity of tinnitus and negative impact on patients life.

    Total TFI score is analyzed at three time points as described above. Statistical analysis is performed using repeated measures ANOVA to evaluate if there is a significant difference in the mean TFI score at the three time points.

Secondary outcomes

  1. Tinnitus Handicap Inventory (THI), Polish validated version

    Time frame: as for TFI

    • Tinnitus Handicap Inventory (THI), Polish validated version

    Tinnitus Handicap Inventory measures the impact of tinnitus on the daily life of the patients. The questionnaire is subdivided into categories functional (11 questions), emotional (9 questions) and catastrophic (5 questions) :Tinnitus Handicap Inventory comprises 25 questions with three options for answer: "Yes", "NO", "Sometimes". The scoring for these options is "Yes"= 4,"NO "=0 ,"sometimes"=2. The possible score for Tinnitus Handicap Inventory can range from 0 to 100. Higher scores are interpreted as greater handicap due to tinnitus.Total THI score will be analyzed at three time points as for TFI.

  2. Visual Analogue Scale (VAS)

    Time frame: as for TFI

    The Visual Analogue Scale (was used to asses subjective tinnitus loudness). The patient will report averaged loudness of their tinnitus in the past week on a 10 centimeter line. The left end of the line was marked with 0 indicating no tinnitus, while the right end was marked with 10, indicating maximum loudness of tinnitus. Visual Analogue scale score will be assessed on three time points - as for TFI. Visual Analogue scale score will be assessed on three time points - as for TFI.

  3. Range of motion of cervical spine

    Time frame: as for TFI

    This is the range of neck movements that the patient can actively perform, measured from the neutral to maximum position (cervical flexion, cervical rotation to left and to right, cervical side bending to left and right. The SFTR method where S represents - sagittal (sagittal plane);

    • Page 3 of 6 [DRAFT] -

    F - Frontal plane; T - transverse (transverse plane); R - rotation (rotational movements) will be used for assessment and recording cervical spine range of movement (Gerhardt,1983). The normal range of movement of cervical spine according to SFTR method in centimetres, is as follows:

    Cervical Spine flexion

    • 18-40 years adults- 3 cm.
    • 41-60 years adults- 2.5 cm.
    • 61-85 years adults- 2 cm

    Cervical Side bending

    • 18-40 years adults- 6.5 cm.
    • 41-60 years adults- 5 cm.
    • 61-85 years adults- 4 cm

    Cervical rotation

    • 18-40 years adults- 8 cm.
    • 41-60 years adults- 7.5 cm.
    • 61-85 years adults- 6 cm.

  4. Cervical muscle tension (MST)

    Time frame: same as for TFI

    The cervical muscle tension will be assessed by palpation. Palpation is widely used as a physiotherapy assessment tool in patient examination (MAITLAND, 1982). Muscle tension will be graded using the dichotomous scale of 0 and 1 where 0 will be interpreted as normal and 1 will be interpreted as presence of pathological muscle tension.

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

Physiotherapy Methods in Tinnitus Treatment

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2021
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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