Neck Kinesiotherapy and Massage in Tinnitus Treatment

May 20, 2021 updated by: Medical University of Lodz

Physiotherapy Methods 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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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Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lodz, Zeromskiego 113 Street
      • Lodz, Lodz, Zeromskiego 113 Street, Poland, 90-549
        • Department of Otolaryngology, Laryngological Oncology, Audiology and Phoniatrics, Teaching Hospital of Medical university of Lodz, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinesiotherapy group
This is the group (n=59) receives treatment i.e complex set of neck exercises and massage
Other: Complex set of kinesiotherapy of cervical spine and delicate massage

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

  1. 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.
  2. Massage of cervical interspinales muscles performed by therapist 3 minutes.
  3. Post Isometric Relaxation (PIR) performed by physiotherapist. 15 minutes.
  4. Active neck exercises - the same as mentioned in step 1. 5 minutes. Total duration of one treatment session is around 30 minutes.
No Intervention: Waiting List group
Individuals registered in the waiting list for receiving the treatment specified for kinesiotherapy group (n=59).These patients receive no treatment for tinnitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time point 0: Baseline, Time point 1: 2 weeks after baseline, Time point 2: 4 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI), Polish validated version
Time Frame: as for TFI

2. 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.
as for TFI
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.
as for TFI
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);

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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.
as for TFI
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.
same as for TFI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Principal Investigator: Assoc. Prof. Marzena Mielczarek, MD PhD, Medical University of Lodz Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

March 28, 2020

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESITESR14

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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