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Subjective TinnitusNCT04696588

Neck Kinesiotherapy and Massage in Tinnitus Treatment

A study testing Complex set of kinesiotherapy of cervical spine and delicate massage in people with Subjective Tinnitus, run by Medical University of Lodz at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Subjective Tinnitus
What is being tested?
Complex set of kinesiotherapy of cervical spine and delicate massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 sitePoland
Study dates
1 Apr 2019to 28 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

    Lodz, Lodz, Zeromskiego 113 Street, 90-549

Other trials in Poland

About this study

Official title: 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.

Read the 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.

.

Being tested
Complex set of kinesiotherapy of cervical spine and delicate massage
Keywords
Subjective tinnitus,, massage, Post Isometric Relaxation Exercises, Kinesiotherapy
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complex set of kinesiotherapy of cervical spine and delicate massageOther

    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.
Study groups in NCT04696588
Study groupRoleWhat they receive
Kinesiotherapy groupExperimentalThis is the group (n=59) receives treatment i.e complex set of neck exercises and massage
Receives: Other: Complex set of kinesiotherapy of cervical spine and delicate massage
Waiting List groupNo interventionIndividuals registered in the waiting list for receiving the treatment specified for kinesiotherapy group (n=59).These patients receive no treatment for tinnitus.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (4)

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

    1. 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.

    Measured: as for TFI

  2. Visual Analogue Scale (VAS)

    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.

    Measured: as for TFI

  3. Range of motion of cervical spine

    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.

    Measured: as for TFI

  4. Cervical muscle tension (MST)

    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.

    Measured: same as for TFI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start1 Apr 2019
  3. Primary completion27 Feb 2020
  4. Study completion28 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
It is a non randomized controlled trial
Masking
Single blind
Who is masked
Investigator
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696588
Sponsor's protocol ID
ESITESR14
Status last verified
May 2021
First submitted
10 Dec 2019
Last updated
21 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.

    PubMed 22156949

  • Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.

    PubMed 20634268

  • Wrzosek M, Szymiec E, Klemens W, Kotylo P, Schlee W, Modrzynska M, Lang-Malecka A, Preis A, Bulla J. Polish Translation and Validation of the Tinnitus Handicap Inventory and the Tinnitus Functional Index. Front Psychol. 2016 Nov 29;7:1871. doi: 10.3389/fpsyg.2016.01871. eCollection 2016.

    PubMed 27965609

  • Michiels S, De Hertogh W, Truijen S, Van de Heyning P. Cervical spine dysfunctions in patients with chronic subjective tinnitus. Otol Neurotol. 2015 Apr;36(4):741-5. doi: 10.1097/MAO.0000000000000670.

    PubMed 25415466

  • Michiels S, Harrison S, Vesala M, Schlee W. The Presence of Physical Symptoms in Patients With Tinnitus: International Web-Based Survey. Interact J Med Res. 2019 Jul 30;8(3):e14519. doi: 10.2196/14519.

    PubMed 31364603

  • Latifpour DH, Grenner J, Sjodahl C. The effect of a new treatment based on somatosensory stimulation in a group of patients with somatically related tinnitus. Int Tinnitus J. 2009;15(1):94-9.

    PubMed 19842352

  • Sanchez TG, Rocha CB. Diagnosis and management of somatosensory tinnitus: review article. Clinics (Sao Paulo). 2011;66(6):1089-94. doi: 10.1590/s1807-59322011000600028.

    PubMed 21808880

  • Michiels S, Naessens S, Van de Heyning P, Braem M, Visscher CM, Gilles A, De Hertogh W. The Effect of Physical Therapy Treatment in Patients with Subjective Tinnitus: A Systematic Review. Front Neurosci. 2016 Nov 29;10:545. doi: 10.3389/fnins.2016.00545. eCollection 2016.

    PubMed 27965530

  • Maitland GD. Palpation examination of the posterior cervical spine: the ideal, average and abnormal. Aust J Physiother. 1982 Jun;28(3):3-12. doi: 10.1016/S0004-9514(14)60768-6.

    PubMed 25025844

  • Gerhardt JJ. Clinical measurements of joint motion and position in the neutral-zero method and SFTR recording: basic principles. Int Rehabil Med. 1983;5(4):161-4. doi: 10.3109/03790798309167039.

    PubMed 6662609

Questions about this trial

What is this clinical trial studying?

A study testing Complex set of kinesiotherapy of cervical spine and delicate massage in people with Subjective Tinnitus, run by Medical University of Lodz at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04696588, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.

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