Clinical trial NCT04696588: Neck Kinesiotherapy and Massage in Tinnitus Treatment
Official title: Physiotherapy Methods in Tinnitus Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Tinnitus
Keywords: Subjective tinnitus,
massage
Post Isometric Relaxation Exercises
Kinesiotherapy
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a non randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

.

Eligibility criteria: 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.

Primary outcomes:
measure: Tinnitus Functional Index (TFI), a Polish validated version (Wrzosek et al., 2016).
timeFrame: Time point 0: Baseline, Time point 1: 2 weeks after baseline, Time point 2: 4 weeks after baseline
Secondary outcomes:
measure: Tinnitus Handicap Inventory (THI), Polish validated version
timeFrame: as for TFI
measure: Visual Analogue Scale (VAS)
timeFrame: as for TFI
measure: Range of motion of cervical spine
timeFrame: as for TFI
measure: Cervical muscle tension (MST)
timeFrame: same as for TFI
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Otolaryngology, Laryngological Oncology, Audiology and Phoniatrics, Teaching Hospital of Medical university of Lodz, Poland
state: Lodz, Zeromskiego 113 Street
Study officials:
affiliation: Medical University of Lodz Poland
name: Assoc. Prof. Marzena Mielczarek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.