Study Results
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Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2019-04-01
2020-03-28
Brief Summary
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Detailed Description
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(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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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Kinesiotherapy group
This is the group (n=59) receives treatment i.e complex set of neck exercises and massage
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Medical University of Lodz
OTHER
Responsible Party
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Principal Investigators
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Assoc. Prof. Marzena Mielczarek, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lodz Poland
Locations
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Department of Otolaryngology, Laryngological Oncology, Audiology and Phoniatrics, Teaching Hospital of Medical university of Lodz, Poland
Lodz, Lodz, Zeromskiego 113 Street, Poland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ESITESR14
Identifier Type: -
Identifier Source: org_study_id
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