Neck Kinesiotherapy and Massage in Tinnitus Treatment

NCT04696588 | Completed

• 1 other identifier: ESITESR14
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Tinnitus

Keywords

Subjective tinnitus,; massage; Post Isometric Relaxation Exercises; Kinesiotherapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Tinnitus Handicap Inventory (THI), Polish validated version

  as for TFI

• Visual Analogue Scale (VAS)

  as for TFI

• Range of motion of cervical spine

  as for TFI

• Cervical muscle tension (MST)

  same as for TFI

Study Arms (2)

Kinesiotherapy group

EXPERIMENTAL

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

Waiting List group

NO INTERVENTION

Individuals registered in the waiting list for receiving the treatment specified for kinesiotherapy group (n=59).These patients receive no treatment for tinnitus.

Interventions

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. 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.

Kinesiotherapy group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

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

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

Location

Related Publications (10)

• 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.

  PMID: 22156949 RESULT

• 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.

  PMID: 20634268 RESULT

• 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.

  PMID: 27965609 RESULT

• 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.

  PMID: 25415466 RESULT

• 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.

  PMID: 31364603 RESULT

• 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.

  PMID: 19842352 RESULT

• 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.

  PMID: 21808880 RESULT

• 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.

  PMID: 27965530 RESULT

• 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.

  PMID: 25025844 RESULT

• 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.

  PMID: 6662609 RESULT

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Assoc. Prof. Marzena Mielczarek, MD PhD

  Medical University of Lodz Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The responsible investigator is blinded .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a non randomized controlled trial

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 6, 2021
• Study Start: April 1, 2019
• Primary Completion: February 27, 2020
• Study Completion: March 28, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)