search
Back to results

Neck Kinesiotherapy and Massage in Tinnitus Treatment

Primary Purpose

Subjective Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Complex set of kinesiotherapy of cervical spine and delicate massage
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Tinnitus focused on measuring Subjective tinnitus,, massage, Post Isometric Relaxation Exercises, Kinesiotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kinesiotherapy group

Waiting List group

Arm Description

This is the group (n=59) receives treatment i.e complex set of neck exercises and massage

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2019
Last Updated
May 20, 2021
Sponsor
Medical University of Lodz
search

1. Study Identification

Unique Protocol Identification Number
NCT04696588
Brief Title
Neck Kinesiotherapy and Massage in Tinnitus Treatment
Official Title
Physiotherapy Methods in Tinnitus Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
March 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Tinnitus
Keywords
Subjective tinnitus,, massage, Post Isometric Relaxation Exercises, Kinesiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a non randomized controlled trial
Masking
Investigator
Masking Description
The responsible investigator is blinded .
Allocation
Non-Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotherapy group
Arm Type
Experimental
Arm Description
This is the group (n=59) receives treatment i.e complex set of neck exercises and massage
Arm Title
Waiting List group
Arm Type
No Intervention
Arm Description
Individuals registered in the waiting list for receiving the treatment specified for kinesiotherapy group (n=59).These patients receive no treatment for tinnitus.
Intervention Type
Other
Intervention Name(s)
Complex set of kinesiotherapy of cervical spine and delicate massage
Intervention Description
Intervention:- A complex neck therapy.Treatment comprises 10 sessions performed on consecutive working days, includes four parts. 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. Massage of cervical interspinales muscles performed by therapist 3 minutes. Post Isometric Relaxation (PIR) performed by physiotherapist. 15 minutes. Active neck exercises - the same as mentioned in step 1. 5 minutes. Total duration of one treatment session is around 30 minutes.
Primary Outcome Measure Information:
Title
Tinnitus Functional Index (TFI), a Polish validated version (Wrzosek et al., 2016).
Description
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 Frame
Time point 0: Baseline, Time point 1: 2 weeks after baseline, Time point 2: 4 weeks after baseline
Secondary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI), Polish validated version
Description
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.
Time Frame
as for TFI
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
as for TFI
Title
Range of motion of cervical spine
Description
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.
Time Frame
as for TFI
Title
Cervical muscle tension (MST)
Description
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.
Time Frame
same as for TFI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assoc. Prof. Marzena Mielczarek, MD PhD
Organizational Affiliation
Medical University of Lodz Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Laryngological Oncology, Audiology and Phoniatrics, Teaching Hospital of Medical university of Lodz, Poland
City
Lodz
State/Province
Lodz, Zeromskiego 113 Street
ZIP/Postal Code
90-549
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22156949
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. Erratum In: Ear Hear. 2012 May;33(3):443.
Results Reference
result
PubMed Identifier
20634268
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.
Results Reference
result
PubMed Identifier
27965609
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.
Results Reference
result
PubMed Identifier
25415466
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.
Results Reference
result
PubMed Identifier
31364603
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.
Results Reference
result
PubMed Identifier
19842352
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.
Results Reference
result
PubMed Identifier
21808880
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.
Results Reference
result
PubMed Identifier
27965530
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.
Results Reference
result
PubMed Identifier
25025844
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.
Results Reference
result
PubMed Identifier
6662609
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.
Results Reference
result

Learn more about this trial

Neck Kinesiotherapy and Massage in Tinnitus Treatment

We'll reach out to this number within 24 hrs