Musculoskeletal Pain in Long-term Dizziness (MUPID)
Primary Purpose
Vestibular Disease, Musculoskeletal Pain, Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Vestibular exercises combined with body awareness exercises and cognitive therapy
Exergaming
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Disease focused on measuring vestibular disease, musculoskeletal pain, prognosis, vestibular rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness)
- Patients must be bothered with dizziness at the time of consultation
Exclusion Criteria:
- Patients uable to fill in questionnaires due language barriers
- Patients not able to undergo diagnostic and testing procedures
- Patients with vestibular Schwannoma
- Patients with diving-related inner ear injuries
Sites / Locations
- Haukeland University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vestibular exercises combined with cognitive therapy
Exergaming
Arm Description
The intervention is in groups of 8-10 patients. The interventions consists of cognitive therapy, vestibular exercises and body awareness therapy, 8 group sessions
The intervention is individual and consist of non-immersive virtual reality exercises to improve balance
Outcomes
Primary Outcome Measures
Dizziness Handicap Inventory. 0-100 (high score worst)
Baseline status and change in dizziness handicap
Secondary Outcome Measures
Nordic Pain Questionnaire. 0-10 (high score worst)
Baseline status and change in musculoskeletal pain
Vertigo Symptom Scale. 0-60 (high score worst)
Baseline status and change in vertigo symptoms
RAND-12 health related quality of life. 0-60 (high score better)
Baseline status and change in health related quality of life
Hospital Anxiety and Depression Scale. 0-42 (high score worst)
Baseline status and change in anxiety and depression symptoms
Dizziness Catastrophising Scale. 0-52 (high score worst)
Baseline status and change in catastrophising thoughts about the dizziness
Posturography. Body sway while standing on a force platform.
Baseline status and change after intervention
Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52
Baseline status and change after intervention
Walking test preferred speed, 6 m (m/s)
Baseline status and change after intervention
Walking test fast speed, 6 m (m/s)
Baseline status and change after intervention
Grip Strength
Baseline
Full Information
NCT ID
NCT04241822
First Posted
January 15, 2020
Last Updated
April 24, 2023
Sponsor
Western Norway University of Applied Sciences
Collaborators
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04241822
Brief Title
Musculoskeletal Pain in Long-term Dizziness
Acronym
MUPID
Official Title
Musculoskeletal Pain in Long-term Dizziness- Incidence, Prognosis and Measures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Norway University of Applied Sciences
Collaborators
Haukeland University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is aimed at patients with dizziness believed to be due to conditions in the balance organ in the inner ear (vestibular diseases). Dizziness can be bothersome and influence postural control negatively, and can cause secondary musculoskeletal disorders. Dizziness can also result in reduced work capacity. The purpose of the project is to strengthen the knowledge base regarding symptom burden, prognosis and treatment of prolonged dizziness. The hypothesis is that musculoskeletal pain at baseline is a prognostic factor for prolonged dizziness.
Detailed Description
Patients referred to an tertiary otorhinolarynglogical clinic due to dizziness will be invited to participate in the study. The aims are to examine the prevalence, extent and distribution of musculoskeletal pain in patients with prolonged dizziness, and to investigate the associations between musculoskeletal pain, dizziness symptoms, psychological and physical function and health-related quality of life.
Furthermore, the aim is to monitor the natural course of the dizziness symptoms and functional status in these patients, and examine risk factors for prolonged disability after 6 and 12 months. The hypothesis is that muscle pain and distress at baseline may be independently associated with prolonged complaints at follow-up.
Finally, patients who still are dizzy and have pain after 12 months will be invited to participate in one of two group interventions a) modified vestibular rehabilitation and b) virtual reality / exergaming. The interventions will be feasibility studies with a pre-post design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disease, Musculoskeletal Pain, Rehabilitation
Keywords
vestibular disease, musculoskeletal pain, prognosis, vestibular rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After 1 year participants who still have dizziness complaints will be offered one of two interventions:
Group-based vestibular rehabilitation combining cognitive intervention, vestiular exercises and body awareness therapy
Exergaming intervention with virtual reality exercises using data games and videos, and other balance exercises.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vestibular exercises combined with cognitive therapy
Arm Type
Experimental
Arm Description
The intervention is in groups of 8-10 patients. The interventions consists of cognitive therapy, vestibular exercises and body awareness therapy, 8 group sessions
Arm Title
Exergaming
Arm Type
Experimental
Arm Description
The intervention is individual and consist of non-immersive virtual reality exercises to improve balance
Intervention Type
Behavioral
Intervention Name(s)
Vestibular exercises combined with body awareness exercises and cognitive therapy
Intervention Description
The intervention is group based and is a combination of information/education, vestibular exercises (head movements and gaze stability exercises) body awareness exercises and cognitive therapy
Intervention Type
Behavioral
Intervention Name(s)
Exergaming
Intervention Description
The intervention consists of different balance exercises using non-immersive virtual reality
Primary Outcome Measure Information:
Title
Dizziness Handicap Inventory. 0-100 (high score worst)
Description
Baseline status and change in dizziness handicap
Time Frame
Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Secondary Outcome Measure Information:
Title
Nordic Pain Questionnaire. 0-10 (high score worst)
Description
Baseline status and change in musculoskeletal pain
Time Frame
Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Title
Vertigo Symptom Scale. 0-60 (high score worst)
Description
Baseline status and change in vertigo symptoms
Time Frame
Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Title
RAND-12 health related quality of life. 0-60 (high score better)
Description
Baseline status and change in health related quality of life
Time Frame
Baseline, 26 weeks, 1 year
Title
Hospital Anxiety and Depression Scale. 0-42 (high score worst)
Description
Baseline status and change in anxiety and depression symptoms
Time Frame
Baseline, 26 weeks, 1 year
Title
Dizziness Catastrophising Scale. 0-52 (high score worst)
Description
Baseline status and change in catastrophising thoughts about the dizziness
Time Frame
Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Title
Posturography. Body sway while standing on a force platform.
Description
Baseline status and change after intervention
Time Frame
Baseline,1 year, through study completion, an average 18 months
Title
Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52
Description
Baseline status and change after intervention
Time Frame
Baseline,1 year, through study completion, an average 18 months
Title
Walking test preferred speed, 6 m (m/s)
Description
Baseline status and change after intervention
Time Frame
Baseline,1 year, through study completion, an average 18 months
Title
Walking test fast speed, 6 m (m/s)
Description
Baseline status and change after intervention
Time Frame
Baseline,1 year, through study completion, an average 18 months
Title
Grip Strength
Description
Baseline
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness)
Patients must be bothered with dizziness at the time of consultation
Exclusion Criteria:
Patients uable to fill in questionnaires due language barriers
Patients not able to undergo diagnostic and testing procedures
Patients with vestibular Schwannoma
Patients with diving-related inner ear injuries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liv H Magnussen, Professor
Phone
+4755585631
Email
liv.magnussen@hvl.no
First Name & Middle Initial & Last Name or Official Title & Degree
Unni Moen, Ph.d.student
Phone
+ 4792684699
Email
unni.moen@hvl.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gro Anita F Flaten, ph.d.
Organizational Affiliation
Western Norway University of Applied Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Evelyn Neppelberg, ph.d.
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5020
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Neppelberg, ph.d.
Email
evelyn.neppelberg@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Frederik K Goplen, ph.d.
Email
frederik.goplen@helse-bergen.no
12. IPD Sharing Statement
Learn more about this trial
Musculoskeletal Pain in Long-term Dizziness
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