Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001557325
Ethics application status
Approved
Date submitted
5/11/2017
Date registered
15/11/2017
Date last updated
5/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Scalp Itch Study - Treatment of Scalp Itch with Simple Exercises and Stretches
Scientific title
Treatment of Scalp Dysesthesia Utilising Simple Exercises And Stretches: A Pilot Study
Secondary ID [1] 293285 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scalp dysesthesia 305362 0
Condition category
Condition code
Skin 304645 304645 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants will be provided with access to an online questionnaire. Baseline patient characteristics and the severity of pruritus, measured through a validated VAS of 0 to 10, will be collected. At the conclusion of the questionnaire study participants will be provided with a Physiotherapist designed exercise protocol, with accompanying clear instructions and photographs detailing how to effectively complete them. Study participants will be instructed to complete these exercises twice a day for 4 weeks independently. The exercise protocol consists of 4 stretches and 2 cervical ranging exercises with strict instructions on how to perform the exercises and accompanying instructional photos. The exercise program should take approximately 10 minutes to complete each time. The exercise protocol is based on empirical knowledge and specifically designed to lengthen muscles which restrict cervical movement and restore segmental cervical range. Compliance and VAS will be self assessed through weekly questionnaires. No strategies will be used to maintain or improve fidelity
Intervention code [1] 299539 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303869 0
Visual analogue scale for pruritus severity
Timepoint [1] 303869 0
Changes in the primary outcome from Baseline, 1, 2, 3, and 4 weeks (5 time-points) post commencement of intervention
Secondary outcome [1] 340322 0
Nil
Timepoint [1] 340322 0
Nil

Eligibility
Key inclusion criteria
Age between 18-70+
Diagnosis of scalp dysesthesia
Possess sufficient English language skills to give consent complete all questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent
A whiplash injury within the past 6 weeks
History of spinal tumours, spinal infection, cervical spine fracture, vertebrobasilar insufficiency or previous neck surgery
Any pending legal action regarding neck pain
A diagnosis of central cervical spinal stenosis
Bilateral upper extremity neurological symptoms
Two positive neurologic findings at the same nerve root level
Musculoskeletal deformity such as severe spondylolysis or spondylolithesis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be described with frequency and percentage (categorical variables) and measures of central tendency (continuous variables). The Primary Study outcome (Visual Analogue Scale for pruritus) will be described based on the normality of the data distribution.

Pending the assessment of normality; the VAS-pruritus will be described with paired (repeated/related) tests, i.e. paired t-test or paired Mann-Whitney U-test, across Baseline (T0 and 4 weeks (T5)

Changes in the primary outcome VAS-pruritus score from Baseline, 1, 2, 3, and 4 weeks (5 time-points) will be assessed with Linear Mixed Effect Modelling to determine the changes within participant levels within and between the 5 time-points and adjusted for selected clinical characteristics, such as, age and gender.

The sample size was determined according to the desired precision of the primary outcome, intensity of dysesthesia at week 4.

The initial (crude) paired t-test comparison of VAS-pruritus from Baseline to week 4 would require a sample size of 31 participants to detect a 50% reduction in VAS-pruritus scores between those timepoints.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2017
Actual
14/12/2017
Date of last participant enrolment
Anticipated
28/02/2018
Actual
13/02/2018
Date of last data collection
Anticipated
28/03/2018
Actual
20/03/2018
Sample size
Target
31
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9344 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 18018 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 297988 0
Self funded/Unfunded
Name [1] 297988 0
Unfunded
Country [1] 297988 0
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave
Nedlands 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 297007 0
None
Name [1] 297007 0
Address [1] 297007 0
Country [1] 297007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298960 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 298960 0
Sir Charles Gairdner Hospital
2nd Floor A Block
Hospital Avenue
NEDLANDS WA 6009
Ethics committee country [1] 298960 0
Australia
Date submitted for ethics approval [1] 298960 0
27/07/2017
Approval date [1] 298960 0
30/10/2017
Ethics approval number [1] 298960 0
RGS0000000535

Summary
Brief summary
Scalp dysesthesia is characterised by abnormal cutaneous sensations such as burning, stinging or itching of the scalp in the absence of objective dermatological findings. Scalp dysesthesia has been associated with cervical spine dysfunction, however there is no unified pathogenesis or agreed upon effective treatment. We hypothesise that the unpleasant sensations of scalp dysesthesia are the result of a sensory neuropathy secondary to cervical spine dysfunction. The aim of this pilot study is to evaluate the use of an exercise protocol consisting of cervical spine range of movement exercises, gentle mobilisation and muscle stretches over 4 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78798 0
Dr Nicholas Laidler
Address 78798 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA, 6009
Country 78798 0
Australia
Phone 78798 0
+61 08 6457 3333
Fax 78798 0
Email 78798 0
[email protected]
Contact person for public queries
Name 78799 0
Nicholas Laidler
Address 78799 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA, 6009
Country 78799 0
Australia
Phone 78799 0
+61 08 6457 3333
Fax 78799 0
Email 78799 0
[email protected]
Contact person for scientific queries
Name 78800 0
Nicholas Laidler
Address 78800 0
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA, 6009
Country 78800 0
Australia
Phone 78800 0
+61 08 6457 3333
Fax 78800 0
Email 78800 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.