Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001183471
Ethics application status
Approved
Date submitted
19/08/2016
Date registered
29/08/2016
Date last updated
22/02/2024
Date data sharing statement initially provided
22/02/2024
Date results provided
22/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
How does the neck contribute to post-concussion symptoms?
Scientific title
How does the neck contribute to post-concussion symptoms?
Secondary ID [1] 289883 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
concussion 299826 0
neck conditions 299827 0
Condition category
Condition code
Neurological 299747 299747 0 0
Other neurological disorders
Musculoskeletal 299748 299748 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will observe people who have had a concussion presenting to a concussion provider through the New Zealand Accident Compensation Corporation (ACC) Concussion Service, when it is suspected the neck is contributing to their symptoms, at the time they present to a Physiotherapist for neck assessment and treatment.
Participants will complete neck Physiotherapy as normal. This will involve a detailed assessment of the neck including movements, palpation and tests. Treatment will be decided by the participant in collaboration with the Physiotherapist and may include hands-on therapy, exercise, education, advice etc. Treatment will typically span several sessions (e.g. 6 sessions), and is expected to be completed within 2 months of their first appointment. Again, this will be decided by the participant along with the Physiotherapist and healthcare team.
Standardised outcomes will be measured at the initial Physiotherapy visit, and again at the final Physiotherapy visit. This will involve questionnaires, clinical measures of symptoms and function, clinical findings in the neck, and saliva samples. Descriptive findings, treatment and outcomes will be retrieved from the clinical notes at the end of their neck Physiotherapy treatment.
Intervention code [1] 295558 0
Not applicable
Comparator / control treatment
No intervention or control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299203 0
Description and change in symptoms measured by the Rivermead post-concussion symptoms questionnaire
Timepoint [1] 299203 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [1] 326491 0
Impact of neck problem as measured by the Neck disability index
Timepoint [1] 326491 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [2] 326492 0
Impact of dizziness as measured by Dizziness Handicap Inventory
Timepoint [2] 326492 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [3] 326493 0
Headache category based on Physiotherapy assessment, simply recorded as cervicogenic or non-cervicogenic.
Timepoint [3] 326493 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [4] 326494 0
Headache sidedness, categorised as bilateral, unilateral with side shift, or unilateral without side shift.
Timepoint [4] 326494 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [5] 326495 0
Headache frequency, recorded as number of headache days in the last week.
Timepoint [5] 326495 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [6] 326496 0
Headache duration (typical episode), recorded in minutes or hours.
Timepoint [6] 326496 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [7] 326497 0
Headache severity (typical episode), recorded on an 11-point numeric rating scale (0-10).
Timepoint [7] 326497 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [8] 326498 0
Dizziness frequency recorded in seconds or minutes.
Then categorised on a six point categorical scale (0=no dizziness, 1=<once/month, 2=1-4 episodes/month, 3=1-4 episodes/week, 4=once daily, 5=>once daily or constant).
Timepoint [8] 326498 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [9] 326499 0
Dizziness duration (typical episode), recorded in seconds or minutes.
Timepoint [9] 326499 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [10] 326947 0
Dizziness severity/intensity as measured by an 11 point numeric rating scale (0-10).
Timepoint [10] 326947 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [11] 326948 0
Neck pain severity using the 11-point numeric pain rating scale (0-10).
Timepoint [11] 326948 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [12] 326949 0
Neck range of motion, including flexion-rotation test. Measured using a CROM and modified CROM device respectively.
Timepoint [12] 326949 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [13] 326950 0
Segmental assessment of the neck - pain. This is a manual examination by the Physiotherapist recording the cervical spine levels that are painful and/or stiff. Pain will be measured using the numeric pain rating scale (0-10).
Timepoint [13] 326950 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [14] 326951 0
Segmental assessment of the neck - stiffness. This is a manual examination by the Physiotherapist recording the cervical spine levels that are painful and/or stiff. Stiffness will be measured using a 7-point scale indicated by hypermobile (1-3), normal (4), hypomobile (5-7).
Timepoint [14] 326951 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [15] 326952 0
Other key relevant qualitative desciptors of the participant's neck findings or response to Physiotherapy treatment as recorded in the clinical notes (e.g. behaviour of symptoms).
Key findings will be highlighted (*) or repeated in follow-up sessions, and considered on a case by case basis.
Timepoint [15] 326952 0
At initial neck assessment by Physiotherapist, then after Physiotherapy neck treatment.
Secondary outcome [16] 326953 0
Salivary cortisol levels using passive drool test
Timepoint [16] 326953 0
Prior to and after the initial neck treatment by Physiotherapist, then prior to and after the final Physiotherapy neck treatment.
Secondary outcome [17] 326954 0
Salivary testosterone levels using passive drool test
Timepoint [17] 326954 0
Prior to and after the initial neck treatment by Physiotherapist, then prior to and after the final Physiotherapy neck treatment.

Eligibility
Key inclusion criteria
These are: Patients presenting through the ACC Concussion service to APM Limited OR Advantage South concussion assessors with persistent (> 10 days) headaches, dizziness and/or neck pain; subjective history suggesting the neck may contribute to their symptoms*; who accept and follow through with a referral for neck assessment and treatment by a Physiotherapist with postgraduate manual therapy training.
*Potential for the neck to contribute to patient’s symptoms will be informed by:
1. Increased neck pain or stiffness since their concussion injury OR
2. Headache consistent with symptoms arising from the neck: headache triggered by neck movement/positioning, or external pressure to the neck/head; restricted neck range of movement; neck, shoulder or arm pain on the same side (Sjaastad, Fredriksen, and Pfaffenrath 1998) OR
3. Dizziness consistent with symptoms arising from the neck: non-rotatory dizziness described as imbalance or unsteadiness; and triggered by neck movements or positions (Reid et al. 2014).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
These are: Contraindications to manual therapy for the neck (e.g. fracture, inflammatory joint conditions, and infection); other significant neurological conditions; patients under the age of 16 years.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In line with recommendations for a prospective case series the main analysis will be descriptive rather than statistical (Carey and Boden 2003; Kooistra et al. 2009). Patient characteristics and flow through the study will be reported, including loss to follow-up and other potential areas of bias.
Outcome measures will be tabulated for easy comparison of cases, and common clinical features of the neck contributing to people’s symptoms will be discussed. Changes in outcomes pre and post manual therapy will be reported, identifying and discussing common themes. Where appropriate, basic statistical analysis comparing pre and post manual therapy outcomes may be performed (e.g. paired t-test). Note that statistical analysis is not designed to establish causal effects or treatment efficacy, but to identify areas where manual therapy has an impact on participant’s symptoms.
For these purposes a target study sample of 30 participants was discussed and agreed upon by the research team. Note that as this is a descriptive case series this number is not based on power calculations for statistical analysis, but numbers considered achievable and appropriate for descriptive purposes.
The levels of cortisol and testosterone in all the salivary samples will be measured using commercially available ELISA kit (Salimetrics, USA) according to the manufacturer’s instruction. This will be performed at the Department of Physiology, University of Otago.
The feasibility aspects of the research will be reported and discussed based on the quality and quantity of data collected over the study period. This will also inform service delivery.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2016
Actual
5/09/2016
Date of last participant enrolment
Anticipated
28/10/2016
Actual
11/11/2016
Date of last data collection
Anticipated
22/12/2017
Actual
22/12/2017
Sample size
Target
30
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 8085 0
New Zealand
State/province [1] 8085 0
Otago

Funding & Sponsors
Funding source category [1] 294247 0
University
Name [1] 294247 0
University of Otago
Country [1] 294247 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293081 0
None
Name [1] 293081 0
N/A
Address [1] 293081 0
N/A
Country [1] 293081 0
Other collaborator category [1] 279150 0
Individual
Name [1] 279150 0
Mr Dusty Quinn
Address [1] 279150 0
Back in Motion Ltd
27-29 Albany Street
Dunedin 9016
Country [1] 279150 0
New Zealand
Other collaborator category [2] 279163 0
Individual
Name [2] 279163 0
Dr Cathy Chapple
Address [2] 279163 0
School of Physiotherapy
325 Great King Street
University of Otago
Dunedin 9016
New Zealand
Country [2] 279163 0
New Zealand
Other collaborator category [3] 279164 0
Individual
Name [3] 279164 0
Dr Steve Tumilty
Address [3] 279164 0
School of Physiotherapy
325 Great King Street
University of Otago
Dunedin 9016
New Zealand
Country [3] 279164 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295670 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 295670 0
Ethics committee country [1] 295670 0
New Zealand
Date submitted for ethics approval [1] 295670 0
08/07/2016
Approval date [1] 295670 0
16/08/2016
Ethics approval number [1] 295670 0
H19/089
Ethics committee name [2] 295671 0
ACC Ethics Committee
Ethics committee address [2] 295671 0
Ethics committee country [2] 295671 0
New Zealand
Date submitted for ethics approval [2] 295671 0
18/07/2016
Approval date [2] 295671 0
15/08/2016
Ethics approval number [2] 295671 0
#314

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68090 0
Dr Ewan Kennedy
Address 68090 0
School of Physiotherapy
325 Great King Street
University of Otago
Dunedin 9016
Country 68090 0
New Zealand
Phone 68090 0
+64 3 4795424
Fax 68090 0
Email 68090 0
[email protected]
Contact person for public queries
Name 68091 0
Ewan Kennedy
Address 68091 0
School of Physiotherapy
325 Great King Street
University of Otago
Dunedin 9016
Country 68091 0
New Zealand
Phone 68091 0
+64 3 4795424
Fax 68091 0
Email 68091 0
[email protected]
Contact person for scientific queries
Name 68092 0
Ewan Kennedy
Address 68092 0
School of Physiotherapy
325 Great King Street
University of Otago
Dunedin 9016
Country 68092 0
New Zealand
Phone 68092 0
+64 3 4795424
Fax 68092 0
Email 68092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.