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Trial registered on ANZCTR


Registration number
ACTRN12623000847617
Ethics application status
Approved
Date submitted
21/07/2023
Date registered
8/08/2023
Date last updated
10/04/2024
Date data sharing statement initially provided
8/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindful proprioceptive training and neck pain
Scientific title
Effect of mindful proprioceptive training on pain intensity for people with neck pain
Secondary ID [1] 310174 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck pain 330759 0
Condition category
Condition code
Musculoskeletal 327591 327591 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindful proprioceptive training for people with neck pain.
The approach is a modern blend of western and eastern mind-body awareness routines designed in part to address the neurology of pain states, with an aim to:
- Reduce pain and disability
- Improve locus of control through clinical reasoning education to facilitate autonomy
- Restore proprioception (e.g. sense of force), variability of movement and autonomic nervous system homeostasis

The program is delivered through:

Education
Education is evidence-based and focused on empowering participants with control over their condition. Common themes include:
Debunking common contributing factors to neck pain (Hogg-Johnson et al., 2008):
No association: BMI, imaging (disc degeneration not associated)
Age – risk for neck pain increases with age to peak at 40-49, then reduces
Personal reflection as a self-generated clinical reasoning tool to identify potential contributing factors to the perpetual nature of their condition (unhelpful movement patterns and positions)
Use of proprioception to optimise body function in daily life i.e., awareness continues throughout the day (additional to group exercise and home exercise times)
Findings of people with neck pain: reduced proprioception, reduced variability of movement, increased muscle activity / tone, and anatomy and physiology of relevant body systems (e.g. in this case, cervical spine, temporomandibular joint, and the autonomic nervous system)

Group exercise class
Movement retraining commences 1-week following the education session and aims to bring participant attention to the present moment using proprioceptive awareness. Proprioceptive awareness is used at rest and during movement to obtain voluntary control of tonic muscle activity. In each class, participants are taken through progressive stages:
Stage 1. Recognising your form. Attention is focused on proprioception in its current form (i.e., existing tonic activity; sense of position, movement, and force).
Stage 2. Regaining control of your form. Awareness is applied to modify form for optimal comfort (often reducing tonic muscle activity).
Stage 3. Exploring movement. Active movements (self-generated) are performed whilst proprioceptive attention is retained (stage 1). Movement is repeated and modified accordingly (stage 2).
Active movements are performed initially in the supine position to reduce tonic muscle activity and allow isolated self-examination of specific body regions. All movements are:
Minimal in effort/force: no resistance is applied, and the goal is to use the least amount of effort possible
Self-limiting: they are directed by the participant and determined by comfort and capacity (what they’re comfortably able to do)
Mostly submaximal in range (we are not ‘stretching’)
Repeated 10-20 times with a goal to make the movement as easy as possible

Week 1: supine temporomandibular, cervical, and lumbopelvic movement
Week 2: recap week 1; then prone cervical and lumbopelvic movement
Week 3: recap previous; then supine and prone cervical rotation active movement using sliders
Week 4: recap previous; then supine rolling; shell stretch weight-bearing

Home exercise program
Participants are encouraged to complete a daily home exercise program for 30 minutes, based on the weekly in-class exercises

Journal entries
Participants keep a journal of their neck pain experience throughout the program, starting from the first education session. The journal will serves as a tool for self-reflection and clinical reasoning, enabling participants to gain insights into potential contributing factors to the perpetuation of their problem, leading to enhance internal locus of control regarding their condition.

The intervention will be provided by the primary researcher Mr Daniel English, a physiotherapist who developed the intervention following 15 years’ experience working with people with head and neck conditions.

The intervention will be delivered face-to-face at a University teaching facility with projector available

Participants will receive one initial education session lasting 1-hour, and brief discussions will also occur during the weekly exercise class group sessions to that will reinforce educational themes. Participants will be provided with x4 1 x4-hour group exercise sessions over 4 weeks, and a daily home-exercise program to complete for 30 minutes over 4 weeks.

Participants will be required to document their progress individual journal from the initial education session until the completion of the face-to-face intervention.

Treatment adherence for the group sessions will be evaluated by recording the attendance of participants at each session. Adherence to the home exercise program adherence will be recorded using a self-reported checklist. Participant experience will be recorded using in the participant journal qualitative data and will be used as a co-design tool for a future study
Intervention code [1] 326567 0
Treatment: Other
Intervention code [2] 326568 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335427 0
Pain intensity (numerical rating scale)
Timepoint [1] 335427 0
Baseline, 1-week post-intervention, 8-weeks post intervention
Secondary outcome [1] 424490 0
Disability (neck disability index)
Timepoint [1] 424490 0
Baseline, 1-week post-intervention, 8-weeks post intervention
Secondary outcome [2] 424491 0
Health locus of control (multi-dimensional health locus of control scales - form C)
Timepoint [2] 424491 0
Baseline, 1-week post-intervention, 8-weeks post intervention
Secondary outcome [3] 424492 0
Experience of neck pain (qualitative - written journal)
Timepoint [3] 424492 0
Baseline, 1-week post-intervention, 8-weeks post intervention
Secondary outcome [4] 424907 0
Experience of intervention (qualitative - journal)
Timepoint [4] 424907 0
Baseline, 1-week post-intervention, 8-weeks post intervention
Secondary outcome [5] 433858 0
Feasibility measures: recruitment time taken to recruit target sample (study log audit), recruitment source (self referred versus clinician referred via screening process), participation in treatment program (attendance of group class, adherence to home program via self-report checklist; most beneficial aspects & least beneficial aspects), follow up rate.
Timepoint [5] 433858 0
Secondary outcome [6] 433859 0
Feasibility measures: recruitment time taken to recruit target sample (study log audit), recruitment source (self referred versus clinician referred via screening process), participation in treatment program (attendance of group class, adherence to home program via self-report checklist; most beneficial aspects & least beneficial aspects), follow up rate.
Timepoint [6] 433859 0
Post intervention

Eligibility
Key inclusion criteria
Pain in the neck for three months or longer
Complete Neck Disability Index (need to be more than 10% or 5/50)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Myelopathy (low back pain and arm/leg pain/tingling/numbness/weakness; decreased fine motor skills/coordination; bowel/bladder dysfunction; difficulty walking)

Major structural pathology of the cervical spine (e.g., fracture, dislocation, myelopathy, cancer, systemic disease)
Central neurological disorders (e.g., multiple sclerosis, traumatic brain injury, cerebrovascular injury)
Impairment of the peripheral vestibular system (e.g., positional vertigo, vestibular neuritis, Meniere’s disease) or vertigo without established diagnosis
Pregnancy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
18/10/2023
Date of last participant enrolment
Anticipated
1/03/2024
Actual
20/02/2024
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
15
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 40901 0
3550 - Bendigo
Recruitment postcode(s) [2] 40902 0
3551 - Junortoun

Funding & Sponsors
Funding source category [1] 314337 0
University
Name [1] 314337 0
La Trobe University
Country [1] 314337 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Edwards Road
Flora Hill
Bendigo
Victoria
3550
Country
Australia
Secondary sponsor category [1] 316285 0
None
Name [1] 316285 0
Address [1] 316285 0
Country [1] 316285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313437 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 313437 0
Ethics committee country [1] 313437 0
Australia
Date submitted for ethics approval [1] 313437 0
14/08/2023
Approval date [1] 313437 0
09/10/2023
Ethics approval number [1] 313437 0
HEC23323

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

Contacts
Principal investigator
Name 128158 0
Mr Rodrigo Rico Bini
Address 128158 0
La Trobe University
PO Box 199
Bendigo
Victoria 3552
Country 128158 0
Australia
Phone 128158 0
+61354447466
Fax 128158 0
Email 128158 0
r.bini@latrobe.edu.au
Contact person for public queries
Name 128159 0
Daniel English
Address 128159 0
La Trobe University
PO Box 199
Bendigo
Victoria 3552
Country 128159 0
Australia
Phone 128159 0
+61 400079200
Fax 128159 0
Email 128159 0
d.english@latrobe.edu.au
Contact person for scientific queries
Name 128160 0
Daniel English
Address 128160 0
La Trobe University
PO Box 199
Bendigo
Victoria 3552
Country 128160 0
Australia
Phone 128160 0
+61 400079200
Fax 128160 0
Email 128160 0
d.english@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be deidentified and limited to the research team to protect participant anonymity.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19765Study protocol    Ethics approved, final protocol form completed 386275-(Uploaded-10-10-2023-09-50-20)-Study-related document.docx
19766Ethical approval  d.english@latrobe.edu.au Ethics has been approved. 386275-(Uploaded-11-10-2023-18-33-51)-Study-related document.msg



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.