ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neck pain

Condition category

Condition code

Musculoskeletal

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]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Pain intensity (numerical rating scale)

Timepoint [1]