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Trial registered on ANZCTR


Registration number
ACTRN12625000068460
Ethics application status
Approved
Date submitted
7/12/2024
Date registered
23/01/2025
Date last updated
23/01/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Weak muscle neurophysiology and chiropractic care
Scientific title
Exploring Neuromuscular and Biomechanical Properties of Weak Muscle: Assessing Muscle Response to Applied Kinesiology Manual Muscle Testing and Chiropractic Intervention in Adults with Subclinical Neck Pain
Secondary ID [1] 313180 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subclinical neck pain 335464 0
Condition category
Condition code
Musculoskeletal 332024 332024 0 0
Normal musculoskeletal and cartilage development and function
Musculoskeletal 332025 332025 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A registered chiropractor with at least five years of clinical experience will assess the cervical spine for vertebral dysfunction with the participant either standing or seated on a chiropractic table. The clinical indicators used to assess spinal function before spinal adjustment include evaluating joint tenderness to palpation, manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and checking for any abnormal or restricted joint play and end-feel of the joints. Chiropractors use these biomechanical characteristics as clinical indicators of spinal dysfunction and vertebral subluxation.

All spinal adjustments in this study will involve high-velocity, low-amplitude thrusts to the cervical spine, a standard adjusting technique used by chiropractors. This will be delivered while the participant is lying flat on their back on a chiropractic table. The mechanical properties of chiropractic adjustment have been investigated, and although the actual force applied depends on the chiropractor, the patient, and the spinal location of the subluxation, the general shape of the force-time history of spinal adjustments is very consistent, with the duration of the thrust always being less than 200 milliseconds. This type of adjustment has been specifically chosen because previous research has shown that reflex electromyographic activation observed after adjustments only occurred following high-velocity, low-amplitude adjustments, as opposed to lower-velocity mobilizations. This adjustment technique has also been used in studies investigating the neurophysiological effects of spinal adjustment.
The neck assessment and chiropractic adjustment, which may take around 15 minutes in total, will be conducted in a single session.
Intervention code [1] 329756 0
Treatment: Other
Comparator / control treatment
The participants head and/or cervical spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The control intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust. Loading a joint, as is done before spinal adjustment, has been shown to alter paraspinal proprioceptive firing in anaesthetized cats and therefore will be carefully avoided by ending the movement before end-range-of-motion when passively moving the participants. No spinal adjustment will be performed during any control intervention. This control intervention is not intended to act as a sham treatment session. Instead, it will act as a physiological control for possible changes occurring due to the cutaneous, muscular or vestibular input with the passive and active movements involved in preparing a participant/patient for an adjustment.
Control group
Active

Outcomes
Primary outcome [1] 339627 0
Deltoid muscle activity
Timepoint [1] 339627 0
Pre-intervention MMTs in the clear (four trials), during therapy localization (four trials), and during challenges (four trials), both in standing and lying positions. Post-intervention MMTs in the clear (four trials), during therapy localization (four trials), and during challenges (four trials), in both standing and lying positions.
Primary outcome [2] 340065 0
Force/displacement analysis
Timepoint [2] 340065 0
Pre-intervention MMTs in the clear (four trials), during therapy localization (four trials), and during challenges (four trials), both in standing and lying positions. Post-intervention MMTs in the clear (four trials), during therapy localization (four trials), and during challenges (four trials), in both standing and lying position.
Secondary outcome [1] 440667 0
Postural stability
Timepoint [1] 440667 0
Pre-intervention: 1) quiet standing with eyes open and eyes closed, 2) MMTs in the clear (four trials), during therapy localization (four trials), and during challenges (four trials), both in standing. Post-intervention: 1) quiet standing with eyes open and eyes closed, 2) MMTs in the clear (four trials), during therapy localization (four trials), and during challenges (four trials), in both standing position.

Eligibility
Key inclusion criteria
Thirty six participants will be included if they are aged between 18 and 65 years and have subclinical neck pain. Subclinical spinal pain refers to recurrent spinal ache, pain or stiffness, for which the person has not yet sought treatment. The participants will be pain-free at the time of their baseline assessment (less than or equal to 3/10 on a visual analogue scale (VAS) of pain). We will recruit people with subclinical pain because subclinical pain participants are more likely to have altered neurophysiological and biomechanical function than healthy participants. The participants will be included if they have not received any chiropractic adjustment or any other manual therapy in the past week of their data collection session.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have a history of recent spinal fractures, any metabolic disease, any inflammatory disease, any neoplastic disease, neurological conditions or any shoulder injury, weakness or pain.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following recruitment, screening and informed consent, eligible participants will be randomly allocated to either intervention or control group using a randomisation schedule generated by a computer system. This will be held by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation stratified by age and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 26633 0
New Zealand
State/province [1] 26633 0
Auckland

Funding & Sponsors
Funding source category [1] 317628 0
Other
Name [1] 317628 0
New Zealand College of Chiropractic
Country [1] 317628 0
New Zealand
Funding source category [2] 317971 0
Other
Name [2] 317971 0
International College of Applied Kinesiology
Country [2] 317971 0
United States of America
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
Country
New Zealand
Secondary sponsor category [1] 320310 0
None
Name [1] 320310 0
Address [1] 320310 0
Country [1] 320310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316328 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316328 0
Ethics committee country [1] 316328 0
New Zealand
Date submitted for ethics approval [1] 316328 0
03/12/2024
Approval date [1] 316328 0
14/01/2025
Ethics approval number [1] 316328 0
2024 EXP 19856

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

Contacts
Principal investigator
Name 137538 0
Dr Nitika Kumari
Address 137538 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060 New Zealand
Country 137538 0
New Zealand
Phone 137538 0
+64 273707917
Fax 137538 0
Email 137538 0
[email protected]
Contact person for public queries
Name 137539 0
Nitika Kumari
Address 137539 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060 New Zealand
Country 137539 0
New Zealand
Phone 137539 0
+64 273707917
Fax 137539 0
Email 137539 0
[email protected]
Contact person for scientific queries
Name 137540 0
Nitika Kumari
Address 137540 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060 New Zealand
Country 137540 0
New Zealand
Phone 137540 0
+64 273707917
Fax 137540 0
Email 137540 0
[email protected]

Data sharing statement
Will there be any conditions when requesting access to individual participant data?
No
-

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.