Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001021369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/03/2026
Date registered
Help: Date registered
19/08/2026
Date last updated
Help: Date last updated
19/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Chiropractic Care for Spinal Pain and Mental Health in Ambulance Personnel
Scientific title
Effects of chiropractic care on spinal pain and mental health in Ambulance Personnel
Additional trial identifiers [1] 316416 0
None
Universal Trial Number (UTN)
U1111-1335-4994
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Chronic spinal pain 340510 0
Stress 340512 0
Anxiety 340513 0
Depression 340514 0
Back pain 341725 0
Condition category
Condition code
Musculoskeletal 336710 336710 0 0
Other muscular and skeletal disorders
Mental Health 336711 336711 0 0
Anxiety
Mental Health 336712 336712 0 0
Depression
Physical Medicine / Rehabilitation 337801 337801 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Chiropractic Intervention:
Due to the pragmatic nature of the study, the chiropractic group will receive six weeks (2-3 visits per week) of chiropractic intervention and each session will take around 15 minutes.
The entire spine and both sacroiliac joints will be assessed for vertebral subluxations and adjusted where deemed necessary by an experienced chiropractor of minimum 10 years’ experience. The clinical indicators of vertebral subluxations include tenderness to palpation of the relevant joints, manual palpation for restricted intersegmental range of motion, palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. Chiropractic intervention will involve high-velocity low-amplitude thrusts to sites deemed to have vertebral subluxations as identified using the indicators above. Adherence will be assessed via session attendance and intervention fidelity. Attendance will be recorded for all scheduled sessions, and adherence calculated as the percentage of sessions attended. Chiropractors will complete a standardised data collection sheet to document assessment findings and sites of vertebral subluxation adjusted.
Intervention code [1] 333188 0
Treatment: Other
Description of the comparator or control
Control group:
The control group will receive standardised active and passive movements of the participant’s head, spine, and body consistent with those used during routine chiropractic assessment procedures. Active movements will involve slow, controlled flexion, extension, rotation, and lateral flexion within a comfortable, mid-range of motion. Passive movements will involve gentle clinician-guided spinal movements and light manual contact, along with positioning the participant in common spinal assessment or setup postures (e.g., seated, prone, side-lying). All procedures will mimic clinical handling and positioning but will not include any spinal adjustment thrust, end-range loading, or preloading of spinal joints.
Attendance will be recorded for all scheduled sessions, and adherence calculated as the percentage of sessions attended. Chiropractors will complete a standardised data collection sheet to document assessment findings, movements performed, positioning, and confirmation that no thrust, preload, or end-range loading was applied. Participants in the control group will undergo the above study procedures 2–3 times per week for six weeks, with each session lasting approximately 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 344374 0
Back pain intensity
Timepoint [1] 344374 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit
Primary outcome [2] 344375 0
Functional disability
Timepoint [2] 344375 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit
Primary outcome [3] 344670 0
Composite primary outcome: Mental Health (Stress, Anxiety, Depression)
Timepoint [3] 344670 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit
Secondary outcome [1] 457701 0
Alpha band spectral power
Timepoint [1] 457701 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit.
Secondary outcome [2] 457702 0
Autonomic function
Timepoint [2] 457702 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit.
Secondary outcome [3] 457703 0
Real-world monitoring of continuous heart rate
Timepoint [3] 457703 0
Data will be recorded daily throughout the study period, including pre-assessment, during the six-week intervention or control period, and after six weeks of intervention or control on the day of the final visit, to monitor ongoing changes.
Secondary outcome [4] 457704 0
On-call acute stress
Timepoint [4] 457704 0
Following each emergency call-out or critical incident attended during work shifts throughout the study period,
Secondary outcome [5] 457705 0
Health-related quality of life
Timepoint [5] 457705 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit.
Secondary outcome [6] 458806 0
Recruitment efficiency
Timepoint [6] 458806 0
Recruitment efficiency will be monitored throughout the recruitment period.
Secondary outcome [7] 458807 0
Participant experiences with chiropractic care, including perceived acceptability, barriers and facilitators, perceived benefits, and recommendations for implementation in workplace settings. This will be assessed as a composite outcome.
Timepoint [7] 458807 0
Following completion of the 6-week intervention (chiropractic or control) and post-assessment recordings, a subset of participants who provide consent will be invited to participate in semi-structured interviews within one week of the final assessment. Participants will be recruited on a voluntary opt-in basis until approximately 8–12 participants are enrolled, or until data saturation is reached.
Secondary outcome [8] 461110 0
Beta band spectral power
Timepoint [8] 461110 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit.
Secondary outcome [9] 461111 0
Frontal alpha asymmetry
Timepoint [9] 461111 0
Before and after six weeks of chiropractic or control intervention on the day of the final visit.
Secondary outcome [10] 461113 0
Real-world monitoring of physical activity
Timepoint [10] 461113 0
Data will be recorded daily throughout the study period, including pre-assessment, during the six-week intervention or control period, and after six weeks of intervention or control on the day of the final visit, to monitor ongoing changes.
Secondary outcome [11] 461114 0
Real-world monitoring of sleep
Timepoint [11] 461114 0
Data will be recorded daily throughout the study period, including pre-assessment, during the six-week intervention or control period, and after six weeks of intervention or control on the day of the final visit, to monitor ongoing changes.
Secondary outcome [12] 463065 0
Protocol implementation
Timepoint [12] 463065 0
Protocol implementation will be assessed at the end of the study.
Secondary outcome [13] 463066 0
Data integrity
Timepoint [13] 463066 0
Data integrity will be assessed at the end of the study.

Eligibility
Key inclusion criteria
-Participants must be 18 years of age or older.
-Participants must currently work as frontline ambulance staff (e.g., paramedics, ambulance officers, emergency medical technicians, or similar roles involving emergency response and patient care).
-Participants must experience ongoing spinal pain in the lower back or pelvis. The pain must have been present for at least three months at some point within the past year (i.e., chronic pain).
-Participants must not have a known medical diagnosis explaining their spinal pain (e.g., fracture, infection, cancer, or inflammatory disease).
-Participants must experience stress, anxiety, or low mood. They must be willing to complete the Depression, Anxiety and Stress Scale-21 (DASS-21), with scores falling within the required range (Depression: 14–27, Anxiety: 10–19, or Stress: 19–33).
-Participants must be willing and able to attend all study sessions and complete the required assessments.
-Participants must be able to provide written informed consent prior to participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
-Participants with a current pain level greater than 7/10 on a visual analogue scale (VAS).
-Participants with any contraindications to chiropractic adjustments (e.g., recent spinal fractures, inflammatory diseases such as rheumatoid arthritis, or a recent history of cancer).
-Participants with any neurological disorder (e.g., stroke or seizures).
-Participants with a recent head injury accompanied by ongoing symptoms.
-Participants with metal implants in the head.
-Participants with severe psychiatric disorders (e.g., schizophrenia).
-Participants experiencing acute pain or a serious injury requiring urgent medical care.
-Participants with substance use disorders (ongoing problems related to alcohol or drug misuse).
-Participants with major health conditions (e.g., heart disease).
-Participants with a history of aggressive behaviour, suicidal ideation, or difficulty cooperating.

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)
Minimisation randomisation will be used to allocate participants, with balancing based on age and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
7/09/2026
Actual
Date of last participant enrolment
Anticipated
29/10/2027
Actual
Date of last data collection
Anticipated
17/12/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 27818 0
New Zealand
State/province [1] 27818 0
Auckland

Funding & Sponsors
Funding source category [1] 321021 0
Charities/Societies/Foundations
Name [1] 321021 0
Lotteries Health Research Funding
Country [1] 321021 0
New Zealand
Funding source category [2] 321139 0
Other
Name [2] 321139 0
New Zealand College of Chiropractic
Country [2] 321139 0
New Zealand
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
Country
New Zealand
Secondary sponsor category [1] 324229 0
None
Name [1] 324229 0
Address [1] 324229 0
Country [1] 324229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319558 0
Health and Disability Ethics Committee 
Ethics committee address [1] 319558 0
Ethics committee country [1] 319558 0
New Zealand
Date submitted for ethics approval [1] 319558 0
22/01/2026
Approval date [1] 319558 0
25/02/2026
Ethics approval number [1] 319558 0
2026 EXP 24610

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

Contacts
Principal investigator
Name 147702 0
Dr Nitika Kumari
Address 147702 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060 New Zealand
Country 147702 0
New Zealand
Phone 147702 0
+64 273707917
Fax 147702 0
Email 147702 0
[email protected]
Contact person for public queries
Name 147703 0
Nitika Kumari
Address 147703 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060 New Zealand
Country 147703 0
New Zealand
Phone 147703 0
+64 273707917
Fax 147703 0
Email 147703 0
[email protected]
Contact person for scientific queries
Name 147704 0
Nitika Kumari
Address 147704 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060 New Zealand
Country 147704 0
New Zealand
Phone 147704 0
+64 273707917
Fax 147704 0
Email 147704 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.