Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000900415
Ethics application status
Approved
Date submitted
1/08/2025
Date registered
19/08/2025
Date last updated
19/08/2025
Date data sharing statement initially provided
19/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Chiropractic Care on Gene Expression and Pain in People with Non-Specific Low Back Pain
Scientific title
Investigating the Role of Chiropractic Care in Modulating Gene Expression and Pain in People with Non-Specific Low Back Pain: A Randomized Controlled Study
Secondary ID [1] 315032 0
None
Universal Trial Number (UTN)
U1111-1326-2533
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific low back pain 338375 0
Condition category
Condition code
Musculoskeletal 334677 334677 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive chiropractic care three times per week for two weeks (six sessions in total), including spinal adjustments performed by a registered chiropractor. A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor with at least five years of clinical experience. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked 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 carried out in this study will be high-velocity, low-amplitude thrusts to the spine or pelvic joints, a standard adjusting technique used by chiropractors. The mechanical properties of chiropractic adjustment have been investigated; and although the actual force applied to the patient's spine 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 and the duration of the thrust is always less than 200 milliseconds. The whole assessment and intervention will take around 15 minutes. Adherence to the intervention will be assessed using clinic attendance records documenting chiropractic visits (sessions attended vs. sessions scheduled).
Intervention code [1] 331630 0
Rehabilitation
Intervention code [2] 331727 0
Treatment: Other
Comparator / control treatment
The participant's head and/or 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 be delivered by a registered 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. The whole assessment and control intervention will take around 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 342351 0
Gene expression profiling by mRNA sequencing
Timepoint [1] 342351 0
In both intervention and control groups, data assessment will be conducted at three-time points: baseline, immediately after the single session of intervention or control, and after the end of the two-weeks of intervention or control. Blood samples will be collected at baseline, after the single session of intervention or control, and again after two weeks of intervention or control to analyze gene expression changes.
Secondary outcome [1] 450462 0
Pain
Timepoint [1] 450462 0
Baseline and after 2 weeks of intervention or control
Secondary outcome [2] 450527 0
Oswestry Disability Index for functional impairment
Timepoint [2] 450527 0
Baseline and after 2 weeks of intervention or control
Secondary outcome [3] 450528 0
Quality of Life
Timepoint [3] 450528 0
Baseline and after 2 weeks of intervention or control

Eligibility
Key inclusion criteria
Participants aged between 20 and 50 years, with chronic non-specific lower back pain (LBP) lasting more than three months will be included. Participants must be able to provide informed consent and be willing to attend the required study sessions and comply with the intervention protocols.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant individuals or those planning pregnancy during the study period.
People with specific diagnoses related to their lower back pain, such as herniated discs, fractures, or previous spinal surgery.
Individuals with neurological disorders or other conditions that may interfere with the study outcomes, as well as participants currently undergoing other active treatments that could influence the results (e.g., other chiropractic care or spinal injections).
Those with significant cognitive impairments or disabilities that would prevent participation in the study will be excluded.

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)
The minimizer (Microsoft Corp., Redmond, WA) will create the randomization sequence with a 1:1 allocation to the intervention or control groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
25/08/2025
Actual
Date of last participant enrolment
Anticipated
15/10/2025
Actual
Date of last data collection
Anticipated
7/11/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 27262 0
New Zealand
State/province [1] 27262 0

Funding & Sponsors
Funding source category [1] 319596 0
Other
Name [1] 319596 0
New Zealand College of Chiropractic
Country [1] 319596 0
New Zealand
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
Country
New Zealand
Secondary sponsor category [1] 322097 0
None
Name [1] 322097 0
Address [1] 322097 0
Country [1] 322097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318160 0
Health and Disability Ethics Committee
Ethics committee address [1] 318160 0
Ethics committee country [1] 318160 0
New Zealand
Date submitted for ethics approval [1] 318160 0
14/05/2025
Approval date [1] 318160 0
12/06/2025
Ethics approval number [1] 318160 0
2025 EXP 23090

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

Contacts
Principal investigator
Name 143306 0
Dr Imran Amjad
Address 143306 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 143306 0
New Zealand
Phone 143306 0
+64 2108906707
Fax 143306 0
Email 143306 0
[email protected]
Contact person for public queries
Name 143307 0
Imran Amjad
Address 143307 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 143307 0
New Zealand
Phone 143307 0
+64 2108906707
Fax 143307 0
Email 143307 0
[email protected]
Contact person for scientific queries
Name 143308 0
Imran Amjad
Address 143308 0
New Zealand College of Chiropractic 6 Harrison Road Mount Wellington Auckland 1060
Country 143308 0
New Zealand
Phone 143308 0
+64 2108906707
Fax 143308 0
Email 143308 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.