Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001273370p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
1/10/2026
Date registered
Help: Date registered
23/10/2026
Date last updated
Help: Date last updated
23/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of the Feasibility of a Chiropractor-Led Boot Camp Program for Older Adults with Lumbar Spinal Stenosis
Scientific title
A study of the feasibility of a chiropractor-led lumbar spinal stenosis boot camp program for older adults with lumbar spinal stenosis
Additional trial identifiers [1] 318568 0
Contract ID: 2026770021
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Lumbar Spinal Stenosis 343764 0
Condition category
Condition code
Musculoskeletal 339892 339892 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 339993 339993 0 0
Physiotherapy
Public Health 339994 339994 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is a chiropractor-led conservative management program for older adults with lumbar spinal stenosis (LSS) and neurogenic claudication, based on the established LSS Boot Camp model created by Chiropractor Carlo Ammendolia. Participants will complete a structured 6-week program comprising 12 treatment visits (two visits [30-40 minutes each] per week for 6 weeks) delivered at the Macquarie University Chiropractic Clinic within Macquarie University Health. The program is delivered within an integrated tertiary spine care environment that supports collaboration and referral pathways between chiropractors, general practitioners, spine surgeons, neurologists, and other healthcare professionals.

The intervention includes both passive and active treatment components delivered according to a standardised treatment manual. The passive component consists of patient education (ergonomic and postural advice), reassurance, manual therapy, spinal manipulative therapy, joint mobilisation, soft tissue therapies, and stretching delivered by trained chiropractors. The active component consists of a home-based, low-moderate intensity, exercise program including stretching, strengthening, and aerobic exercises (e.g. stationary bike) lasting 10-40 minutes daily for 6 weeks, together with self-management strategies such as ergonomic and postural advice. Treatment is individualised to the participant's clinical presentation while maintaining fidelity to the standardised protocol.
Intervention code [1] 335474 0
Treatment: Other
Intervention code [2] 335475 0
Rehabilitation
Description of the comparator or control
Non-control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 347072 0
Recruitment rate
Timepoint [1] 347072 0
Continuously throughout the recruitment period; assessed at study completion (approximately 18 months after recruitment commences).
Primary outcome [2] 347073 0
Eligibility rate
Timepoint [2] 347073 0
Continuously throughout the recruitment period; assessed at study completion (approximately 18 months after recruitment commences).
Primary outcome [3] 347074 0
Consent rate
Timepoint [3] 347074 0
Continuously throughout the recruitment period; assessed at study completion (approximately 18 months after recruitment commences).
Secondary outcome [1] 468781 0
Participant retention rate
Timepoint [1] 468781 0
Week 12 (12-week follow-up assessment).
Secondary outcome [2] 468782 0
Adverse events and safety (Composite outcome)
Timepoint [2] 468782 0
Assessed continuously throughout the 6-week intervention period and at the 12-week follow-up assessment.
Secondary outcome [3] 468783 0
Swiss Spinal Stenosis Questionnaire - Symptom Severity Subscale
Timepoint [3] 468783 0
Baseline (Week 1), end of treatment (Week 6), and follow-up (Week 12).
Secondary outcome [4] 468784 0
Treatment adherence
Timepoint [4] 468784 0
Assessed throughout the 6-week intervention period and summarised at Week 6 (end of treatment).
Secondary outcome [5] 468786 0
Data completeness
Timepoint [5] 468786 0
Assessed at Week 12.
Secondary outcome [6] 468787 0
Acceptability of the Lumbar Spinal Stenosis Boot Camp Program
Timepoint [6] 468787 0
Semi-structured qualitative interviews will be conducted following completion of the intervention, within 2 weeks of the Week 6 assessment.
Secondary outcome [7] 468788 0
Feasibility of Integrating Chiropractors into Tertiary Spine Care Referral Pathways (Composite outcome)
Timepoint [7] 468788 0
Assessed throughout the study period and summarised at study completion (following completion of participant recruitment, intervention delivery, and follow-up assessments).
Secondary outcome [8] 468789 0
Barriers and Facilitators to Implementation (composite qualitative outcome)
Timepoint [8] 468789 0
Assessed at study completion (approximately 18 months after recruitment commences).
Secondary outcome [9] 468790 0
Walking Capacity
Timepoint [9] 468790 0
Baseline, Week 6, and Week 12.
Secondary outcome [10] 468791 0
Global Assessment of Change
Timepoint [10] 468791 0
Week 6 and Week 12
Secondary outcome [11] 468793 0
Health-Related Quality of Life
Timepoint [11] 468793 0
Baseline, Week 6, and Week 12
Secondary outcome [12] 468794 0
Health Care Utilisation and Associated Costs (composite outcome)
Timepoint [12] 468794 0
Collected prospectively throughout the study and assessed at Week 6 and Week 12.
Secondary outcome [13] 468801 0
Service integration indicators (composite outcome)
Timepoint [13] 468801 0
Assessed at study completion (approximately 18 months after recruitment commences).
Secondary outcome [14] 469223 0
Swiss Spinal Stenosis Questionnaire - Physical Function subscale
Timepoint [14] 469223 0
Baseline (Week 1), end of treatment (Week 6), and follow-up (Week 12).

Eligibility
Key inclusion criteria
Inclusion criteria: Adults (at least 60 years of age); able to read and comprehend information provided in English; previously diagnosed as having LSS with clinical symptoms consistent with neurogenic claudication (leg or buttock pain aggravated by walking/standing and relieved by sitting or spinal flexion and/or recumbency); able to supply magnetic resonance imaging or computed tomography evidence of narrowing of the central canal, lateral recess, and/or foramen; able to walk without assistive devices for at least 20 metres and less than 30 minutes continuously and availability to attend MQ Chiropractic clinic for assessment and treatment.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Individuals not able to read and comprehend information provided in English; prior lumbar decompression/fusion surgery; urgent surgical indications; cauda equina symptoms; inability to complete a self-paced walking test; contraindications to manual therapy or exercise (e.g., cancer, severe cardiac disease, advanced osteoporosis); inability to engage in mild exercise; told by a physician not to engage in physical exercise; psychological or cognitive disorders; neurological disorders unrelated to LSS; and severe co-morbidities precluding participation (e.g., severe hip/knee osteoarthritis limiting walking, cognitive impairment, peripheral vascular disease); or unwillingness to undergo full treatment procedure.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2027
Actual
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
22/09/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 323147 0
Charities/Societies/Foundations
Name [1] 323147 0
Australian Chiropractors' Education and Research Foundation (ACERF)
Country [1] 323147 0
Australia
Funding source category [2] 323219 0
Charities/Societies/Foundations
Name [2] 323219 0
The Chiropractic Alumni (tCa)
Country [2] 323219 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 326105 0
None
Name [1] 326105 0
N/A
Address [1] 326105 0
Country [1] 326105 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321550 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 321550 0
Ethics committee country [1] 321550 0
Australia
Date submitted for ethics approval [1] 321550 0
20/11/2026
Approval date [1] 321550 0
Ethics approval number [1] 321550 0

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

Contacts
Principal investigator
Name 154046 0
Dr Benjamin Brown
Address 154046 0
Department of Chiropractic, Macquarie University, 75 Talavera Rd, Macquarie Park, NSW, 2113
Country 154046 0
Australia
Phone 154046 0
+61424340124
Fax 154046 0
Email 154046 0
[email protected]
Contact person for public queries
Name 154047 0
Dr Benjamin Brown
Address 154047 0
Department of Chiropractic, Macquarie University, 75 Talavera Rd, Macquarie Park, NSW, 2113
Country 154047 0
Australia
Phone 154047 0
+61424340124
Fax 154047 0
Email 154047 0
[email protected]
Contact person for scientific queries
Name 154048 0
Dr Benjamin Brown
Address 154048 0
Department of Chiropractic, Macquarie University, 75 Talavera Rd, Macquarie Park, NSW, 2113
Country 154048 0
Australia
Phone 154048 0
+61424340124
Fax 154048 0
Email 154048 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.