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Trial registered on ANZCTR


Registration number
ACTRN12620000356965p
Ethics application status
Not yet submitted
Date submitted
24/02/2020
Date registered
12/03/2020
Date last updated
12/03/2020
Date data sharing statement initially provided
12/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined Chiropractic and Podiatric Treatment for Chronic Low Back Pain in Adults with Collapsed Arch in One Foot:
Protocol for a Multicentre Pilot Randomised Controlled Trial.
Scientific title
Combined Chiropractic and Podiatric Treatment for Adult Chronic Low Back Pain Concomitant with Unilateral Hyperpronation of the Foot: Protocol for a Multicentre Pilot Randomised Controlled Trial.
Secondary ID [1] 300637 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CHIROPOD Trial (combined CHIROpractic and PODiatric treatment for low back pain Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 316415 0
Foot Hyperpronation 316416 0
Condition category
Condition code
Musculoskeletal 314672 314672 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multimodal chiropractic treatment provided by a chiropractor, of at least 3 years' clinical experience, comprising of any combination of the following: lumbar and thoracic manipulation (such as diversified or Thompson drop-piece maneuvers), mobilization, massage, application of heat to the spine and prescription of stretching or strengthening (isometric and/or isotonic) exercise to be performed at home. The exact choice of chiropractic treatment combination as well as the intensity and duration of any exercises that may be prescribed will depend on the clinical judgement of the chiropractic clinician. Treatment will take 4 weeks of three sessions per week. The above chiropractic treatment will be provided PLUS Podiatric treatment comprising of: custom-made orthotic treatment, as fabricated and fitted by a qualified podiatrist for 4 weeks. (briefly, a mould will be made of both of the participants' feet and used to construct custom-made orthoses to be worn as insoles). The participants will be instructed to use the orthoses in every pair of shoes that they wear during the day (with the exception of flip-flops). The podiatric treatment will be provided by a podiatrist of at least 3 years' clinical experience. Treatments will be administered one-on-one at the chiropractic or the podiatric clinic. Those receiving the combined chiropractic and podiatric treatment will be asked at every chiropractic visit to report for how many days they had worn the orthotics in the previous week.
Intervention code [1] 316964 0
Rehabilitation
Intervention code [2] 316965 0
Treatment: Devices
Comparator / control treatment
Multimodal chiropractic treatment comprising of any combination of the following: lumbar and thoracic manipulation, mobilization, massage, application of heat to the spine and prescription of stretching or strengthening exercise to be performed at home. Treatment will take 4 weeks of three sessions per week.
Control group
Active

Outcomes
Primary outcome [1] 322997 0
Feasibility as assessed by recruitment rate determined by percentage of consented versus individually approached participants.
Timepoint [1] 322997 0
Conclusion of treatment. (End of week 4)
Primary outcome [2] 322998 0
Rolland Morris Disability Questionnaire
Timepoint [2] 322998 0
Conclusion of the treatment period (End of week 4 of treatment)
Secondary outcome [1] 380487 0
Pain (NRS-11 Score)
Timepoint [1] 380487 0
Immediately following the end of the treatment period (End of week 4 of treatment)
Secondary outcome [2] 380488 0
Satisfaction with Treatment (5 point scale)
Timepoint [2] 380488 0
Immediately following the end of the treatment period (End of week 4 of treatment)
Secondary outcome [3] 380489 0
Harms (Subjective report by participants)
Timepoint [3] 380489 0
Immediately following the end of the treatment period (End of week 4 of treatment)

Eligibility
Key inclusion criteria
Non-specific low back pain of at least three-months duration; Unilateral foot hyperpronation of +6 score on Foot Posture Index (FPI); and dorsiflexion of the ipsilateral ankle of less than 10 degrees. Radiographic examination of the relative heights of the femoral heads at baseline in standard lumbopelvic views will need to demonstrate that the shorter leg is ipsilateral to the hyper-pronated foot.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
specific pathologies that may cause back pain such as internal organ disease, active inflammatory spondylo-arthropathies osteomyelitis and spinal tumours; recent spinal trauma or surgery; detection of a shorter leg contralateral to unilateral foot hyperpronation; lumbar spinal manipulation in the previous six months; radicular leg pain; diagnosed foot pathology (other than functional hyper-pronation) including trauma structural deformities or +6 score (or above) on FPI in both feet; and any previous fitting or use of orthotics.

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)
Group allocations will be concealed from investigators by placing them in opaque, consecutively numbered sealed envelopes. Once participants are determined eligible to participate, the treating clinician will open the envelope and commence treatment according to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants at each site will be randomised using a computer-generated permuted block randomization protocol (blocks of four) to either the single or combined treatment group (i.e. Group A or B).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering 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
Descriptive statistics (frequencies and proportions or means and standard deviations [SDs]) will be used for demographic variables (i.e. age, sex, other musculoskeletal pain, and comorbidities), chronicity of low back pain, and treatment satisfaction. Means and 95% confidence intervals (CIs) will be calculated for RMQD and NRS-11 scores pre- and post-treatment, and for pre/post treatment differences. As this study is not sufficiently statistically powered to investigate treatment efficacy or effectiveness, formal tests of statistical significance will not be conducted. However, any clinically meaningful group differences will be reported. All data analysis will be done using GraphPad Prism 7 for Windows.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16054 0
RMIT Health Sciences Clinic - Bundoora
Recruitment postcode(s) [1] 29455 0
3083 - Bundoora
Recruitment outside Australia
Country [1] 22376 0
Spain
State/province [1] 22376 0
Madrid
Country [2] 22377 0
Spain
State/province [2] 22377 0
Andalucia

Funding & Sponsors
Funding source category [1] 305061 0
University
Name [1] 305061 0
RMIT University
Address [1] 305061 0
School of Health and Biomedical Sciences, RMIT University, Bundoora Campus, Plenty Road, Bundoora VIC 3083
Country [1] 305061 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Azari
Address
Azari Chiropractics P/L
401 Blackburn Rd., Mount Waverley VIC 3149
Country
Australia
Secondary sponsor category [1] 305425 0
Individual
Name [1] 305425 0
Dr Arantxa Ortega de Mues
Address [1] 305425 0
Real Centro Universitario Maria Cristina
Paseo de los Alamillos, 2 28200 San Lorenzo de el Escorial, Madrid, Spain
Country [1] 305425 0
Spain
Secondary sponsor category [2] 305426 0
Individual
Name [2] 305426 0
Dr Aurora Castro Mendez
Address [2] 305426 0
Dpto. de Podologia, Universidad de Sevilla,
Calle San Fernando 4 41004 Sevilla, Spain
Country [2] 305426 0
Spain

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305446 0
Human research ethics committee of Hospital Universitario Fundacion Jimenez Diaz
Ethics committee address [1] 305446 0
Avenido de los Reyes Católicos, 2, 28040 Madrid
Ethics committee country [1] 305446 0
Spain
Date submitted for ethics approval [1] 305446 0
30/03/2020
Approval date [1] 305446 0
Ethics approval number [1] 305446 0

Summary
Brief summary
A variety of different treatments have been found to have similar levels of effectiveness for chronic low back pain (CLBP). Addressing postural abnormalities in both the lower back and the feet in the subpopulation of CLBP cases that also suffer from an un-level back due to fall of the arch in the foot on one side (FSL-UFHP) may prove to be a more effective treatment combination. Through this trial we take the first step in investigating this possibility.
Methods: One hundred and thirty-eight adults with CLBP and FSL-UFHP to be recruited in Melbourne Australia and Madrid and Seville Spain. Forty six participants at each site to be randomized to: a) multimodal chiropractic treatment including spinal manipulation, or b) multimodal chiropractic treatment together with custom-made foot orthoses. Chiropractic visits to comprise of 12 treatments over 4 weeks. Outcome measures to include recruitment, CLBP-related disability (RMQ) and perceived LBP (NRS-11).
Combining multimodal chiropractic treatment with orthoses to correct a functional short leg due to a fallen foot arch may be a promising therapeutic strategy in this subpopulation of CLBP patients, hence deserving rigorous methods of scientific investigation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100418 0
Dr Michael Azari
Address 100418 0
Azari Chiropractics P/L
401 Blackburn Rd., Mount Waverley VIC 3149
Country 100418 0
Australia
Phone 100418 0
+61 432960015
Fax 100418 0
Email 100418 0
AzariChiropractics@gmail.com
Contact person for public queries
Name 100419 0
Dr Michael Azari
Address 100419 0
Azari Chiropractics P/L
401 Blackburn Rd., Mount Waverley VIC 3149
Country 100419 0
Australia
Phone 100419 0
+61 432960015
Fax 100419 0
Email 100419 0
AzariChiropractics@gmail.com
Contact person for scientific queries
Name 100420 0
Dr Michael Azari
Address 100420 0
Azari Chiropractics P/L
401 Blackburn Rd., Mount Waverley VIC 3149
Country 100420 0
Australia
Phone 100420 0
+61 432960015
Fax 100420 0
Email 100420 0
AzariChiropractics@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate unidentified data will be shared to ensure privacy of participant information.
What supporting documents are/will be available?
No other documents available
Summary results
No Results