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Trial registered on ANZCTR


Registration number
ACTRN12617001094369
Ethics application status
Approved
Date submitted
21/07/2017
Date registered
27/07/2017
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Chiropractic and pain sensitivity in people with lower back pain
Scientific title
Effect of chiropractic treatment on pain sensitivity in people with lower back pain
Secondary ID [1] 292498 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 304129 0
Condition category
Condition code
Musculoskeletal 303461 303461 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The initial visit will involve randomisation to receive either an active intervention or sham. The active intervention is a single high-velocity low-amplitude lumbar manipulation targeting the L5-S1 facet joint on the participant's most symptomatic side. The participant will be in the side-lying position, with the upper leg bent and lower leg straight. The clinician will contact the target joint with their hand, and stabilise the participant at the shoulder and knee. The clinician will then deliver a rapid and short thrust into the joint into the joint. A “cracking” or “popping” noise may be heard during the SMT. This will take approximately 1 minute to complete, and will be delivered in a private research room, on a chiropractic examination table, by a chiropractor with a minimum of 3 years clinical experience. Several chiropractors will deliver these interventions, and will receive training to standardise techniques and participant interaction, in the form of a single 30-60 minute small group workshop run by a researcher who is also a chiropractor.
At each of 3 follow-up visits, the intervention is a pragmatic chiropractic treatment (not randomised) involving a combination of mid and lower back spinal manipulation, spinal mobilisation, soft tissue therapy, education, and advice as appropriate for the individual participant. The specific treatment approach will be determined based on the participant's history and physical examination. The follow-up treatments are expected to take 10-15 minutes, and are intended to replicate an evidence-based private practice chiropractic treatment. These will be delivered by a researcher who is a chiropractor with >3 years clinical experience, and each of the 3 follow-up visits will occur within 4-10 days of the previous visit. Treatment notes will be kept at each follow-up visit, recording symptomatic change, physical examination findings, specific treatments delivered, and advice provided.
Intervention code [1] 298675 0
Treatment: Other
Comparator / control treatment
At the initial visit, lumbar manipulation will be compared against a sham manipulation which involves similar positioning but without a thrust to the spine. This will be delivered by trained chiropractors with >3 years' clinical experience. No sham interventions will be delivered at the follow-up visits.
20 healthy volunteers (without a history lower back pain) will not receive an intervention, undergoing baseline measures only.
Control group
Placebo

Outcomes
Primary outcome [1] 302832 0
Pressure pain threshold at the deltoid, lumbar paraspinals, & gastrocnemius bilaterally. This will be measured using a digital pressure algometer with a 1cm2 rubber probe (Wagner FPIX 50, USA).
Timepoint [1] 302832 0
Initial visit: baseline, immediately following intervention, after 15 minutes & after 30 minutes.
Follow-up visits (each at 4-10 day intervals): baseline.
Primary outcome [2] 302833 0
Temporal sensory summation at palmar hands & plantar feet. This will be measured using a semi-sharp pinprick device (Neuropen with Neurotips, Owen Mumford).
Timepoint [2] 302833 0
Initial visit: baseline, immediately following intervention, after 15 minutes & after 30 minutes.
Follow-up visits (each at 4-10 day intervals): baseline.
Secondary outcome [1] 337191 0
Modified Global Back Recovery Scale to measure improvement (or worsening) of subjective lower back pain on a scale from -5 to +5.
Timepoint [1] 337191 0
30 minutes after initial intervention, roughly 24 hours after initial visit, at beginning of each follow-up visit (each at 4-10 day intervals).
Secondary outcome [2] 337192 0
Modified Back Pain Inventory, specifically a 4-item subjective pain intensity questionnaire on lower back pain over the previous 24 hours.
Timepoint [2] 337192 0
Baseline, roughly 24 hours after the initial visit, at beginning of each follow-up visit (each at 4-10 day intervals).

Eligibility
Key inclusion criteria
For symptomatic participants: history of LBP in the previous 12 months
For healthy participants: no history of LBP in the previous 12 months
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Are a current chiropractic student or chiropractor (not relevant for healthy participants)
2. Have had spinal manipulation within the previous 6 days
3. Skin condition at pain sensitivity testing site
4. Any absolute or pertinent relative contraindications to mid or lower back manipulation
5. Have active “pinching” of mid or lower back spinal nerves, neurological symptoms, or a neurological condition (e.g. stroke, multiple sclerosis, Parkinson’s syndrome)
6. Have fibromyalgia or chronic widespread pain
7. Have an inflammatory joint condition (e.g. rheumatoid arthritis)
8. Have a bleeding disorder or take anticoagulant medication (e.g. warfarin) [does not include low-dose aspirin]
9. Have had pain-relieving medication, more than 2 standard drinks of alcohol, or recreational drugs in the previous 24 hours

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)
The clinician providing the intervention at the initial visit will randomise the participant to one of two groups with the use of sequentially numbered, sealed, opaque envelopes containing randomised 1s or 2s. Group one will receive a lumbar manipulation and group two will receive a sham lumbar manipulation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The ones and twos will be generated and placed into the sequential envelopes using an online random number generator with 1:1 allocation, by a researcher not involved in data collection (http://www.graphpad.com/quickcalcs/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
After the initial visit, the study becomes observational only, with active interventions provided to all participants.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on a study by Waller et al. 2015, to see a 15% change (effect size 0.64) in pressure pain threshold at the lumbar spine, based on 80% power and with alpha at 5%, a sample size of 40 per intervention group (80 total) will be required. An additional 20 healthy volunteers (no lower back pain) will be required at baseline.
This also satisfies sample size calculations for the other primary outcome measure, and for the observational studies also planned using the data from this trial.
Data analysis is planned as a repeated measures ANOVAs with factors of time and group. The data will also be analysed based on subjective lower back pain features and psychosocial questionnaires. Pearson's correlation and multiple regression are planned for observational data. A biostatistician will assist in choosing and running appropriate analyses.

Recruitment
Recruitment status
Completed
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)
WA

Funding & Sponsors
Funding source category [1] 297068 0
University
Name [1] 297068 0
Murdoch University
Address [1] 297068 0
90 South St
Murdoch WA
6150
Country [1] 297068 0
Australia
Primary sponsor type
University
Name
School of Health Professions, Murdoch University
Address
90 South St
Murdoch WA
6150
Country
Australia
Secondary sponsor category [1] 296072 0
None
Name [1] 296072 0
Address [1] 296072 0
Country [1] 296072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298249 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 298249 0
Murdoch University
90 South St
Murdoch WA
6150
Ethics committee country [1] 298249 0
Australia
Date submitted for ethics approval [1] 298249 0
20/07/2017
Approval date [1] 298249 0
05/09/2017
Ethics approval number [1] 298249 0

Summary
Brief summary
This study is a randomised trial looking at how pressure pain threshold and temporal sensory summation change following lumbar spinal manipulative therapy, by comparing this to a sham treatment. It also aims to look at how pain sensitivity differs between people with and without lower back pain, depending on the severity of lower back pain, and based on how they respond to treatment. We will recruit 80 participants with lower back pain, who will randomly receive either a lumbar or sham manipulation. Pain sensitivity will then be measured at various areas of the body for 30 minutes. Participants will then return for 3 additional visits, where pain sensitivity will be measured again before receiving a real treatment, involve manipulation, mobilisation, and soft tissue therapy as deemed appropriate for that participant. 20 healthy volunteers without lower back pain will also have their pain sensitivity measured, but will not receive treatment.
Trial website
http://www.murdoch.edu.au/School-of-Health-Professions/Our-Research/Back-Pain-Study/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76470 0
A/Prof Bruce F Walker
Address 76470 0
Murdoch University
90 South St
Murdoch WA
6150
Country 76470 0
Australia
Phone 76470 0
+61 8 9360 1297
Fax 76470 0
Email 76470 0
bruce.walker@murdoch.edu.au
Contact person for public queries
Name 76471 0
Ms Sasha L Aspinall
Address 76471 0
Murdoch University
90 South St
Murdoch WA
6150
Country 76471 0
Australia
Phone 76471 0
+61 8 9360 2114
Fax 76471 0
Email 76471 0
s.dorron@murdoch.ed.au
Contact person for scientific queries
Name 76472 0
Ms Sasha L Aspinall
Address 76472 0
Murdoch University
90 South St
Murdoch WA
6150
Country 76472 0
Australia
Phone 76472 0
+61 8 9360 2114
Fax 76472 0
Email 76472 0
s.dorron@murdoch.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary