Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000260527
Ethics application status
Approved
Date submitted
13/02/2024
Date registered
15/03/2024
Date last updated
15/03/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted care for chronic plantar heel pain: Shockwave therapy for bone marrow lesions (the BALSA trial)
Scientific title
Efficacy of shockwave therapy for pain in participants with a bone marrow lesion phenotype of chronic plantar heel pain: the BALSA trial.
Secondary ID [1] 311466 0
nil known
Universal Trial Number (UTN)
U1111-1303-7626
Trial acronym
BALSA (Bone mArrow Lesions and ShockwAve)
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
chronic plantar heel pain 332769 0
Condition category
Condition code
Musculoskeletal 329488 329488 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Shockwave & advice
Three sessions of radial shockwave, directed at the plantar calcaneus, will be provided at weekly intervals, delivered using the same branded machine (EMS Swiss DolorClast Master Touch). Shockwave application will be directed to the most painful aspect of the plantar heel, marked prior to application with an indelible pen.

Treatment will be tailored to the participant as is standard clinical practice, but must deliver a total minimum energy dose of at least 1000 mJ/mm^2 (minimum 2000 pulses, frequency to max 4Hz, energy 0.02 to 0.33mJ/mm^2). Each session will last less than 20 minutes and details of treatment (machine settings, total session energy dose, maximum energy intensity, participant response) will be recorded on a treatment log for each participant.
As there is a dose response relationship with energy delivered during shockwave application, the clinician is instructed to deliver the highest tolerable dose. If participants do not receive the minimum dose across the 3 sessions, a 4th ‘top-up’ session will be offered. If a top-up session is required, this will be matched with a top-up session to an equal number of participants in the sham group. Sessions will be booked in consecutive weeks in advance however we will allow missed sessions to be caught up with treatment gaps not exceeding 2 weeks.

An advice sheet designed specifically for this trial detailing flare management, post treatment session advice, footwear and simple activity recommendations will be provided to both groups.
Intervention code [1] 327916 0
Treatment: Devices
Comparator / control treatment
Sham shockwave & advice
Three sessions of radial shockwave, delivered at weekly intervals for a total of 3 sessions, at a placebo dose of total energy 6.0mJ/mm^2 (100 pulses, 1Hz, energy flux 0.02mJ/mm^2). To maintain blinding, participants will perceive energy delivery at this dose, and set up, instructions, advice and exposure time to the intervention are closely matched to the active treatment. Clinician interaction during delivery will be standardised and they will be instructed to manipulate energy settings through the session to preserve the notion of individualised care. Other staff at the test site will be unaware of allocation, and only the treating clinician will handle the machine which will be out of direct sight of the participant due to prone positioning and curtaining off of the lower body. Attendance and any participant response will be recorded on a treatment log.

An advice sheet designed specifically for this trial detailing flare management, post treatment session advice, footwear and simple activity recommendations will be provided to both groups.
Control group
Placebo

Outcomes
Primary outcome [1] 337292 0
Pain
Timepoint [1] 337292 0
Baseline, 4 months (primary endpoint) & 12-months post-baseline assessment.
Secondary outcome [1] 431364 0
Foot related physical function
Timepoint [1] 431364 0
Baseline, 4- & 12-months post-baseline assessment.
Secondary outcome [2] 431365 0
Global rating of change- pain.
Timepoint [2] 431365 0
4 and 12-months post-baseline assessment.
Secondary outcome [3] 431366 0
Change in size of bone marrow lesion size (mm^2)
Timepoint [3] 431366 0
BML areal size measured at baseline and 4-months post-baseline assessment.
Secondary outcome [4] 431367 0
Quality of life
Timepoint [4] 431367 0
Baseline, 4- & 12-months post-baseline assessment.
Secondary outcome [5] 431369 0
Safety
Timepoint [5] 431369 0
4- & 12-months post-baseline assessment and monitored continuously in-between.
Secondary outcome [6] 432255 0
Global rating of change- activity and participation.
Timepoint [6] 432255 0
4- & 12-months post-baseline assessment.

Eligibility
Key inclusion criteria
Inclusion: (i) aged >=18yrs, (ii) pain under the heel on most days aggravated by weightbearing, for at least 3 months, (iii) pain level > 30 on a 100mm pain visual analogue scale (VAS, 0 no pain, 100 worst possible pain), (iv) plantar calcaneal BML on T2w sagittal MRI > 22mm^2 (22mm^2 is the Least Significant Change, as calculated from our preliminary data).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: (i) other lower limb pain or injury affecting mobility or participation in the past 3 months, (ii) past foot surgery or fracture involving the ankle, hind or midfoot, excluding avulsion injuries confirmed on X-ray, (iii) injection into the heel in last 3 months (iv) previous shockwave treatment, (v) diabetes or inflammatory disease, (vi) fibromyalgia, (vii) contraindication to MRI^, (viii) currently receiving professional treatment*, (ix) lower limb neurological disease, (x) vascular disease affecting lower limbs, (xi) sciatica in last 6 months, (xii) contraindication to having shockwave treatment (Table 1), (xiii) past or current bisphosphonate use, and (xiv) unwilling or unable to commit to full treatment course or complete questionnaires online.
*Discontinuing current treatment with a 2-week washout for non-steroidal anti-inflammatory use, 6-weeks for glucocorticoid use, or 3-week wash-out for conservative professional interventions such as manual therapy, would void this exclusion. Participants who maintain a stable approach in the preceding 6 weeks to ongoing self-administered treatments such as footwear or orthotic use or exercise, may continue with those interventions and maintain eligibility.
^Although not an absolute contra-indication, we will exclude pregnant participants. If there is any doubt about pregnancy status we will request participants undergo a urine pregnancy screening test before proceeding to MRI.


Table 1. Contraindications to shockwave therapy
Anti-coagulant therapy, haemhorrhagic conditions
Local infection
Wound/ skin lesions
Malignancy
Impaired circulation/ ischaemic conditions
Prosthetic device in treatment area

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)
A blinded study assistant will generate the allocation schedule off-site. The participant and treating staff will be informed of allocation by telephone after baseline measures have been collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation block randomised in groups of 6, using REDCap.
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
Effects on the primary outcome of change in FHSQ pain at 4- and 12-months from baseline will be determined by linear mixed models with group allocation, time and their interaction as fixed effects, and participant ID as a random effect.
Our primary and secondary analyses will be intention-to-treat, however we will also conduct a secondary per protocol analysis for study participants who receive the targeted total energy dose of 1000mJ/mm2 for the primary outcome of pain at 4 months. To preserve blinding, analyses will be conducted on the 4 and 12-month data only once the final 12-month data is collected.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 42004 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 315750 0
Charities/Societies/Foundations
Name [1] 315750 0
Royal Hobart Hospital Research Foundation
Country [1] 315750 0
Australia
Primary sponsor type
University
Name
Menzies Institute for Medical Research, University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 317864 0
None
Name [1] 317864 0
Address [1] 317864 0
Country [1] 317864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314609 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 314609 0
http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu
Ethics committee country [1] 314609 0
Australia
Date submitted for ethics approval [1] 314609 0
13/02/2024
Approval date [1] 314609 0
26/02/2024
Ethics approval number [1] 314609 0
29837

Summary
Brief summary
Up to 50% of people with chronic plantar heel pain have a bone marrow lesion (BML) in the calcaneus. Calcaneal bone marrow lesions are high signal lesions on MRI that are associated with having chronic plantar heel pain and with poorer longer-term pain and function outcomes. Shockwave therapy is an approved therapeutic device in Australia for treating musculoskeletal pain, including plantar heel pain. It emits high levels of acoustic energy that has been shown to improve pain and shrink bone marrow lesions at other body sites, but it has never been tested for its effect on pain in people with a bone marrow lesion sub-type of chronic plantar heel pain. The primary aim of this study therefore is to determine whether shockwave therapy is effective at improving pain in a BML-positive subgroup of participants with chronic plantar heel pain.
Ninety participants will be randomly allocated to either an active or sham shockwave group (45 per arm), each receiving one treatment per week over three weeks. Pain will be assessed by validated questionnaire at baseline, 4- and 12-months to determine if shockwave is effective at reducing pain. Secondary measures for physical function and quality of life will be assessed at baseline, 4- and 12-months and perception of global rating of change assessed at 4- and 12-months. As an exploratory analysis BML size will be measured by MRI at baseline and 4-months to determine if change in BML is associated with change in pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132166 0
Dr Jason Rogers
Address 132166 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart TAS 7000
Country 132166 0
Australia
Phone 132166 0
+61 3 6220 8525
Fax 132166 0
Email 132166 0
jason.rogers@utas.edu.au
Contact person for public queries
Name 132167 0
Jason Rogers
Address 132167 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart TAS 7000
Country 132167 0
Australia
Phone 132167 0
+61 3 6220 8525
Fax 132167 0
Email 132167 0
jason.rogers@utas.edu.au
Contact person for scientific queries
Name 132168 0
Jason Rogers
Address 132168 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart TAS 7000
Country 132168 0
Australia
Phone 132168 0
+61 3 6220 8525
Fax 132168 0
Email 132168 0
jason.rogers@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-re-identifiable individual participant outcome data, including composite scores for all covariates and additional measures.
When will data be available (start and end dates)?
After publication, with no end-date specified.
Available to whom?
Mediated access will be made available on reasonable request to researchers who provide a study plan for intended use.
Available for what types of analyses?
IPD meta-analyses, any other approved purpose as outlined in the access request.
How or where can data be obtained?
Access to data will be mediated by the study PI (jason.rogers@utas.edu.au), provided via the University of Tasmania's Research Data Portal. This portal enables access to a Creative Commons licensed, searchable and metadata labelled database.


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.