Targeted care for chronic plantar heel pain: Shockwave therapy for bone marrow lesions (the BALSA trial)
- Conditions
- chronic plantar heel painMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12624000260527
- Lead Sponsor
- Menzies Institute for Medical Research, University of Tasmania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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 PD-FS sagittal MRI > 22mm^2 (22mm^2 is the Least Significant Change, as calculated from our preliminary data).
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain[Foot health status questionnaire pain sub scale Baseline, 4 months (primary endpoint) & 12-months post-baseline assessment.]
- Secondary Outcome Measures
Name Time Method