None listed
Conditions
Brief summary
Background: Medial tibial stress syndrome affects 4-20% of the population with increased incidence in athletes and the military. It has a complex aetiology of bone loading and fascial traction and is often difficult to treat. Stretching, calf strengthening, load management and rest have shown benefit, however, there remains a group of patients who do not benefit from these methods and for many athletes and military personnel prolonged rest is not ideal. Hypothesis: The purpose of this study was to examine the effect of an investigational device on MTSS symptoms compared to a placebo. Study Design: A prospective double-blinded randomised placebo-controlled trial. Methods: Included participants were those with symptomatic MTSS lasting 6 weeks or more. Excluded were those with other lower limb or systemic pathologies. Fourteen participants formed the study cohort. Participants were required to wear the devices daily for up to 2hrs, before and after exercise. Additional treatment modalities were recorded. The primary outcome was a MTSS Severity Score at the initial assessment and 1-6, 8, 12, and 24 weeks. Secondary outcomes were return to activity, exercise frequency and device usage data collected at the same time points.
Interventions
The purpose of this study was to determine whether current MTSS treatment methods with an adjuvant novel device are more effective in treating MTSS pain symptoms than the current treatment methods without the device.
The investigational device is an external orthosis comprised of a calf sleeve with 3 rubber ellipsoids that compressed the musculotendinous junctions of the soleus muscle with the aid of circumferential elastic strapping (posterior to fibular head, mid-diaphysis of posteromedial ti
The purpose of this study was to determine whether current MTSS treatment methods with an adjuvant novel device are more effective in treating MTSS pain symptoms than the current treatment methods without the device. The investigational device is an external orthosis comprised of a calf sleeve with 3 rubber ellipsoids that compressed the musculotendinous junctions of the soleus muscle with the aid of circumferential elastic strapping (posterior to fibular head, mid-diaphysis of posteromedial tibia, Achilles tendon). Another rubber component in the shape of a 10cm rod compressed the posteromedial border of the distal one-third of the tibia. It is therefore applied like a sock reaching from proximal tibial to distal tibia, it is worn up to 2hrs at a time before exercise and up to 2hrs after exercise each day and up to 4hrs in 2x2hr periods on days where no exercise takes place. Participants in the study completed weekly diaries that recorded device usage in detail. They wore the device and recorded device usage over a 6 month period. Participants already engaging in treatment for their MTSS were not discouraged from continuing these activities. These included stretching and calf strengthening exercises, dry needling, rest, icing, orthotics for shoes. These were administered according to the physicians treating the patients prior to the study.
Sponsors
William McNamara
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Symptomatic medial tibial stress syndrome of at least 6 weeks duration, diagnosed on the basis of: o History of diffuse, dull shin pain that is associated with exercise, o Palpable tenderness of the posteromedial tibial border
Exclusion criteria
• Diagnosis of stress fracture in the previous 6 months • Clinical suspicion of a current stress fracture due to localised point tenderness on the anterior or medial border of the tibia unless ruled out by an MRI (MRI negative for bone stress reaction) • Signs of plantar fasciitis including heel pain on first steps in the morning and tenderness to palpation over the posteromedial calcaneal tuberosity • Previous diagnosis of compartment syndrome • Suspicion of chronic exertional compartment syndrome on the basis of history of shin or calf pain brought on at a predictable point in activity, that worsens if exercise continues and is relieved by rest, unless excluded with compartment pressure testing • Clinical signs of complex regional pain syndrome including pain out of proportion to the inciting event, allodynia, hyperalgesia, diffuse oedema, skin changes and difference in temperature between limbs • Previous diagnosis of popliteal artery entrapment syndrome • Clinical suspicion of popliteal artery entrapment syndrome based on disappearance of pedal pulses on repetitive plantarflexion • Clinical suspicion of radicular leg pain including history of back pain associated with the leg pain and/or reproduction of leg pain on SLR testing with added dorsiflexion • Neurological disease affecting the lower leg • Coagulation disease • Pregnancy
Outcome results
None listed