Treatment of Medial Tibial Stress Syndrome using anInvestigational Lower Leg Device. A RandomisedControlled Trial.

Not Applicable

Completed

• Conditions: Medial tibial stress syndrome; Physical Medicine / Rehabilitation - Physiotherapy; Musculoskeletal - Other muscular and skeletal disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12620000906954
• Lead Sponsor: William McNamara

Brief Summary

Comparison of MTSS Severity Scores between groups from 5-24 weeks demonstrated a significantly lower score in the device group (p < 0.03). Comparison within the placebo group did not demonstrate a statistically significant difference at any time point (p > 0.05) and the device group yielded a significant reduction in MTSS severity from 0-5 weeks (p < 0.03), 0 to 12 weeks (p < 0.03), and 0-24 weeks respectively (p < 0.03). Ordinal logistic regression analysis did not identify any significant confounders.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-31
• Study Start: 2020-09-14
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

•Symptomatic medial tibial stress syndrome of at least 6 weeks duration, diagnosed on the basis of:
oHistory of diffuse, dull shin pain that is associated with exercise,
oPalpable 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified