The effectiveness of Pulsed Electromagnetic Field in the treatment of medial tibial stress syndrome: a pilot study.
Completed
- Conditions
- periostitisshin splints10005959
- Registration Number
- NL-OMON36565
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Physical active men and women between 18 and 45 years of age, with MTSS (complaints > 6 weeks).
Exclusion Criteria
- tibial stress fracture
- chronic compartment syndrome
- lower extremity neurovascular disease
- the use of anticoagulant drugs or corticosteroids
- pregnancy
- the use of pacemaker or insulin pump
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Pain experience 3 weeks, 6 weeks, 3 months, and 6 months after inclusion<br /><br>(NRS).<br /><br>- Degree of restrictions caused by MTSS in sportactivity, daily life and<br /><br>work/education 3 weeks, 6 weeks, 3 months, and 6 months after inclusion (on a<br /><br>5-point Liker scale).<br /><br>- Degree of recovery compared with baseline 3 weeks, 6 weeks, 3 months, and 6<br /><br>months after inclusion (on a 6-point Liker scale).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- standard deviation of the primary out outcome measure, which is needed to<br /><br>estimate sample size in main study<br /><br>- willingness of participants to be randomized,<br /><br>- number of eligible patients,<br /><br>- characteristics of the proposed outcome measure,<br /><br>- follow-up rates, response rates to questionnaires, and adherence/compliance<br /><br>rates<br /><br>- Comfort, side effects of PEMF device</p><br>