Muscle Loss Post Anterior Cruciate Ligament Reconstruction
Conditions
Keywords
Pulsed electromagnetic field, Anterior cruciate ligament reconstruction, Muscle
Brief summary
This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction surgery. Half of the participants will receive the PEMF therapy in combination with standard rehabilitation programme, while the other half will receive sham therapy in combination with standard rehabilitation programme.
Detailed description
This is a single-site, randomized, double-blinded, prospective pilot study of the effectiveness of once-weekly PEMF therapy in the promotion of muscle maintenance following ACL reconstruction surgery. Eligible subjects will be randomized in a 1:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device, in addition to the standard rehabilitation regimen.
Interventions
Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Field (PEMF) once a week for a total of 16 weeks. The PEMF device produces pulsed magnetic fields at flux densities up to 1 mT peak.
DEVICESham Therapy
Participants of this arm will be exposed to 10 minutes of sham therapy once a week for a total of 16 weeks. The Sham device is identical to the PEMF device in physical appearance.
Sponsors
National University of Singapore
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have undergone unilateral first-time athroscopic reconstruction with single bundle hamstring graft using both transtibial and transportal techniques for rupture anterior cruciate ligament * Informed consent signed
Exclusion criteria
* Subjects requiring concomitant knee ligament reconstruction * Subjects having other than hamstring graft for the ACL reconstruction * Subjects with history of cardiac, neurological, and rheumatological diseases, and previous lower limb surgery/ fracture * Subjects with Leg circumference \> 63 cm * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Volume | Week 1 and Week 16 post-ACL reconstruction | % change in muscle volume at the end of 16 weeks compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps strength | Baseline and Week 8, 12, 16 post-ACL reconstruction | Quadricep strength (Ib) measurement by dynamometer |
| Knee and thigh circumference | Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction | Measurement of knee girth (cm) from mid portion of the patella and thigh girth (cm) 5 cm above from the superior border of the patella |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Week 16 post-ACL reconstruction | Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 subscales: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. |
Countries
Singapore
Outcome results
None listed