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Anterior cruciate ligament (ACL) tear is common. It accounts for over 50% of all knee injuries. Anterior cruciate ligament reconstruction (ACLR) with hamstring tendon (HT) autograft is the common graft choice for ACLR. However, the outcomes of donor site healing and recovery of muscle strength of HT are not satisfactory, resulting in hamstring muscle weakness and hamstring strength deficit during deep knee flexion, which may lead to hamstring strain after ACLR. Moreover, activation of the hamstring muscle is vital for maintaining dynamic knee joint stability and preventing excessive ACL shear forces. The presence of hamstring muscle deficits after surgery therefore affects the function of the reconstruction ACL. A previous study has reported that the hamstring muscle showed nearly 20% strength deficit at 4 months after ACLR with hamstring autograft
Pulsed electromagnetic field (PEMF) treatment is a non-invasive therapy that has been shown to enhance muscle cell activity and accelerate tissue repair. In clinic, PEMF treatment has been reported to be safe.
This study aims to conduct a double-blinded, placebo-controlled randomised clinical trial to investigate the effects of PEMF therapy for improving the tissue regeneration and strength of the HT donor site in ACLR patients with HT autograft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEMF treatment | Experimental | Patient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of PEMF exposure in total. |
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| Placebo treatment | Placebo Comparator | Patient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of placebo exposure in total. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEMF treatment | Device | Pulsed electromagnetic field (PEMF) therapy is an emerging modality for the treatment of musculoskeletal disorders. Time-varying magnetic pulses are generated by passing an electrical current through a coil. PEMF has been shown to be effective in vitro and in vivo studies for tissue repair and accelerating muscle regeneration. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Isokinetic Test | The Cybex dynamometer will be used to test the hamstring muscle strength. | Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months |
| Isokinetic Test | The Cybex dynamometer will be used to test the hamstring muscle strength. | Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 6 months |
| Isokinetic Test | The Cybex dynamometer will be used to test the hamstring muscle strength. | Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Shatin | Hong Kong |
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| Placebo treatment | Device | In this study the placebo group uses the same PEMF machine, but it does not generate any electrical current that have treatment effect. As the active PEMF device does not produce heat or cause any sensation to the tissue, participants are blinded to the treatment. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes. |
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