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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008483-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Liverpool University Hospitals NHS Foundation Trust | OTHER_GOV |
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Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and scores in the Timed Up and Go (TUG) test.
Knee osteoarthritis is a severe debilitating condition that greatly impacts patient quality of life, function, emotional well-being and everyday pain levels. Total knee arthroplasty (TKA) is performed as a means of alleviating these symptoms in the long term however short term muscle weakness following surgery can elicit its own detrimental effect on performance and activities of daily living. This underlines the importance of mitigating strength loss in the immediate post-operative period.
Recent reviews suggest that Neuromuscular Electrical Stimulation (NMES) of the quadriceps femoris muscle can be beneficial in the rehabilitation period following knee surgery. It appears that early use of NMES can help to recover exercise capacity in the muscle, thus allowing the patient to benefit more from volitional exercise therapy later in the rehabilitation period1. This in turn can lead to accelerated recovery and improved outcomes. A recent and as yet unpublished study of 96 patients following ACL reconstruction has demonstrated a clear benefit to the use of Kneehab. The benefit seemed to accrue in the six-week post-operative period.
A recent pilot study by Walls 2 also suggests that NMES applied in the immediate pre-operative period before TKA leads to increased muscle strength and improved functional abilities. Previously, Mizner (2005) has shown pre operative strength to be a good predictor of functional outcome 1 year after surgery3. This proposed study aims to examine whether NMES applied in the peri-operative timeframe, 6 weeks before and 6 weeks after, can improve outcomes for patients undergoing total knee replacement. The rationale for this approach is that NMES can help prepare the quadriceps muscle for the rehabilitation phase by building exercise capacity before the operation. The immediate deficit, which normally follows knee surgery, would therefore be compensated to some extent and the post-operative NMES treatment would be expected to counteract the activation inhibition that is thought to occur in the early weeks following surgery. Overall, the patient would be in a better position to benefit from conventional rehabilitation exercises aimed at improved co-ordination and functional performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group standard physiotherapy | Other | Standard pathway of care pre-and post-TKA without using NMES. |
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| Kneehab | Experimental | Kneehab on the quadriceps of the affected leg, 20 minutes, twice per day, 5 days per week over 12-week intervention (6 weeks pre-op, 6 weeks post op). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Physiotherapy | Other | The Control group will complete the standard physiotherapy care pre and post-TKA surgery without NMES. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Kneehab in promoting early recovery of quadriceps performance following knee arthoplasty. | Isometric muscle strength of the knee extensors will be measured by dynamometer with the knee flexed to 60°. Functional ability will be measured using the Timed Get Up and Go (TUG) and Stair Climb Test (SCT). | 6 weeks Pre-Op and 6, 12 and 52 weeks post op. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the effect of Kneehab in promoting quality of life measures and health economic outcomes, compared to controls. | Administration of the Western Ontario McMaster University Osteoarthritis Index (WOMAC) and The Medical Outcomes Survey (SF-12). Health economic data will include patient length of stay post surgery; number of outpatient physiotherapy visits in the following year, and change in analgesic medication use during the 6 weeks pre- and 12 weeks post surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alasdair Santini, M.D. | Royal Liverpool & Broadgreen University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Liverpool and Broadgreen University Hospital NHS Trust | Liverpool | Liverpool | L7 8XP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18201117 | Background | Paillard T. Combined application of neuromuscular electrical stimulation and voluntary muscular contractions. Sports Med. 2008;38(2):161-77. doi: 10.2165/00007256-200838020-00005. | |
| 16078331 | Background | Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D020966 | Muscular Disorders, Atrophic |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Kneehab | Device | NMES 2 x 20 minute sessions/day, 5 days/week, 6 weeks pre and 6 weeks post TKA. Kneehab™ (Bio-Medical Research, Ltd., Galway, Ireland) is a NMES device with Multipath™ technology, designed to activate the quadriceps muscle. Kneehab™ is a battery operated, portable, 2-channel cutaneous electrical muscle stimulator, which operates using constant current pulses to stimulate the nerves innervating the quadriceps muscle. Kneehab™, consists of a thigh wrap with anatomically shaped electrodes and a control unit. Electrodes are placed over the quadriceps muscles and the garment is wrapped around the leg above the knee. Brief electrical impulses are delivered through the skin surface adhesive electrodes. |
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| 6 Weeks pre-Op and 6, 12 and 52 weeks post-Op |
| 12919862 | Background | Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003 Sep;21(5):775-9. doi: 10.1016/S0736-0266(03)00052-4. |
| 17156487 | Background | Kennedy DM, Stratford PW, Hanna SE, Wessel J, Gollish JD. Modeling early recovery of physical function following hip and knee arthroplasty. BMC Musculoskelet Disord. 2006 Dec 11;7:100. doi: 10.1186/1471-2474-7-100. |
| D012216 |
| Rheumatic Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |