A randomised, controlled, parallel group study was designed in order to evaluate the effectiveness of EMG-BFB in the case of rehabilitating patients with meniscal tears who benefited from meniscal repair. In our study design, we compared the recovery of patients with meniscal tears treated by meniscal suture and a rehabilitation program that included EMG-BFB was compared with the evolution of a parallel group of patients, for whom the diagnosis and treatment methods were similar, except that the rehabilitation protocol did not include EMG-BFB. The study was conducted between January 2009 and June 2012. A total of 64 patients, sportspeople, aged between 20 and 50 years and diagnosed with isolated internal and/or external meniscal tears, which were treated by arthroscopic meniscal repair, were randomly assigned to the study group or the control group. All the patients signed a consent form to participate in the study. We excluded from the study the patients with following conditions: associated capsular or ligament injuries, other previous meniscus injuries, knee osteoarthritis or degenerative meniscal changes, the presence of any other pathology contraindicating the implementation of the physical therapy protocol, or the absence from the rehabilitation schedule. Out of the 450 patients that underwent meniscal suture during this period in the clinic, only 99 have fulfilled the criteria of eligibility and only 64 (64.65%) accepted to take part in the study. The two groups are as follows: the study group (SG), which followed a rehabilitation protocol that included EMG-BFB sessions, and a control group (CG), which followed the same rehabilitation program, but without EMG-BFB. Instead of EMG-BFB protocol, the CG patients followed the same period of isometric contraction sessions. SG (n = 33) consisted of 11 females and 22 males with an average age of 33.23 ± 6.51 years, an average height of 1.68 ± 0. 11m, an average weight of 67.51 ± 8.21 kg and CG (n = 31) consisted of 10 females and 21 males with an average age of 32.45 ± 5.76 years, an average height of 1.66 ± 0.15m and an average weight of 65. 42 ± 7.82 kg. All the meniscal tears were posttraumatic and the diagnosis was performed by clinical and arthroscopic assessments. All the patients presented vertical longitudinal tears in the peripheral side of the injured meniscus. The location of the tears in the 2 groups is presented in Table 1. The rehabilitation protocol for SG is presented in Table 2 (Brotzmann and Manske, 2011; Ip, 2007). The EMG-BFB sessions were conducted daily between the 1st and 8th week of surveillance on the SG. The surface EMG was assessed using an EMG-BFB device (Myomed 134) with 2 channels, an EMG sensitivity of 0.28 µV - 150 mV, a raw EMG signal of 1,000 Hz, a processed signal of 100 Hz and an amplification of 10.8X. We used an acoustic signal to initiate the physiological response of the selected muscle. The patients were able to see a visual representation which increased when more muscle fibres were recruited. Upon hearing the first acoustic signal, the patient had to conduct an isometric contraction of the given muscle and to follow on the screen the graph which visualized the electrical potential of the contracted muscle by attempting to maintain its highest possible value; upon hearing the next acoustic signal, the patient had to relax the muscle; then, the cycle was repeated. A work-rest protocol (each for 5 seconds) was selected initially for the first week (the term "work" designated an isometric contraction). The period of isometric contraction was increased weekly by 2 seconds, so that in the 8th week a protocol consisting of 20 seconds of isometric contraction and 5 seconds of rest was used, based on the principles of motor learning (Schmidt and Lee, 1988). The EMG-BFB protocol was applied daily for 20 minutes. The EMG signals from four muscle groups (Vastus Lateralis, Vastus Medialis, Biceps Femoris and Semimembranosus) were recorded using surface EMG electrodes. The selection of these muscles was based on studies which reported that they are the most important for dynamic knee stability and reduced load of passive knee structures (Jarvela et al., 2002; Williams et al., 2001). According to some recent studies (De Luca et al., 2012), the sensor (an arrangement of 2 adhesive surface disk electrodes, model 3444222) was located in the middle of the muscles bellies; the distance between the two active electrodes was 10 mm, which is considered optimal for reducing crosstalk contamination in isometric contraction assessment (De Luca et al., 2012). The ground electrode from each EMG unit was placed in an equidistant position from the corresponding two active electrodes. Before applying the electrodes, the skin surface was wiped with alcohol and, if necessary, the excess body hair was shaved. All patients (from SG and CG) attended all the therapy sessions; there were no drop-outs or adverse events. The patients (SG and CG) were assessed 2 times: baseline - after 1 postoperative week and follow-up - after 8 postoperative weeks by surface EMG, by hand-held dynamometry of thigh muscles and by administered the Knee injury and Osteoarthritis Outcome Score (KOOS) (Roos et al., 1998). All the patients (from SG and CG) were tested by EMG; for each test time, 3 trials were performed for biofeedback task for each patient and the best one was taken into consideration. Different persons conducted the intervention (BFB-EMG sessions) and the EMG assessments. From the characteristics of the surface EMG, the average electrical potential during contraction and rest, the onset time and offset time (latency periods needed for initiating the muscular contraction or relaxation after an acoustic signal) were used. The average values for the onset and offset times for all monitored muscles were taken into consideration. KOOS consists of 5 subscales: Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (Roos, 2012). The strength of the main knee flexors and extensors were measured using hand-held dynamometry. A Chatillon MSC-500 dynamometer was used to assess the MVIC (maximum voluntary isometric contraction) forces of the vastii muscles and hamstrings (Deones et al., 1994). To assess the force developed in knee extension, the subject stayed in dorsal decubitus on the test table with the knee flexed (20°); the patients' arms were placed across their chest; the dynamometer was positioned on the front of the calf, proximal to the ankle joint. The subjects were asked to perform a knee extension (they were asked to push as strongly as they could the dynamometer with their calf), and the evaluator made a resistance movement in the opposite direction. To determine the force developed in knee flexion, the subject was positioned in ventral decubitus on the testing table with the knee flexed (20°); the arms were placed alongside the body on the test table, in an internal rotation; the dynamometer was positioned on the back of the calf, proximal to the ankle joint. The subject is asked to perform a knee flexion (they were asked to push as strongly as they could the dynamometer with their calf), and the assessor had to make a resistance movement in the opposite direction. In both cases, the subjects were stabilised with thoracic and pelvic belts. An angle of 20° was used because this range of motion could be achieved for knee flexion by all the patients, at the baseline. The subjects did 3 consecutive 3-second MVIC trials of the assessed muscle group, with 50 seconds of rest between trials. The torque for each contraction was averaged for the 3 trials, and this average was used as the MVIC. The measurements were done each time by the same tester for all the patients. The statistical analysis was made with GraphPad Prism 5 software. Levene's test was used for establishing the equality of variance; for the comparison between groups (SG and CG), the Mann-Whitney test was used (because the variables were not normally distributed); in order to compare the values for the same group in time (between baseline and follow-up), the Wilcoxon signed paired test was used. G*Power was used for establishing the sample size in order to have enough power to detect differences between groups. The differences between the groups were considered to be significant at p < 0.05. |