Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial.

PURPOSE: To (i) compare the acceptance of a newly developed, novel biofeedback device (PelviSense) with that of conventional biofeedback (CB) using an intravaginal probe for the treatment of stress urinary incontinence (SUI) in women, (ii) examine the feasibility and safety of using the PelviSense device as a pelvic floor muscle (PFM) training (PFMT) adjunct, and (iii) compare the PFMT adherence and effectiveness of CB, the PelviSense device, with PFMT alone for women with SUI. METHODS: An assessor-blinded, three-arm, randomized controlled pilot trial was conducted among 51 women with SUI. Women were randomly allocated to one of three study groups (PelviSense-assisted PFMT, CB-assisted PFMT, or PFMT alone [control]). Outcome measures included the International Consultation on Incontinence Questionnaire-Short Form, the 1-h pad test, and the Modified Oxford Scale. RESULTS: Participants in the PelviSense-assisted PFMT group expressed good device acceptance. PFMT adherence was greater in the PelviSense-assisted PFMT group than in the unassisted or CB-assisted PFMT groups. Between-groups analysis revealed significant effects on improved SUI symptoms, urine loss severity, and PFM strength for the PelviSense-assisted PFMT group compared with the CB-assisted and PFMT alone groups. CONCLUSIONS: The pilot trial results demonstrated moderate to high PFMT adherence in the PelviSense-assisted PFMT group and supported the safety of using the PelviSense device. The preliminary results of the pilot trial showed that PelviSense-assisted PFMT was more effective for reducing SUI symptoms among women than unassisted or CB-assisted PFMT. TRIAL REGISTRATION: This trial was registered in http://ClinicalTrials.gov (reference number: NCT04638348) before the recruitment of the first participant.

Electrophysical therapy for managing diabetic foot ulcers: a systematic review.

To systematically assess published reports on the efficacy of electrophysical therapy in the treatment of diabetic foot ulcers, including electrical stimulation, low-level laser therapy, therapeutic ultrasound and electromagnetic therapy. Databases searched included MEDLINE, CINAHL, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) from 1966 to 2011. Studies reviewed included only randomised controlled trials (RCTs) on treatment with electrophysical modalities compared with sham, conventional treatment or other electrophysical modalities. Information extracted were objective measures of healing and data useful for the calculation of effect size. Eight RCTs were eventually included in the critical appraisal, with a combined total of 325 participants. Five studies were conducted on electrical stimulation, two on phototherapy and one on ultrasound. All studies reported that the experimental group was significantly more favourable than the control or sham group. The pooled estimate of the number of healed ulcers of the three studies on electrical stimulation compared to the control or sham electrical stimulation showed statistical significance [mean difference of 2·8 (95% CI = 1·5-5·5, P = 0·002] in favour of electrical stimulation. The results indicated potential benefit of using electrophysical therapy for managing diabetic foot ulcers. However, due to the small number of trials ever conducted, the possibility of any harmful effects cannot be ruled out, and high-quality trials with larger sample sizes are warranted.

A randomized controlled trial of auricular transcutaneous electrical nerve stimulation for managing posthysterectomy pain.

Background. A patient- and assessor-blinded randomized controlled trial was conducted to examine the effectiveness of auricular transcutaneous electrical nerve stimulation (TENS) in relieving posthysterectomy pain. Method. Forty-eight women who had undergone a total abdominal hysterectomy were randomly assigned into three groups (n = 16 each) to receive either (i) auricular TENS to therapeutic points (the true TENS group), (ii) auricular TENS to inappropriate points (the sham TENS group), or (iii) 20 minutes of bed rest with no stimulation (the control group). The intervention was delivered about 24 hours after the operation. A visual analogue scale was used to assess pain while resting (VAS-rest) and upon huffing (VAS-huff) and coughing (VAS-cough), and the peak expiratory flow rate (PEFR) was assessed before and at 0, 15, and 30 minutes after the intervention. Result. As compared to the baseline, only the true TENS group reported a significant reduction in VAS-rest (P = .001), VAS-huff (P = .004), and VAS-cough (P = .001), while no significant reduction in any of the VAS scores was seen in the sham TENS group (all P > .05). In contrast, a small rising trend was observed in the VAS-rest and VAS-huff scores of the control group, while the VAS-cough score remained largely unchanged during the period of the study. A between-group comparison revealed that all three VAS scores of the true TENS group were significantly lower than those of the control group at 15 and 30 minutes after the intervention (all P < .02). No significant between-group difference was observed in PEFR at any point in time. Conclusion. A single session of auricular TENS applied at specific therapeutic points significantly reduced resting (VAS-rest) and movement-evoked pain (VAS-huff, VAS-cough), and the effects lasted for at least 30 minutes after the stimulation. The analgesic effects of auricular TENS appeared to be point specific and could not be attributed to the placebo effect alone. However, auricular TENS did not produce any significant improvement in the performance of PEFR.

Managing postmastectomy lymphedema with low-level laser therapy.

OBJECTIVE: We aimed to investigate the effects of low-level laser therapy (LLLT) in managing postmastectomy lymphedema. BACKGROUND DATA: Postmastectomy lymphedema (PML) is a common complication of breast cancer treatment that causes various symptoms, functional impairment, or even psychosocial morbidity. A prospective, single-blinded, controlled clinical trial was conducted to examine the effectiveness of LLLT on managing PML. METHODS: Twenty-one women suffering from unilateral PML were randomly allocated to receive either 12 sessions of LLLT in 4 wk (the laser group) or no laser irradiation (the control group). Volumetry and tonometry were used to monitor arm volume and tissue resistance; the Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire was used for measuring subjective symptoms. Outcome measures were assessed before and after the treatment period and at the 4 wk follow-up. RESULTS: Reduction in arm volume and increase in tissue softening was found in the laser group only. At the follow-up session, significant between-group differences (all p < 0.05) were found in arm volume and tissue resistance at the anterior torso and forearm region. The laser group had a 16% reduction in the arm volume at the end of the treatment period, that dropped to 28% in the follow-up. Moreover, the laser group demonstrated a cumulative increase from 15% to 33% in the tonometry readings over the forearm and anterior torso. The DASH score of the laser group showed progressive improvement over time. CONCLUSION: LLLT was effective in the management of PML, and the effects were maintained to the 4 wk follow-up.

Influence of choice of electrical stimulation site on peripheral neurophysiological and hypoalgesic effects.

OBJECTIVE: To investigate whether the choice of electrode placement site in transcutaneous electrical nerve stimulation (TENS) over acupuncture points vs peripheral nerve points influences the peripheral neurophysiological effects as reflected in negative peak latency in the superficial radial nerve, and on sensory changes in terms of peripheral mechanical pain threshold and mechanical pain tolerance in humans. DESIGN: Randomized controlled trial. SUBJECTS: Forty-five healthy subjects by convenience sampling. METHODS: Subjects were randomly assigned to receive: (i) TENS with electrode placement on acupuncture points; (ii) TENS on non-acupuncture points along the same peripheral nerve; or (iii) no stimulation as the control. In the TENS groups, electrical stimulation was delivered at a frequency of 4 Hz and pulse duration of 200 mus for 30 min. RESULTS: Significant increases in negative peak latency and mechanical pain threshold over time (p = 0.015, 0.002) were found within the 2 active TENS groups. However, there was no significant difference between the 3 groups in all outcome measures at any of the measurement points (all p = 0.05). CONCLUSION: TENS over acupuncture points offers no additional hypoalgesic effects vs TENS over peripheral nerve points in a specific anatomical region.

Effectiveness of electroacupuncture and interferential eloctrotherapy in the management of frozen shoulder.

OBJECTIVE: To examine whether the addition of either electroacupuncture or interferential electrotherapy to shoulder exercises would be more effective in the management of frozen shoulder. DESIGN: A double-blinded, randomized, controlled trial. METHODS: A total of 70 subjects were randomly allocated to receive either: (i) electroacupuncture plus exercise; (ii) interferential electrotherapy plus exercise; or (iii) no treatment (the control group). Subjects in groups (i) and (ii) received 10 sessions of the respective treatment, while the control group received no treatment for 4 weeks. Each subject's score on the Constant Murley Assessment and visual analogue scale were recorded at baseline, post-treatment session and subsequent follow-up sessions. RESULTS: In both the electroacupuncture and interferential electrotherapy groups, the Constant Murley Assessment score increased and the visual analogue scale score decreased significantly (both p < 0.001). No significant change was found in any outcome of the control group, and no significant difference was found between the 2 intervention groups (all p > 0.05). The observed improvement was well maintained in both intervention groups at least until the 6-month follow-up session. CONCLUSION: Either electroacupuncture or interferential electrotherapy in combination with shoulder exercises is effective in treating frozen shoulder patients. However, no significant difference was found between these types of treatment.

Would the addition of TENS to exercise training produce better physical performance outcomes in people with knee osteoarthritis than either intervention alone?

OBJECTIVE: To examine if the addition of transcutaneous electrical nerve stimulation (TENS) to exercise training would produce better physical outcomes than TENS or exercise alone in people with knee osteoarthritis. DESIGN: Sixty-two subjects were randomly allocated to four groups. INTERVENTIONS: Patients received either (1) TENS, (2) placebo stimulation, (3) exercise training, or (4) TENS and exercise training five days a week for four weeks. MAIN OUTCOME MEASURES: The isometric peak torque, spatiotemporal gait parameters and range of knee movement were assessed in treatment session1, session10 and session20 and the four-week follow-up. RESULTS: By session20, the TENS and exercise group demonstrated an average of 26.6% cumulative gain in the knee extensor peak torque for the different knee positions (all p < 0.05). Although the between-group difference was short of being statistically significant, the gain found in the TENS and exercise group was greater than that found in the other three groups. The TENS and exercise group also tended to show greater cumulative increase in stride length (12.6%, p = 0.006), walking cadence (9.3%, p = 0.098) and gait velocity (22.4%, p = 0.034) than the other groups. By session20, it was the only group that produced a significant increase in the range of knee motion during walking (12.0%, p = 0.000). The TENS group and the exercise group both demonstrated some improvements in the above physical outcomes, but negligible change was found in the group receiving placebo stimulation (all p > 0.05). CONCLUSION: No significant difference was found among the four treatment protocols, but the addition of TENS to exercise training tended to produce the best overall improvement in physical outcomes in people with knee osteoarthritis.

Predicting osteoarthritic knee rehabilitation outcome by using a prediction model developed by data mining techniques.

Artificial neural networks (ANN) have been applied to assist in clinical decision-making and prediction. While we consider possible effective treatments for patients with osteoarthritic knee such as Transcutaneous Electrical Nerve Stimulation (TENS), exercise, and TENS with exercise respectively, we have to select a treatment protocol for patients such that they would gain the best improvements according to their clinical conditions. To facilitate this functionality with the existing patient assessment, we hope to apply the ANN programming techniques to develop a computerized prediction system. A preliminary validation was performed to test the validity of the newly developed prediction protocol on knee rehabilitation. We input the key clinical attributes of 62 patients who have undergone the three above-mentioned knee treatments to the protocol. The expected pain improvement of each patient as predicted by the protocol was obtained. Spearman rank-order correlation was used to identify whether there was a significant correlation between the rankings of the observed and expected pain improvement. We found that the Spearman's rho was 0.424, which is statistically significant at p < 0.001. From this preliminary analysis, we are confident that this newly developed prediction protocol will be useful when deciding which treatment regime best suits a patient.

Optimal stimulation frequency of transcutaneous electrical nerve stimulation on people with knee osteoarthritis.

OBJECTIVE: This is a double blind study that examined the optimal stimulation frequency of transcutaneous electrical nerve stimulation in reducing pain due to knee osteoarthritis. SUBJECTS: Thirty-four subjects were randomly allocated into 4 groups receiving transcutaneous electrical nerve stimulation at either: (i) 2 Hz; (ii) 100 Hz; (iii) an alternating frequency of 2 Hz and 100 Hz (2/100 Hz); or (iv) a placebo transcutaneous electrical nerve stimulation. METHODS: Treatment was administered 5 days a week for 2 weeks. The outcome measures included: (i) a visual analogue scale; (ii) a timed up-and-go test; and (iii) a range of knee motion. RESULTS: The 3 active transcutaneous electrical nerve stimulation groups (2 Hz, 100 Hz, 2/100 Hz), but not the placebo group, significantly reduced osteoarthritic knee pain across treatment sessions. However, no significant between-group difference was found. Similarly, the 3 active transcutaneous electrical nerve stimulation groups, but not the placebo group, produced significant reductions in the amount of time required to perform the timed up-and-go test, and an increase in the maximum passive knee range of motion. CONCLUSION: Our findings suggested that 2 weeks of repeated applications of transcutaneous electrical nerve stimulation at 2 Hz, 100 Hz or 2/100 Hz produced similar treatment effects for people suffering from osteoarthritic knee.

The effectiveness of electroacupuncture versus electrical heat acupuncture in the management of chronic low-back pain.

DESIGN: Forty-two (42) subjects suffering from chronic low-back pain were matched with the nature of their occupations and then randomly allocated into: (1) an electroacupuncture group (EA); (2) an electrical heat acupuncture (EH) group or; (3) a control group. INTERVENTIONS: Subjects in the EA group and the EH group received treatment for 20 minutes on a total of 6 acupuncture points. Treatment was delivered twice per week for 4 weeks (a total of 8 sessions). Back exercise was taught to all subjects including the control group as a home program. OUTCOMES MEASURES: A numerical rating scale of pain (NPRS), straight leg raise (SLR), and Roland Morris Disability Questionnaire (RMDQ) were recorded. RESULTS: There were significant reduction of NPRS within the EA (p = 0.000), EH (p = 0.000), and control (p = 0.013) groups across sessions. Significant between-group differences were shown in session 4 (p = 0.006), session 8 (p = 0.001), and 1-month follow-up sessions (p = 0.001). Posthoc tests showed that the NPRS of the EH group was significantly lower than that of the EA group and the control group by session 4 (p = 0.004). After session 8, the NPRS of both the EA group (p = 0.003) and the EH group (p = 0.001) were significantly lower than that of the control group. Such a difference was maintained at least up to the 1-month follow-up. Only the EA group had significant improvement in the measurement of SLR across sessions (p = 0.000). The between-group difference reached significance level in session 8 (p = 0.001) and at 1-month follow-up (p = 0.002). Posthoc tests showed that EA group had significantly greater gain than the EH group and the control group. For the RMDQ score, the improvement was statistically significant within each of the three groups over time (p = 0.000). However, the between-group difference did not reach statistical significance. CONCLUSIONS: Our findings suggest that 4 sessions of EH treatment over 2 weeks produced significantly greater reduction in the NPRS than that of the EA or the control. However, EA produced greater improvement in SLR and reduction in RMDQ score than that of the EH and the control.

Optimal stimulation duration of tens in the management of osteoarthritic knee pain.

OBJECTIVE: This study examined the optimal stimulation duration of transcutaneous electrical nerve stimulation (TENS) for relieving osteoarthritic knee pain and the duration (as measured by half-life) of post-stimulation analgesia. SUBJECTS: Thirty-eight patients received either: (i) 20 minutes (TENS20); (ii) 40 minutes (TENS40); (iii) 60 minutes (TENS60) of TENS; or (iv) 60 minutes of placebo TENS (TENS(PL)) 5 days a week for 2 weeks. METHODS: A visual analogue scale recorded the magnitude and pain relief period for up to 10 hours after stimulation. RESULTS: By Day10, a significantly greater cumulative reduction in the visual analogue scale scores was found in the TENS40 (83.40%) and TENS60 (68.37%) groups than in the TENS20 (54.59%) and TENS(PL) (6.14%) groups (p < 0.000), such a group difference was maintained in the 2-week follow-up session (p < 0.000). In terms of the duration of post-stimulation analgesia period, the duration for the TENS40 (256 minutes) and TENS60 (258 minutes) groups was more prolonged than in the other 2 groups (TENS20 = 168 minutes, TENS(PL) = 35 minutes) by Day10 (p < 0.000). However, the TENS40 group produced the longest pain relief period by the follow-up session. CONCLUSION: 40 minutes is the optimal treatment duration of TENS, in terms of both the magnitude (VAS scores) of pain reduction and the duration of post-stimulation analgesia for knee osetoarthritis.

Analgesic effects of transcutaneous electrical nerve stimulation and interferential currents on heat pain in healthy subjects.

This study examined whether transcutaneous electrical nerve stimulation or interferential current was more effective in reducing experimentally induced heat pain. Forty-eight young healthy subjects were randomly divided into the following groups: (i) transcutaneous electrical nerve stimulation; (ii) interferential current; and (iii) no stimulation. A multi-function electrical stimulator was used to generate the transcutaneous electrical nerve stimulation or interferential current. A thermal sensory analyser was used to record the heat pain threshold. The stimulation lasted for 30 minutes and the heat pain thresholds were measured before, during and after the stimulation. Transcutaneous electrical nerve stimulation (p = 0.003) and interferential current (p = 0.004) significantly elevated the heat pain threshold, but "no stimulation" did not. The thresholds of the transcutaneous electrical nerve stimulation and interferential current groups were significantly higher than that of the control group 30 minutes into the stimulation (p = 0.017). Both transcutaneous electrical nerve stimulation and interferential current increased the heat pain threshold to a similar extent during stimulation. However, the post-stimulation effect of interferential current lasted longer than that of transcutaneous electrical nerve stimulation.

Does four weeks of TENS and/or isometric exercise produce cumulative reduction of osteoarthritic knee pain?

OBJECTIVE: To evaluate the cumulative effect of repeated transcutaneous electrical nerve stimulation (TENS) on chronic osteoarthritic (OA) knee pain over a four-week treatment period, comparing it to that of placebo stimulation and exercise training given alone or in combination with TENS. DESIGN: Sixty-two patients, aged 50-75, were stratified according to age, gender and body mass ratio before being randomly assigned to four groups. INTERVENTIONS: Patients received either (1) 60 minutes of TENS, (2) 60 minutes of placebo stimulation, (3) isometric exercise training, or (4) TENS and exercise (TENS & Ex) five days a week for four weeks. MAIN OUTCOME MEASURES: Visual analogue scale (VAS) was used to measure knee pain intensity before and after each treatment session over a four-week period, and at the four-week follow-up session. RESULTS: Repeated measures ANOVA showed a significant cumulative reduction in the VAS scores across the four treatment sessions (session 1, 10, 20 and the follow-up) in the TENS group (45.9% by session 20, p < 0.001) and the placebo group (43.3% by session 20, p = 0.034). However, linear regression of the daily recordings of the VAS indicated that the slope in the TENS group (slope = -2.415, r = 0.943) was similar to the exercise group (slope = -2.625, r = 0.935), which were steeper than the other two groups. Note that the reduction of OA knee pain was maintained in the TENS group and the TENS & Ex group at the four-week follow-up session, but not in the other two groups. CONCLUSIONS: The four treatment protocols did not show significant between-group difference over the study period. It was interesting to note that isometric exercise training of the quadriceps alone also reduced knee pain towards the end of the treatment period.