High-intensity non-invasive ventilation during exercise-training versus without in people with very severe COPD and chronic hypercapnic respiratory failure: a randomised controlled trial.

BACKGROUND: People with very severe chronic obstructive pulmonary disease (COPD) using nocturnal non-invasive ventilation (NIV) for chronic hypercapnic respiratory failure (CHRF) experience reduced exercise capacity and severe dyspnoea during exercise training (ET). The use of NIV during ET can personalise training during pulmonary rehabilitation (PR) but whether high-intensity NIV (HI-NIV) during exercise is accepted and improves outcomes in these extremely physically limited patients is unknown. The aim of this trial was to determine if ET with HI-NIV during PR was more effective than without at improving exercise capacity and reducing dyspnoea during exercise. METHODS: Patients with COPD, CHRF and nocturnal-NIV were randomised to supervised cycle-ET as part of PR with HI-NIV or without (control). Primary outcome was change in cycle endurance time (ΔCETtime), while secondary outcomes were dyspnoea at isotime during the cycle endurance test and during ET-sessions and for the HI-NIV group, post-trial preferred exercising method. RESULTS: Twenty-six participants (forced expiratory volume in 1 s 22±7%pred, PaCO251±7 mm Hg) completed the trial (HI-NIV: n=13, ET: IPAP 26±3/EPAP 6±1 cm H2O; control n=13). At completion of a 3 week ET-programme, no significant between-group differences in ΔCETtime were seen (HI-NIV-control: Δ105 s 95% CI (-92 to 302), p=0.608). Within-group ΔCETtime was significant (HI-NIV: +246 s 95% CI (61 to 432); control: +141 s 95% CI (60 to 222); all p<0.05). The number of responders (Δ>minimal important difference (MID)101 s: n=53.8%) was the same in both groups for absolute ΔCETtime and 69.2% of control and 76.9% of the HI-NIV group had a %change>MID33%.Compared with control, the HI-NIV group reported less isotime dyspnoea (Δ-2.0 pts. 95% CI (-3.2 to -0.8), p=0.005) and during ET (Δ-3.2 pts. 95% CI (-4.6 to -1.9), p<0.001). Most of the HI-NIV group (n=12/13) preferred exercising with NIV. CONCLUSION: In this small group of patients with very severe COPD requiring nocturnal NIV, participation in an ET-programme during PR significantly improved exercise capacity irrespective of HI-NIV use. Reported dyspnoea was in favour of HI-NIV. TRIAL REGISTRATION NUMBER: NCT03803358.

The effect of manual therapy to the thoracic spine on pain-free grip and sympathetic activity in patients with lateral epicondylalgia humeri. A randomized, sample sized planned, placebo-controlled, patient-blinded monocentric trial.

BACKGROUND: The treatment of first choice for lateral epicondylalgia humeri is conservative therapy. Recent findings indicate that spinal manual therapy is effective in the treatment of lateral epicondylalgia. We hypothesized that thoracic spinal mobilization in patients with epicondylalgia would have a positive short-term effect on pain and sympathetic activity. METHODS: Thirty patients (all analyzed) with clinically diagnosed (physical examination) lateral epicondylalgia were enrolled in this randomized, sample size planned, placebo-controlled, patient-blinded, monocentric trial. Pain-free grip, skin conductance and peripheral skin temperature were measured before and after the intervention. The treatment group (15 patients) received a one-time 2-min T5 costovertebral mobilization (2 Hz), and the placebo group (15 patients) received a 2-min one-time sham ultrasound therapy. RESULTS: Mobilization at the thoracic spine resulted in significantly increased strength of pain-free grip + 4.6 kg ± 6.10 (p = 0.008) and skin conductance + 0.76 µS ± 0.73 (p = 0.000004) as well as a decrease in peripheral skin temperature by - 0.80 °C ± 0.35 (p < 0.0000001) within the treatment group. CONCLUSION: A thoracic costovertebral T5 mobilization at a frequency of 2 Hz shows an immediate positive effect on pain-free grip and sympathetic activity in patients with lateral epicondylalgia. CLINICAL TRIAL REGISTRATION: German clinical trial register DRKS00013964, retrospectively registered on 2.2.2018.

TENS compared to opioids in postoperative analgesic therapy after major spinal surgery with regard to cognitive function.

BACKGROUND: Long-term use of opioids causes cognitive decline. Transcutaneous nerve stimulation (TENS) applied preincisionally and postoperatively reduces postoperative opioid requirement and provides sufficient analgesia after major spinal surgery. Aim of this study was to find out the impact of TENS compared to opioids, prescribed for postoperative analgesia on early postoperative cognitive function. METHODS: This study was prospective and randomised-controlled. Patients and observers were blinded to the study design. Forty-one patients of both sexes planned for lumbar interbody fusion were admitted and divided randomly into 2 groups. 35 Patients finished the study. Group A received TENS preincisionally and postoperatively, group B received piritramide intravenously (i.v.) by patient-controlled analgesia pump. The adjuvant analgesic therapy diclofenac 75 mg i.v. and the rescue medication paracetamol 1g i.v. was the same for all patients. Pain intensity was assessed by visual analogue scale (VAS). A battery of objective, standardized psychological tests was administered in the same order the day before surgery and 24 to 30 hours postoperatively. RESULTS: The two groups were compared by pairs. Pre- and postoperative attention and memory differed significantly in both groups (p < 0.05). The postoperative fatigue was lower in group A (p < 0.05). Neither age, sex, body mass index, duration of operation, the need of rescue medication nor the incidents of hypotensive phases showed any significant association with postoperative cognitive decline. CONCLUSIONS: Augmentation of fatigue in early postoperative phase was less in patients treated with TENS than with opioids for analgesic therapy after major spinal surgery. Further investigations on the duration of opioid therapy when cognitive functions decline are necessary.

Postoperative and preincisional electrical nerve stimulation TENS reduce postoperative opioid requirement after major spinal surgery.

BACKGROUND AND OBJECTIVE: Preincisional and postoperative transcutaneous electrical nerve stimulation (TENS) administration reduces postoperative opioid demand in abdominal surgery. Aim of this study was to find out whether a comparable effect of TENS applies in major spinal surgery. METHODS: Thirty-eight patients of both sex scheduled for lumbar interbody fusion were enrolled and divided randomly into 3 groups. Group A received TENS preincisional and postoperative, group B received this treatment postoperative only, and group C was the sham controlled. The postoperative demand on piritramid to achieve a visual anlog scale pain score <3 was delivered either by nurse or by a patient-controlled analgesia pump, when the patients were alert. The setting of the patient-controlled analgesia pump, bolus of piritramid 2 mg intravenously (IV), lockout time of 20 minutes, and maximum dose of piritramid 15 mg within 4 hours, the coanalgesic therapy diclofenac 75 mg IV, and the rescue medication metamizol 1 g IV was identical for all patients. The total amount of piritramid administered over the first 24 hours after surgery and an optional rescue medication were recorded. RESULTS: All groups were compared by pairs. The postoperative demand on piritramid differed significantly A versus B (P<0.05), A versus C (P<0.05), and B versus C (P<0.05). Neither sex, body mass index, current, duration, and type of operation nor the occurrence of hypotensive phases showed any significant association with postoperative piritramid demand. The necessity of rescue medication was significantly higher in group C than in group A. CONCLUSIONS: Postoperative TENS as well as the combination of preincisional and postoperative TENS therapy reduce the postoperative demand of piritramid in major spinal surgery in a safe and simple way free of systemic side effects.