Neuromuscular Electrical Stimulation-Enhanced Physical Therapist Intervention for Functional Posterior Shoulder Instability (Type B1): A Multicenter Randomized Controlled Trial.

OBJECTIVE: Functional posterior shoulder instability (FPSI) (type B1) is a severe type of instability, mainly in teenagers and young adults, that leads to loss of function, pain, and stigmatization among peers. An experimental nonsurgical treatment protocol based on neuromuscular electrical stimulation (NMES) showed very promising early results in the treatment of FPSI. The hypothesis of this study was that NMES-enhanced physical therapy leads to better outcomes than physical therapy alone as the current gold standard of treatment in patients with FPSI. METHODS: In this multicenter randomized controlled trial, patients with FPSI were randomly allocated in a 1:1 ratio to either 6 weeks of physical therapy or 6 weeks of physical therapy with simultaneous motion-triggered NMES. Baseline scores as well as outcome scores at 6 weeks, 3 months, 6 months, and 12 months after the intervention were obtained. The predefined primary outcome of this trial was the Western Ontario Shoulder Instability Index (WOSI) at the 3-month time point. RESULTS: Forty-nine patients were randomized and eligible for the trial. The group that received physical therapy with simultaneous motion-triggered NMES showed a significantly better main outcome measurement in terms of the 3-month WOSI score (64% [SD = 16%] vs 51% [SD = 24%]). Two-thirds of the patients from the physical therapist group crossed over to the group that received physical therapy with simultaneous motion-triggered NMES due to dissatisfaction after the 3-month follow-up and showed a significant increase in their WOSI score from 49% [SD = 8%] to 67% [SD = 24%]. The frequency of instability episodes showed a significant improvement in the group that received physical therapy with simultaneous motion-triggered NMES at the 3-month follow-up and beyond, while in the physical therapist group, no significant difference was observed. CONCLUSION: The current study shows that NMES-enhanced physical therapy led to statistically significant and clinically relevant improvement in outcomes in the treatment of FPSI compared to conventional physical therapy alone-from which even patients with prior unsatisfactory results after conventional physical therapy can benefit. IMPACT: Based on the results of this study, NMES-enhanced physical therapy is an effective new treatment option for FPSI, a severe type of shoulder instability. NMES-enhanced physical therapy should be preferred over conventional physical therapy for the treatment of patients with FPSI.

Effect of intraoperative infiltration with local anesthesia on the development of chronic pain after inguinal hernia repair: a randomized, triple-blinded, placebo-controlled trial.

BACKGROUND: Chronic pain is a common complication after inguinal hernia repair. The objective of this randomized trial was to assess the effect of intraoperative infiltration with local anesthetic versus placebo on the development of chronic pain after inguinal hernia repair. METHODS: Patients with single- or double-sided inguinal hernia were enrolled in a randomized, controlled, triple-blinded trial with a sequential adaptive design. Hernias were randomized to 1 of 2 treatment groups. The intervention group received a local infiltration of 20 mL bupivacaine 0.25% and the placebo group 20 mL saline 0.9% at the end of the operation. Two interim analyses were performed according to predefined stopping criteria allowing for design and sample size adaption. The primary endpoint was chronic pain defined on a visual analog scale (VAS) as ≥30 in any quality (at rest, lying, walking, climbing stairs, and bending over) 3 months postoperatively. A logistic regression model was built to compare the incidence of chronic pain using generalized estimating equations to adjust for clustering in bilateral hernias. RESULTS: Among 357 patients, there were 406 hernias randomized. A total of 5.8% (10/173) experienced VAS ≥ 30 in any quality in the intervention group and 2.3% (4/174) in the placebo group (P = .114) at 3 months postoperatively. Multivariable analysis revealed no evidence of between-group differences for the development of any pain (odds ratio [OR], 1.03; 95% CI, 0.67-1.57; P = .905), whereas preoperative pain was an independent risk factor (OR, 2.52; 95% CI, 1.12-5.68; P = .025). CONCLUSION: We did not find any evidence that intraoperative infiltration of local anesthetic had an impact on the development of chronic postoperative pain.