Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial

Introduction Knee osteoarthritis is a common disease with pain as the most prevalent symptom. Previous cohort studies have shown genicular artery embolization to reduce pain symptoms in patients with mild to moderate knee osteoarthritis. Patients resistant to conservative therapy but not eligible yet for surgical treatment due to young age or comorbidities may profit from an effective and sustained pain reduction treatment. This study is a randomized sham-controlled trial to evaluate the efficacy of genicular artery embolization in patients with knee osteoarthritis. Methods and analysis Fifty-eight patients with mild-to-moderate knee osteoarthritis will be recruited and randomly allocated to the treatment or control group in a 1:1 ratio. Participants in the treatment group will undergo genicular artery embolization. Patients in the control group will undergo sham treatment. Outcome measurements will be assessed at baseline and after 1, 4, 8, and 12 months with questionnaires, pressure pain threshold testing, and MR imaging. The MR imaging protocol is designed to (semi)quantitatively assess osteoarthritis in the knee joint. The primary outcome is the change from baseline of the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale after 4 months. Secondary outcomes include change in osteoarthritis-related questionnaires, pressure pain threshold, and OA-related MRI features, particularly synovitis and bone marrow lesions. Ethics and dissemination This trial will determine the efficacy of genicular artery embolization compared to a sham treatment. This is of importance to assess before proceeding to larger-scale efficiency studies and, ultimately, implementing this treatment into day to day clinical practice. Trial registration ClinicalTrials.gov NCT03884049. Registered on 21 March 2019

Relationship between Eccentric-Exercise-Induced Loss in Muscle Function to Muscle Soreness and Tissue Hardness

It is well-known that unusual exercise, especially eccentric contraction (ECC), could cause delayed-onset muscle soreness. However, the factors related to the loss of muscle strength and range of motion (ROM) caused by eccentrically damaged muscle, such as increases in muscle soreness, tissue hardness, and pain threshold, have not been investigated in detail. Thus, this study was conducted to investigate the factors related to the loss of muscle strength and ROM caused by eccentrically damaged muscle in a large sample. Fifty-six sedentary healthy young male volunteers were instructed to perform 60 repetitions of ECC exercise. The outcome variables were measured before and 48 h after the ECC exercise. The results showed that a decrease in ROM was correlated to an increase in tissue hardness, whereas a decrease in muscle strength was correlated to an increase in muscle soreness. Our results suggested that tissue hardness must be controlled for ROM loss, and muscle soreness must be controlled for muscle-strength loss.

Immediate Effects of Spinal Manipulation on Painful Sensitivity and Postural Stability in Patients with Chronic Nonspecific Low Back Pain: Study Protocol for A Controlled Randomised Clinical Trial.

Background: Low back pain is one of the main public health concerns. Chronic low back pain (cLBP)reduces functional capacity and affects postural stability.Although health professionals widely use spinal manipulation, its immediate effect on painful sensitivity and postural stability is lacking. This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP. Methods: A two-arm, placebo-controlled clinical trial with parallel groups and examiner-blinded will be conducted with 80 participants with cLBPfrom an outpatient physical therapy department,randomly allocated at a 1:1 distribution. The experimental group will receive a lumbar spinal manipulation technique, and the placebo group will receive a simulated lumbar spinal manipulation. Both groups will receive one session of treatment and will be evaluated before and immediately after the intervention.The primary outcomes will be the pressure pain threshold and postural stability. Pain intensity and patient´s expectation will be assessed as a secondary outcome. The pressure pain threshold will be assessed using a pressure algometer in 6 different anatomical regions. The evaluation of postural stability will be performed in a baropodometry exam by displacing the centre of pressure. The pain intensity will be measuredusing the Numeric Pain Rating Scale. A Likert scale will be used for the patient´s expectationabout the treatment. A two-way analysis of variance will compare the effect of the interventions between groups. Discussion:This study will provide insights regarding the immediate effects of spinal manipulation in patients with cLBPagainst a simulated spinal manipulation using objective outcomes and considering patients’ expectations regarding the treatment.Trial registration: Brazilian Registry of Clinical Trials:RBR-3ksq2c; registered on 13 July 2020.

Cutaneous allodynia in pediatric and adolescent patients and their mothers: A comparative study

Background Allodynia in adults with migraine is related to disease duration. In pediatric patients with migraine, the same proportion reported allodynia in the first six months of migraine presentation as in prolonged disease. This study examined a possible association between migraine pediatric allodynia and maternal allodynia. Methods We interviewed children with migraine first, and then their mothers, regarding allodynia and headache symptoms. We reviewed hospital charts on pediatric medical background and headache symptoms. Mothers and children older than 11 years filled the Strengths and Difficulties Questionnaire. Results Ninety-eight children with migraine, mean age 13.49 ± 3.1 years, and their mothers, mean age 43.5 ± 6.2 years were recruited to the study. Pediatric allodynia was associated with maternal allodynia; the latter was reported in 82.8% of children with allodynia versus 35.3% of children without allodynia (p < 0.001). Maternal migraine was reported in 44 (68.7%) of children with allodynia versus 16.3% without allodynia, p < 0.001. No difference was found in Strengths and Difficulties Questionnaire scores, between children with and without allodynia. Conclusions Pediatric allodynia is associated with maternal migraine. Genetic and environmental factors such as maternal behavior may contribute to reduced pain threshold.

Tourniquet Use Does Not Affect Pain and Function after Total Knee Arthroplasty: Patient Evaluation According to Pain Threshold

We evaluated the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold (PT). Overall, 120 patients who were assessed preoperatively with an algometer were recruited for this prospective, double-blinded, randomized controlled trial. Patients were randomized to undergo total knee arthroplasty (TKA) with a tourniquet (group 1, 60 patients) and without tourniquet (group 2, 60 patients). Primary outcome measures were visual analog scale (VAS) pain scores at 24, 36, and 48 hours postoperatively and functional assessment with Knee Society Score (KSS) test at 1 year postoperatively. No significant differences were observed between groups in terms of gender (49 females and 8 males in group 1 vs. 53 females and 6 males in group 2; p = 0.201) and age (68.9 years in group 1 vs. 68.7 years in group 2; p = 0.811). There was no significant difference between groups in all the VAS and KSS 1 and KSS 2 scores. PT measurements ranged from 2.5 to 11.5 with a mean of 7.69 ± 1.70 and a median of 8. Total 54 patients with a median value of < 8 were defined as the low-PT group, and 62 patients with a median value of ≥ 8 were defined as the high-PT group. When the groups were evaluated according to using the tourniquet, 21 patients were operated on with a tourniquet and 33 patients without it in the low-PT group, while 36 patients were operated on with a tourniquet and 26 patients without it in the high-PT group. There was no significant difference in pain or functional scores between patients when comparing with-tourniquet and without-tourniquet or when comparing the low- and high-PT groups. This showed that the use of a tourniquet during TKA was not associated with either early-stage pain or 1-year postoperative functional outcomes according to algometer evaluation.Level of evidence: Level 1 prospective randomized study.