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

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.

Significant other interactions in people with chronic low back pain: Subgrouping and multidimensional profiles

Background: Back pain is complex. Social support and significant other interactions influence the pain experience. Purpose: To statistically derive subgroups of people with chronic low back pain based upon their interactions with significant others, and profile subgroups across multidimensional variables. Research Design: Longitudinal cohort study. Study Sample: People with chronic axial low back pain ( n = 262). Data Collection and Analysis: Latent class analysis of significant other interaction data was used to derive subgroups of people with chronic low back pain. Subgroups were profiled across baseline multidimensional variables and one-year follow-up pain intensity, disability and bothersomeness. Results: Three clusters were identified: Cluster 1 (7.6%) characterised by the lowest distracting, punishing and solicitous interactions. Cluster 2 (16.0%) characterised by the highest distracting and solicitous responses and social support. Cluster 3 (76.3%) characterised by the highest punishing and lowest social support. Cluster 1 reported less disability than Clusters 2 and 3. Mindfulness was significantly different across all subgroups with Cluster 1 being most mindful and Cluster 3 least mindful. Depression, anxiety and stress were significantly higher in Cluster 3 than Cluster 1. Pain catastrophising was higher for Cluster 2 than Clusters 1 and 3. Cluster 2 had lower pressure pain threshold than Clusters 1 and 3. Conclusions: These results support the association between significant other interactions and the experience of back pain. Considering significant other interactions in clinical practice may be important for managing some people’s presentation.

The impact of gender of the examiner on orofacial pain perception and pain reporting among healthy volunteers

Objectives Pain on palpation of jaw muscles is a commonly used diagnostic criterion when examining patients with orofacial pain. It is not known, however, if pain reports are affected by the gender of the examiner. Our aim was to investigate if pressure pain threshold (PPT), pressure pain tolerance (PTol), and pain intensity assessed over the masseter muscles in healthy individuals are affected by the gender of the examiner. Materials and methods Healthy, pain-free individuals were recruited on a voluntary basis. PPT and PTol were assessed using pressure algometry. At the PTol level, participants also rated pain intensity on a 0–10 numeric rating scale. Assessments of PPT and PTol were conducted with six repeated measurements performed twice, separately by one female and one male examiner, on each participant. Results In total, 84 participants (43 women; median age 24, IQR 6) were included. With a female examiner, women reported higher pain intensity than men (Mann Whitney U, p = 0.005). In the multivariable analysis, significantly higher PTol was predicted by male examiner. Also, a higher ratio between PTol and reported pain intensity was predicted by male examiner. Conclusions The gender of the examiner influences pain reporting and perception in an experimental setting. This effect on pain perception related to gender of the examiner is probably related to normative gender behaviors rather than to biological alterations within the examined individual. Clinical relevance In clinical and experimental settings, gender of the examiner may affect not only pain perception but also pain reporting, with potential implications for diagnostics in patients with pain.

Central Sensıtızatıon ın Axıal Spondyloarthrıtıs: An Exploratıve Study wıth Quantıtatıve Sensory Testıng and Clınıcal Scales

ABSTRACT Objective To evaluate the central sensitization (CS) and the related parameters in patients with axial spondyloarthritis (axSpA). Methods Quantitative sensory testing (QST) which consists of pressure pain threshold (PPT), temporal summation (TS), and conditioned pain modulation (CPM) were applied to the participants. Disease activity, functional status, sleep quality, pain, depression, and fatigue were assessed. Patients were divided as the ones with and without CS according to the central sensitization inventory (CSI) and the results were compared. Results One hundred patients and fifty controls were recruited. Sixty axSpA patients had CS. When QST results were compared between the patient and control groups, all PPT scores were found lower (p<0.05) in patients. Regarding the comparison of the patients with and without CS, sacroiliac, and trapezius PPT scores were found lower in the patients with CS (p<0.05). On the other hand, there was no significant difference in the mean TS scores (p>0.05) between patients and controls, and in patients with and without CS. All investigated comorbidities were found to be significantly more frequent (p<0.001) in the patients with CS. In regression analysis female gender, morning stiffness duration, CPM, depression, and fatigue were detected as related parameters with CSI scores. Conclusion CS and related comorbidities were found to be increased in axSpA patients. This increase should be taken into consideration in the management of these patients.

MusicCohort: Pilot feasibility of a protocol to assess students’ physical and mental health in a Canadian post-secondary school of music

Objective Music-related physical and mental health conditions are common among post-secondary music students, with many studies reporting a prevalence greater than 70%. However, there is currently no consensus on appropriate, validated assessments for this population. The aim of this pilot study was to test the feasibility of an assessment protocol developed for a German longitudinal study with Canadian post-secondary music students, and to compare the health of music students to non-music students. Using a cross-sectional design, first-semester music and non-music control students were recruited at two campuses at the same university. Both groups completed questionnaires and physical testing, including range of motion, core strength, and pressure pain threshold. Nineteen music students and 50 non-music student controls participated in this study. Results The German protocol is feasible in a Canadian post-secondary setting. Canadian music students demonstrated similar health outcomes to those in the parent study. All participants demonstrated poorer mental and physical quality of life than the Canadian norms, though this was not statistically significant. The results of this study should be confirmed in a larger study. Future studies with larger sample sizes can provide further insight into the health of Canadian music students, providing a basis for prevention and intervention.

Efficacy of Exercise on Postneedling Soreness: A Randomized Controlled Trial

This study aimed to investigate the efficacy of concentric, eccentric, and isometric exercise protocols on the postneedling soreness (PNS) after the dry needling (DN) of latent myofascial trigger points (MTrP) in the medial gastrocnemius muscle. A randomized clinical trial was carried out. Volunteers, ≥18 years old, with a latent MTrP in the medial gastrocnemius muscle were included. Subjects with contraindications to DN, active MTrPs, and/or other treatments in MTrPs in the 3 months prior to recruitment were excluded. A total of 69 participants were randomly allocated to four groups, where post-DN intervention consisted of an eccentric, concentric, or isometric exercise, or no exercise, and they were assessed for PNS intensity (visual analog scale (pVAS)), pressure pain threshold (PPT, analog algometer), pain intensity (nVAS), and local twitch responses (LTRs) during DN, as well as demographics and anthropometrics. The mixed-model analyses of variance showed significant interaction between time and pVAS, and between time and PPT (p < 0.001). While the multivariate test confirmed that PNS and PPT improved over time within each group, specifically between 6–12 h post-intervention, the post hoc analyses did not show significant differences between groups. The mixed-model analyses of covariance showed a significant nVAS effect (p < 0.01) on PNS decrease, and some effect of the LTRs (p < 0.01) and sex (p = 0.08) on PPT changes. All groups improved PNS and PPT, but none of them showed a greater improvement above the others. The most dramatic decrease was observed between 6–12 h post-exercise, although concentric and eccentric exercise had an effect immediately after the intervention. Between all potential modifiers, pain during DN significantly influenced PNS progression, while LTRs and sex seemed to determine PPT course over time.

Conditioned Pain Modulation Is Not Impaired in Individuals with Frozen Shoulder: A Case-Control Study

Frozen shoulder (FS) is a poorly understood condition resulting in substantial shoulder pain and mobility deficits. The mechanisms behind FS are not yet fully understood, but, similar to other persistent pain states, central pain mechanisms may contribute to ongoing symptoms in this population. The objective of this research was to investigate conditioned pain modulation (CPM) in people with FS compared with pain-free individuals. A total of 64 individuals with FS and 64 healthy volunteers participated in this cross-sectional study. CPM was assessed by using the pressure pain threshold (PPT) and an occlusion cuff (tourniquet test) as the test and conditioning stimulus, respectively. The absolute and percentage of change in PPT (CPM effect) as well as pain profiles (pro-nociceptive vs. anti-nociceptive) of individuals with FS and healthy controls were calculated. No significant differences in the absolute change in the PPT or CPM effect were found in people with FS compared to pain-free controls. Moreover, no between-group differences in the percentage of subjects with pro-nociceptive and anti-nociceptive pain profiles were observed. These results suggest that endogenous pain inhibition is normally functioning in people with FS. Altered central pain-processing mechanisms may thus not be a characteristic of this population.

Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial

Background Cervical exercise has been shown to be an effective treatment for neck pain, but there is still a need for more clinical trials evaluating the effectiveness of adding manual therapy to the exercise approach. There is a lack of evidence on the effect of these techniques in patients with neck pain and upper cervical rotation restriction. Purpose To compare the effectiveness of adding manual therapy to a cervical exercise protocol for the treatment of patients with chronic neck pain and upper cervical rotation restriction. Methods Single-blind randomized clinical trial. Fifty-eight subjects: 29 for the Manual Therapy+Exercise (MT+Exercise) Group and 29 for the Exercise group. Neck disability index, pain intensity (0–10), pressure pain threshold (kPa), flexion-rotation test (°), and cervical range of motion (°) were measured at the beginning and at the end of the intervention, and at 3-and 6-month follow-ups. The MT+Exercise Group received one 20-min session of manual therapy and exercise once a week for 4 weeks and home exercise. The Exercise Group received one 20-min session of exercise once a week for 4 weeks and home exercise. Results The MT+Exercise Group showed significant better values post-intervention in all variables: neck disability index: 0% patient with moderate, severe, or complete disability compared to 31% in the Exercise Group (p = 0.000) at 6-months; flexion-rotation test (p = 0.000) and pain intensity (p = 0.000) from the first follow-up to the end of the study; cervical flexion (p = 0.002), extension (p = 0.002), right lateral-flexion (p = 0.000), left lateral-flexion (p = 0.001), right rotation (p = 0.000) and left rotation (p = 0.005) at 6-months of the study, except for flexion, with significative changes from 3-months of follow up; pressure pain threshold from the first follow-up to the end of the study (p values range: 0.003–0.000). Conclusion Four 20-min sessions of manual therapy and exercise, along with a home-exercise program, was found to be more effective than an exercise protocol and a home-exercise program in improving the neck disability index, flexion-rotation test, pain intensity, and pressure pain threshold, in the short, medium, and medium-long term in patients with chronic neck pain and upper rotation restriction. Cervical range of motion improved with the addition of manual therapy in the medium and medium-long term. The high dropout rate may have compromised the external validity of the study.