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

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
T. A. van Zadelhoff ◽  
A. Moelker ◽  
S. M. A. Bierma-Zeinstra ◽  
P. K. Bos ◽  
G. P. Krestin ◽  
...  

Abstract 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

Author(s):  
Tijmen A. van Zadelhoff ◽  
Yuji Okuno ◽  
Pieter K. Bos ◽  
Sita M.A. Bierma-Zeinstra ◽  
Gabriel P. Krestin ◽  
...  

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Marta Imamura ◽  
Fernando Ezquerro ◽  
Fábio Marcon Alfieri ◽  
Lucy Vilas Boas ◽  
Tania Regina Tozetto-Mendoza ◽  
...  

Osteoarthritis (OA) is the most common joint disorder in the world. Among the mechanisms involved in osteoarthritis, biomarkers (cytokines profile) may be related to pain and pain intensity, functional capacity, and pressure pain thresholds (PPT). Thus, the study of these relationships may offer useful information about pathophysiology and associated mechanisms involved in osteoarthritis. Therefore, the objective of this study was to investigate the seric concentration of pro (IL-6, IL-8, and TNF-α) and anti-inflammatory (IL-10) cytokines in patients with painful knee osteoarthritis and to correlate the levels of these biomarkers with the patients’ functional capacity and pressure pain threshold (PPT) values.


2020 ◽  
Author(s):  
Miguel Malo-Urriés ◽  
José Miguel Tricás-Moreno ◽  
Elena Estébanez-de-Miguel ◽  
Elena Bueno-Gracia ◽  
Pablo Fanlo-Mazas ◽  
...  

Abstract Objective The purpose of this study was to evaluate the effects of upper cervical translatoric spinal mobilization (UC-TSM) on headache, quality of life, cervical mobility and pressure pain threshold in subjects with cervicogenic headache (CEH). Methods Eighty-two volunteers (41.5 ± 15.3 years; 20 males and 62 females) with CEH participated in the study and were randomly assigned to control or treatment group. The treatment group received 3 sessions of UC-TSM and the control group remained the same sessions, in the same position and time but received no treatment. Primary outcomes were Headache Impact Test for headache-related quality of life and flexion-rotation test for upper cervical mobility. Secondary outcomes included intensity, frequency and duration of headache, general cervical mobility and pressure pain thresholds over cervical spine. They were measured at baseline, at the end of the treatment and one month after the intervention. Results UC-TSM group increased significantly headache-related quality of life (p < .001; d = .857). Headache intensity, frequency and duration improved in UC-TSM group (p = .000-.013), in contrast to control group which did not obtain significant changes (p = .234-.965). UC-TSM group presented significant increases in upper cervical mobility (p < .001). Between-group effect sizes were considered large at T1 (d = 0.90–1.21) and moderate to large at T2 (d = 0.78–1.17). Conclusions Three sessions of UC-TSM increased headache-related quality of life and upper cervical mobility in subjects with CEH. Intensity, duration and frequency of headache, cervical mobility and PPT also improved. Further research considering the limitations of the present clinical trial is required to confirm this tendency.


2020 ◽  
Vol 9 (12) ◽  
pp. 4062
Author(s):  
Ángela Río-González ◽  
Ester Cerezo-Téllez ◽  
Cristina Gala-Guirao ◽  
Laura González-Fernández ◽  
Raquel Díaz-Meco Conde ◽  
...  

The aim of this study is to describe the short-term effects of manual lymph drainage (MLD) isolated in supraclavicular area in healthy subjects. A 4-week cross-sectional, double-blinded randomized clinical trial was conducted. Participants: 24 healthy participants between 18 and 30 years old were recruited from Universidad Europea de Madrid from December 2018 to September 2019. A total of four groups were studied: control, placebo, Vodder, and Godoy. The order of the interventions was randomized. Resting Heart Rate and Oxygen Saturation, blood pressure, pressure pain threshold of trapezius muscle, respiratory rate, range of active cervical movements were measured before and after every intervention. All the participants fulfilled four different interventions with a one-week-wash-out period. No statistically significant differences were found between groups in descriptive data; neither in saturation of oxygen, diastolic blood pressure and cervical range of motion. Significant differences were found in favor of Vodder (p = 0.026) in heart rate diminution and in cardiac-rate-reduction. A significant difference in respiratory rate diminution is found in favor of the Godoy group in comparison with the control group (p = 0.020). A significant difference is found in favor of the Godoy group in systolic blood pressure decrease (p = 0.015) even in pressure pain threshold (p < 0.05). MLD decreases systolic blood pressure in healthy participants. However, it does not produce any changes in other physiologic outcomes maintaining physiologic values, which may suggest the safety of the technique in patients suffering from other pathologies.


2012 ◽  
Vol 35 (1) ◽  
pp. 59-68 ◽  
Author(s):  
Olav Olsen ◽  
Mona Sjøhaug ◽  
Mireille Van Beekvelt ◽  
Paul Jarle Mork

The aim of the present study was to investigate the effect of warm-up and cool-down exercise on delayed onset of muscle soreness at the distal and central parts of rectus femoris following leg resistance exercise. Thirty-six volunteers (21 women, 15 men) were randomly assigned to the warm-up (20 min ergometer cycling prior to the resistance exercise), cool-down (20 min cycling after the resistance exercise), or control group performing resistance exercise only. The resistance exercise consisted of front lunges (10x5 repetitions/sets) with external loading of 40% (women) and 50% (men) of body mass. Primary outcomes were pressure pain threshold along rectus femoris and maximal isometric knee extension force. Data were recorded before the resistance exercise and on the two consecutive days. Pressure pain threshold at the central muscle belly was significantly reduced for the control group on both day 2 and 3 (p≤0.003) but not for the warm-up group (p≥0.21). For the cool-down group, pressure pain threshold at the central muscle belly was significantly reduced on day 2 (p≤0.005) and was also lower compared to the warm-up group (p=0.025). Force was significantly reduced on day 2 and 3 for all groups (p<0.001). This study indicates that aerobic warm-up exercise performed prior to resistance exercise may prevent muscle soreness at the central but not distal muscle regions, but it does not prevent loss of muscle force.


2015 ◽  
Vol 20 (3) ◽  
pp. 137-140 ◽  
Author(s):  
Hasan Terzi ◽  
Rabia Terzi ◽  
Ahmet Kale

OBJECTIVE: To evaluate the number of tender points, pressure pain threshold and presence of fibromyalgia among women with or without dyspareunia.METHODS: The present cross-sectional study included 40 patients with dyspareunia and 30 healthy controls. The participants were asked if they had engaged in sexual intercourse during the previous four weeks, and dyspareunia was rated from 0 to 3 based on the Marinoff Dyspareunia Scale. A pressure algometer (dolorimeter) was used to measure the pressure pain threshold. Fibromyalgia was diagnosed based on the 1990 American College of Rheumatology criteria. The depression status of the participants was assessed using the Beck Depression Inventory.RESULTS: No statistically significant difference was found with regard to age, body mass index, habits (alcohol use and smoking), educational status and occupational status between the two groups. Total myalgic score, total control score and tender point mean pain threshold were significantly lower in the group with dyspareunia. The number of tender points was significantly higher in patients with dyspareunia. The mean Beck Depression Inventory score was 14.7 ±8.4 in the dyspareunia group compared with 11.2 ±7.1 in the control group. Five (12.5%) of the patients with dyspareunia were diagnosed with fibromyalgia, whereas no patients in the control group were diagnosed with fibromyalgia. There was no significant difference between the two groups with regard to the presence of fibromyalgia.CONCLUSION: The finding of lower pressure pain thresholds and a higher number of tender points among patients with dyspareunia suggests that these patients may have increased generalized pain thresholds. Additional studies involving a larger number of patients are required to investigate the presence of central mechanisms in the pathogenesis of dyspareunia.


2019 ◽  
Vol 28 (1) ◽  
pp. 39-45 ◽  
Author(s):  
Scott W. Cheatham ◽  
Kyle R. Stull ◽  
Morey J. Kolber

Background: Roller massage (RM) has become a common intervention among health and fitness professionals. Recently, manufacturers have merged the science of vibration therapy and RM with the development of vibration rollers. Of interest, is the therapeutic effects of such RM devices. Purpose: The purpose of this study was to compare the effects of a vibration roller and nonvibration roller intervention on prone knee-flexion passive range of motion (ROM) and pressure pain threshold (PPT) of the quadriceps musculature. Methods: Forty-five recreationally active adults were randomly allocated to one of 3 groups: vibration roller, nonvibration roller, and control. Each roller intervention lasted a total of 2 minutes. The control group did not roll. Dependent variables included prone knee-flexion ROM and PPT measures. Statistical analysis included parametric and nonparametric tests to measure changes among groups. Results: The vibration roller demonstrated the greatest increase in PPT (180 kPa, P < .001), followed by the nonvibration roller (112 kPa, P < .001) and control (61 kPa, P < .001). For knee flexion ROM, the vibration roller demonstrated the greatest increase in ROM (7°, P < .001), followed by the nonvibration roller (5°, P < .001) and control (2°, P < .001). Between groups, there was a significant difference in PPT between the vibration and nonvibration roller (P = .03) and vibration roller and control (P < .001). There was also a significant difference between the nonvibration roller and control (P < .001). For knee ROM, there was no significant difference between the vibration and nonvibration roller (P = .31). A significant difference was found between the vibration roller and control group (P < .001) and nonvibration roller and control group (P < .001). Conclusion: The results suggest that a vibration roller may increase an individual’s tolerance to pain greater than a nonvibration roller. This investigation should be considered a starting point for future research on this technology.


2017 ◽  
Vol 16 (2) ◽  
pp. 137-140 ◽  
Author(s):  
Ana Elisa Zuliani Stroppa-Marques ◽  
João Simão de Melo-Neto ◽  
Sâmela Parente do Valle ◽  
Cristiane Rodrigues Pedroni

ABSTRACT Objective: The objective of this study was to analyze the pressure pain threshold (PPT) of the sternocleidomastoid (SCM), suboccipital (SO) and upper trapezius (UT) muscles and the craniocervical posture in individuals with episodic tension-type headache (ETTH). Methods: This study was a cross-sectional, non-randomized study with 60 young adults (77% female) comprising both sexes and an age range of 18-27 years. Individuals were distributed into a control group (G1) and individuals with ETTH (G2). The frequency of headaches per month was recorded. A pressure dynamometer was used to evaluate the PPT. Photogrammetry was used to evaluate the cervical lordosis (CL) and cephalic protrusion (CP). The data were statistically analyzed. Results: There were differences in the PPT, where the UT, SO and SCM muscles presented lower sensitivity to pain, respectively. The SCM muscle presented a lower PPT in G2. The CL and CP angles were significantly lower in G2. Conclusion: Individuals with ETTH exhibited a significantly lower PPT in the SCM and SO muscles than in the UT muscle. Nevertheless, individuals with ETTH presented with the SCM muscle being more sensitive to pain as well as higher CL and CP than individuals without symptomatology.


2017 ◽  
Vol 25 (2) ◽  
pp. 122-128 ◽  
Author(s):  
Jessica Albers ◽  
Anne Jäkel ◽  
Kai Wellmann ◽  
Ulrike von Hehn ◽  
Tobias Schmidt

Objective: To assess the effectiveness of osteopathic intervention (OI) and general osteopathic treatment (GOT) in individuals with fibromyalgia syndrome (FMS). Methods: The trial was designed as a randomized controlled trial with 2 osteopathic interventions and 1 untreated control group. The patients in the two osteopathic groups received 10 osteopathic treatments (OI or GOT) within a time period of 12 weeks. The control group did not receive any osteopathic treatment. The primary outcome was the average pain intensity (API) assessed by visual analog scale (VAS). Secondary outcomes were the pressure-pain threshold rated by means of a tender point score, and disease severity, assessed by the Fibromyalgia Impact Questionnaire (FIQ). Results: 50 patients were randomized. The primary outcome parameter API decreased from 7.2 to 4.7 in the OI group, from 6.3 to 4.3 in the GOT group, and increased slightly in the control group from 6.2 to 6.6. There were significant differences for the change in API between the OI group and the control group (VAS: 2.9, 95% confidence interval (CI) = 1.12-4.52), and between the GOT group and the control group (VAS: 2.4, 95% CI = 0.65-4.11), but no significant differences between the OI group and the GOT group. There were no significant differences for the secondary outcome parameters between the groups. Conclusion: A series of osteopathic treatments might be beneficial for patients suffering from FMS.


2014 ◽  
Vol 32 (3) ◽  
pp. 236-241 ◽  
Author(s):  
Ralph Plaster ◽  
Wellington Bueno Vieira ◽  
Flávia Alves Duarte Alencar ◽  
Eduardo Yoshio Nakano ◽  
Richard Eloin Liebano

Objective To compare the immediate effects of electroacupuncture and manual acupuncture on pain, mobility and muscle strength in patients with knee osteoarthritis. Methods Sixty patients with knee osteoarthritis, with a pain intensity of ≥2 on the pain Numerical Rating Scale, were included. The patients were randomised into two groups: manual acupuncture and electroacupuncture. Pain intensity, degree of dysfunction (Timed Up and Go (TUG) test), maximal voluntary isometric contraction and pressure pain threshold were assessed before and after a single session of manual acupuncture or electroacupuncture treatments. Results Both groups showed a significant reduction in pain intensity (p<0.001) and time to run the TUG test after the acupuncture treatment (p=0.005 for the manual acupuncture group and p=0.002 for the electroacupuncture group). There were no differences between the groups regarding pain intensity (p=0.25), TUG test (p=0.70), maximum voluntary isometric contraction (p=0.43) or pressure pain threshold (p=0.27). Conclusions This study found no difference between the immediate effects of a single session of manual acupuncture and electroacupuncture on pain, muscle strength and mobility in patients with knee osteoarthritis. Trial Registration Number RBR-9TCN2X.


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