scholarly journals Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
David Noriega ◽  
Gianluca Maestretti ◽  
Christian Renaud ◽  
Natale Francaviglia ◽  
Mourad Ould-Slimane ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Clinical Performance ◽  
Vertebral Compression Fractures ◽  
Fracture Rate ◽  
Sustained Improvement ◽  
Traumatic Origin ◽  
Eq Vas

This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°;p<0.001), remained at 12 months (-4.4±6.0°,p=0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

scholarly journals Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
David Noriega ◽  
Antonio Krüger ◽  
Francisco Ardura ◽  
Nils Hansen-Algenstaedt ◽  
Frank Hassel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Observational Study ◽  
Oswestry Disability Index ◽  
Clinical Performance ◽  
Compression Fracture ◽  
Cement Leakage ◽  
Vertebral Compression Fractures ◽  
Multicentric Study ◽  
Pmma Bone Cement

The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

Acceptance and commitment therapy for fibromyalgia: A randomized controlled trial

2012 ◽  
Vol 3 (3) ◽  
pp. 183-183
Author(s):  
G.L. Olsson ◽  
M. Kemani ◽  
K. Jensen ◽  
E. Kosek ◽  
D. Kadetoff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Intensity ◽  
Acceptance And Commitment Therapy ◽  
Primary Outcome ◽  
Psychological Inflexibility ◽  
Mediation Analyses ◽  
Pain Disability ◽  
Commitment Therapy ◽  
Acceptance And Commitment

Abstract Background Recent developments within cognitive behavior therapy (CBT) have emphasized the utility of acceptance and mindfulness strategies, contrasting interventions focused on reduction or control of symptoms. A study of fMRI changes after CBT in females with fibromyalgia (FM) has been performed and results are presented elsewhere (under review). The aim of the present study was evaluate the effectiveness of Acceptance and Commitment Therapy (ACT)-based intervention for patient diagnosed with FM in comparison with a wait-list control Method Female patients aged 18–55 years, fulfilling the American College of Rheumatology classification criteria for FM, and with a weekly self-reported average pain intensity of >40 (VAS 0–100) were considered eligible for inclusion. Participants completed a set of questionnaires prior to treatment, immediately following the treatment and at follow 3–4 months post treatment. Primary outcome variable was pain disability (PDI). FIQ, SF36, SES, STAI, pain intensity, BDI, PIPS (psychological inflexibility in pain scale) were also used. The ACT-intervention consisted of twelve weekly group sessions, ten with psychologist and two with pain physician. Treatment was evaluated and mediation analyses were performed. Results Primary outcome measure (PDI): A significant improvement in pain disability for ACT in relation to the control condition, p < 0.001. Secondary outcome measures: ACT showed significant improvement in mental health quality of life, self-efficacy, depression, and anxiety. Consistent with hypotheses, ACT did not result in significant changes in either physical quality of life or pain intensity. Mediation analyses: A decrease in psychological inflexibility from pre to post assessments significantly mediated the improvement in pain disability. Conclusion The present study supports the utility of using a relatively brief ACT intervention in a group format for women diagnosed with fibromyalgia, and data suggests a mediating function on improvements in psychological flexibility.

Rationale, baseline characteristics and methodology of the non-interventional VIVA study in postmenopausal osteoporosis

2014 ◽  
Vol 23 (01) ◽  
pp. 49-55
Author(s):  
L. C. Hofbauer ◽  
D. Felsenberg ◽  
M. Amling ◽  
A. Kurth ◽  
P. Hadji
Keyword(s):  
Quality Of Life ◽  
Postmenopausal Osteoporosis ◽  
Primary Outcome ◽  
Osteoporosis Treatment ◽  
Secondary Outcome ◽  
Matched Pairs ◽  
Fracture History ◽  
Baseline Characteristics ◽  
Study Inclusion

SummaryIt is important to understand compliance and persistence with medication use in the clinical practice of osteoporosis treatment. The purpose of this work is to describe the “intravenous ibandronate versus oral alendronate” (VIVA) study, a non-interventional trial to assess the compliance and persistence of osteopenic postmenopausal women with treatment via weekly oral alendronate or intravenous ibandronate (Bonviva®) every three months.4477 patients receiving ibandronate 3 mg i. v. quarterly and 1491 patients receiving alendronate 70 mg orally weekly were included in the study. Matched pairs of 901 subjects in each group were also generated. Matching was performed on the basis of age, body mass index, fracture history at study inclusion, prior treatment with bisphosphonates and the number of concomitant disorders. Secondary outcome measures of osteoporosis related fractures, mobility restriction and pain, analgesia, quality of life questionnaires as well as attitudes to medications were assessed. The primary outcome parameters of compliance and persistence will be tracked in these subjects.At baseline, the entire collectives differed significantly on body weight (less in ibandronate group), duration since osteo - porosis diagnosis (longer in ibandronate), and incidence of prior osteoporotic fracture (higher in ibandronate group). The matched-pairs differed only on mobility restriction and quality of life (both worse in ibandronate group).The results from the VIVA study trial will provide scientific rationale for clinical recommendations in the pharmacological treatment of postmenopausal osteoporosis.

scholarly journals What Does the Future Hold? Health-Related Quality of Life 3–12 Years Following a Youth Sport-Related Knee Injury

2021 ◽  
Vol 18 (13) ◽  
pp. 6877
Author(s):  
Christina Y. Le ◽  
Clodagh M. Toomey ◽  
Carolyn A. Emery ◽  
Jackie L. Whittaker
Keyword(s):  
Quality Of Life ◽  
Knee Injury ◽  
Youth Sport ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Knee Trauma ◽  
Strenuous Physical Activity ◽  
Eq Vas

Knee trauma can lead to poor health-related quality of life (HRQoL) and osteoarthritis. We aimed to assess HRQoL 3–12 years following youth sport-related knee injury considering HRQoL and osteoarthritis determinants. Generic (EQ-5D-5L index, EQ-VAS) and condition-specific (Knee injury and Osteoarthritis Outcome Score quality of life subscale, KOOS QOL) HRQoL were assessed in 124 individuals 3–12 years following youth sport-related knee injury and 129 uninjured controls of similar age, sex, and sport. Linear regression examined differences in HRQoL outcomes by injury group. Multivariable linear regression explored the influence of sex, time-since-injury, injury type, body mass index, knee muscle strength, Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and Godin Leisure-Time Exercise Questionnaire (GLTEQ) moderate-to-strenuous physical activity. Participant median (range) age was 23 years (14–29) and 55% were female. Injury history was associated with poorer KOOS QOL (−8.41; 95%CI −10.76, −6.06) but not EQ-5D-5L (−0.0074; −0.0238, 0.0089) or EQ-VAS (−3.82; −8.77, 1.14). Injury history (−5.14; −6.90, −3.38), worse ICOAP score (−0.40; −0.45, −0.36), and anterior cruciate ligament tear (−1.41; −2.77, −0.06) contributed to poorer KOOS QOL. Worse ICOAP score contributed to poorer EQ-5D-5L (−0.0024; −0.0034, −0.0015) and higher GLTEQ moderate-to-strenuous physical activity to better EQ-VAS (0.10; 0.03, 0.17). Knee trauma is associated with poorer condition-specific but not generic HRQoL 3–12 years post-injury.

scholarly journals The effect of intravenous golimumab on health-related quality of life and work productivity in patients with active psoriatic arthritis: results of the Phase 3 GO-VIBRANT trial

2021 ◽  
Author(s):  
Alexis Ogdie ◽  
Jessica A. Walsh ◽  
Soumya D. Chakravarty ◽  
Steven Peterson ◽  
Kim Hung Lo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Productivity Loss ◽  
Health Related Quality ◽  
Functional Capability ◽  
Related Quality ◽  
Health Related ◽  
Eq Vas

Abstract Introduction/objectives To evaluate changes in health-related quality of life (HRQoL) and productivity following treatment with intravenous (IV) golimumab in patients with psoriatic arthritis (PsA). Methods Patients were randomized to IV golimumab 2 mg/kg (n=241) at Weeks 0, 4, then every 8 weeks (q8w) through Week 52 or placebo (n=239) at Weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at Weeks 24, 28, then q8w through Week 52. Change from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, and the Work Limitations Questionnaire (WLQ) was assessed. Relationships between these outcomes and disease activity and patient functional capability were evaluated post hoc. Results At Week 8, change from baseline in EQ-5D-5L index (0.14 vs 0.04), EQ-VAS (17.16 vs 3.69), daily productivity VAS (−2.91 vs −0.71), and WLQ productivity loss score (−2.92 vs −0.78) was greater in the golimumab group versus the placebo group, respectively. At Week 52, change from baseline was similar in the golimumab and placebo-crossover groups (EQ-5D-5L index: 0.17 and 0.15; EQ-VAS: 21.61 and 20.84; daily productivity VAS: −2.89 and −3.31; WLQ productivity loss: −4.49 and −3.28, respectively). HRQoL and productivity were generally associated with disease activity and functional capability, with continued association from Week 8 through Week 52. Conclusion IV golimumab resulted in early and sustained improvements in HRQoL and productivity from Week 8 through 1 year in patients with PsA. HRQoL and productivity improvements were associated with improvements in disease activity and patient functional capability. Key Points• In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year• Improvements in HRQoL and productivity outcomes in patients with PsA treated with IV golimumab were associated with improvements in disease activity and patient functional capability outcomes• IV golimumab is an effective treatment option for PsA that can mitigate the negative effects of the disease on HRQoL and productivity

scholarly journals Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

2021 ◽  
pp. annrheumdis-2020-219091 ◽  
Author(s):  
Gary J Macfarlane ◽  
Marcus Beasley ◽  
Neil Scott ◽  
Huey Chong ◽  
Paul McNamee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Behavioural Therapy ◽  
Short Course ◽  
Life Years ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

Sleep disturbance in patients attending specialized chronic pain clinics in Denmark: a longitudinal study examining the relationship between sleep and pain outcomes

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Henrik Bjarke Vaegter ◽  
Mette Terp Høybye ◽  
Frederik Hjorth Bergen ◽  
Christine E. Parsons
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Sleep Quality ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Pain Disability ◽  
Pain Clinics ◽  
Pain Outcomes

Abstract Objectives Sleep disturbances are highly prevalent in patients with chronic pain. However, the majority of studies to date examining sleep disturbances in patients with chronic pain have been population-based cross-sectional studies. The aims of this study were to 1) examine the frequency of sleep disturbances in patients referred to two interdisciplinary chronic pain clinics in Denmark, 2) explore associations between sleep disturbances and pain intensity, disability and quality of life at baseline and follow-up, and 3) explore whether changes in sleep quality mediated the relationships between pain outcomes at baseline and pain outcomes at follow-up. Methods We carried out a longitudinal observational study, examining patients enrolled in two chronic pain clinics assessed at baseline (n=2,531) and post-treatment follow-up (n=657). Patients reported on their sleep disturbances using the sleep quality subscale of the Karolinska Sleep Questionnaire (KSQ), their pain intensity using 0–10 numerical rating scales, their pain-related disability using the Pain Disability Index (PDI), and quality of life using the EuroQol-VAS scale. The average time between baseline and follow-up was 207 days (SD=154). Results At baseline, the majority of patients reported frequent sleep disturbances. We found a significant association at baseline between self-reported sleep disturbances and pain intensity, pain-related disability, and quality of life, where greater sleep disturbance was associated with poorer outcomes. At follow-up, patients reported significant improvements across all pain and sleep outcomes. In two mediation models, we showed that changes in sleep disturbances from baseline to follow-up were significantly associated with (i) pain intensity at follow-up, and (ii) pain disability at follow-up. However, baseline pain intensity and disability scores were not associated with changes in sleep disturbances and, we did not find evidence for significant mediation of either pain outcome by changes in sleep disturbances. Conclusions Self-reported sleep disturbances were associated with pain outcomes at baseline and follow-up, with greater sleep disturbances associated with poorer pain outcomes. Changes in sleep quality did not mediate the relationships between baseline and follow-up scores for pain intensity and disability. These findings contribute to a growing body of evidence confirming an association between sleep and chronic pain experience, particularly suggestive of a sleep to pain link. Our data following patients after interdisciplinary treatment suggests that improved sleep is a marker for a better outcome after treatment.

scholarly journals Topical TRPM8 Agonist for Relieving Neuropathic Ocular Pain in Patients with Dry Eye: A Pilot Study

2021 ◽  
Vol 10 (2) ◽  
pp. 250
Author(s):  
Hyeon Jeong Yoon ◽  
Jonghwa Kim ◽  
Jee Myung Yang ◽  
Edward T. Wei ◽  
Seong Jin Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pilot Study ◽  
Pain Intensity ◽  
Dry Eye ◽  
Associated Factors ◽  
Treatment Result ◽  
Ocular Pain ◽  
Eye Pain ◽  
Validated Questionnaire

Background: Activation of TRPM8, a cold-sensing receptor located on the cornea and eyelid, has the potential to relieve the neuropathic ocular pain (NOP) in dry eye (DE) by inhibiting other aberrant nociceptive inputs. We aimed to investigate the effect of a topical TRPM8 agonist, cryosim-3 (C3), on relieving DE-associated NOP. Methods: We conducted a prospective pilot study of 15 patients with DE-associated NOP. These patients applied topical C3 to their eyelid, 4 times/day for 1 month. The patients underwent clinical examinations. They also completed the Ocular Pain Assessment Survey (OPAS), which is a validated questionnaire for NOP, at baseline, 1 week, and 1 month after treatment. Result: At 1 week, the OPAS scores of eye pain intensity, quality of life (driving/watching TV, general activity, sleep, and enjoying life/relations with other people), and associated factors (burning sensation, light sensitivity, and tearing) improved. The total OPAS scores of eye pain intensity, quality of life, and associated factors remained improved at 1 month. The Schirmer test scores also improved at 1 month. Conclusion: TRPM8 agonist (C3) could be a novel agent for treating patients with DE-associated NOP who are unresponsive to conventional treatments.

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