Individual brief art therapy can be helpful for women with breast cancer: A randomized controlled clinical study

2009 ◽  
Vol 7 (1) ◽  
pp. 87-95 ◽  
Author(s):  
Karin Egberg Thyme ◽  
Eva C. Sundin ◽  
Britt Wiberg ◽  
Inger Öster ◽  
Sture Åström ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Art Therapy ◽  
Rating Scales ◽  
Psychiatric Symptoms ◽  
Therapy Group ◽  
Postoperative Radiotherapy ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

ABSTRACTObjective:Recent research shows that almost every second woman with breast cancer is depressed or has anxiety; the risk for younger women is even higher. Moreover, research shows that women are at risk for developing depression, also a threat for women with breast cancer. The aim of this randomized controlled clinical trial was to study the outcome of five sessions of art therapy given at a 5-week period of postoperative radiotherapy.Methods:The participants were between 37 and 69 years old; six participants in each group were below 50 years of age. Half of the participants (n = 20) received art therapy and the other half (n = 21) were assigned to a control group. At the first measurement, at least 17% (n = 7) of the participants medicated with antidepressants. Data were collected before and after art therapy and at a 4-month follow-up using self-rating scales that measure self-image (the Structural Analysis of Social Behaviour) and psychiatric symptoms (the Symptom Check List–90).Results:At follow-up, significant lower ratings of depression, anxiety, and somatic symptoms and less general symptoms were reported for the art therapy group compared to the control group. The regression analysis showed that art therapy relates to lower ratings of depression, anxiety, and general symptoms; chemotherapeutic treatment predicts lower depressive symptoms; in contrast to axilliary surgery and hormonal treatment as well as being a parent predicts higher ratings of anxiety and general symptoms.Significance of results:The conclusion suggests that art therapy has a long-term effect on the crisis following the breast cancer and its consequences.

Art therapy improves coping resources: A randomized, controlled study among women with breast cancer

2006 ◽  
Vol 4 (1) ◽  
pp. 57-64 ◽  
Author(s):  
INGER ÖSTER ◽  
ANN-CHRISTINE SVENSK ◽  
EVA MAGNUSSON ◽  
KARIN EGBERG THYME ◽  
MARIE SJÕDIN ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Art Therapy ◽  
Primary Breast Cancer ◽  
Intervention Program ◽  
Postoperative Radiotherapy ◽  
Coping Resources ◽  
University Hospital ◽  
Controlled Study ◽  
Control Group ◽  
Therapy Intervention

Objective: Women with breast cancer suffer from considerable stress related to the diagnosis, surgery, and medical treatment. It is important to develop strategies to strengthen coping resources among these women. Research in art therapy has shown outcomes such as an increase in self-esteem and cohesion, significant improvement in global health, and a decrease in anxiety and depression. The aim of the present article was to describe the effects of an art therapy intervention program on coping resources in women with primary breast cancer.Method: In this article, we report some of the results from a study including 41 women, aged 37–69 years old, with nonmetastatic primary breast cancer, referred to the Department of Oncology at Umeå University Hospital in Sweden for postoperative radiotherapy. The women represented various socioeconomic backgrounds. They were randomized to a study group (n = 20) with individual art therapy for 1 h/week during postoperative radiotherapy or to a control group (n = 21). The article focuses on changes in coping resources, as measured by the Coping Resources Inventory (CRI) before and 2 and 6 months after the start of radiotherapy. The study protocol was approved by the Umeå University Ethical Committee at the Medical Faculty (archive number 99–386).Results: There was an overall increase in coping resources among women with breast cancer after taking part in the art therapy intervention. Significant differences were seen between the study and control groups in the social domain on the second and third occasions. Significant differences were also observed in the total score on the second occasion.Significance of results: This study shows that individual art therapy provided by a trained art therapist in a clinical setting can give beneficial support to women with primary breast cancer undergoing radiotherapy, as it can improve their coping resources.

scholarly journals MILD® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial

2016 ◽  
Vol 4;19 (4;5) ◽  
pp. 229-242 ◽  
Author(s):  
Ramsin Benyamin
Keyword(s):  
Ligamentum Flavum ◽  
Responder Rate ◽  
Control Group ◽  
Neurogenic Claudication ◽  
Controlled Clinical Trial ◽  
Epidural Steroid Injections ◽  
Randomized Controlled ◽  
Lumbar Spinal ◽  
Epidural Steroid

Background: Lumbar spinal stenosis (LSS) is a common degenerative condition of the spine, which is a major cause of pain and functional disability for the elderly. Neurogenic claudication symptoms are a hallmark of LSS, where patients develop low back or leg pain when walking or standing that is relieved by sitting or lumbar flexion. The treatment of LSS generally begins with conservative management such as physical therapy, home exercise programs, and oral analgesics. Once these therapies fail, patients commonly move forward with interventional pain treatment options such as epidural steroid injections (ESIs) or MILD® as the next step. Objective: To assess improvement of function and reduction in pain for Medicare beneficiaries following treatment with MILD (treatment group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy and to compare to a control group receiving ESIs. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Methods: Patients in this trial were randomized one to one into 2 study arms. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Outcomes are assessed using the Oswestry Disability Index (ODI), Numeric Pain Rating Scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the ESI group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy is the proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device- or procedure-related adverse events in each group. This report presents safety and efficacy results at 1-year follow-up. Outcomes at 2 years will be collected and reported for patients in the MILD group only. Results: At 1-year follow-up, ODI, NPRS, and all 3 ZCQ domains (Symptom Severity, Physical Function and Patient Satisfaction) demonstrated statistically significant superiority of MILD versus the active control. For primary efficacy, the 58.0% ODI responder rate in the MILD group was higher than the 27.1% responder rate in the epidural steroid group (P < 0.001). The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: There was a lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to adjunctive pain therapy study restrictions. Study enrollment was not limited to patients that had never received ESI therapy. Conclusions: One-year results of this randomized controlled clinical trial demonstrate that MILD is statistically superior to ESIs in the treatment of LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. Primary and secondary efficacy outcome measures achieved statistical superiority in the MILD group compared to the control group. With 95% of patients in this study presenting with 5 or more LSS co-factors, it is important to note that patients with spinal co-morbidities also experienced statistically significant improved function that was durable through 1 year. Key words: MILD, minimally invasive lumbar decompression, interlaminar epidural steroid injections, ESI neurogenic claudication, ligamentum flavum, ENCORE, PILD, CED Study, LSS

Art therapy and self-image: A 5-year follow-up art therapy RCT study of women diagnosed with breast cancer

2021 ◽  
pp. 1-9
Author(s):  
Karin Egberg Thyme ◽  
Björn Tavelin ◽  
Inger Öster ◽  
Jack Lindh ◽  
Britt Wiberg
Keyword(s):  
Breast Cancer ◽  
Art Therapy ◽  
Intervention Group ◽  
Control Group ◽  
Long Term Effects ◽  
Post Intervention ◽  
Follow Up Study ◽  
Self Image ◽  
Behavioral System

Abstract Objective This follow-up study on perceived self-image and psychophysical distress/psychic symptoms was based on a ranomized contolled study of art therapy on women with breast cancer. Method The aim was to examine the long-term effects of time-limited art therapy using the instruments of Structural Analysis of Social Behavior (SASB) and Symptom Check List-90 (SCL-90). Results Three attachment clusters of the SASB showed significant changes post therapy: Autonomous self (cluster 1), Accepting self (cluster 2), and Loving self (cluster 3). Clusters 2 and 3 continued to change in favor of the intervention group at the 5-year follow-up. There were no significant differences in the SCL-90 results between the intervention group and the control group in the follow-up study. Significance of results The art therapy intervention was both therapeutic and psycho-educative. The conclusion of this study is that approaching emotions through time-limited art therapy seems to have a long-lasting effect on the attachment behavioral system shown in the SASB model post intervention, and this effect remained 5 years later.

A Randomized, Controlled Trial of Varying D-Dimer Cutpoints According to Clinical Pretest Probability Compared with a Uniform D-Dimer Cutpoint for Diagnosis of Deep Vein Thrombosis

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5116-5116
Author(s):  
Lori Ann Linkins ◽  
Shannon M. Bates ◽  
Susan Kahn ◽  
Eddy Lang ◽  
Jim Julian ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pretest Probability ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diagnostic Strategies ◽  
Vein Thrombosis ◽  
Randomized Controlled ◽  
Venous Thromboembolic Events ◽  
D Dimer

Abstract Abstract 5116 Background: D-dimer assays are currently used as a one-size-fits-all diagnostic test for DVT where the same cutpoint is used to define a positive result for all patients. This approach ignores the relationship between the diagnostic properties of the assay and the pretest probability of the disease. Objective: We conducted a randomized, allocation concealed, controlled, assessor-blinded trial to compare the safety and efficiency of two diagnostic strategies for D-dimer testing for first acute DVT of the lower limb: Selective use of D-dimer testing, using different D-dimer cutpoint levels according to clinical pretest probability (C-PTP) and the traditional Uniform approach. Method: 1723 consecutive eligible inpatients and outpatients at 5 clinical centres (4 in Ontario, 1 in Montreal) had their C-PTP assessed using the Wells' Score and were randomized to either: Uniform D-dimer testing, in which all patients had a D-dimer test and a level of <0.5 μ g fibrinogen equivalent units (FEU)/mL was classified as negative (the control group); or Selective D-dimer testing, in which D-dimer testing was (a) performed in patients with Low and Moderate C-PTP only, (patients with a High C-PTP had an ultrasound, but no D-dimer testing), and (b) was classified as negative if the D-dimer level was <0.5 μ g FEU/mL with Moderate C-PTP or <1.0 μ g FEU/mL with Low C-PTP (the experimental group). The D-dimer assays used in this study were the MDA D-Dimer (bioMerieux, Inc and Trinity Biotech) and STA Liatest D-Dimer(Diagnostica Stago). All patients with a positive D-dimer had an ultrasound of their leg. Symptomatic venous thromboembolic events (VTE) during 3 months of follow-up were objectively confirmed and independently adjudicated. Results: The incidence of VTE during 3 months of follow-up in patients who were not diagnosed with DVT at initial presentation was 1.1% (9/811) with Uniform testing, and 1.1% (9/814) with Selective testing (difference 0.004%, 95% CI:-1.122, 1.111). The incidence of VTE during 3 months of follow-up in patients in the Low C-PTP Select arm (D-dimer cutpoint 1.0 μ g FEU/mL) was 0% (0/356), and in the Low C-PTP Uniform arm (D-dimer cutpoint 0.5 μ g FEU/mL), it was 0.3% (1/336). Conclusion: This is the first randomized controlled clinical trial to show that Selective use of D-dimer testing, with a higher D-dimer cutpoint in patients with Low C-PTP, is safe and potentially more efficient than current practice. Funded by the Heart & Stroke Foundation of Ontario. Disclosures: Linkins: Trinity Biotech: in-kind donation of D-dimer kits; BioMerieux: in-kind donation of D-dimer kits; Stago Diagnostica: in-kind donation of D-dimer kits. Bates:bioMerieux: in-kind donation of D-dimer kits; Trinity Biotech: Consultancy, in-kind donation of D-dimer kits. Kearon:BioMerieux: in-kind donation of D-dimer kits; Trinity Biotech: in-kind donation of D-dimer kits; Stago Diagnostica: in-kind donation of D-dimer kits.

scholarly journals Observation on Pain Release by Long-Round Needle Therapy in Knee Osteoarthritis Related with Meridian-Sinews Theory

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Yuan-shi Liu ◽  
Li-gong Xue ◽  
Xiao-jian Ma ◽  
Chun-shan Liu
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Therapy Group ◽  
Controlled Trial ◽  
Control Group ◽  
Curative Effect ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Therapy Sessions

To evaluate the effectiveness of long-round needle therapy for pain relief in patients with knee osteoarthritis, 192 patients were included in a multicenter, randomized, controlled trial. 97 patients were randomized to the long-round needle therapy group (EG), and 95 patients were randomized to the control group (CG). In EG, the long-round needle therapy was performed once every 7 days for 3 therapy sessions. Ibuprofen sustained-release capsules were administered orally in CG, 1 pill each time, twice daily for 3 weeks. Curative effect was measured after the therapy and was evaluated at a 3-month follow-up interview. In EG, the treatment resulted in a basic cure for 79 patients, was effective for 15 patients, and was ineffective for 1 patient. In CG, the treatment resulted in a basic cure for 30 patients, was effective for 38 patients, and was ineffective for 21 patients. In the follow-up examination in EG, 75 patients were basically cured, and the treatment was effective for 11 patients and ineffective for 9. In CG, 22 were basically cured, 31 found the treatment effective, and 36 found the treatment ineffective. The curative effects in EG after both the treatment and the 3-mouth followup were significantly more superior than that in CG (P<0.01) which should be adopted more widely.

scholarly journals Effects of Orthoptic Therapy in Children with Intermittent Exotropia After Surgery: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Meiping Xu ◽  
Fuhao Zheng ◽  
Tingting Peng ◽  
Chunxiao Wang ◽  
Jiangtao Lou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Therapy Group ◽  
High Rate ◽  
Controlled Study ◽  
Control Group ◽  
Blank Control Group ◽  
Intermittent Exotropia ◽  
Randomized Controlled ◽  
Cover Test

Abstract Background Intermittent exotropia (IXT) is the most common type of exotropia in China. Surgery is usually required to align the eye deviation to maintain or obtain better binocular visual function. However, there is a high rate of exodrift or recurrence in surgically treated patients. Orthoptic therapy is sometimes recommended for IXT patients after surgery. However, there is a lack of high-quality randomized controlled trials to prove that orthoptic therapy could be an effective supplement to surgical treatment for IXT patients. This study was designed to confirm such an application. This report describes the design and methodology of the Intermittent Exotropia Post-operative Treatment Clinical Trial, which is the first large-sample, blank-controlled, randomized clinical trial. Methods A total of 136 IXT patients (aged 7 to 17 years) will be enrolled and assigned to the orthoptic therapy group or blank control group according to a simple randomization scheme. Patients in the orthoptic therapy group will receive at least 2 months of orthoptic therapy, such as anti-suppression, vergence, and accommodation training. Patients in the blank control group will receive only refractive correction. All enrolled patients will need regular follow-up observation until 2 years after surgery. The primary outcome will be the proportion of participants meeting suboptimal surgical outcomes in this 2-year follow-up, which is defined as (1) exodeviation of 10 prism diopters (PD) at distance or near using the simultaneous prism and cover test (SPCT) or (2) loss of 2 or more octaves of stereoacuity from baseline, at any masked follow-up visit examination. The secondary outcomes will be the exodeviation at distance and near using the simultaneous prism and alternate cover test (PACT), magnitude of fusional convergence, stereoacuity, and accommodation. Measurements will be taken at baseline and at the 6-, 12-, 18-, and 24-month follow-ups. Discussion To the best of our knowledge, this will be the first prospective, randomized controlled study of binocular training in IXT patients after surgery. The aim of this work is to confirm the efficacy of orthoptic therapy in reducing the proportion of recurrence among IXT patients after surgery and improving binocular vision function. Trial registration: Chinese Clinical Trial Registry ChiCTR1900026891. Registered on 25 October 2019.

scholarly journals Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial) (Preprint)

2018 ◽  
Author(s):  
Katsuhiro Mizuno ◽  
Takayuki Abe ◽  
Junichi Ushiba ◽  
Michiyuki Kawakami ◽  
Tomomi Ohwa ◽  
...  
Keyword(s):  
Occupational Therapy ◽  
Neural Plasticity ◽  
Controlled Trial ◽  
Brain Machine Interface ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Multicenter Rct ◽  
Machine Interface

BACKGROUND We developed a brain-machine interface (BMI) system for poststroke patients with severe hemiplegia to detect event-related desynchronization (ERD) on scalp electroencephalogram (EEG) and to operate a motor-driven hand orthosis combined with neuromuscular electrical stimulation. ERD arises when the excitability of the ipsi-lesional sensorimotor cortex increases. OBJECTIVE The aim of this study was to evaluate our hypothesis that motor training using this BMI system could improve severe hemiparesis that is resistant to improvement by conventional rehabilitation. We, therefore, planned and implemented a randomized controlled clinical trial (RCT) to evaluate the effectiveness and safety of intensive rehabilitation using the BMI system. METHODS We conducted a single blind, multicenter RCT and recruited chronic poststroke patients with severe hemiparesis more than 90 days after onset (N=40). Participants were randomly allocated to the BMI group (n=20) or the control group (n=20). Patients in the BMI group repeated 10-second motor attempts to operate EEG-BMI 40 min every day followed by 40 min of conventional occupational therapy. The interventions were repeated 10 times in 2 weeks. Control participants performed a simple motor imagery without servo-action of the orthosis, and electrostimulation was given for 10 seconds for 40 min, similar to the BMI intervention. Overall, 40 min of conventional occupational therapy was also given every day after the control intervention, which was also repeated 10 times in 2 weeks. Motor functions and electrophysiological phenotypes of the paretic hands were characterized before (baseline), immediately after (post), and 4 weeks after (follow-up) the intervention. Improvement in the upper extremity score of the Fugl-Meyer assessment between baseline and follow-up was the main outcome of this study. RESULTS Recruitment started in March 2017 and ended in July 2018. This trial is currently in the data correcting phase. This RCT is expected to be completed by October 31, 2018. CONCLUSIONS No widely accepted intervention has been established to improve finger function of chronic poststroke patients with severe hemiparesis. The results of this study will provide clinical data for regulatory approval and novel, important understanding of the role of sensory-motor feedback based on BMI to induce neural plasticity and motor recovery. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000026372; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000030299 (Archived by WebCite at http://www.webcitation.org/743zBJj3D) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12339

scholarly journals Group meta-cognitive therapy and depression in women with breast cancer: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elham Zahedian ◽  
Masoud Bahreini ◽  
Nezamaddin Ghasemi ◽  
Kamran Mirzaei
Keyword(s):  
Breast Cancer ◽  
Cognitive Therapy ◽  
Control Group ◽  
Cognitive Emotion Regulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Cognitive Beliefs ◽  
The Mean ◽  
Experimental Group

Abstract Background Breast cancer is one of the most common cancers in Iranian women. They will experience a mental health problem like depression before, during or after treatment. This study aimed to determine the effectiveness of group metacognitive therapy on depression, cognitive-emotional regulation, and meta-cognitive beliefs in women with breast cancer. Methods In this randomized controlled clinical trial, a total of 24 depressed patients with breast cancer were randomly allocated to experimental and control groups. The experimental group received meta-cognitive therapy in 8 weekly sessions, but the control group received treatment as usual. Beck Depressive Inventory, cognitive emotion regulation questionnaire, and meta-cognitions questionnaire were completed before, after and one month after the intervention. Data were analyzed using Wilcoxon and Chi-square tests. Results The mean score of depression in the experimental group was reduced from 21.6 ± 4.83 in the pre-test to 13.83 ± 8.12 in one-month follow-up (p = 0.16); however, there was no significant difference in the control group. The mean score of cognitive emotion regulation did not show a significant change in the two groups during the study and follow-up period. The mean score of meta-cognitive beliefs reached 68.75 ± 15.74 from 79.51 ± 10.72 in the experimental group during the follow-up period (p = 0.006); however, there was no significant difference in the control group in the score of metacognitive beliefs. Conclusion These findings support the efficacy of meta-cognitive therapy as a viable psychosocial intervention in depressed patients with breast cancer. Trial registration IRCT201606288473N5. Registered on: 05/09/2016 https://www.irct.ir/trial/8946.

scholarly journals Effectiveness of an Interdisciplinary Program Performed on Obese People Regarding Nutritional Habits and Metabolic Comorbidity: A Randomized Controlled Clinical Trial

2020 ◽  
Vol 17 (1) ◽  
pp. 336
Author(s):  
Virginia Esperanza Fernández-Ruiz ◽  
Antonio Jesús Ramos-Morcillo ◽  
María Solé-Agustí ◽  
José Antonio Paniagua-Urbano ◽  
David Armero-Barranco
Keyword(s):  
Behavioral Therapy ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Obese People ◽  
Interdisciplinary Program ◽  
Nutritional Habits ◽  
Randomized Controlled ◽  
Experimental Group

Obesity is an important public health problem. The combined use of different therapies performed by an interdisciplinary group can improve the management of this health issue. The main goal of this research is to determine the effectiveness of a multidisciplinary program based on healthy eating, exercise, cognitive-behavioral therapy, and health education in improving metabolic comorbidity, Body Mass Index (BMI), and nutritional habits among obese adults, at short (12 months) and long term (24 months). A randomized controlled clinical trial was conducted at a community care center between February 2014 and February 2016. A random sampling was done (299), total population (3262). A sample of 74 subjects diagnosed with obesity (experimental group, n = 37 and control group, n = 37) was conducted. Inclusion criteria: obese people (BMI: >30 kg/m2) with metabolic comorbidity and bad nutritional habits. Exclusion criteria: other comorbidities. A 12-month interdisciplinary program (with pre-test, 12 months and 24 months of follow-up) was applied. Intervention is based on healthy eating, exercise, and cognitive behavioral therapy. The intervention had a positive effect on nutritional habits (F2;144 = 115.305; p < 0.001). The experimental group increased fruit and vegetable intake (F2;144 = 39.604, p < 0.001), as well as fortified foods (F2;144 = 10,076, p < 0.001) and reduced fats, oils, and sweets F2;144 = 24,086, p < 0.001). In the experimental group, a BMI reduction of 2.6 to 24 months was observed. At follow-up, no participant had inadequate nutritional habits, compared to 35.1% of the control group (χ22 = 33,398; p < 0.001). There was also a positive response of metabolic comorbidities in the intervention group. The interdisciplinary program improved all participants’ metabolic parameters, BMI, and nutritional habits while maintaining the long-term effects (24 months).

scholarly journals MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results

2016 ◽  
Vol 19 (2;2) ◽  
pp. 25-37
Author(s):  
Peter S. Staats
Keyword(s):  
Clinical Trial ◽  
Active Control ◽  
Ligamentum Flavum ◽  
Control Group ◽  
Neurogenic Claudication ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Epidural Steroid

Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Study Design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcome Measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of ≥10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. Key words: MILD, lumbar central spinal stenosis, minimally invasive lumbar decompression, interlaminar epidural steroid injection, neurogenic claudication, ligamentum flavum, Oswestry Disability Index, ODI, Numeric Pain Rating Scale, NPRS, Zurich Claudication Questionnaire, ZCQ

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