Effect of Systematic Exercise Rehabilitation on Patients With Knee Osteoarthritis: A Randomized Controlled Trial

Cartilage ◽  
2020 ◽  
pp. 194760352090344
Author(s):  
Jing Chao ◽  
Zhang Jing ◽  
Bai Xuehua ◽  
Yang Peilei ◽  
Gong Qi
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Short Form ◽  
Controlled Trial ◽  
Control Group ◽  
Exercise Rehabilitation ◽  
The Mean ◽  
Cox 2 Inhibitors

Objectives We aimed to compare the outcomes of exercise rehabilitation and conventional treatment in patients with knee osteoarthritis. Methods This trial included a total of 166 patients diagnosed with knee osteoarthritis; they were randomly divided into groups. The experimental group underwent systematic exercise rehabilitation, while the control group received naproxen ( n = 28), diclofenac ( n = 27), or celecoxib ( n = 19). Improvement in symptoms, knee function, and quality of life were compared. SPSS Statistics 24.0 was used for the data analysis. Results The mean age of patients was 56.0 ± 10.5 years, and the average follow-up time was 12 ± 2.3 weeks. No statistically significant differences were seen in age, body mass index, and sex ( P > 0.05) between the groups. The average Western Ontario and MacMaster Universities (WOMAC) scores after treatment were 84.4 ± 15.2, 108.3 ± 3.9, 107.4 ± 5.4, and 107 ± 6.0 in the exercise rehabilitation, diclofenac, naproxen, and celecoxib groups, respectively. The mean Lysholm scores were 60.3 ± 14.9, 41.0 ± 0.1, 43.5 ± 5.3, and 41.7 ± 3.6 in the exercise rehabilitation, diclofenac, naproxen, and celecoxib groups, respectively. The mean SF-36 (Short Form-36 Survey) scores were 105.4 ± 21.5, 82.5 ± 3.7, 84.2 ± 3.5, and 83.7 ± 5.0 in the exercise rehabilitation, naproxen, celecoxib, and diclofenac groups, respectively. The average ranges of knee motion were 125.0 ± 6.2°, 116.4 ± 1.4°, 114.7 ± 1.1°, and 115.7 ± 0.8° after exercise rehabilitation, diclofenac, naproxen, and celecoxib treatments, respectively. These data presented statistical differences between the groups. Conclusion Exercise better improved symptoms and quality of life in patients with knee osteoarthritis over a 12-week follow-up period than that achieved with nonsteroidal anti-inflammatory drugs and COX-2 inhibitors.

scholarly journals Effectiveness of Cognitive-Behavioral Therapy (CBT) on Quality of Life (QOL) and Worry in Patients with Generalized Anxiety Disorder (GAD)

2015 ◽  
Vol 2 (2) ◽  
Author(s):  
Sheida Jabalameli ◽  
Hamid Taher Neshat Doost ◽  
Mohammad Bagher Kajbaf ◽  
Hossein Molavi
Keyword(s):  
Quality Of Life ◽  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Behavioral Therapy ◽  
Control Group ◽  
Generalized Anxiety ◽  
The Mean ◽  
Experimental Group

Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders. It has been reported that psychological treatments like Cognitive-Behavioral Therapy (CBT) is effective for patients with GAD. The purpose of the present research was to investigate the effectiveness of CBT on Quality of Life (QOL) and worry in patients with GAD. A sample of 30 patients with GAD who had been referred to psychiatry offices in Isfahan, Iran were selected and assigned into an experimental group (n=15) and a control group (n=15) randomly.  The experimental group received CBT in 8 weekly sessions. All participants completed the World Health Organization Quality Of Life-Brief (WHOQOL-BREF) questionnaire and the Penn State Worry Questionnaire (PSWQ) at pretest, posttest and follow up. The results of MANCOVA showed that the mean scores of QOL in the experimental group was significantly higher than the control group at the posttest and follow up (P<0.05) and the mean scores of worry in the experimental group was significantly lower than the control group at the posttest and follow up (P<0.05) It is concluded that CBT can be applied for the patients with GAD as a useful psychological treatment. In general, CBT can improve QOL and decrease worry in patients with GAD.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

scholarly journals Effectiveness of a Program Combining Strengthening, Stretching, and Aerobic Training Exercises in a Standing versus a Sitting Position in Overweight Subjects with Knee Osteoarthritis: A Randomized Controlled Trial

2020 ◽  
Vol 9 (12) ◽  
pp. 4113
Author(s):  
Betsy Denisse Perez-Huerta ◽  
Belén Díaz-Pulido ◽  
Daniel Pecos-Martin ◽  
David Beckwee ◽  
Enrique Lluch-Girbes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Global Increase ◽  
Experimental Group ◽  
Overweight Subjects

There is an increasing incidence, prevalence, and burden of knee osteoarthritis due to a global increase in obesity and an aging population. The aim of the present study was to compare the effectiveness of the addition of aerobic exercises performed in an unloaded or loaded position to a conventional exercise program in overweight subjects with knee osteoarthritis. Twenty-four subjects were randomly allocated to receive 36 sessions of 30-min duration of either sitting aerobic exercises (experimental group) or standing aerobic exercises (control group). Pain intensity, knee disability, and quality-of-life data were collected at baseline and at 12, 24, and 36 sessions. Generalized linear mixed models (GLMMs) were constructed for the analysis of the differences. Significant differences were found in the experimental group for self-reported pain and knee pain and disability at 24 and 36 sessions (p < 0.05). Significant between-group differences were observed in change in self-reported knee pain and disability and quality of life from baseline to 24th- and 36th-session measurements in favor of the experimental group. Adherence to treatment was higher in the experimental group. Adding aerobic exercises in an unloaded position to a conventional exercise program produced superior effects over time for self-reported knee pain, knee pain and disability and quality of life compared to loaded aerobic exercises in overweight subjects with knee osteoarthritis.

scholarly journals Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

scholarly journals The Effect of Solution-Focused Counseling on Violence Rate and Quality of Life of Pregnant Women at Risk of Domestic Violence: A randomized Controlled Trial

2020 ◽  
Author(s):  
Sepideh Din Mohammadi ◽  
Mohsen Dadashi ◽  
Elahe Ahmadnia ◽  
leila Janani ◽  
Roghieh Kharaghani
Keyword(s):  
Quality Of Life ◽  
At Risk ◽  
Domestic Violence ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Solution Focused

Abstract Background: Domestic violence is considered as one of the most common social problems, which can affect the quality of life of women. The problem of preventing and controlling this problem, especially during pregnancy, is one of the basic challenges of health systems. The aim of this study was to determine the effect of counseling based on conflict solution on the rate of violence and quality of life of pregnant women at risk of domestic violence. Methods: This study was a randomized controlled trial on 90 pregnant women, who were selected from maternity wards in health center number three in Zanjan city. Women who had inclusion criteria based on the domestic violence conflict tactics scale (CTS-2) selected with convenience sampling and randomly divided into two groups of intervention (45 people) and control (45 people) with a blocked randomization method. The intervention group received six counseling sessions with a solution-focused approach and the control group received no intervention. Study tool included demographic and reproductive questionnaires CTS- 2 and short form health survey (SF-36); which completed at baseline and six weeks follow-up in both groups. The results were analyzed by nonparametric ANCOVA using SPSS and R soft wares.Results: The results showed that there was a significant difference in the physical violence (P=0.001), psychological violence (P=0.001), and sexual violence (P=0.001) in the intervention group compared to the control group at six weeks follow- up. There were significant improvements in negotiation scores in the intervention group (P˂0.001). Moreover, there were significant differences in the quality of life scores (P=0.001), vitality (p=0.003), psychological health (p=0.004), bodily pain (p=0.014), physical functioning (p=0.023), and social functioning (p=0.019) between the two groups at the follow- up period.Conclusion: According to the result, individual counseling based on a solution-based approach reduces the amount of domestic violence and increases the quality of life of pregnant women at risk of violence.Trial registration: Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

scholarly journals Effect of Nucart VG (Boswellia serrata in combination with veg glucosamine sulphate) in comparison with glucosamine sulphate to improve quality of life of knee osteoarthritis patients: a randomized controlled trial

2021 ◽  
Vol 7 (5) ◽  
pp. 976
Author(s):  
Vijay G. Goni ◽  
Mukesh Mishra ◽  
Sailee Kadam ◽  
Sharat S. Gandhi
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Open Label ◽  
Boswellia Serrata ◽  
Group Randomized Trial ◽  
Glucosamine Sulphate

<p class="abstract"><strong>Background:</strong> <em>Boswellia serrata</em> has been proved to be an effective and safe herb for the treatment of osteoarthritis (OA). This study aims at assessing the synergistic effect of this herb with vegetarian glucosamine sulphate, a nutritional supplement, on knee osteoarthritis using quality of life indicators.</p><p class="abstract"><strong>Methods:</strong> This<strong> </strong>was an open label, parallel group randomized trial of 12-week duration. Sixty-six subjects were equally randomized to two treatment arms: <em>Boswellia serrata</em> extract (600 mg) and glucosamine (750 mg) [Nucart VG]; and glucosamine sulphate (market comparator) 750 mg. Patients were administered 1 tablet twice-a-day post-meal for three months. Efficacy of treatment was measured on primary end-points like EuroQol-5D (EQ-5D) (health status indicator), visual analogue scale (VAS) and Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scale (pain indicators), while safety was measured in terms of vital parameters. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed for comparing scores between the two groups.<strong></strong></p><p class="abstract"><strong>Results:</strong> The baseline characteristics of patients between two groups were insignificantly different (p&gt;0.05). In ITT analysis, the health status (EQ-5D score) of patients in Nucart VG group improved significantly than the comparator group at follow up 2 (p=0.037) and showed further improvement at follow up 3 (p=0.012). The pain indicators i.e. VAS and WOMAC scores were significantly lower in Nucart VG group right from follow up 1 till follow up 3 (p&lt;0.05). Similar were the observations during PP analysis.</p><p class="abstract"><strong>Conclusions:</strong> Nucart VG is beneficial for the treatment of mild to moderate knee OA, as inferred from the functional and health status assessment.</p>

scholarly journals Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marjolein M. Iversen ◽  
Jannicke Igland ◽  
Hilde Smith-Strøm ◽  
Truls Østbye ◽  
Grethe S. Tell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Well Being ◽  
Foot Ulcers ◽  
Control Group ◽  
Patient Reported ◽  
Reported Health

Abstract Background Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. Methods The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. Results In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. Conclusions There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration Clinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

Prospective Randomized Trial Comparing HAL-RAR Versus Excisional Hemorrhoidectomy: Postoperative Pain, Clinical Outcomes, and Quality of Life

2019 ◽  
Vol 26 (3) ◽  
pp. 328-336 ◽  
Author(s):  
Fernando Carvajal López ◽  
Carlos Hoyuela Alonso ◽  
Montserrat Juvany Gómez ◽  
Daniel Troyano Escribano ◽  
Miguel Angel Trias Bisbal ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postoperative Pain ◽  
Postoperative Morbidity ◽  
Short Form ◽  
Controlled Trial ◽  
Primary Objective ◽  
Artery Ligation ◽  
Symptom Resolution

Purpose. To compare outcomes of hemorrhoid artery ligation with recto-anal repair (HAL-RAR) and excisional hemorrhoidectomy (EH). The primary objective was to compare postoperative pain, and the secondary objectives were the following: symptom resolution rates, postoperative morbidity, recurrence, and changes in quality of life. Method. Prospective randomized controlled trial, including 40 patients with grades III-IV hemorrhoids who were allocated 1:1 to HAL-RAR and EH. Follow-up evaluation was performed at 15 days, 30 days, 6 months, 12 months, and then annually. Pain was measured using a Visual Analogic Scale and was self-recorded by patients. Quality of life was measured with Short Form Survey-36 questionnaire. Results. Postoperative pain was lower in the HAL-RAR group during the first 30 postoperative days. Moreover, from day 7 onward more patients in the HAL-RAR group reported complete absence of pain (Visual Analogic Scale score = 0). Globally, symptom resolution was significantly higher ( P = .03) in the HAL-RAR group at day 15. Bleeding resolution was observed earlier in the HAL-RAR group than in the EH group ( P = .04), but no differences in the resolution of prolapse, itching, and soiling were observed during the 30-day follow-up. After a mean follow-up of 15 months (range 12-27 months), no differences in postoperative morbidity and no recurrences were observed. An improvement was observed in all sections evaluated by the Short Form Survey-36 questionnaire with both techniques. Conclusion. HAL-RAR provokes less postoperative pain during a shorter period than EH and achieves resolution of hemorrhoidal symptoms with less postoperative complaints. No differences in morbidity and recurrence rate were observed after 12 months of follow-up.

Pilates method in the treatment of patients with Chikungunya fever: a randomized controlled trial

2019 ◽  
Vol 33 (10) ◽  
pp. 1614-1624 ◽  
Author(s):  
Bruna Fernanda Alves de Oliveira ◽  
Paulo Roberto Cavalcanti Carvalho ◽  
Alessandro Spencer de Souza Holanda ◽  
Rebeca Izis Silva Barbosa dos Santos ◽  
Filipe Alax Xavier da Silva ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Controlled Trial ◽  
Control Group ◽  
Joint Movement ◽  
Range Of Movement ◽  
Chikungunya Fever ◽  
Randomized Controlled ◽  
Pilates Method

Objective: The aim of this study was to evaluate the effects of the Pilates method on the reduction of pain, improvement of joint function, and quality of life of patients with chronic Chikungunya fever. Design: This is a randomized, controlled, blind trial for the evaluators. Setting: The study was conducted at the Advanced Laboratory in Physical Education and Health at Federal University of Pernambuco, Brazil. Subjects: A total of 51 patients were allocated randomly and divided into 2 groups: a Pilates group (26 patients) and a control group (25 patients). After 12 weeks, 4 patients in the Pilates group and 5 in the control group were lost to follow-up. Intervention: The Pilates group performed 24 Pilates method intervention sessions; the control group continued to receive standard clinical treatment at the outpatient clinic. Main measures: The main measures were as follows: visual analogue scale (VAS) for pain, functional capacity evaluated by Health Assessment Questionaire (HAQ), quality of life measured by the 12-Item Short-Form Health Survey (SF-12), and range of joint motion by goniometry. Results: After 12 weeks, patients in the Pilates group presented lower VAS ( P < 0.001), lower HAQ scores ( P < 0.001), and higher quality-of-life scores ( P < 0.001) compared with the control group. We found statistically significant results for the Pilates group in the range of movement for shoulder, knee, ankle, and lumbar spine ( P < 0.001). In the intragroup analysis, there was a significant improvement in all outcomes evaluated. Conclusion: In this study, patients undertaking Pilates method for 12 weeks had less pain, better function and quality of life, and increased range of joint movement.

Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial

2019 ◽  
Vol 47 (13) ◽  
pp. 3238-3246 ◽  
Author(s):  
Joost C. Peerbooms ◽  
Paul Lodder ◽  
Brenda L. den Oudsten ◽  
Kamiel Doorgeest ◽  
Hans M. Schuller ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Plantar Fasciitis ◽  
Platelet Rich Plasma ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Scores

Background: When nonoperative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporary pain reduction but no healing. Platelet-rich plasma (PRP) has proven to be a safe therapeutic option in the treatment of tendon, muscle, bone, and cartilage injuries. Purpose: To determine the effectiveness of PRP as compared with corticosteroid injections for chronic plantar fasciitis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with chronic plantar fasciitis were allocated to have steroid injection or PRP. The primary outcome measure was the Foot Function Index (FFI) Pain score. Secondary outcome measures were function, as scored by the FFI Activity, FFI Disability, and American Orthopaedic Foot & Ankle Society, and quality of life, as scored with the short version of the World Health Organization Quality of Life (WHOQOL-BREF). All outcomes were measured at baseline and at 4, 12, and 26 weeks and 1 year after the procedure. Results: Of the 115 patients, 63 were allocated to the PRP group, of which 46 (73%) completed the study, and 52 were allocated to the control group (corticosteroid injection), of which 36 (69%) completed the study. In the control group, FFI Pain scores decreased quickly and then remained stable during follow-up. In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group. After adjusting for baseline differences, the PRP group showed significantly lower pain scores at the 1-year follow-up than the control group (mean difference, 14.4; 95% CI, 3.2-25.6). The number of patients with at least 25% improvement (FFI Pain score) between baseline and 12-month follow-up differed significantly between the groups. Of the 46 patients in the PRP group, 39 (84.4%) improved at least 25%, while only 20 (55.6%) of the 36 in the control group showed such an improvement ( P = .003). The PRP group showed significantly lower FFI Disability scores than the control group (mean difference, 12.0; 95% CI, 2.3-21.6). Conclusion: Treatment of patients with chronic plantar fasciitis with PRP seems to reduce pain and increase function more as compared with the effect of corticosteroid injection. Registration: NCT00758641 (ClinicalTrials.gov identifier).

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