Efficacy of mud plus bath therapy as compared to bath therapy in osteoarthritis of hands and knees: a pilot single-blinded randomized controlled trial

The primary objective of this study was to assess the efficacy of mud plus bath therapy in comparison to bath therapy alone in hand and knee osteoarthritis (HOA and KOA). We conducted a single-blinded randomized controlled trial (RCT). Patients were randomly assigned to either mud plus bath therapy (group 1) or balneotherapy (group 2). The primary outcome was a change in AUSCAN questionnaire for HOA and in WOMAC for KOA at month 12. Evaluations were performed at baseline (B), immediately after the interventions (week 2, W2) and after 3 (M3), 6 (M6), 9 (M9) and 12 (M12) months. 37 patients with KOA and 52 with HOA were randomized in the study. In HOA patients, AUSCAN pain improved more in group 1 compared to group 2 at M3, M6 and M12 (p<0.001, p=0.001 and p=0.038, respectively). AUSCAN stiffness improved more in group 1 at M3 (p=0.001). AUSCAN function improved more at M3, M6, M9 and M12 (p=0.001, p=0.001, p=0.014 and p=0.018, respectively). Regarding, KOA, WOMAC function decreased more prominently in group 1 compared to group 2 at M9 (p=0.007). The absolute values of WOMAC function at M6 and M9 were lower in group 1 compared to group 2 (p=0.029 and p=0.001, respectively). WOMAC pain absolute values were lower in group 1 at W2 (p=0.044) and at M9 (p=0.08). We conducted a RCT on the efficacy of mud plus balneotherapy over balneotherapy alone in HOA and KOA. We found that mud plus balneotherapy was more effective than balneotherapy alone on clinical outcomes of HOA. Differences in clinical outcomes of KOA were not significant, yet numerically higher.

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Arthroscopic microfracture with atelocollagen augmentation for osteochondral lesion of the talus: a multicenter randomized controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/s12891-020-03730-3 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Young Koo Lee ◽

Ki Won Young ◽

Jin Su Kim ◽

Hong Seop Lee ◽

Whi-Je Cho ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Clinical Outcomes ◽

Controlled Trial ◽

Osteochondral Lesion ◽

Randomized Controlled ◽

Arthroscopic Microfracture ◽

Multicenter Randomized Controlled Trial ◽

Group 2 ◽

Group 1

Abstract Background We aimed to evaluate whether arthroscopic microfracture with atelocollagen augmentation could improve the clinical outcomes and quality of regenerated cartilage in patients with osteochondral lesion of the talus (OLT). We hypothesized that the clinical outcomes and quality of the regenerated cartilage would be superior in patients undergoing arthroscopic microfracture with atelocollagen augmentation compared to those undergoing arthroscopic microfracture alone. Methods In this multicenter, randomized controlled trial, 60 patients were randomly allocated to two groups: arthroscopic microfracture with atelocollagen augmentation (group 1, n = 31) and arthroscopic microfracture alone (group 2, n = 29). Mean 100-mm visual analog scale (VAS), Hannover scoring system (HSS), and American Orthopedic Foot and Ankle Society (AOFAS) scores were assessed 2 years postoperatively and compared between the groups. The quality of the regenerated cartilage was assessed according to the Magnetic Resonance Observation of CArtilage Repair Tissue (MOCART) score based on magnetic resonance imaging. Results Forty-six patients (22 in group 1, 23 in group 2) completed the 2-year follow-up. The quality of the regenerated cartilage assessed based on the MOCART score was significantly superior in group 1 compared to group 2 (64.49 ± 18.27 vs 53.01 ± 12.14, p = 0.018). Clinical outcomes in terms of 100-mm VAS (17.25 ± 20.31 vs 19.37 ± 18.58, p = 0.72), HSS (93.09 ± 13.64 vs 86.09 ± 13.36, p = 0.14), and AOFAS (91.23 ± 8.62 vs 86.91 ± 10.68, p = 0.09) scores were superior in group 1 compared to group 2, but the differences were not statistically significant. Both groups showed significant improvements in clinical outcomes compared with the preoperative values. Conclusion The quality of the regenerated cartilage was superior after arthroscopic microfracture with atelocollagen augmentation compared to that after microfracture alone in patients with OLT. Clinical outcomes assessed 2 years postoperatively were superior in patients who underwent arthroscopic microfracture with atelocollagen augmentation compared to those who underwent arthroscopic microfracture alone, although the differences were not statistically significant. A long-term study of the cohort is required to confirm these findings. Trial registration ClinicalTrials.gov (NCT02519881), August 11, 2015.

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Comparison of intrauterine insemination and timed intercourse following controlled ovarian hyperstimulation in unexplained infertility: a randomized controlled trial

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20190876 ◽

2019 ◽

Vol 8 (3) ◽

pp. 1035

Author(s):

Sayanti Paul ◽

Saumen Mandal ◽

Arghya Pal ◽

Sumit Ranjan Pramanik

Keyword(s):

Randomized Controlled Trial ◽

Intrauterine Insemination ◽

Controlled Trial ◽

Controlled Ovarian Hyperstimulation ◽

Unexplained Infertility ◽

Clinical Pregnancy ◽

Ovarian Hyperstimulation ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Background: Being a diagnosis of exclusion the treatment options of unexplained infertility are often empiric. There is significant dilemma regarding the superiority of one over another. Despite increasing use of intrauterine insemination (IUI) in adjunct to controlled ovarian hyperstimulation (COH) there is scarcity of randomized controlled trials (RCT) from developing countries. Objective was to compare IUI and timed intercourse (TI) in super ovulated cycles among couples with unexplained infertility over one year.Methods: In this prospective randomized controlled trial total 85 patients were randomly assigned into group 1 (COH with IUI, N= 44) and group 2 (COH with TI, N=41). Patients underwent COH using sequential Clomiphene Citrate and injection human menopausal gonadotrophin followed by IUI in group 1 and timed intercourse in group 2. Either protocol was repeated for three consecutive cycles. Finally, both groups were compared for clinical pregnancy rate, adverse effects and acceptability of the treatment process and outcome. Comparison was done by Student’s unpaired t test for continuous and 2-tailed chi square test for categorical variables.Results: Clinical pregnancy rates following COH/IUI and COH/TI were 13.64% and 19.51% respectively. There was observable difference in the acceptability of the outcome (38.64% in IUI and 56.09% in TI group). All the results including complications and side effect rates were statistically insignificant.Conclusions: Present study failed to show any improvement of pregnancy rates following addition of IUI over TI and it raised the probability that the outcome of the procedure may not be well accepted.

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Effects of Water Restriction and Supplementation on Cognitive Performances and Mood among Young Adults in Baoding, China: A Randomized Controlled Trial (RCT)

Nutrients ◽

10.3390/nu13103645 ◽

2021 ◽

Vol 13 (10) ◽

pp. 3645

Author(s):

Jianfen Zhang ◽

Guansheng Ma ◽

Songming Du ◽

Shufang Liu ◽

Na Zhang

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Hydration Status ◽

Water Restriction ◽

Operation Span ◽

Randomized Controlled ◽

Baseline Test ◽

Group 2 ◽

Water Supplementation ◽

Group 1

The brain is approximately 75% water. Therefore, insufficient water intake may affect the cognitive performance of humans. The present study aimed to investigate the effects of water restriction and supplementation on cognitive performances and mood, and the optimum amount of water to alleviate the detrimental effects of dehydration, among young adults. A randomized controlled trial was conducted with 76 young, healthy adults aged 18–23 years old from Baoding, China. After fasting overnight for 12 h, at 8:00 a.m. of day 2, the osmolality of the first morning urine and blood, cognitive performance, and mood were measured as a baseline test. After water restriction for 24 h, at 8:00 a.m. of day 3, the same indexes were measured as a dehydration test. Participants were randomly assigned into four groups: water supplementation group (WS group) 1, 2, or 3 (given 1000, 500, or 200 mL purified water), and the no water supplementation group (NW group). Furthermore, participants were instructed to drink all the water within 10 min. Ninety minutes later, the same measurements were performed as a rehydration test. Compared with the baseline test, participants were all in dehydration and their scores on the portrait memory test, vigor, and self-esteem decreased (34 vs. 27, p < 0.001; 11.8 vs. 9.2, p < 0.001; 7.8 vs. 6.4, p < 0.001). Fatigue and TMD (total mood disturbance) increased (3.6 vs. 4.8, p = 0.004; 95.7 vs. 101.8, p < 0.001) in the dehydration test. Significant interactions between time and volume were found in hydration status, fatigue, vigor, TMD, symbol search test, and operation span test (F = 6.302, p = 0.001; F = 3.118, p = 0.029; F = 2.849, p = 0.043; F = 2.859, p = 0.043; F = 3.463, p = 0.021) when comparing the rehydration and dehydration test. Furthermore, the hydration status was better in WS group 1 compared to WS group 2; the fatigue and TMD scores decreased, and the symbol search test and operation span test scores increased, only in WS group 1 and WS group 2 (p < 0.05). There was no significant difference between them (p > 0.05). Dehydration impaired episodic memory and mood. Water supplementation improved processing speed, working memory, and mood, and 1000 mL was the optimum volume.

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Comparison of Single Antibiotic Paste Nitrofurantoin and Calcium Hydroxide Paste as Intracanal Medicaments in Alleviating Post-Operative Pain in Patients with Symptomatic Irreversible Pulpitis -A Randomized Controlled Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i46a32891 ◽

2021 ◽

pp. 484-494

Author(s):

Hira Abbasi ◽

Abhishek Lal ◽

Ammara Shamim Jaffrani

Keyword(s):

Randomized Controlled Trial ◽

Calcium Hydroxide ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Scores ◽

Post Operative Pain ◽

Group 2 ◽

Irreversible Pulpitis ◽

Group 1

Aims: This study aims to compare the efficacy in alleviating pain between intracanal medicaments, namely Nitrofurantoin and Calcium Hydroxide Paste. Study Design: Randomized Controlled Trial. Place and Duration of Study: Sample: Department of Operative Dentistry, Sir Syed College of Medical Sciences, Pakistan, between January 2021 and May 2021. Methodology: 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single rooted teeth with patients suffering from symptomatic irreversible pulpitis Results: Majority of the patients in all 3 groups were initially presented with moderate to severe pre-operative pain. After 72 hours post-operatively, 50% patients in Group 1 reported no pain, while 5% patients in both Group 2 and 3 had no pain. Pain significantly subsided in Group 1 as compared to Group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups Conclusion: Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.

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Role of intermittent pneumatic compression in the treatment of breast cancer–related lymphoedema: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519888792 ◽

2019 ◽

Vol 34 (2) ◽

pp. 220-228 ◽

Cited By ~ 1

Author(s):

Engin Tastaban ◽

Aykut Soyder ◽

Elif Aydin ◽

Omer Faruk Sendur ◽

Yasemin Turan ◽

...

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Excess Volume ◽

Controlled Trial ◽

Intermittent Pneumatic Compression ◽

University Hospital ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Objective: To evaluate the role of intermittent pneumatic compression in the treatment of breast cancer–related lymphoedema. Design: Randomized controlled trial. Setting: Physical medicine and rehabilitation clinic at a university hospital. Subjects: Seventy-six patients with lymphoedema. Interventions: Patients were allocated into Group 1 (complex decongestive treatment, n = 38) and Group 2 (complex decongestive treatment + intermittent pneumatic compression, n = 38). The complex decongestive treatment involved skin care, manual lymphatic drainage, compression bandaging, and exercise for 20 sessions. Group 2 additionally received intermittent pneumatic compression. Main measures: Quantitative outcomes consisted of volumetric measures prior to and after the treatment. Clinical assessments included severity of pain, heaviness and tightness, disability, grip strength, and depression. Results: Lymphoedema was similar at baseline, but treatments significantly reduced the excess volume (from 373 mL to 203 mL in Group 1 and 379.5 mL to 189.5 mL in Group 2). Percentage excess volumes (PEVs) decreased in both groups. The percentage reduction of excess volume was better in Group 2 than Group 1, but the intergroup difference was not significant. The clinical scores reflected improvements, but the heaviness and tightness read significantly lower in Group 2 than Group 1. Conclusion: Intermittent pneumatic compression seems to add no benefit when combined with complex decongestive treatment of lymphoedema, but, may be functional in reducing the sensations of heaviness and tightness for the patients with pitting oedema.

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Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total knee arthroplasty: results of a randomized controlled trial (TRAC-24)

The Bone & Joint Journal ◽

10.1302/0301-620x.103b10.bjj-2020-2308.r1 ◽

2021 ◽

Vol 103-B (10) ◽

pp. 1595-1603

Author(s):

Paul Magill ◽

Janet C. Hill ◽

Leeann Bryce ◽

Una Martin ◽

Al Dorman ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Randomized Controlled Trial ◽

Blood Loss ◽

Controlled Trial ◽

Randomized Controlled ◽

History Of ◽

Total Knee ◽

Group 3 ◽

Group 2 ◽

Group 1

Aims In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from ‘high-risk’ patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss. Methods TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA. Results Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group. Conclusion These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(10):1595–1603.

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Accuracy and efficacy of diagnosis using clinical characteristics integrated with metabolomics in patients with polycystic ovary syndrome: study protocol for a randomized controlled trial

10.21203/rs.2.12197/v2 ◽

2019 ◽

Author(s):

Cheng-Ming Ni ◽

Wen-Long Huang ◽

Yan-min Jiang ◽

Juan Xu ◽

Ru Duan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Polycystic Ovary Syndrome ◽

Clinical Characteristics ◽

Polycystic Ovary ◽

Controlled Trial ◽

Control Group ◽

Ovary Syndrome ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Abstract Background Polycystic ovary syndrome (PCOS) is defined as a complex endocrine syndrome, and the mechanisms underlying its various clinical signs and symptoms are still poorly understood. It is critical to precisely diagnose the phenotypes of PCOS in order to provide patients with individualized therapy[1, 2] . However, the criteria by which to diagnose different phenotypes, which are mostly based on symptoms, physical examination, and laboratory evaluation, remain unclear. The aim of this study is to compare the accuracy and precision of metabolomic markers with common clinical characteristics to determine a more effective way to diagnose and treat two subgroups, one based on clinical indexes and another based on metabolomic indexes[3], of PCOS patients. The effects of different the interventions based on the two subgroups will also be observed. Methods This is a prospective, multicenter, analyst-blinded, randomized controlled trial. There will be one healthy control group and two parallel experimental arms in this study: (1) people without PCOS (health control group); (2) PCOS patients diagnosed based on clinical indexes (group 1); (3) PCOS patients diagnosed based on metabolomic indexes (group 2). A total of 276 eligible people will be recruited, including 60 healthy people and 216 PCOS patients, who will be randomly assigned to different diagnosis groups in a 1:1 ratio. Patients in the two different diagnosis groups will be divided into two different subgroups based on their clinical characteristics (group 1 based on clinical indexes, group 2 based on metabolomic indexes); thereafter, they will receive a 6-month different treatment. The primary outcome for experimental groups will be the treatment effect of PCOS. Discussion The purpose of this trial is to determine whether integrated metabolomic indexes are more accurate and effective than clinical characteristics in the diagnosis of the phenotypes of reproductive females with PCOS. This trial will therefore contribute to the provision of a solid foundation for the precise clinical diagnosis of two PCOS subgroups, as well as for future research on individualized PCOS therapy.

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Perbandingan Status Fungsional pada Pasien Nyeri Punggung Bawah Akut Non-Spesifik yang Diberikan Kombinasi Ibuprofen dan Eperison versus Ibuprofen

e-CliniC ◽

10.35790/ecl.v9i2.36205 ◽

2021 ◽

Vol 9 (2) ◽

pp. 524

Author(s):

Raven C. P. Maubanu ◽

Rizaldy T. Pinzon ◽

M. M. A. Dewi Lestari

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Back Pain ◽

Functional Status ◽

Controlled Trial ◽

Low Back ◽

Chi Square ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Abstract: There are several types of medications that can be used to relieve pain in low back pain (LBP) cases, inter alia non-steroidal anti-inflammatory drugs (NSAIDs), opioids, non-opioid analgesics, antidepressants, and muscle relaxants. This study was aimed to compare the functional status of patients treated with combination of ibuprofen and eperisone hydrochloride and those treated with ibuprofen only. This was a randomized controlled trial. Samples were taken by using purposive sampling with a total of 100 samples as subjects, divided into two groups: group 1 as the experimental group treated with combination therapies of ibuprofen and eperisone hydrochloride and group 2 as the control group treated with ibuprofen only. The therapy was performed for three times with a span of two weeks between each visit. The functional status was measured with finger-to-floor distance (FFD) test and the analysis was performed by using the chi-square test. The results showed 39 males and 61 females as subjects. There was no meaningful difference on the basic characteristics. The functional status of the subjects improved as the intensity of pain decreased. The results of the FFD test indicated that there was improvement of functional status of each group on the second visit, as follows: group 1 had 30 subjects (62.5%) with a distance of <10 cm and group 2 had 24 subjects (55.8%) with a distance of <10 cm. In conclusion, the functional status of non-specific acute lower back pain patients treated with combination of ibuprofen and eperisone hydrochloride was better than those treated with ibuprofen only.Keywords: low back pain; functional status; ibuprofen; eperisone hydrochloride combination Abstrak: Terdapat beberapa jenis obat yang dapat digunakan untuk menghilangkan nyeri pada nyeri punggung bawah (NPB), antara lain golongan obat anti inflamasi non steroid (OAINS), opioid, analgesik non-opioid, antidepresan, dan pelemas otot. Hasil penelitian menunjukkan bahwa OAINS tidak cukup memadai sehingga perlu tambahan pelemas otot. Penelitian ini bertujuan untuk mendapatkan perbandingan status fungsional pasien yang diberikan terapi kombinasi ibuprofen dan eperison dengan yang diberikan terapi ibuprofen saja. Penelitian ini menggunakan randomized controlled trial. Sampel diambil menggunakan purposive sampling dengan total 100 sampel sebagai subjek. Subjek dibagi menjadi dua kelompok, yaitu kelompok 1 sebagai kelompok eksperimental yang diberikan terapi kombinasi ibuprofen dan eperison dan kelompok 2 sebagai kelompok pembanding yang diberikan terapi ibuprofen. Terapi dilakukan sebanyak 3 (tiga) kali dengan rentang waktu dua minggu antara setiap kunjungan. Status fungsional diukur dengan finger-to-floor distance test (FFD). Data penelitian dianalisis dengan uji chi-square. Hasil penelitian mendapatkan 39 laki-laki dan 61 perempuan sebagai subyek penelitian. Tidak terdapat perbedaan bermakna pada karakteristik dasar. Status fungsional subjek semakin membaik bila intensitas nyeri semakin berkurang. Hasil FFD test menunjukkan adanya perbaikan status fungsional setiap kelompok pada kunjungan kedua, yaitu pada kelompok 1 terdapat 30 subjek (62,5%) yang memiliki jarak <10 cm dan pada kelompok 2 terdapat 24 subjek (55,8%) yang memiliki jarak <10 cm. Simpulan penelitian ini ialah status fungsional pada pasien NPB akut non-spesifik yang diberikan pengobatan terapi kombinasi ibuprofen dan eperison lebih baik daripada yang diberikan pengobatan ibuprofen saja.Kata kunci: nyeri punggung bawah; status fungsional; ibuprofen; eperison

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Use of Fecal transplantation with a novel diet for mild to moderate active ulcerative colitis: The CRAFT UC randomized controlled trial

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab165 ◽

2021 ◽

Author(s):

Chen Sarbagili Shabat ◽

Franco Scaldaferri ◽

Eran Zittan ◽

Ayal Hirsch ◽

Maria Chiara Mentella ◽

...

Keyword(s):

Ulcerative Colitis ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Mucosal Healing ◽

Fecal Transplantation ◽

Randomized Controlled ◽

Single Donor ◽

Group 3 ◽

Group 2 ◽

Group 1

Abstract Background We evaluated whether integration of novel diets for donors and patients in addition to fecal transplantation (FT) could increase FT remission rate in refractory ulcerative colitis (UC). Methods This was a blinded randomized controlled trial in adults with active UC, defined by a simple clinical colitis activity index (SCCAI) of ≥5 and ≤ 11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on day 1and rectal enemas on days 2 and 14 without dietary conditioning of the donor. Group 2: FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet (UCED) for the patients. Group 3 received the UCED alone. The primary endpoint was week 8 clinical steroid free remission, defined as SCCAI <3. Results Sixty two of 96 planned patients were enrolled. Remission week 8 Group 1 was 2/17 (11.8%), Group 2 4/19 (21.1%), Group 3 6/15 (40%) (NS). Endoscopic remission was Group 1 2/17 (12%), Group 2 3/19 (16%), Group 3 4/15 (27%) (Group 1 vs.3 p=0.38). Mucosal healing (Mayo 0) was achieved only in Group 3 (3/15, 20%) vs. 0/36 FT patients (p=0.022). Exacerbation of disease occurred in 3/17 (17.6%) Group 1, 4/19 (21.1%) Group 2, and 1/15 (6.7%) Group 3 (Group 2 vs.3, p=0.35). Conclusions UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.

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Rotator Cuff Calcific Tendinitis: Ultrasound-Guided Needling and Lavage Versus Subacromial Corticosteroids: Five-Year Outcomes of a Randomized Controlled Trial

The American Journal of Sports Medicine ◽

10.1177/0363546517721686 ◽

2017 ◽

Vol 45 (14) ◽

pp. 3305-3314 ◽

Cited By ~ 13

Author(s):

Pieter Bas de Witte ◽

Arjen Kolk ◽

Ferdinand Overes ◽

Rob G.H.H. Nelissen ◽

Monique Reijnierse

Keyword(s):

Randomized Controlled Trial ◽

Rotator Cuff ◽

Repeated Measures ◽

Mixed Model ◽

Controlled Trial ◽

Randomized Controlled ◽

The Mean ◽

Group 2 ◽

Group 1

Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 ( P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 ( P = .32). There was total resorption in 62% of group 1 and 73% of group 2 ( P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period ( P < .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry).

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