scholarly journals A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees

2021 ◽  
Vol 14 ◽  
pp. 117954412110313
Author(s):  
Varah Yuenyongviwat ◽  
Khanin Iamthanaporn ◽  
Pakjai Tuntarattanapong ◽  
Theerawit Hongnaparak ◽  
Boonsin Tangtrakulwanich
Keyword(s):  
Knee Osteoarthritis ◽  
Rescue Medication ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Topical Therapy ◽  
Phospholipid Vesicles ◽  
Control Group ◽  
Drug Free

Background: There are a number of topical agents that are used for treatment of knee osteoarthritis. Drug-free gels, containing ultra-deformable phospholipid vesicles (TDT 064) are one such topical therapy, which have been stated to act as a bio lubricant. However, the evidence of TDT 064 in treatment of knee osteoarthritis is limited. Hence, the aim of this study was to evaluate the efficacy of pain control as a primary outcome and safety of TDT 064 compared with a topical placebo. Methods: Sixty-four patients with primary osteoarthritis, with radiographic showing Kellgren and Lawrence classification grade II to III, were randomized into 2 groups. In the first group of 32 patients TDT 064 was used as topical agent, whilst in the second group of 32 patients a placebo identical in appearance was used instead. The verbal numerical rating scale (VNRS) was used for recording pain levels, Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) as well as amounts of rescue medication were also recorded. The data were recorded at the start of the study, and then at follow-up appointments of 14 days, 6 weeks, and 3 months. Results: The mean VNRS for pain in both groups were significantly improved, when compared to the start of treatment ( P < .0001); however, there were no differences between groups at any follow up visit. KOOS in all subscales were not significantly different between both groups at baseline and at the end of treatment. However, the average amount of NSAIDs in the TDT 064 group was 26.39 ± 22.11 tabs, which was significantly lower than the control group; which used an average 37.03 ± 19.22 tabs in 3 months ( P = .047). Conclusions: There were no differences in the VNRS for pain and KOOS scores between the active and placebo groups. Although, TDT 064 could decrease usage of rescue medication the difference with use of a placebo was minimal. Further, larger trials would also be beneficial to demonstrate any differences between TDT 064 and a placebo. Trial Registration: TCTR, TCTR 20190302001. Registered 1 March, 2019: http://www.clinicaltrials.in.th

scholarly journals The Efficacy of Backward Walking on Static Stability, Proprioception, Pain, and Physical Function of Patients with Knee Osteoarthritis: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Zehua Chen ◽  
Xiangling Ye ◽  
Yi Wang ◽  
Zhen Shen ◽  
Jiatao Wu ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Physical Function ◽  
Rating Scale ◽  
Center Of Pressure ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Static Stability ◽  
Control Group ◽  
Backward Walking ◽  
Before And After

Objective. Impaired static stability and proprioception have been observed in individuals with knee osteoarthritis (KOA), which serves as a major factor increasing risk of fall. This study aimed to investigate the effects of backward walking (BW) on static stability, proprioception, pain, and physical function in KOA patients. Methods. Thirty-two subjects with knee osteoarthritis were randomly assigned to either an BW group (BG, n = 16) or a control group (CG, n = 16). The participants in the BG received combination treatment of a 4-week BW training and conventional treatments, while those in the CG was treated with conventional treatments alone. All the participants were tested for the assessment of static stability [center of pressure (COP) sway, including sway length (SL, mm) and sway area (SA, mm2)] and proprioception [average trajectory error (ATE, %) and completion time (CT, second)]. Additionally, pain and knee function scores were measured by the numerical rating scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, respectively. The assessments were conducted before and after intervention. Results. The COP sway (SA and SL), ATE, NRS, and WOMAC showed a significant decline at week 4 in the two groups in contrast to their baseline ( P < 0.05 ). Moreover, after 4-week intervention, the SA [(610.50 ± 464.26) mm2 vs. (538.69 ± 420.52) mm2], NRS [(1.56 ± 0.63) vs. (2.25 ± 0.86)], and WOMAC [(11.69 ± 2.50) vs. (16.19 ± 3.94)] showed a significantly greater decrease in the BG compared to the CG ( P < 0.05 , respectively). However, the proprioception (ATE and CT) was closely similar between both groups at week 4 ( P > 0.05 ). Conclusion. BW is an effective adjunct to conventional treatment in reducing pain, improving physical function and static stability for KOA patients. It should be taken into consideration when developing rehabilitation programs for people with KOA.

scholarly journals Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034003
Author(s):  
Kun Peng ◽  
Min Zeng ◽  
Jia Dong ◽  
Xiang Yan ◽  
Dexiang Wang ◽  
...  
Keyword(s):  
Nerve Block ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Cervical Plexus ◽  
Ethics Review ◽  
Superficial Cervical Plexus Block ◽  
Cervical Plexus Block ◽  
Plexus Block

IntroductionScalp nerve block has been proven to be an alternative choice to opioids in multimodal analgesia. However, for the infratentorial space-occupying craniotomy, especially the suboccipital retrosigmoid craniotomy, scalp nerve block is insufficient.Methods and analysisThe study is a prospective, single-centre, randomised, paralleled-group controlled trial. Patients scheduled to receive elective suboccipital retrosigmoid craniotomy will be randomly assigned to the superficial cervical plexus block group or the control group. After anaesthesia induction, superficial cervical plexus nerve block will be performed under the guidance of ultrasound. The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery. Secondary outcomes include the cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score.Ethics and disseminationThe protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT04036812

scholarly journals Electroacupuncture to alleviate postoperative pain after a laparoscopic appendectomy: study protocol for a three-arm, randomised, controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015286 ◽  
Author(s):  
Seunghoon Lee ◽  
Dongwoo Nam ◽  
Minsoo Kwon ◽  
Won Seo Park ◽  
Sun Jin Park
Keyword(s):  
Postoperative Pain ◽  
Laparoscopic Appendectomy ◽  
Pain Control ◽  
Rating Scale ◽  
Acupuncture Treatment ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Acupuncture Points ◽  
Postoperative Pain Control

BackgroundThe purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for postoperative pain after laparoscopic appendectomy compared with sham electroacupuncture (SEA) and no acupuncture treatment.Methods and analysisThis study is a protocol for a three-arm, randomised, patient-assessor-blinded (to the type of acupuncture treatment), controlled, parallel trial. 138 participants diagnosed with appendicitis and scheduled for laparoscopic appendectomy will be randomly assigned to the EA group (n=46), SEA group (n=46) or control group (n=46). The EA group will receive acupuncture treatment at both regional and distal acupuncture points with electrostimulation. The SEA group will receive sham acupuncture treatment with mock electrostimulation. Both EA and SEA groups will receive a total of four treatments 1 hour preoperative, 1 hour postoperative and during the morning and afternoon the day after surgery with the same routine postoperative pain control. The control group will receive only routine postoperative pain control. The primary outcome is the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 24 hours after surgery. The secondary outcomes are the PI-NRS, analgesic consumption, opioid-related side effects, time to first passing flatus, quality of life and adverse events evaluated 6, 12, 24 and 36 hours and 7 days after surgery.Ethics and disseminationThe study was planned in accordance with the Helsinki Declaration and the Korean Good Clinical Practice Guidelines to protect the participants and was approved by the institutional review board (IRB) of Kyung Hee University Medical Center (KMC IRB-1427–02). The results will be disseminated in peer-reviewed journals and presented at international conferences.Trial registration numberClinical Research Information Service (KCT0001328).

scholarly journals Effectiveness of the quadriceps strengthening exercise on pain and functional ability of the women with Osteoarthritis (OA)

2021 ◽  
Vol 8 (9) ◽  
pp. 1-6
Author(s):  
Absar Ahmed Qureshi ◽  
◽  
Shadia Hamoud Alshahrani ◽  
Premalatha Paulsamy ◽  
Krishnaraju Venkatesan ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Functional Ability ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Exercise Group ◽  
Control Group ◽  
Timed Up And Go ◽  
Strengthening Exercise ◽  
Study Results ◽  
Numerical Rating

A Quasi experimental design was adopted for this study to find out the effectiveness of quadriceps strengthening exercise program on pain and functional ability of women with knee osteoarthritis (OA). Fifty women with OA were selected in which first 25 women were enrolled in the control group and second 25 women were allotted in the exercise group. Assessments were performed at baseline and at 8 weeks. The functional ability was assessed using the Timed Up and Go (TUG) test and Numerical Rating Scale (NRS) was used to assess the pain level .For the exercise group, quadriceps strengthening exercises were taught and asked the patients to follow the exercise schedule for 8 weeks. The study results show that the pain and functional abilty scores were improved in the exercise group and the difference was statistically significant (p<0.001). The study concluded that a simple quadriceps strengthening exercise programme can significantly improve self reported knee pain and functional ability among women with Knee osteoarthritis. Keywords: Osteoarthritis, Pain, Functional Ability, Exercise, Quadriceps strengthening, Timed Up and Go (TUG) test, Numerical Rating Scale (NRS)

scholarly journals Effectiveness of Platelet Rich Plasma for the Management of Knee Osteoarthritis

2021 ◽  
Vol 15 (7) ◽  
pp. 1553-1556
Author(s):  
Adnan Qamar ◽  
Saima Naz Mohsin ◽  
Uzma Nasim Siddiqui ◽  
Sana Naz ◽  
Sana Danish
Keyword(s):  
Knee Osteoarthritis ◽  
Normal Saline ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Saline Group ◽  
Control Group ◽  
Plasma Therapy ◽  
Vas Score ◽  
To Receive

Aim: To determine impact of platelet rich plasma therapy for the management of knee osteoarthritis. Study design: Prospective double-blinded, add –on randomized, placebo-controlled trial Place and duration of study: Department of Orthopedics, Shaikh Zayed Hospital Lahore from 1st January 2019 to 30th June 2019 Methodology: Fifty volunteer participants fulfilling inclusion criteria were enrolled. One hundred knees of patients were randomly allocated into two groups. Knees were assigned either of the two groups. Platelet rich plasma group which was assigned to receive 5ml of platelet rich plasma and normal saline (NS) group which was assigned to receive 5ml of NS labeled as control group. All patients given 3 successive intra-articular injections of 5 mL of autologous platelet rich plasma or 5ml of normal saline was given at weekly intervals. Patients were blinded and subjected to a standardized injection protocol and the intensity of pain was assessed on visual analog scale (VAS) for pain. Results: The VAS scores decreased from 50.9±14.7 at baseline assessment to 43.6±16.2 at 1-month follow-up after completion of therapy for PRP group (p<0.0203). The improvement was maintained from the end of the therapy to 3 and 6 months’ follow-up, as measure of VAS score as 30.54±11.8 and 20.2±8.6 respectively (p<0.0001). In normal saline group, there was very slight decrease in VAS score from baseline i.e. 49.8±19.5 to 48±22.7, 44±16.6, and 42±21.7 at 1, 3 and 6 months interval. Conclusion: Platelet rich plasma therapy can provide effective pain control up to 6 months post injection in knee osteoarthritis. Key words: Platelet rich plasma (PRP), Knee osteoarthritis (OA), Pain score

scholarly journals Evaluating the efficacy of Internet-Based Exercise programme Aimed at Treating knee Osteoarthritis (iBEAT-OA) in the community: a study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030564
Author(s):  
Sameer Akram Gohir ◽  
Paul Greenhaff ◽  
Abhishek Abhishek ◽  
Ana M. Valdes
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Controlled Trial ◽  
Maximum Voluntary Contraction ◽  
Intervention Group ◽  
Exercise Programme ◽  
Control Group ◽  
Knee Oa ◽  
Randomised Controlled

IntroductionKnee osteoarthritis (OA) is the most common joint disease worldwide. As of today, there are no disease-modifying drugs, but there is evidence that muscle strengthening exercises can substantially reduce pain and improve function in this disorder, and one very well tested physiotherapy protocol is the ‘Better Management of Patients with Osteoarthritis’ developed in Sweden. Given the high prevalence of knee OA, a potentially cost-effective, digitally delivered approach to treat knee OA should be trialled. This study aims to explore the benefits of iBEAT-OA (Internet-Based Exercise programme Aimed at Treating knee Osteoarthritis) in modulating pain, function and other health-related outcomes in individuals with knee OA.Methods and analysisA randomised controlled trial was designed to evaluate the efficacy of a web-based exercise programme in a population with knee OA compared with standard community care provided by general practitioners (GPs) in the UK. We anticipate recruiting participants into equal groups. The intervention group (n=67) will exercise for 20–30 min daily for six consecutive weeks, whereas the control group (n=67) will follow GP-recommended routine care. The participants will be assessed using a Numerical Rating Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the Arthritis Research UK Musculoskeletal Health Questionnaire, the Pittsburgh Sleep Quality Index, 30 s sit to stand test, timed up and go test, quantitative sensory testing, musculoskeletal ultrasound scan, muscle thickness assessment of the vastus lateralis, and quadriceps muscles force generation during an isokinetic maximum voluntary contraction (MVC). Samples of urine, blood, faeces and synovial fluid will be collected to establish biomarkers associated with changes in pain and sleep patterns in individuals affected with knee OA. Standard parametric regression methods will be used for statistical analysis.Ethics and disseminationEthical approval was obtained from the Research Ethics Committee (ref: 18/EM/0154) and the Health Research Authority (protocol no: 18021). The study was registered in June 2018. The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03545048

scholarly journals The effectiveness of Kinesio Taping® for pain management in knee osteoarthritis: a randomized, double-blind, controlled clinical trial

2019 ◽  
Vol 11 ◽  
pp. 1759720X1986913 ◽  
Author(s):  
Venta Donec ◽  
Raimondas Kubilius
Keyword(s):  
Pain Management ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Rating Scale ◽  
Pain Tolerance ◽  
Control Group ◽  
Double Blind ◽  
Kinesio Taping ◽  
Pain Subscale

Background: Kinesio Taping® method is a nonpharmacological alternative for pain management in musculoskeletal disorders. However, the existing evidence is insufficient to assess its full effectiveness for pain management in knee osteoarthritis (KO). Our aim was to evaluate the effectiveness of the Kinesio Taping method in reducing knee pain for KO patients. Methods: In this randomized, double blind, controlled trial, we recruited 187 patients with grade I-III KO who were allocated to either the Kinesio Taping or control group. The study was carried out in outpatient facility. Either Kinesio Taping or nonspecific taping was applied on the affected knee area for 4 weeks. Pain evaluation was performed at baseline, after 1 month of taping and after 1 further month without taping. The data on usage of painkillers were collected; Numeric Pain Rating Scale; an algometer, and Knee injury and Osteoarthritis Outcome Scores (KOOS) pain subscale were used to assess pain. Tolerance and subjective opinions toward the effectiveness of taping were evaluated. The chosen level of significance was p < 0.05, ß ⩽ 0.2. Results: The majority (>70%) of both groups’ patients indicated that tapes reduced the knee pain. The reported use of painkillers decreased, in addition to self-reported increase in the KOOS subscale, thereby indicating pain alleviation. All self-reported improvement remained at the 1-month follow up ( p < 0.05). Significantly higher and clinically meaningful reduction of pain intensity was found in the Kinesio Taping group after the treatment month, in comparison with the control group ( p < 0.05). More pain reduction was reported in the daytime for participants in the Kinesio Taping group at the follow up ( p = 0.022). No changes in algometry results were observed. Conclusions: Elastic taping can safely relieve knee pain and reduce the need for pharmacological management in KO. A specific Kinesio Taping technique is clinically more beneficial for knee-pain alleviation in comparison with nonspecific taping. [ ClinicalTrials.gov identifier: NCT03076177.]

scholarly journals Laughter and Stress Relief in Cancer Patients: A Pilot Study

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
S. H. Kim ◽  
Y. H. Kim ◽  
H. J. Kim
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Numerical Rating ◽  
Anxiety Depression

The purpose of this study was to examine the effect of a therapeutic laughter program and the number of program sessions on anxiety, depression, and stress in breast cancer patients. A randomized controlled trial was conducted involving 31 patients who received four sessions of therapeutic laughter program comprised and 29 who were assigned to the no-program control group. Scores for anxiety, depression, and stress were measured using an 11-point numerical rating scale. While no change was detected in the control group, the program group reported reductions of 1.94, 1.84, and 2.06 points for anxiety, depression, and stress, respectively (p<0.01,p<0.01, andp<0.01). Scores decreased significantly after the first therapeutic laughter session (p<0.05,p<0.01, andp<0.01). As the therapeutic laughter program was effective after only a single session in reducing anxiety, depression, and stress in breast cancer patients, it could be recommended as a first-line complementary/alternative therapy.

scholarly journals The Efficacy of Scrambler Therapy for the Management of Head, Neck and Thoracic Cancer Pain: A Randomized Controlled Trial

2020 ◽  
Vol 5;23 (9;5) ◽  
pp. 495-506
Author(s):  
Prof. Sushma Bhatnagar
Keyword(s):  
Cancer Pain ◽  
Head And Neck ◽  
Rating Scale ◽  
Pain Treatment ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Thoracic Cancer ◽  
Scrambler Therapy

Background: Pain is still a common feature in all types of cancers including head and neck and thoracic cancer. Neuromodulatory techniques have gained popularity over opioids in recent times because of the risks associated with chronic opioid therapy. There are no clinical trials evaluating the efficacy of scrambler therapy (ST) for the management of pain due to head and neck and thoracic cancer. Objective: This trial was undertaken to evaluate the efficacy of scrambler therapy (ST) for pain relief and to assess the possible effect of ST on the dosage of opioids in patients suffering from cancer pain. Study design: A randomized control trial (RCT) was performed. Setting: The trial was conducted at the Pain and Palliative Care Unit of the Dr. B.R. Ambedkar Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi, India. Method: Forty patients were included in each of the 2 arms, control and Intervention. In both arms, patients were given pain management drugs. In the intervention group, patients additionally received 10 consecutive sessions of ST with one follow-up after 7 days. A numeric rating scale (NRS-11) was used to measure pain. Drug dosage was also recorded. Results: Overall, pain decreased in both arms. However, pain decreased more in the intervention arm as compared to the control arm. The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively. Differences between pain scores in both arms became significant from day 3 onwards. Mean morphine dose was significantly lower in the intervention arm from day 7 onwards. Limitations: The study followed the patients until one week after the last treatment session and encouraged patients to return for treatment if their pain returned to previous levels within 10 days. Moreover, patients in the control arm received the standard of care in the form of pharmacological treatment but did not receive either transcutaneous electrical nerve stimulation (TENS) or a sham (placebo) procedure. Conclusions: The trial showed that ST is an effective treatment for the management of pain due to head and neck and thoracic cancer. On the basis of this study, the use of ST for the management of refractory cancer pain in head and neck and thoracic cancer is recommended. Key words: Calmare Therapy, cancer pain, noninvasive pain treatment, numerical rating scale, opioids, RCT, scrambler therapy, TENS

scholarly journals Moderators of Effects of Internet-Delivered Exercise and Pain Coping Skills Training for People With Knee Osteoarthritis: Exploratory Analysis of the IMPACT Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Belinda J Lawford ◽  
Rana S Hinman ◽  
Jessica Kasza ◽  
Rachel Nelligan ◽  
Francis Keefe ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Self Efficacy ◽  
Rating Scale ◽  
Coping Skills ◽  
Numerical Rating Scale ◽  
Skills Training ◽  
Control Group ◽  
Pain Coping ◽  
Coping Skills Training ◽  
Numerical Rating

BACKGROUND Internet-delivered exercise, education, and pain coping skills training is effective for people with knee osteoarthritis, yet it is not clear whether this treatment is better suited to particular subgroups of patients. OBJECTIVE The aim was to explore demographic and clinical moderators of the effect of an internet-delivered intervention on changes in pain and physical function in people with knee osteoarthritis. METHODS Exploratory analysis of data from 148 people with knee osteoarthritis who participated in a randomized controlled trial comparing internet-delivered exercise, education, and pain coping skills training to internet-delivered education alone. Primary outcomes were changes in knee pain while walking (11-point Numerical Rating Scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index function subscale) at 3 and 9 months. Separate regression models were fit with moderator variables (age, gender, expectations of outcomes, self-efficacy [pain], education, employment status, pain catastrophizing, body mass index) and study group as covariates, including an interaction between the two. RESULTS Participants in the intervention group who were currently employed had significantly greater reductions in pain at 3 months than similar participants in the control group (between-group difference: mean 2.38, 95% CI 1.52-3.23 Numerical Rating Scale units; interaction P=.02). Additionally, within the intervention group, pain at 3 months reduced by mean 0.53 (95% CI 0.28-0.78) Numerical Rating Scale units per unit increase in baseline self-efficacy for managing pain compared to mean 0.11 Numerical Rating Scale units (95% CI –0.13 to 0.35; interaction P=.02) for the control group. CONCLUSIONS People who were employed and had higher self-efficacy at baseline were more likely to experience greater improvements in pain at 3 months after an internet-delivered exercise, education, and pain coping skills training program. There was no evidence of a difference in the effect across gender, educational level, expectation of treatment outcome, or across age, body mass index, or tendency to catastrophize pain. Findings support the effectiveness of internet-delivered care for a wide range of people with knee osteoarthritis, but future confirmatory research is needed. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12614000243617; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365812&isReview=true (Archived by WebCite at http://www.webcitation.org/6z466oTPs)

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