scholarly journals Nutraceuticals for Knee Osteoarthritis Pain Relief. Results from a Preliminary Randomised Clinical Trial

Dietetics ◽  
2021 ◽  
Vol 1 (1) ◽  
pp. 2-14
Author(s):  
Evdokia Valsamidou ◽  
Charalampia Amerikanou ◽  
Chara Tzavara ◽  
Panagiotis Zoumpoulakis ◽  
Theodoros D. Mariolis-Sapsakos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ascorbic Acid ◽  
Phenolic Compounds ◽  
Pain Relief ◽  
Knee Osteoarthritis ◽  
Plant Secondary Metabolites ◽  
Randomised Clinical Trial ◽  
Secondary Outcome ◽  
Pain Subscale ◽  
To Receive

Osteoarthritis is the most common inflammation-based joint disease. Polyphenols are plant secondary metabolites with established antioxidant and anti-inflammatory properties. Recognizing the need for holistic approaches in the management of knee osteoarthritis, we designed a two-arm, randomised clinical trial to evaluate the efficacy of a supplement rich in phenolic compounds in OA. Primary outcomes included changes in Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain subscale. Secondary outcome measures were the changes in WOMAC stiffness and functionality subscales. Patients were randomised (1:1) to receive a mixture of phenolic compounds and ascorbic acid (PhAA,) or ascorbic acid (AA). Μedical history, biochemical profile and anthropometric measurements were obtained. Eighty-six patients were screened and 25 were randomly allocated in a pilot study to receive a mixture of phenolic compounds and ascorbic acid (PhAA,) or ascorbic acid (AA) adjunct to stable medical treatment. The nutraceutical supplements were well tolerated and no adverse events were reported. VAS decreased in the PhAA group (p < 0.001). Additionally, WOMAC composite score decreased significantly only in the PhAA group (p < 0.05). The WOMAC subscale of pain decreased in both treatment groups (p = 0.001 for the PhAA group, p < 0.05 for the AA group). The decrease in the subscales of stiffness and physical function was not significant for either group. A possible improvement in the quality of life of these patients using nutraceutical supplements is apparent. Although preliminary, our positive results support the hypothesis that treatment with nutraceuticals may be effective for pain relief in osteoarthritis. ClinicalTrials.gov Identifier: NCT04783792.

scholarly journals Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019103 ◽  
Author(s):  
Regina Wing Shan Sit ◽  
Keith Kwok Wai Chan ◽  
Benjamin Hon Kei Yip ◽  
Daisy Dexing Zhang ◽  
Kenneth Dean Reeves ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Physical Function ◽  
Medical Condition ◽  
Randomised Clinical Trial ◽  
Waiting List ◽  
Oblique Muscle ◽  
Womac Pain ◽  
Timed Up And Go ◽  
Pain Subscale

IntroductionKnee osteoarthritis (KOA) is a common, disabling and costly medical condition. The patellofemoral joint is a critical source of pain in individuals with KOA, and coexistence of patellofemoral osteoarthritis (PFOA) and tibiofemoral osteoarthritis (TFOA) is sometimes observed. The identification of subgroups with PFOA and customised interventions to correct underlying pathomechanics is beneficial for individuals with KOA. This study aims to evaluate whether a clinic-based patella mobilisation therapy (PMT) leads to significant improvement in pain, physical function and quality of life of individuals with KOA.Methods and analysisA total of 208 participants with coexistence of PFOA and TFOA will be recruited. A pragmatic randomised clinical trial will be conducted, and participants will be randomised into the PMT and waiting list groups. For the PMT group, three manual mobilisation sessions, along with home-based vastus medialis oblique muscle exercise, will be conducted at 2-month intervals. The waiting list group will continue to receive their usual care, and as an incentive the waiting list group will be offered PMT after the study period is over. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and secondary outcomes include the WOMAC function and stiffness subscales, scores for objective physical function tests (the 30 s chair stand, 40-metre fast-paced walk test, the Timed Up and Go Test), and the EuroQol-5D scores. All outcomes will be evaluated at baseline and 6 months using intention-to-treat and incorporating covariate analysis.Ethics and disseminationEthics approval has been obtained (CREC no: 2014.379). Results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberChiCTR-IPC-15006618; Pre-results.

scholarly journals Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041458
Author(s):  
Vicki Anderson ◽  
Vanessa C Rausa ◽  
Nicholas Anderson ◽  
Georgia Parkin ◽  
Cathriona Clarke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Normal Activity ◽  
Secondary Outcome ◽  
Open Label ◽  
Human Research Ethics ◽  
Postconcussive Symptoms ◽  
Study Results ◽  
Registration Number ◽  
Initial Injury

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

scholarly journals PO 8576 EFFECT OF IVERMECTIN TREATMENT ON THE FREQUENCY OF SEIZURES IN PERSONS WITH ONCHOCERCIASIS-ASSOCIATED EPILEPSY: PRELIMINARY RESULTS OF A RANDOMISED CLINICAL TRIAL

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A57.1-A57
Author(s):  
Mandro Ndahura ◽  
Deby Mukendi ◽  
Françoise Nyisi ◽  
Deogracias Rossy ◽  
Joseph Siewe ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Seizure Frequency ◽  
Randomised Clinical Trial ◽  
Added Value ◽  
Secondary Outcome ◽  
Primary Study ◽  
Seizure Freedom ◽  
Ivermectin Treatment ◽  
Significant Difference ◽  
Republic Of The Congo

BackgroundMany studies reported an association between epilepsy and onchocerciasis. Moreover, anecdotal evidence suggests that ivermectin may reduce seizure frequency in persons with onchocerciasis-associated epilepsy (PWOAE). Therefore, we performed a randomised clinical trial among ivermectin-naïve persons with epilepsy in onchocerciasis-endemic villages in the Ituri province, Democratic Republic of the Congo.MethodsPWOAE were randomised in an arm receiving immediate (arm A) or delayed (4 months later) ivermectin treatment (arm B). All participants were receiving anti-epileptic drugs. Inclusion criteria were: age >5 years, signed informed consent, normal neurological development until onset of epilepsy between 5–18 years of age, seizure frequency of ≥2 seizures/month, presence of microfilaria in skin snip and/or antibodies against the Ov16 antigen. Primary study outcome: seizure freedom at month 4; secondary outcome:>50% reduction in seizure frequency at month 4 compared to reported seizure frequency at randomisation. The proposed sample size was 110 PWOAE.Results93 PWOAE, 57 males and 36 females, (mean age 22), were enrolled between October and November 2017. On March 2018, 90 (97%) participant completed their 4th-month evaluation. One serious adverse event was observed during the trial (Steven Johnson reaction caused by phenobarbital). Considering all participants there was no significant difference in outcome between the 2 arms. However, considering participants with presence of microfilariae at enrollment, at month 4, 26/39 (66.6%) in arm A and 20/44 (45.5%) in arm B were seizure free (p=0.05) and a 50% reduction of the number of seizures was observed in 9/39 (23.1% ) in arm A and 7/43 (16.3%) in arm B. (p=0.4).ConclusionIvermectin may have an added value in reducing the frequency of seizures in PWOAE treated with anti-epileptic drugs. However, a larger study is needed to confirm this.

scholarly journals The effect of rehabilitation protocol using mobile health in overweight and obese patients with knee osteoarthritis: a clinical trial

2021 ◽  
Vol 61 (1) ◽  
Author(s):  
Muhammad Tariq Rafiq ◽  
Mohamad Shariff Abdul Hamid ◽  
Eliza Hafiz
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Mobile Health ◽  
Functional Activity ◽  
Analysis Of Covariance ◽  
Secondary Outcome ◽  
Patient Specific ◽  
Control Group ◽  
Rehabilitation Protocol ◽  
To Receive

Abstract Objective The objective of this randomized controlled trial (RCT) was to investigate the effectiveness of the lower limb rehabilitation protocol (LLRP) combined with mobile health (mHealth) applications on knee pain, mobility, functional activity and activities of daily living (ADL) among knee osteoarthritis (OA) patients who were overweight and obese. Methods This study was a single-blind, RCT conducted at Teaching Bay of Rehmatul-Lil-Alameen Post Graduate Institute of Cardiology between February and November 2020. 114 knee OA patients who were overweight and obese were randomly divided by a computer-generated number into the rehabilitation group with mHealth (RGw-mHealth) to receive LLRP + instructions of daily care (IDC) combined with mHealth intervention, rehabilitation group without mHealth (RGwo-mHealth) to receive LLRP + IDC intervention and control group (CG) to receive IDC intervention. All three groups were also provided leaflets explaining about their intervention. The primary outcome measure was knee pain measured by the Western Ontario and McMaster Universities Osteoarthritis Index score. The secondary outcome measures were mobility measured by the Timed up and go (TUG) test, functional activity measured by the patient-specific functional scale (PSFS), and ADL measured by the Katz Index of independence in ADL scores. Results Among the 114 patients who were randomized (mean age, 53 years), 96 (84%) completed the trial. After 3-months of intervention, patients in all three groups had statistically significant knee pain reduction (RGw-mHealth: 2.54; RGwo-mHealth: 1.47; and CG: 0.37) within groups (P < 0.05). Furthermore, patients in the RGw-mHealth and RGwo-mHealth had statistically significant improvement in mobility, functional activity, and ADL within groups (P < 0.05), but no improvement was noted in the CG (p > 0.05). As indicated in the overall analysis of covariance, there were statistically significant differences in the mean knee pain, mobility, functional activity, and ADL changes between groups after 3-months (p < 0.001). The pairwise between-group comparisons (Bonferroni post hoc analysis) of the knee pain, mobility, functional activity, and ADL scores at 3-months revealed that patients in the RGw-mHealth had significantly higher mean change in the knee pain, TUG test, functional activity, and ADL scores compared to patients in the RGwo-mHealth or CG. Conclusion Reduction in knee pain, improvement in mobility, functional activity, and ADL were more among patients in the RGw-mHealth compared with the RGwo-mHealth or CG. Trial registration National Medical Research Registry: NMRR-20-1094-52911. Date of registration: 05–05-2020. URL: https://www.nmrr.gov.my.

scholarly journals The Ghana PrenaBelt trial: a double-blind, sham-controlled, randomised clinical trial to evaluate the effect of maternal positional therapy during third-trimester sleep on birth weight

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e022981
Author(s):  
Jerry Coleman ◽  
Maxfield Okere ◽  
Joseph Seffah ◽  
Allan Kember ◽  
Louise M O’Brien ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Birth Weight ◽  
Randomised Clinical Trial ◽  
Sleep Diary ◽  
Secondary Outcome ◽  
Positional Therapy ◽  
Third Trimester ◽  
Double Blind ◽  
Home Setting ◽  
Sleeping Position

ObjectiveTo evaluate the effect, on birth weight and birth weight centile, of use of the PrenaBelt, a maternal positional therapy device, during sleep in the home setting throughout the third trimester of pregnancy.DesignA double-blind, sham-controlled, randomised clinical trial.SettingConducted from September 2015 to May 2016, at a single, tertiary-level centre in Accra, Ghana.ParticipantsTwo-hundred participants entered the study. One-hundred-eighty-one participants completed the study. Participants were women, 18 to 35 years of age, with low-risk, singleton, pregnancies in their third-trimester, with body mass index <35 kg/m2at the first antenatal appointment for the index pregnancy and without known foetal abnormalities, pregnancy complications or medical conditions complicating sleep.InterventionsParticipants were randomised by computer-generated, one-to-one, simple randomisation to receive either the PrenaBelt or sham-PrenaBelt. Participants were instructed to wear their assigned device to sleep every night for the remainder of their pregnancy (approximately 12 weeks in total) and were provided a sleep diary to track their use. Allocation concealment was by unmarked, security-tinted, sealed envelopes. Participants and the outcomes assessor were blinded to allocation.Primary and secondary outcome measuresThe primary outcomes were birth weight and birth weight centile. Secondary outcomes included adherence to using the assigned device nightly, sleeping position, pregnancy outcomes and feedback from participants and maternity personnel.ResultsOne-hundred-sixty-seven participants were included in the primary analysis. The adherence to using the assigned device nightly was 56%. The mean ±SD birth weight in the PrenaBelt group (n=83) was 3191g±483 and in the sham-PrenaBelt group (n=84) was 3081g±484 (difference 110 g, 95% CI −38 to 258, p=0.14). The median (IQR) customised birth weight centile in the PrenaBelt group was 43% (18 to 67) and in the sham-PrenaBelt group was 31% (14 to 58) (difference 7%, 95% CI −2 to 17, p=0.11).ConclusionsThe PrenaBelt did not have a statistically significant effect on birth weight or birth weight centile in comparison to the sham-PrenaBelt.Trial registration numberNCT02379728.

scholarly journals Effectiveness of manual therapy for chronic tension-type headache: A pragmatic, randomised, clinical trial

Cephalalgia ◽  
2010 ◽  
Vol 31 (2) ◽  
pp. 133-143 ◽  
Author(s):  
René F Castien ◽  
Daniëlle AWM van der Windt ◽  
Anneke Grooten ◽  
Joost Dekker
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Manual Therapy ◽  
Randomised Clinical Trial ◽  
Tension Type Headache ◽  
Secondary Outcome ◽  
Chronic Tension Type Headache ◽  
Headache Disability ◽  
Type Headache ◽  
Gp Care

Objective: To evaluate the effectiveness of manual therapy (MT) in participants with chronic tension-type headache (CTTH). Subjects and Methods: We conducted a multicentre, pragmatic, randomised, clinical trial with partly blinded outcome assessment. Eighty-two participants with CTTH were randomly assigned to MT or to usual care by the general practitioner (GP). Primary outcome measures were frequency of headache and use of medication. Secondary outcome measures were severity of headache, disability and cervical function. Results: After 8 weeks ( n = 80) and 26 weeks ( n = 75), a significantly larger reduction of headache frequency was found for the MT group (mean difference at 8 weeks, −6.4 days; 95% CI −8.3 to −4.5; effect size, 1.6). Disability and cervical function showed significant differences in favour of the MT group at 8 weeks but were not significantly different at 26 weeks. Conclusions: Manual therapy is more effective than usual GP care in the short- and longer term in reducing symptoms of CTTH. Dutch Trial Registration no. TR 1074.

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