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1.
Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial.
Raj, JP, Venkatachalam, S, Racha, P, Bhaskaran, S, Amaravati, RS
Complementary therapies in medicine. 2020;:102522
Abstract
OBJECTIVE Curcuma longa has been widely used in Ayurveda for its medicinal properties and Turmacin was developed from C. longa as a standardized extract containing turmerosaccharides. In this clinical trial, the effect of Turmacin on knee joint discomfort in healthy adults subjected to strenuous physical activity was evaluated. DESIGN Double-blind, triple-arm, parallel-group, randomized placebo-controlled trial. SETTING Healthy participants from an urban tertiary care teaching hospital. INTERVENTION Healthy participants were randomized in 1:1:1 ratio to receive either Turmacin 0.5 g/1 g or placebo once daily for 84 days. The participants were subjected to 10-minute strenuous exercise. OUTCOME MEASURES Time to initial pain, final pain score on a visual analogue scale, range of movement (ROM) of knee and the force of contractions of muscles around the knee joint. RESULTS A total of n = 90 participants were recruited. The mean final pain scores were significantly lower in the Turmacin 1 g and Turmacin 0.5 g when compared with the placebo from day-7 and day-5 onwards respectively. The survival analysis consistently showed a decreased hazard for early onset of pain in both the Turmacin groups. On day-84, the difference in mean ROM between Turmacin 0.5 g and placebo was 4.79 degrees (p = 0.008) and that for Turmacin 1 g and placebo was 2.34 degrees (p = 0.306). The difference in muscle force for isokinetic contractions of the quadriceps at angular velocities of 120 and 180 was significant between Turmacin 0.5 g and placebo (p = 0.002 and p = 0.005 respectively) while that for Turmacin 1 g & Turmacin 0.5 g (p = 0.206 and p = 0.414 respectively) and Turmacin 1 g & Placebo (p = 0.046 and p = 0.037) were not significant. However, in the within group analysis participants in Turmacin 1 g group had better preserved muscle functions than Turmacin 0.5 g group at angular velocities of 120 and 180 when compared with placebo. CONCLUSION Turmacin (0.5 g and 1 g) was efficacious when compared to placebo in increasing the pain threshold and knee ROM in healthy participants with minor adverse events.
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2.
The effect of curcumin ointment on knee pain in older adults with osteoarthritis: a randomized placebo trial.
Jamali, N, Adib-Hajbaghery, M, Soleimani, A
BMC complementary medicine and therapies. 2020;(1):305
Abstract
BACKGROUND Some studies have shown the effect of oral administration of curcumin on knee pain. However, limited studies are available on the effect of topical curcumin. This study aimed to investigate the effect of curcumin ointment on knee pain in older adults with osteoarthritis. METHODS This double-blind randomized placebo trial was conducted on 72 older adults with knee pain associated with osteoarthritis. The subjects were randomly assigned into an intervention and a placebo group to apply either curcumin 5% ointment or Vaseline ointment twice daily for 6 weeks. Using a Visual Analog Scale, the severity of knee pain was measured at the beginning of the study, at the end of the fourth and sixth week. Data were analyzed using descriptive and inferential methods. RESULTS The mean baseline knee pain intensity was not significantly different between the two groups (P = 0.15). The mean pain intensity was significantly lower in the intervention group than in the placebo group at the third measurement (P = 0.02). The repeated-measures analysis showed that over time, the curcumin significantly decreased the mean pain intensity in the intervention group (P = 0.001). The mixed model showed an absolute difference of 1.133 (i.e. 11.33 mm) score which signifies a medium effect size and that the patient in the intervention group achieved the minimal clinically important difference. CONCLUSION Topical administration of curcumin 5% ointment can significantly reduce knee pain in older adults with knee osteoarthritis. Curcumin ointment can be used as an alternative treatment in older adults with knee pain associated with osteoarthritis. TRIAL REGISTRATION Retrospectively registered in the Iranian Registry of Clinical Trials (IRCT) (IRCT20100403003618N6, 2019-03-08), https://en.irct.ir/trial/37155.
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3.
An infrapatellar nerve block reduces knee pain in patients with chronic anterior knee pain after tibial nailing: a randomized, placebo-controlled trial in 34 patients.
Leliveld, MS, Kamphuis, SJM, Verhofstad, MHJ
Acta orthopaedica. 2019;(4):377-382
Abstract
Background and purpose - Anterior knee pain is common after tibial nailing. Its origin is poorly understood. Injury of the infrapatellar nerve is a possible cause. In this randomized controlled trial we compared changes in knee pain after an infrapatellar nerve block with lidocaine or placebo in patients with persistent knee pain after tibial nailing. Patients and methods - Patients with chronic knee pain after tibial nailing were randomized to an infrapatellar nerve block with 5 ml 2% lidocaine or placebo (sodium chloride 0.9%), after which they performed 8 daily activities. Before and after these activities, pain was recorded using a numeric rating scale (NRS; 0-10). Primary endpoint was the change in pain during kneeling after the infrapatellar nerve block. Secondary outcomes were changes in pain after the nerve block during the other activities. Results - 34 patients (age 18-62 years) were equally randomized. A significant reduction of the NRS for kneeling pain with an infrapatellar nerve block with lidocaine was found compared with placebo (-4.5 [range -10 to -1] versus -1 [-9 to 2]; p = 0.002). There were no differences between the treatments for the NRS values for pain during other activities. Interpretation - Compared with placebo, an infrapatellar nerve block with lidocaine was more effective in reducing pain during kneeling in patients with chronic knee pain after tibial nailing. Our findings support the contention that kneeling pain after tibial nailing is a peripheral nerve-related problem.
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4.
Effect of a low-intensity, self-management lifestyle intervention on knee pain in community-based young to middle-aged rural women: a cluster randomised controlled trial.
Wang, Y, Lombard, C, Hussain, SM, Harrison, C, Kozica, S, Brady, SRE, Teede, H, Cicuttini, FM
Arthritis research & therapy. 2018;(1):74
Abstract
BACKGROUND Knee pain is common with obesity and weight gain being important risk factors. Previous clinical trials have focused on overweight or obese adults with knee pain and osteoarthritis and demonstrated modest effects of intense weight loss programs on reducing knee pain despite very significant weight loss. There has been no lifestyle intervention that targets community-based adults to test its effect on prevention of knee pain. We aimed to determine the effect of a simple low-intensity self-management lifestyle intervention (HeLP-her), proven in randomised controlled trials to improve lifestyle and prevent weight gain, on knee pain in community-based young to middle-aged rural women. METHODS A 1-year pragmatic, cluster randomised controlled trial was conducted in 649 community-based women (aged 18-50 years) to receive either the HeLP-her program (consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual) or one general women's health education session. Secondary analyses were performed in 390 women who had knee pain measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and 12-month follow-up. "Any knee pain" was defined as a WOMAC pain score ≥ 1. Knee pain worsening was defined as an increase in WOMAC pain score over 12 months. RESULTS Thirty-five percent of women had "any knee pain" at baseline. The risk of knee pain worsening did not differ between the intervention and control groups over 12 months. For women with any knee pain at baseline, those in the intervention arm had a lower risk of knee pain worsening compared with those in the control arm (OR 0.37, 95% CI 0.14-1.01, p = 0.05), with a stronger effect observed in women with body mass index ≥ 25 kg/m2 (OR 0.28, 95% CI 0.09-0.87, p = 0.03). CONCLUSIONS In community-based young to middle-aged women, a simple low-intensity lifestyle program reduced the risk of knee pain worsening in those with any knee pain at baseline, particularly in those overweight or obese. Pragmatic lifestyle programs such as HeLP-her may represent a feasible lifestyle intervention to reduce the burden of knee pain in the community. TRIAL REGISTRATION ACTRN12612000115831 , registered 24 January 2012.
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5.
Individuals With Patellofemoral Pain Have Less Hip Flexibility Than Controls Regardless of Treatment Outcome.
Hamstra-Wright, KL, Earl-Boehm, J, Bolgla, L, Emery, C, Ferber, R
Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine. 2017;(2):97-103
Abstract
OBJECTIVE To examine differences in hip flexibility before and after a 6-week muscle strengthening program between those with patellofemoral pain (PFP) and healthy controls. DESIGN Single-blind, multicentered, randomized controlled trial. SETTING Four clinical research laboratories. SUBJECTS Physically active individuals (199 PFP and 38 controls). INTERVENTIONS Patellofemoral pain and control subjects were randomized into either a hip-focused or a knee-focused muscle strengthening treatment program. MAIN OUTCOME MEASURES Pain-visual analog scale (centimeter), function-Anterior Knee Pain Scale (points), flexibility-passive goniometry (degrees): hip adduction (HADD), hip external rotation (HER), hip internal rotation (HIR), total hip rotation (HROT), hip extension (HEXT) were measured before and after the muscle strengthening treatment program. RESULTS Subjects with patellofemoral pain who successfully completed the treatment program (n = 153) had 65%, 25%, 18%, and 12% less HADD, HER, HROT, and HIR ranges of motion (ROMs), respectively, than controls (P < 0.05). Patellofemoral pain subjects who did not successfully complete the program (n = 41) had 134%, 31%, 22%, and 13% less HADD, HER, HROT, and HIR ROMs, respectively, than controls (P < 0.05). All subjects increased their HIR, HROT, and HEXT ROMs pretest to posttest (P < 0.05), but by less than 2 degree. CONCLUSIONS Individuals with PFP had less hip flexibility than controls regardless of treatment outcome or time. After the 6-week muscle strengthening program, and regardless of treatment success, PFP and control subjects experienced a small but clinically insignificant improvement in hip flexibility. CLINICAL RELEVANCE Hip ROM should be considered as a targeted area of focus in a rehabilitation program for physically active individuals with PFP.
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6.
Effects of dietary supplementation with a standardized aqueous extract of Terminalia chebula fruit (AyuFlex®) on joint mobility, comfort, and functional capacity in healthy overweight subjects: a randomized placebo-controlled clinical trial.
Lopez, HL, Habowski, SM, Sandrock, JE, Raub, B, Kedia, A, Bruno, EJ, Ziegenfuss, TN
BMC complementary and alternative medicine. 2017;(1):475
Abstract
BACKGROUND Joint and connective tissue integrity, comfort and function are paramount to optimal performance in exercise, recreational and occupational activities. The fruit of Terminalia chebula has been used extensively in various traditional health systems for different ailments, with additional preclinical and clinical data demonstrating antioxidant and anti-inflammatory potential. The aim of this study was to evaluate the effects of a standardized aqueous extract of Terminalia chebula fruit (AyuFlex®) dietary supplementation on joint mobility, comfort, and functional capacity in healthy overweight subjects. METHODS One-hundred and five (105) overweight, apparently healthy male and female subjects (35-70 years of age) were pre-screened and randomized to one of three groups for 84 days: placebo, AyuFlex1 (250 mg twice daily) or AyuFlex2 (500 mg twice daily) in a randomized, double-blind, placebo-controlled design. A two-week placebo lead-in period was used to improve data quality/validity. All subjects had no knee joint discomfort at rest, but experienced knee joint discomfort only with activity/exercise of at least 30 on 100 mm Visual Analog Scale (VAS). Primary outcome measures included symptoms of joint health and function as measured by modified-Knee Injury & Osteoarthritis Outcomes Score (mKOOS) global & modified-Western Ontario and McMaster Universities Arthritis Index (mWOMAC) subscales (discomfort, stiffness and function). Secondary outcomes included VAS questionnaires on overall/whole-body joint health, low back health, knee mobility, willingness and ability to exercise, 6-min walk test for distance and range of motion (ROM) of pain-free knee flexion/extension. Tertiary outcome measures included inflammatory (high sensitivity C-reactive protein (hsCRP), tumor necrosis factor (TNF)-α) and extracellular matrix (ECM)/Connective Tissue (COMP) biomarkers, and safety (vital signs and blood markers) & tolerability (Adverse Event (AE)/ side effect profiles). RESULTS Compared to placebo, at day 84 AyuFlex® treatment significantly: 1) improved mKOOS global scores in AyuFlex1 + AyuFlex2 (P = 0.023), and improved total and physical function subscale of mWOMAC relative to baseline, 2) improved VAS scores for Knee Discomfort with activity/exercise in AyuFlex1 + AyuFlex2 (P = 0.001) relative to baseline, 3) improved VAS scores for whole-body joint function in AyuFlex1 + AyuFlex2 (P < 0.029) relative to baseline, 4) improved VAS score for decreased knee joint soreness following leg extension challenge for AyuFlex1 (P = 0.022) and AyuFlex2 (P = 0.043) relative to baseline, 5) improved 6-min walk performance distance covered (P = 0.047) and VAS discomfort (P = 0.026) post-6 min walk in AyuFlex1 + AyuFlex2 relative to baseline, 6) and tended to decrease COMP levels in AyuFlex1 + AyuFLex2 (P = 0.104) relative to baseline. All biomarkers of safety remained within normative limits during the study. Low back health tended to improve in the AyuFlex1 and AyuFlex2 group, but failed to reach significance relative to placebo group. CONCLUSIONS AyuFlex® improved mKOOS global scores, knee joint discomfort with activity/exercise, 6-min walk test distance covered and discomfort post-6 min walk test, overall whole-body joint function, knee soreness following leg extension resistance exercise in a healthy, overweight population, without AE. Differences between 250 mg/BID and 500 mg/BID were non-significant for most of the outcome measures, validating the efficacy of the lower dose. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02589249 ; October 26, 2015.
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7.
[Effect of External Applying Compound Tripterygium wilfordii Hook F. on Joint Pain of Rheumatoid Arthritis Patients].
Jiao, J, Tang, XP, Yuan, J, Liu, X, Liu, H, Zhang, CY, Wang, LY, Jiang, Q
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2016;(1):29-34
Abstract
OBJECTIVE To observe the effectiveness and safety of external applying Compound Tripterygium wilfordii Hook F. (TwHF) in relieving joint pain in rheumatoid arthritis (RA) patients. METHODS In this double-blinded, randomized multicenter trial, a total of 174 moderately active RA patients were enrolled and randomly assigned to the treatment group (treated with Compound TwHF, 87 cases) and the placebo control group (87 cases). Compound TwHF or placebo was externally applied in painful joints, 20 g each time, once per day for 8 weeks. Self-reported joint pain relief was taken as a primary effective indicator. Visual analogue scale for pain (VAS), disease activity score of 28 joints (DAS28), VAS for general health (GH) were evaluated before treatment, at week 4 and after treatment. Erythrocyte sedimentation rate (ESR) and hypersensitive C reactive protein (hs-CRP) were tested before and after treatment. Menstrual changes in females were observed during treatment. Skin irritation occurred during the recording process was assessed using skin irritation strength. Intention to treat (ITT) was statistically analyzed. RESULTS The joint pain relief rate in the treatment group was 90.8% (79/87 cases), higher than that in the placebo control group (69.0%, 60/87 cases; P = 0.001). VAS pain score, DAS28, VAS for GH score were significantly improved in the two groups at week 4 of treatment and after treatment, as compared with before treatment (P < 0.01). ESR and hs-CRP levels significantly decreased in the treatment group after treatment (P < 0.05, P < 0.01). No difference was found in post-treatment VAS pain score, DAS28, VAS for GH score, ESR, or hs-CRP between the two groups (P > 0.05). Eight adverse events occurred in the treatment group (5 skin allergy, 1 intolerance of medical odor, and 2 mild liver injury), while 3 adverse events occurred in the placebo control group (2 skin allergy, 1 mild liver injury). There was no statistical difference in adverse event between the two groups (P > 0.05). No menstrual change occurred in the treatment group. CONCLUSION External applying Compound TwHF was an effective and safe way to relieve-joint pain of RA patients, which could be taken as an adjuvant therapy.
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8.
Effect of Vitamin D Supplementation on Tibial Cartilage Volume and Knee Pain Among Patients With Symptomatic Knee Osteoarthritis: A Randomized Clinical Trial.
Jin, X, Jones, G, Cicuttini, F, Wluka, A, Zhu, Z, Han, W, Antony, B, Wang, X, Winzenberg, T, Blizzard, L, et al
JAMA. 2016;(10):1005-13
Abstract
IMPORTANCE Observational studies suggest that vitamin D supplementation is associated with benefits for knee osteoarthritis, but current trial evidence is contradictory. OBJECTIVE To compare the effects of vitamin D supplementation vs placebo on knee pain and knee cartilage volume in patients with symptomatic knee osteoarthritis and low vitamin D levels. DESIGN, SETTING, AND PARTICIPANTS A multicenter randomized, double-blind, placebo-controlled clinical trial in Tasmania and Victoria, Australia. Participants with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D (12.5-60 nmol/L) were enrolled from June 2010 to December 2011. The trial was completed in December 2013. INTERVENTIONS Participants were randomly assigned to receive monthly treatment with oral vitamin D3 (50,000 IU; n = 209) or an identical placebo (n = 204) for 2 years. MAIN OUTCOMES AND MEASURES Primary outcomes were change in tibial cartilage volume (assessed using magnetic resonance imaging [MRI]) and change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score (0 [no pain] to 500 [worst pain]) from baseline to month 24. Secondary outcomes were cartilage defects and bone marrow lesions (assessed using MRI). RESULTS Of 413 enrolled participants (mean age, 63.2 years; 50% women), 340 (82.3%) completed the study. The level of 25-hydroxyvitamin D increased more in the vitamin D group (40.6 nmol/L) than in the placebo group (6.7 nmol/L) (P < .001) over 2 years. There were no significant differences in annual change of tibial cartilage volume or WOMAC pain score. There were no significant differences in change of tibiofemoral cartilage defects or change in tibiofemoral bone marrow lesions. Adverse events (≥ 1 per patient) occurred in 56 participants in the vitamin D group and in 37 participants in the placebo group (P = .04). [table: see text]. CONCLUSIONS AND RELEVANCE Among patients with symptomatic knee osteoarthritis and low serum 25-hydroxyvitamin D levels, vitamin D supplementation, compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or WOMAC knee pain score over 2 years. These findings do not support the use of vitamin D supplementation for preventing tibial cartilage loss or improving WOMAC knee pain in patients with knee osteoarthritis. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01176344; anzctr.org.au Identifier: ACTRN12610000495022.
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9.
Turmeric (Curcuma longa): Effects of Curcuma longa Extracts Compared With Ibuprofen for Reduction of Pain and Functional Improvement in Patients With Knee Osteoarthritis.
Ross, SM
Holistic nursing practice. 2016;(3):183-6
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10.
Comparative effectiveness of B and e vitamins with diclofenac in reducing pain due to osteoarthritis of the knee.
Dehghan, M
Medical archives (Sarajevo, Bosnia and Herzegovina). 2015;(2):103-6
Abstract
BACKGROUND Knee osteoarthritis is one of the most prevalent chronic disorders. Several pharmacological and non pharmacological approaches are used to treat this disease. Today, the effect of B and E vitamins on rheumatology diseases is being discussed. In this study, the efficacy of B and E vitamins accompanied with diclofenac on pain relief in patients with knee osteoarthritis was investigated and compared. METHODS In this double-blinded clinical trial, 120 patients with knee osteoarthritis referring training Rheumatology and Orthopedics Clinic of Shahrekord University of Medical sciences were investigated. Of these patients, 12 were excluded throughout the study. The patients underwent treatment in three groups (oral diclofenac + oral B vitamin, oral diclofenac + oral vitamin E, and oral diclofenac + placebo). Pain relief was assessed by visual analogue scale (VAS) questionnaire and morning stiffness and physical function were assessed by WOMAC standard questionnaire at three times; the first examination, two weeks, and three weeks after referring. RESULTS The mean score of WOMAC questionnaire at VASs of knee pain, total pain severity, knee joint stiffness, and function of the last 48 hours decreased significantly in all three groups (diclofenac, E and B vitamins) from the first to third examination (P<0.001). Decrease in VAS of knee pain and function of the last 48 hours was higher in B vitamin group than the diclofenac and E vitamin group (P=0.008) and decrease in total pain severity was reported higher in B vitamin group than E vitamin and diclofenac group (P=0.019). Decrease in knee joint stiffness underwent a similar trend in the three groups. CONCLUSION In view similar analgesic and anti-inflammatory properties, as well as very few, non prevalent complications of B and E vitamins, use of two or more drugs with a different mechanism of effect seems necessary to enhance their effect on osteoarthritis treatment.