search
Back to results

Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis (SMILE)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
SYALOX® 300 Plus
Placebo
Sponsored by
River Pharma S.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any gender and age from 45 to 70 years
  • Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination(44). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period.
  • Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint(45).
  • Subjects experienced pain for at least 15 of the 30 days prior to the start of the study.

Exclusion Criteria:

  • Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder.
  • Treatment with oral corticosteroids within 4 weeks before screening.
  • Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening.
  • Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.
  • HA-containing nutritional supplements or cosmetics during the month before the study.
  • Previous surgical treatment of knee joint(s) or its necessity necessity for osteoarthritis (high tibial osteotomy, arthroplasty); complication(s) necessary for hospitalization and surgical treatment.
  • Significant injury to the target joint within the past 6 months prior to screening (identified from medical history).
  • Subjects following an energy-restricted diet for weight loss.
  • Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception.
  • Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
  • Participation in an interventional clinical study in the previous 30 days.
  • Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.

Sites / Locations

  • Opera Contract Research Organization S.r.l.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A: Active comparator SYALOX® 300 Plus

B: Placebo

Arm Description

Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus) 1 tablet/day, oral administration

Placebo 1 tablet/day, oral administration

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS) results at rest. Change is being assessed.
Change in Visual Analogue Scale (VAS) results at rest, measured in mm
Knee Range of Motion (ROM) results measured by goniometer. Change is being assessed.
Change in Range of Motion (ROM) results, measured in grades by goniometer.

Secondary Outcome Measures

Visual Analogue Scale (VAS) results at moving. Change is being assessed.
Change in Visual Analogue Scale (VAS) results at moving, measured in mm
Visual Analogue Scale (VAS) results on pressing. Change is being assessed.
Change in Visual Analogue Scale (VAS) results at pressing, measured in mm
Ultrasonography parameters results. Change is being assessed.
Change of presence or absence of Synovial fluid, Articular cartilage damage, Medial meniscal protrusion, Lateral meniscal protrusion, Medial osteophytes, Lateral osteophytes, Enthesopathies, Effusion is being assessed.
Knee injury and Osteoarthritis Outcome Score (KOOS). Change is being assessed.
Change in parameters of quality of life will be assessed through Knee injury and Osteoarthritis Outcome Score (KOOS).
Index of Severity for Osteoarthritis of the Knee by Lequesne et al. Change is being assessed.
Change in parameters of quality of life will be assessed through Index of Severity for Osteoarthritis of the Knee by Lequesne et al.
Knee movement results using an actimeter (accelerometer). Change is being assessed.
Knee movement based on acceleration results using an actimeter, device based on an accelerometer. The results will be measured in meter/second squared (m/s2) Change is being assessed.

Full Information

First Posted
July 4, 2018
Last Updated
September 30, 2019
Sponsor
River Pharma S.r.l.
search

1. Study Identification

Unique Protocol Identification Number
NCT03612986
Brief Title
Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis
Acronym
SMILE
Official Title
Double Blind, Placebo Controlled Trial to Evaluate the Effects of a Nutraceutical Containing High-Molecular-Weight Hyaluronic Acid (HA) and Acetyl-11-Keto-Beta-Boswellic Acid (AKBA) in Patients Affected by Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
River Pharma S.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Double blind, placebo controlled trial to evaluate the effects of a nutraceutical containing high-molecular-weight hyaluronic acid (HA) and acetyl-11-keto-beta-boswellicacid (AKBA) in patients affected by knee osteoarthritis.
Detailed Description
The primary objective of the trial is to assess the feasibility of implementing Ultrasonography and Range of Motion (ROM) as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing hyaluronic acid (HA). The secondary objectives of the trial are: to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction (optional). to evaluate the enrollment rate in one month. The explorative objectives of the trial are: • Preliminary data on efficacy of the tested product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Active comparator SYALOX® 300 Plus
Arm Type
Active Comparator
Arm Description
Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus) 1 tablet/day, oral administration
Arm Title
B: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tablet/day, oral administration
Intervention Type
Dietary Supplement
Intervention Name(s)
SYALOX® 300 Plus
Intervention Description
Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator. No chemical effect expected
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) results at rest. Change is being assessed.
Description
Change in Visual Analogue Scale (VAS) results at rest, measured in mm
Time Frame
week 0, 4 and 16
Title
Knee Range of Motion (ROM) results measured by goniometer. Change is being assessed.
Description
Change in Range of Motion (ROM) results, measured in grades by goniometer.
Time Frame
week 0, 4 and 16
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) results at moving. Change is being assessed.
Description
Change in Visual Analogue Scale (VAS) results at moving, measured in mm
Time Frame
week 0, 4 and 16
Title
Visual Analogue Scale (VAS) results on pressing. Change is being assessed.
Description
Change in Visual Analogue Scale (VAS) results at pressing, measured in mm
Time Frame
week 0, 4 and 16
Title
Ultrasonography parameters results. Change is being assessed.
Description
Change of presence or absence of Synovial fluid, Articular cartilage damage, Medial meniscal protrusion, Lateral meniscal protrusion, Medial osteophytes, Lateral osteophytes, Enthesopathies, Effusion is being assessed.
Time Frame
week 0 and 16
Title
Knee injury and Osteoarthritis Outcome Score (KOOS). Change is being assessed.
Description
Change in parameters of quality of life will be assessed through Knee injury and Osteoarthritis Outcome Score (KOOS).
Time Frame
week 0, 4 and 16
Title
Index of Severity for Osteoarthritis of the Knee by Lequesne et al. Change is being assessed.
Description
Change in parameters of quality of life will be assessed through Index of Severity for Osteoarthritis of the Knee by Lequesne et al.
Time Frame
week 0, 4 and 16
Title
Knee movement results using an actimeter (accelerometer). Change is being assessed.
Description
Knee movement based on acceleration results using an actimeter, device based on an accelerometer. The results will be measured in meter/second squared (m/s2) Change is being assessed.
Time Frame
week 0 and 16
Other Pre-specified Outcome Measures:
Title
Safety outcomes assessed by number of adverse events (AE)/serious adverse events (SAE)
Description
Adverse events (AE)/serious adverse events (SAE) (number of events occured, related to the investigational product administration)
Time Frame
day 0, week 4 and 16
Title
Safety assessment based on rescue medication (Paracetamol 500mg) administration
Description
Safety assessed by the number of rescue medication tablets administered daily.
Time Frame
day 0, week 4 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any gender and age from 45 to 70 years Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination(44). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period. Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint(45). Subjects experienced pain for at least 15 of the 30 days prior to the start of the study. Exclusion Criteria: Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder. Treatment with oral corticosteroids within 4 weeks before screening. Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening. Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection. HA-containing nutritional supplements or cosmetics during the month before the study. Previous surgical treatment of knee joint(s) or its necessity necessity for osteoarthritis (high tibial osteotomy, arthroplasty); complication(s) necessary for hospitalization and surgical treatment. Significant injury to the target joint within the past 6 months prior to screening (identified from medical history). Subjects following an energy-restricted diet for weight loss. Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception. Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. Participation in an interventional clinical study in the previous 30 days. Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan Andor, MD
Organizational Affiliation
MEDICALI'S
Official's Role
Principal Investigator
Facility Information:
Facility Name
Opera Contract Research Organization S.r.l.
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300209
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
23559821
Citation
Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.
Results Reference
background
PubMed Identifier
20835554
Citation
Carvalho NA, Bittar ST, Pinto FR, Ferreira M, Sitta RR. Manual for guided home exercises for osteoarthritis of the knee. Clinics (Sao Paulo). 2010 Jun;65(8):775-80. doi: 10.1590/s1807-59322010000800006.
Results Reference
background
PubMed Identifier
21972300
Citation
Voelker R. Few adults with knee osteoarthritis meet national guidelines for physical activity. JAMA. 2011 Oct 5;306(13):1428, 1430. doi: 10.1001/jama.2011.1388. No abstract available.
Results Reference
background
PubMed Identifier
7945492
Citation
Pai YC, Chang HJ, Chang RW, Sinacore JM, Lewis JL. Alteration in multijoint dynamics in patients with bilateral knee osteoarthritis. Arthritis Rheum. 1994 Sep;37(9):1297-304. doi: 10.1002/art.1780370905.
Results Reference
background
PubMed Identifier
25677861
Citation
Cutolo M, Berenbaum F, Hochberg M, Punzi L, Reginster JY. Commentary on recent therapeutic guidelines for osteoarthritis. Semin Arthritis Rheum. 2015 Jun;44(6):611-7. doi: 10.1016/j.semarthrit.2014.12.003. Epub 2014 Dec 24.
Results Reference
background
PubMed Identifier
26806188
Citation
Bruyere O, Cooper C, Pelletier JP, Maheu E, Rannou F, Branco J, Luisa Brandi M, Kanis JA, Altman RD, Hochberg MC, Martel-Pelletier J, Reginster JY. A consensus statement on the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) algorithm for the management of knee osteoarthritis-From evidence-based medicine to the real-life setting. Semin Arthritis Rheum. 2016 Feb;45(4 Suppl):S3-11. doi: 10.1016/j.semarthrit.2015.11.010. Epub 2015 Dec 2.
Results Reference
background
PubMed Identifier
19087296
Citation
Bruyere O, Burlet N, Delmas PD, Rizzoli R, Cooper C, Reginster JY. Evaluation of symptomatic slow-acting drugs in osteoarthritis using the GRADE system. BMC Musculoskelet Disord. 2008 Dec 16;9:165. doi: 10.1186/1471-2474-9-165.
Results Reference
background
PubMed Identifier
25560713
Citation
Bannuru RR, Schmid CH, Kent DM, Vaysbrot EE, Wong JB, McAlindon TE. Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis. Ann Intern Med. 2015 Jan 6;162(1):46-54. doi: 10.7326/M14-1231.
Results Reference
background
PubMed Identifier
21852252
Citation
Navarro-Sarabia F, Coronel P, Collantes E, Navarro FJ, de la Serna AR, Naranjo A, Gimeno M, Herrero-Beaumont G; AMELIA study group. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project. Ann Rheum Dis. 2011 Nov;70(11):1957-62. doi: 10.1136/ard.2011.152017. Epub 2011 Aug 17.
Results Reference
background
PubMed Identifier
17330972
Citation
Waddell DD, Bricker DC. Total knee replacement delayed with Hylan G-F 20 use in patients with grade IV osteoarthritis. J Manag Care Pharm. 2007 Mar;13(2):113-121. doi: 10.18553/jmcp.2007.13.2.113.
Results Reference
background
PubMed Identifier
1539704
Citation
Reed RK, Townsley MI, Laurent TC, Taylor AE. Hyaluronan flux from cat intestine: changes with lymph flow. Am J Physiol. 1992 Feb;262(2 Pt 2):H457-62. doi: 10.1152/ajpheart.1992.262.2.H457.
Results Reference
background
PubMed Identifier
18959406
Citation
Balogh L, Polyak A, Mathe D, Kiraly R, Thuroczy J, Terez M, Janoki G, Ting Y, Bucci LR, Schauss AG. Absorption, uptake and tissue affinity of high-molecular-weight hyaluronan after oral administration in rats and dogs. J Agric Food Chem. 2008 Nov 26;56(22):10582-93. doi: 10.1021/jf8017029.
Results Reference
background
PubMed Identifier
18391466
Citation
Hisada N, Satsu H, Mori A, Totsuka M, Kamei J, Nozawa T, Shimizu M. Low-molecular-weight hyaluronan permeates through human intestinal Caco-2 cell monolayers via the paracellular pathway. Biosci Biotechnol Biochem. 2008 Apr;72(4):1111-4. doi: 10.1271/bbb.70748. Epub 2008 Apr 7.
Results Reference
background
PubMed Identifier
22661195
Citation
Laznicek M, Laznickova A, Cozikova D, Velebny V. Preclinical pharmacokinetics of radiolabelled hyaluronan. Pharmacol Rep. 2012;64(2):428-37. doi: 10.1016/s1734-1140(12)70784-3.
Results Reference
background
PubMed Identifier
26503103
Citation
Altman RD, Manjoo A, Fierlinger A, Niazi F, Nicholls M. The mechanism of action for hyaluronic acid treatment in the osteoarthritic knee: a systematic review. BMC Musculoskelet Disord. 2015 Oct 26;16:321. doi: 10.1186/s12891-015-0775-z.
Results Reference
background
PubMed Identifier
24457028
Citation
du Souich P. Absorption, distribution and mechanism of action of SYSADOAS. Pharmacol Ther. 2014 Jun;142(3):362-74. doi: 10.1016/j.pharmthera.2014.01.002. Epub 2014 Jan 21.
Results Reference
background
PubMed Identifier
26818459
Citation
Oe M, Tashiro T, Yoshida H, Nishiyama H, Masuda Y, Maruyama K, Koikeda T, Maruya R, Fukui N. Oral hyaluronan relieves knee pain: a review. Nutr J. 2016 Jan 27;15:11. doi: 10.1186/s12937-016-0128-2.
Results Reference
background
PubMed Identifier
1456177
Citation
Yasui T, Akatsuka M, Tobetto K, Hayaishi M, Ando T. The effect of hyaluronan on interleukin-1 alpha-induced prostaglandin E2 production in human osteoarthritic synovial cells. Agents Actions. 1992 Sep;37(1-2):155-6. doi: 10.1007/BF01987905.
Results Reference
background
PubMed Identifier
15316671
Citation
Homandberg GA, Ummadi V, Kang H. The role of insulin-like growth factor-I in hyaluronan mediated repair of cultured cartilage explants. Inflamm Res. 2004 Aug;53(8):396-404. doi: 10.1007/s00011-004-1276-y. Epub 2004 Aug 10.
Results Reference
background
PubMed Identifier
16806998
Citation
Wang CT, Lin YT, Chiang BL, Lin YH, Hou SM. High molecular weight hyaluronic acid down-regulates the gene expression of osteoarthritis-associated cytokines and enzymes in fibroblast-like synoviocytes from patients with early osteoarthritis. Osteoarthritis Cartilage. 2006 Dec;14(12):1237-47. doi: 10.1016/j.joca.2006.05.009. Epub 2006 Jun 30.
Results Reference
background
PubMed Identifier
22660808
Citation
Waller KA, Zhang LX, Fleming BC, Jay GD. Preventing friction-induced chondrocyte apoptosis: comparison of human synovial fluid and hylan G-F 20. J Rheumatol. 2012 Jul;39(7):1473-80. doi: 10.3899/jrheum.111427. Epub 2012 Jun 1.
Results Reference
background
PubMed Identifier
27101743
Citation
Bernad Pineda M. Current status of symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) in Spain. Reumatol Clin. 2016 Jul-Aug;12(4):181-3. doi: 10.1016/j.reuma.2016.03.012. Epub 2016 Apr 18. No abstract available. English, Spanish.
Results Reference
background
PubMed Identifier
23226979
Citation
Tashiro T, Seino S, Sato T, Matsuoka R, Masuda Y, Fukui N. Oral administration of polymer hyaluronic acid alleviates symptoms of knee osteoarthritis: a double-blind, placebo-controlled study over a 12-month period. ScientificWorldJournal. 2012;2012:167928. doi: 10.1100/2012/167928. Epub 2012 Nov 20.
Results Reference
background
PubMed Identifier
22993606
Citation
Nagaoka I, Nabeshima K, Murakami S, Yamamoto T, Watanabe K, Tomonaga A, Yamaguchi H. Evaluation of the effects of a supplementary diet containing chicken comb extract on symptoms and cartilage metabolism in patients with knee osteoarthritis. Exp Ther Med. 2010 Sep;1(5):817-827. doi: 10.3892/etm.2010.114. Epub 2010 Jul 12.
Results Reference
background
PubMed Identifier
25024048
Citation
Sanchez J, Bonet ML, Keijer J, van Schothorst EM, Molller I, Chetrit C, Martinez-Puig D, Palou A. Blood cells transcriptomics as source of potential biomarkers of articular health improvement: effects of oral intake of a rooster combs extract rich in hyaluronic acid. Genes Nutr. 2014 Sep;9(5):417. doi: 10.1007/s12263-014-0417-3. Epub 2014 Jul 15.
Results Reference
background
PubMed Identifier
15878903
Citation
D'Agostino MA, Conaghan P, Le Bars M, Baron G, Grassi W, Martin-Mola E, Wakefield R, Brasseur JL, So A, Backhaus M, Malaise M, Burmester G, Schmidely N, Ravaud P, Dougados M, Emery P. EULAR report on the use of ultrasonography in painful knee osteoarthritis. Part 1: prevalence of inflammation in osteoarthritis. Ann Rheum Dis. 2005 Dec;64(12):1703-9. doi: 10.1136/ard.2005.037994. Epub 2005 May 5.
Results Reference
background
PubMed Identifier
22183834
Citation
Hartung W, Kellner H, Strunk J, Sattler H, Schmidt WA, Ehrenstein B, Fleck M, Backhaus M. Development and evaluation of a novel ultrasound score for large joints in rheumatoid arthritis: one year of experience in daily clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):675-82. doi: 10.1002/acr.21574.
Results Reference
background
PubMed Identifier
27622408
Citation
Serban O, Porojan M, Deac M, Cozma F, Solomon C, Lenghel M, Micu M, Fodor D. Pain in bilateral knee osteoarthritis - correlations between clinical examination, radiological, and ultrasonographical findings. Med Ultrason. 2016 Sep;18(3):318-25. doi: 10.11152/mu.2013.2066.183.pin.
Results Reference
background
PubMed Identifier
22944523
Citation
Wu PT, Shao CJ, Wu KC, Wu TT, Chern TC, Kuo LC, Jou IM. Pain in patients with equal radiographic grades of osteoarthritis in both knees: the value of gray scale ultrasound. Osteoarthritis Cartilage. 2012 Dec;20(12):1507-13. doi: 10.1016/j.joca.2012.08.021. Epub 2012 Sep 1.
Results Reference
background
PubMed Identifier
23170108
Citation
Yoshimura M, Aoba Y, Watari T, Momomura R, Watanabe K, Tomonaga A, Matsunaga M, Suda Y, Lee WY, Asai K, Yoshimura K, Nakagawa T, Yamamoto T, Yamaguchi H, Nagaoka I. Evaluation of the effect of a chicken comb extract-containing supplement on cartilage and bone metabolism in athletes. Exp Ther Med. 2012 Oct;4(4):577-580. doi: 10.3892/etm.2012.646. Epub 2012 Jul 24.
Results Reference
background
PubMed Identifier
22969911
Citation
Yoshimura M, Aoba Y, Naito K, Watari T, Murakami S, Yoshimura K, Nakagawa T, Yamamoto T, Yamaguchi H, Nagaoka I. Effect of a chicken comb extract-containing supplement on subclinical joint pain in collegiate soccer players. Exp Ther Med. 2012 Mar;3(3):457-462. doi: 10.3892/etm.2011.431. Epub 2011 Dec 23.
Results Reference
background
PubMed Identifier
24625308
Citation
Steins D, Dawes H, Esser P, Collett J. Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review. J Neuroeng Rehabil. 2014 Mar 13;11:36. doi: 10.1186/1743-0003-11-36.
Results Reference
background
PubMed Identifier
22163626
Citation
Yang CC, Hsu YL. A review of accelerometry-based wearable motion detectors for physical activity monitoring. Sensors (Basel). 2010;10(8):7772-88. doi: 10.3390/s100807772. Epub 2010 Aug 20.
Results Reference
background
PubMed Identifier
24494935
Citation
Trudeau J, Van Inwegen R, Eaton T, Bhat G, Paillard F, Ng D, Tan K, Katz NP. Assessment of pain and activity using an electronic pain diary and actigraphy device in a randomized, placebo-controlled crossover trial of celecoxib in osteoarthritis of the knee. Pain Pract. 2015 Mar;15(3):247-55. doi: 10.1111/papr.12167. Epub 2014 Feb 5.
Results Reference
background
PubMed Identifier
24556210
Citation
Wylde V, Lenguerrand E, Brunton L, Dieppe P, Gooberman-Hill R, Mann C, Blom AW. Does measuring the range of motion of the hip and knee add to the assessment of disability in people undergoing joint replacement? Orthop Traumatol Surg Res. 2014 Apr;100(2):183-6. doi: 10.1016/j.otsr.2013.09.016. Epub 2014 Feb 17.
Results Reference
background
PubMed Identifier
20053272
Citation
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59.
Results Reference
background
PubMed Identifier
15189396
Citation
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
Results Reference
background
Links:
URL
http://cogweb.ucla.edu/Discourse/Proverbs/Ashanti.html
Description
Proverb resources: Ashanti Proverbs from Ghana

Learn more about this trial

Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis

We'll reach out to this number within 24 hrs