Participants with sensitisation that significantly deviates from the normal mean as assessed by Quantitative Sensory Testing

All other participants with sensitisation that is not significantly deviating from the normal mean as assessed by Quantitative Sensory Testing

Blood, Urine, Saliva, Synovial fluid from the most painful knee, Faeces (OPTIONAL)

Knee Osteoarthritis

Knee Pain Chronic

PPT: An electronic data collection unit will be used featuring an electronic algometer connected with a laptop where the amount of pressure will be displayed on the screen. When the pressure pain detection threshold is reached (the point where the pressure sensation starts to be experienced as pain), the individual will press a button at a handheld device, that will automatically store the pressure value in the system and serve as an indication, for the examiner, to stop the testing.
TS: A pinprick stimulator (Weight: 256mNewton) will be used. The examiner will apply the pen that features a retractable blunt needle in a repetitive manner (once per second for ten seconds). The individual will be asked for the intensity of pain (NRS) at the first and at the last time and the given score will be noted.
CPM: A manual blood pressure sphygmomanometer will be used in conjunction with the electronic algometer described above (PPT).

Quantitative Sensory Testing

Tibiofemoral and patellofemoral radiographs of the most painful knee will be taken using a standardised protocol (standing posterior-anterior (PA) and skyline views) and will be scored by a single experienced observer in order to generate data for correlation analyses with the primary and secondary outcomes. A Perspex Rosenberg template with lead beads is used for the standing PA view to standardising the degree of knee flexion, foot rotation and magnification. PA radiographs are taken with the participant facing the x-ray tube while standing on the Rosenberg jig and leaning forwards with their thighs touching the anterior aspect of the jig, the x-ray beams passing from the posterior aspect through to the anterior aspect of the knee. Variable jigs are used for the skyline view to obtaining 300 of knee flexion with the participant lying in a reclined supine position on a couch. Grading of radiographs for changes of OA will be based on the Kellgren and Lawrence (K/L) score.

Radiographic Evaluation

Ultrasound scanning will be conducted on the most painful knee to identify synovial effusion. During the ultrasound scan, the supra-patellar pouch, medial and lateral recess of the knees will be assessed for synovial thickening, synovial fluid/effusion and for positive power Doppler. An ultrasonic probe will be used to direct ultrasonic waves onto the knee joint during sonography, and a computer converts the signals received so that they can be presented on the screen. During skin application, a sterile probe cover and sterile acoustic gel will be used. Once the best aspiration location is identified and the location of the needle insertion marked, the skin will be prepared with a cleansing agent such as iodine or chlorhexidine. The needle may be introduced into the skin either parallel to the probe or perpendicular to the probe. Once the aspiration is completed, the needle will be removed, the skin cleansed, and a bandage will be applied.

Ultrasound-guided Aspiration

Isometric testing will be done at 30 and 60 degrees of flexion as done in the previous study and the participant will be in sitting position with hips and knees strapped to keep the position standardised.

Muscle Strength Assessment

The participant will start in a seated position. The participant will stand up upon therapist's command, walk 3 meters, turn around, walk back to the chair and sit down. The time will stop when the participant is seated. The subject can use an assistive device. If the assistive device is used, it will be documented.
Important Note: A practice trial will be completed before the timed trial.

Function Assessment (A)

The 30-Second Chair Test is administered using a chair. The participant is seated in the middle of the chair with arms crossed at the wrists and held against the chest. The participant will practice a repetition or 2 before completing the test. If a participant must use their arms to complete the test, they are scored 0. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand. While monitoring the participant's performance to ensure proper form, the tester silently counts the completion of each correct stand. The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Incorrectly executed stands are not counted. The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather than the amount of time it takes to complete a pre-determined number of repetitions.

Function Assessment (B)

Static balance and postural sway either in the medial-lateral or antero-posterior direction will be assessed using the RS Scan force plate. The participant will be asked to stand on the plate looking straight forward for 30 seconds in two conditions: first with their eyes open and then with eyes closed. Medial-lateral, antero-posterior and total sway will be recorded.

Balance Assessment

Molecular Pathways Involved in Knee Pain

Molecular Pathways Involved in Knee Pain: an Observational Study

PPT is a non-invasive test during which the sensitivity of the nerves is assessed by recording the amount of pressure applied to the skin. Pressure is applied through a probe. The pressure probe used is mounted in a handheld device connected to a computer. Pressure applied to the skin is gradually increased until the participant indicates (by pressing a button) that the sensation has changed from pressure to pain. The probe will be used on 3 sites at the knee area (2cm above the medial and lateral edge of the patella and laterally on the joint line), proximal shin (tibialis anterior muscle - 5cm inferior to the tibial tuberosity) and over the contralateral forearm (brachioradialis muscle) using a standardised protocol used in other studies within the Pain Centre. Each region will be tested one time with short rest periods between each. The participants will be familiarised with the test before it is administered so that they know what to expect and how to respond.

TS is a non-invasive test during which repetitive mechanical stimulation is applied over a short period to get their augmented response. A 256mN weighted pinprick stimulator will be used and applied perpendicular to the skin of suprapatellar region of the painful knee (5cm proximal from the centre of patella). The participant will be asked to rate the pain or sharpness they experience from 0-10 where 0 indicates no pain or sharpness and 10 indicates the most intense pain or sharpness imaginable. The response of the participant will be recorded. The same stimulator at the same site will be applied ten times repeatedly at a rate of 1/second. At the end of the series of 10 pinpricks, the participant will be asked to rate the average pain or sharpness they experienced out of the 10 stimuli using the same scale. The TS value will be calculated as the difference between the two ratings (single stimulus minus the average of the 10 stimuli).

CPM is the application of PPT before and while a pressure cuff is inflated. A 7.5cm wide tourniquet cuff will be wrapped around the arm contra-laterally to the most painful knee. The lower rim of tourniquet cuff will be kept 3cm proximal to cubital fossa. The cuff will be inflated with the aim to reach above-systolic pressure with a maximum of 270mm/Hg. After target pressure is achieved, the participant will be asked to repeatedly make a handgrip or squeeze a foam ball until they develop ischemic pain ≥4 out of 10 on a 0-10 scale. Once NRS of 4/10 will be achieved, the probe of algometer will be applied in the same manner as during PPT testing. Once the participant presses the button, the probe will be withdrawn, and the cuff will be deflated released from the participants arm. The difference in PPT score (PPT with conditioning minus PPT without conditioning) will be considered the CPM value. A positive value indicates efficient CPM whereas a negative value indicates impaired CPM.

Central augmented pain assessed on a 8-item CAP-Knee questionnaire, where items 1-7 are scored from 0-3, 0 indicating "never" and 3 indicating "often" or "always". Item 8 (pain distribution manikin) was allocated a score of 0 if at most 1 knee is shades, and no other regions below the waist, or a score of 3 if both knees were shaded, or one knee plus any additional shaded areas below the waist. A total sum score ranging from 0-24 will be calculated.

Anxiety will be assessed with the Anxiety part of the Hospital Anxiety and Depression Scale (HADS) where patients are asked to indicate their levels of emotion frequency with a 4-level scale (0-3: 0 indicates never and 3 all the time) at 7 questions. A sum of all responses is calculated (21 being the maximum) for analysis. The higher the value the higher the levels of anxiety.

Depression will be assessed with the Depression part of the Hospital Anxiety and Depression Scale (HADS) where patients are asked to indicate their levels of emotion frequency with a 4-level scale (0-3: 0 indicates all the time and 3 never) at 7 questions. A sum of all responses is calculated (21 being the maximum) for analysis. The higher the value the higher the levels of depression.

Cognitive function will be assessed with the Cognitive Failures Questionnaire (CFQ) where participants are asked to indicate symptom frequency with a 0-4 scale (0 indicates never and 4 very often) on 25 statements. A sum of all responses is calculated (100 being the maximum) for analysis. The higher the value the more impaired cognitive function is.

Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) where participants are asked to respond to 18 statements indicating their: 1) sleep duration in minutes/hours on 4 questions, 2) symptom frequency with 4 possible answers spreading from 'not during the past month' to 'three or more times a week' on 12 statements, 3) symptom severity with 4 possible answers spreading from 'no problem at all' to 'very big problem' on 1 statement and 4) sleep quality with 4 possible answers spreading from 'very good' to 'very bad' on 1 statement. Responses are coded from 0-4 (0 indicating no sleeping issues and 4 frequent and severe sleeping problems). A sum of all 18 responses is calculated (72 being the maximum) for analysis. The higher the value the less sleep quality there is.

Knee pain, stiffness and physical functioning will be assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) where participants are asked to rate their symptom severity with a 0-4 scale (0 indicates never and 4 extreme) five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The higher the value in each domain the more pain, stiffness and physical dysfunction there is.

General health will be assessed with the Musculoskeletal Health Questionnaire (MSK-HQ) where participants are asked to indicate symptom frequency with a 0-4 scale (0 indicates very severe and 4 not at all severe) on 14 statements. A sum of all responses is calculated (56 being the maximum) for analysis. The lower the value the more reduced general musculoskeletal health is.

Frailty will be measured with a modified questionnaire where participants will be asked to respond to 8 Yes/No questions (Yes is marked with 1 and No with 0) about inability to walk, using aids, weight loss, co-morbidities and levels of physical activity. A total out of all responses (8 being the maximum) is calculated for analysis. The higher the score, the higher the levels of frailty

Dietary habits will be assessed with the Food Frequency Questionnaire (FFQ) where participants are asked to indicate the consumption frequency of different types of food materials with a 0-9 scale (0 indicates 'never or less than once a month' and 9 'more than 6 times per day') on 150 distinct foods divided into dairy, fruits, vegetables, meat and fish, soups, bread, sweets, potatoes, and beverages. A total score is calculated for each category with the maximum depending on the amount of items in each category. The larger the total value the more frequent the consumption of a food category per day is.

Concentration of inflammatory markers (cytokines) identified in extracted synovial fluid.

Concentration of proteomic concentrations (fibronectin) identified in extracted synovial fluid.

Concentration of gene expression molecules (RNA polymerase II) identified in extracted synovial fluid.

Concentration of stress markers (cortisol) identified in participants' blood samples.

Concentration of insulin resistance markers (fasting blood glucose) identified in participants' blood samples.

Concentration of metabolic rate markers (triglycerides) identified in participants' blood samples.

Concentration of metabolic rate markers (UTXII collagen degradation marker) identified in participants' urine samples.

Concentration of inflammatory regulator markers (maresins) identified in participants' urine samples.

Concentration of stress markers (cortisol) in participants' saliva samples.

Concentration of metabolic rate markers (glucosamine) in participants' faecal samples.

Concentration of metabolic rate markers (chondroitin sulfate) in participants' faecal samples.

Considerations about data sharing will be taken once the main results of this study have been published

University of Nottingham

Versus Arthritis

Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II.

Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I.

Healthy Subject

Overweight

Glucosamine

Placebo

Fred Hutch/University of Washington Cancer Consortium

Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study

shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis [PCOA]).

evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual

Fred Hutchinson Cancer Research Center

Patients randomized in this group will be treated with a combination of platelet-rich plasma plus hyaluronic acid prepared with A-CP HA Kit.

Patients randomized in this group will be treated with hyaluronic acid only (ArthroVisc 40); hyaluronic acid is the same as the one contained in the A-CP HA Kit.

Patients randomized in this group will be treated with a saline solution.

Patients randomized in this group will receive two injections of platelet-rich plasma/hyaluronic acid prepared with the A-CP HA Kit at Day 0 and Month 2

A-CP HA Kit

Patients randomized in this group will receive two injections of hyaluronic acid only (ArthroVisc 40) at Day 0 and Month 2

ArthroVisc 40

Patients randomized in this group will receive two injections of a saline placebo at Day 0 and Month 2

Bert Mandelbaum, MD

Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis

Comparative Evaluation of the Performance and Safety of A-CP HA Kit, for the Preparation of a Combination of Platelet Rich Plasma and Hyaluronic Acid, Versus Hyaluronic Acid Alone and Placebo in Patients With Knee Osteoarthritis

It will be assessed by the mean difference in total WOMAC score on a 100-mm VAS between baseline and Month 6

II t will be assessed by the mean difference on a 100-mm VAS between baseline (D0) and Month 6

It will be assessed by the mean difference in total WOMAC score on a 100-mm VAS between baseline (D0) and Month 1, Month 2, Month 3, Month 4, and month 12.

It will be assessed by the mean difference in WOMAC A1 score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, and Month 12

It will be assessed by the mean difference in total WOMAC A score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

It will be assessed by the mean difference in total WOMAC B score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

It will be assessed by the mean difference in total WOMAC C score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

It will be assessed at Month 1, Month 2, Mont 3, Month 4, Month 6, and Month 12

It will be assessed by the variation in the SF-36 questionnaire, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

Comparison of the use of rescue medication between the three groups of treatment at baseline, Month 1, Month 2, Month 3, Month 4, Month 6 and Month 12

Regen Lab SA

Glucosamine sulphate will be consumed as either supplement A or B (i.e. blinded) for a period of 12-weeks. Glucosamine will be taken 2 times daily with food.
After 12 weeks of supplementation, participants will begin taking the alternative supplement (Aquamin-plus), after a washout period of not less than 1 month between the intervention arms of the study.

Aquamin-plus will be consumed as either supplement A or B (i.e. blinded) for a period of 12-weeks. Aquamin-plus will be taken 2 times daily with food.
After 12 weeks of supplementation, participants will begin taking the alternative supplement (Glucosamine sulphate), after a washout period of not less than 1 month between the intervention arms of the study.

Aquamin (a calcium-rich marine multi-mineral) - 666.7mg magnesium hydroxide - 66.66mg pine bark - 30mg vitamin d3 - 2.5μg
Dosage:
4 Capsules is equal to effective dose

Aquamin-Plus

The Glucosamine sulphate supplement contains 500mg of the active ingredient Glucosamine sulphate per serving (one capsule).
Dosage:
4 Capsules is equal to effective dose

Glucosamine sulphate

Method of preparing a novel antacid pharmaceutical product PATENT

Institue for Sport and Health UCD

The Marigot Osteoarthritis Nutritional Intervention (MOANi) Trial

Investigating the Potential for Marigot's Nutrition Supplement to Improve Symptoms and Physical Function in Those With Mild to Moderate Knee Osteoarthritis (KOA) Versus the Current Market Leader (Glucosamine Sulphate)

The primary outcome measure will be an assessment of the participants' knee pain. This will be measured using the validated Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function sub-scale. This will allow for the determination of the comparability, superiority or otherwise of Aquamin-plus compared to glucosamine sulphate in improving participant's self-reported knee pain and function. Change from baseline assessed.

This will be quantified by the EuroQoL-5D. The EuroQoL-5D will assess participants on their levels of function surrounding mobility, self-care, usual activities, pain / discomfort, anxiety / depression. Change from baseline assessed.

Participants knee joint strength will be assessed using an isokinetic dynamometer (Cybex). Specifically isometric strength of the quadricep and hamstring muscles. Change from baseline assessed.

Muscles activation (via electromyography) during the performance of the isometric testing will be assessed for the quadricep and hamstring muscles. Both the agonist and antagonist muscle activity will be assessed and a co-contraction value will be calculated. Change from baseline assessed.

Biomarkers known to be involved in the biological response to KOA will be assessed to investigate possible mechanistic effects and differences of both interventions. As such, in order to investigate these possible mechanistic parameters include venous blood sampling (10 mL). Change from baseline assessed.

This will be assessed using the Six-minute Walk Test (6MWT) and the Timed Up and Go Test (TUG). These tests indicate levels of functional. Change from baseline assessed.

A Dule-Energy X ray Absorptimetry (DEXA) will be used to assess participants body composition. Change from baseline assessed.

University College Dublin

Marigot Ltd.

The project is a double blind randomized controlled clinical trial (pilot), with a cross-over design. Participants, will be randomized to begin taking either Aquamin-plus or Glucosamine sulphate following medical diagnosis and baseline assessment.
Following 12 weeks of supplementation of Glucosamine sulphate or Aquamin-plus there will be a 4-week washout period before participants consume the other supplement.

The supplements provided by Marigot Ltd. will be marked either A or B. No member of the research team will be aware of the ingredients in either of the supplements, the only distinguishing feature will be the labels - A and B. It is for this reason that we can say that the study will be double blind as neither investigators nor participants will have any knowledge of the supplement that they will be consuming.

glucosamine/lihavuus

Molecular Pathways Involved in Knee Pain

Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients

Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis

The Marigot Osteoarthritis Nutritional Intervention (MOANi) Trial

Effects of Oral Glucosamine on Insulin and Blood Vessel Activity in Normal and Obese People

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