Mild to severe joint and muscle pain Musculoskeletal Diseases
Conditions
Interventions
Thirty men and women (average age 56.0 ± 9.0 years
height 164.4 ± 14 cm
weight 86.5 ± 20.9 kg
BMI 31.0 ± 7.5 kg/m²) with a history of mild to severe joint and muscle pain and inflammation participated in a randomized, double-blind, placebo-controlled, parallel-arm trial. On days 0, 30, and 56
Sponsors
SpecNova
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged between 40 and 75 years 2. History of mild to severe joint and muscle pain with evidence of elevated inflammatory markers in the blood upon entry and/or history of physician-diagnosed osteoarthritis 3. Medically stable with no current uncontrolled cardiovascular, metabolic, or pulmonary disease. Participants will be able to participate if they are taking medications that would not affect study outcomes for non-related chronic diseases or disorders (e.g., to manage blood pressure, blood lipids, thyroid conditions, blood glucose, etc)
Exclusion criteria
Exclusion criteria: 1. No history of mild to severe joint and/or muscle pain. 2. History of uncontrolled cardiovascular, metabolic, or pulmonary disease 3. Pregnancy or a desire to become pregnant during the study 4. Current use of prescription COX-2 inhibitor medications (i.e., Celebrex (Pro)/celecoxib, Vioxx/rofecoxib, Bextra (Pro)/valdecoxib, Consensi (Pro) / amlodipine / celecoxib, Elyxyb (Pro) / celecoxib, indomethacin (Indocin)), corticosteroids (i.e., Alclometasone Dipropionate, Diprolene, Betamethasone Dipropionate, Qvar Redihaler, Beclomethasone Dipropionate, Pulmicort, Budesonide, Temovate, Clobetasol Propionate, Topicort, Desoximetasone, Decadron, Dexamethasone Acetate, Fludrocortisone Acetate, Fluticasone Propionate, Flonase Allergy Relief, Cortef, Hydrocortisone, Medrol, Methylprednisolone, Orapred, Prednisolone Sodium Phosphate, Prednisone, Kenalog, Triamcinolone, Dermotic, Cortone (cortisone), Nasarel (flunisolide), Asmanex (mometasone)), or disease-modifying antirheumatic drugs or DMARDS (i.e., Methotrexate / Rheumatrex, Trexall, Sulfasalazine / Azulfidine, Hydroxychloroquine / Plaquenil, Leflunomide / Arava, Azathioprine / Imuran) including Tumor necrosis factor (TNF) inhibitors (etanercept / Enbrel, infliximab / Remicade, adalimumab / Humira, certolizumab pegol / Cimzia, golimumab / Simponi), Interleukin-1 inhibitors (i.e., anakinra / Kineret), Interleukin-6 inhibitors (tocilizumab / Actermra, sarilumab / Kevzara), T-cell inhibitors (abatacept / Orencia), B-cell inhibitors ( rituximab / Rituxan) or Janus kinase inhibitors or biosimilars (i.e., tofacitinib / Xeljanz, baricitinib / Olumiant, upadacitinib / Rinvoq). 5. A history in the prior month of bleeding disorders or current use of prescription blood thinner medications (e.g., Pradaxa (dabigatran), Eliquis (apixaban), Xarelto (rivaroxaban), Coumadin (warfarin), Plavix (clopidogrel), Effient (prasugrel), Brilinta (ticagrelor)). Low-dose use of OTC aspirin to promote heart health (e.g., < 325 mg/day) will be permitted. Individuals taking prescription medications to control chronic disease (e.g., glucose management, lipid lowering, anti-hypertensive, thyroid medications, etc.) that would not affect primary study outcomes (i.e., perceptions of muscle and joint pain) will also be permitted to participate in the study. 6. Inability to perform functional exercise tasks to be used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Muscle pain measured using the Algometer Graphic Pain Rating Scale (GPRS) 2. Functional capacity measured using three sets of 10 deep knee bends with dumbbells of approximately 30% of body mass 3. Markers of inflammation: creatine kinase, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6) using Clinical Pathology Laboratories (CPL) Measured on days 0, 30, and 56 of supplementation and after 2 days of recovery following each testing session | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Joint flexibility measured using the Sit and Reach Test and a goniometer to measure hip and knee range of motion 2. Quality of life measured using the SF-36 Quality of Life Questionnaire 3. Use of over-the-counter analgesics measured using the Over The Counter (OTC) Analgesic Medication Log 4. Clinical blood markers of safety measured using Chem-14 Panel, CBC, Lipid Panel using Clinical Pathology Laboratories (CPL) 5. Side effects reported using the Side-Effects Assessment Questionnaire Measured on days 0, 30, and 56 of supplementation and after 2 days of recovery following each testing session | — |
Countries
United States of America
Contacts
Public ContactRick Kreider
Outcome results
None listed