Track topics on Twitter Track topics that are important to you
The primary purpose of this study is to assess the effect of 8-weeks ingestion of the Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood inflammation biomarkers in adults with self-reported joint pain.
Allocation: Randomized. Subjects will be randomized to one of two groups: placebo or Instaflex Joint Support. Supplements will be administered in double-blinded fashion.
Intervention Model: Instaflex Joint Support supplement for 8 weeks versus placebo.
Sample Size: N=100, with N=50 per group.
Statistical Procedures: 2 x 2 repeated measures analysis of variance (ANOVA).
Study Duration (per subject): 8 weeks.
Blood sample schedule: Blood draws pre- and post-study.
Monitoring adverse events: Subjects will fill in bi-weekly symptom logs to monitor untoward symptoms. Diagnostic chemistry panels will be measured pre- and post-study.
Rescue medication: Paracetamol (i.e., acetaminophen as found in Tylenol) will be allowed as a rescue medicine for pain during the study as needed. Subjects will record paracetamol usage. Paracetamol can relieve pain in mild arthritis but has no effect on the underlying inflammation, redness, and swelling of the joint.
Lab visit testing sequence (at the Kannapolis YMCA, in the afternoon by appointment.):
1. First visit:
1. Consent form
2. Medical health questionnaire to verify medical history, and lifestyle habits.
3. Symptoms log for previous 2-weeks symptomatology
4. Height, weight, and percent body fat (bioelectrical impedance, Tanita scale)
5. Questionnaires: Western Ontario and McMaster Universities Arthritis Index (WOMAC), Short Form (36) Health Survey (SF-36), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP).
6. Blood sample (followed by a glass of orange juice)
7. 6-minute walk test (at the local YMCA track) (one practice trial, and then repeat for test).
8. Receive supplement organizer tray with 8-weeks supply (and instructions)
2. 8-week study:
a. Subjects will be contacted via email every 2 weeks to monitor compliance and fill in symptom logs.
3. Second lab visit:
1. Same as first lab visit, except for removal of steps "a,b, and h".
Supplements (Instaflex, placebo) will be prepared in colored gel capsules (3 per day, identical looking), and given to the subjects in supplement organizer trays. Subjects will take 3 capsules/day: one capsule each in the morning, at noontime, and in the evening. The placebo capsules will contain magnesium stearate, an inert substance.
Compliance will be monitored with bi-weekly email messages, and by counting unused capsules when subjects return the supplement trays at the end of the 8-week study. If subjects miss one, two, or three days of taking supplements, subjects will be asked to double up usage until back on schedule. Subjects missing more than three days of taking the supplements will be asked to leave the study.
1. Instaflex Joint Support Supplement
A serving size is 3 capsules, and contains the following ingredients:
Glucosamine Sulfate 1500 mg Methylsulfonylmethane 500 mg White Willow Bark Extract (standardized to 15% salicin) 250 mg Ginger Root Concentrate 50 mg Boswella Serrata Extract (Standardized to 65% boswellic acid) 125 mg Turmeric Root Extract 50 mg Cayenne 40m H.U. 50 mg Hyaluronic Acid 4.0 mg Other Ingredients: Rice Flour, Gelatin, Vegetable Magnesium Stearate, Silicon Dioxide
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Joint Pain, Stiffness, Function
ASU Human Performance Laboratory, North Carolina Research Campus
Appalachian State University
Published on BioPortfolio: 2014-08-27T04:00:47-0400
Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the most common site of joint discomfort regardless of age. Nearly half of people with knee joint di...
This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell membrane versus placebo in reducing exercise-induced joint pain & stiffness & cartilage turnove...
This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell membrane versus placebo in reducing exercise-induced joint pain, stiffness & cartilage turnover...
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. Ther...
Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness, and loss of function in the joints. Over time, joint deformity, joint destruction, and loss of funct...
Placebo hypoalgesia has been found to play an important role in every health care by modulating patients' responses to pharmacologically active analgesic treatments. It may be seen as reflecting the c...
Knee osteoarthritis (OA) is associated with ongoing pain and joint damage that can be punctuated by acute flares of pain and inflammation. Synovitis in normal knees might resolve without long-term det...
The goal of this study was to evaluate the effectiveness of an oral joint supplement in working dogs with hip osteoarthritis compared with a positive control group (CG). Fifteen animals were divided i...
The placebo effect is considered the core example of mind-body interactions. However, individual differences produce large placebo response variability in both healthy volunteers and patients. The pla...
Placebo and nocebo effects are currently within the focus of clinical and experimental pain research. Neurophysiological and psychophysiological mechanisms might play an important role. Placebo and no...
A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions.
A symptom complex consisting of pain, muscle tenderness, clicking in the joint, and limitation or alteration of mandibular movement. The symptoms are subjective and manifested primarily in the masticatory muscles rather than the temporomandibular joint itself. Etiologic factors are uncertain but include occlusal dysharmony and psychophysiologic factors.
Muscular pain in numerous body regions that can be reproduced by pressure on trigger points, localized hardenings in skeletal muscle tissue. Pain is referred to a location distant from the trigger points. A prime example is the TEMPOROMANDIBULAR JOINT DYSFUNCTION SYNDROME.
Pain in the region of the METATARSUS. It can include pain in the METATARSAL BONES; METATARSOPHALANGEAL JOINT; and/or intermetatarsal joints (TARSAL JOINTS).
A variety of conditions affecting the anatomic and functional characteristics of the temporomandibular joint. Factors contributing to the complexity of temporomandibular diseases are its relation to dentition and mastication and the symptomatic effects in other areas which account for referred pain to the joint and the difficulties in applying traditional diagnostic procedures to temporomandibular joint pathology where tissue is rarely obtained and x-rays are often inadequate or nonspecific. Common diseases are developmental abnormalities, trauma, subluxation, luxation, arthritis, and neoplasia. (From Thoma's Oral Pathology, 6th ed, pp577-600)
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...