Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

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Abstract

The objective of this study is to retrospectively evaluate the symptomatic effects of crystalline glucosamine sulfate (GS), prescribed for the actually approved indication of knee OA, in addition to conventional therapy, in comparison to the conventional therapy alone in patients with primary hand osteoarthritis (HOA).This is a 6-months retrospective comparative study including patients with concomitant knee and primary HOA, according to the ACR criteria. To be eligible the patients had to present clinical symptoms of hand OA for at least 3 months, defined as global hand pain score superior to 40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score of at least 6. Furthermore, the patients have had a radiographic evidence of HOA within the previous 6 months with a Kellgren-Lawrence score of II-III. The participants are stratified into two groups based on whether or not crystalline GS at the daily dose of 1500 mg was added to the conventional therapy for HOA, including exercise, acetaminophen and non steroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase (COX)-2 inhibitors. Primary outcome measures are the difference between the two groups in the change of VAS pain and in the FIHOA, from baseline after 6 months. Secondary outcomes were health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption.

Dates

Last Verified:	03/31/2019
First Submitted:	04/08/2019
Estimated Enrollment Submitted:	04/08/2019
First Posted:	04/10/2019
Last Update Submitted:	04/09/2019
Last Update Posted:	04/11/2019
Actual Study Start Date:	08/31/2018
Estimated Primary Completion Date:	12/31/2018
Estimated Study Completion Date:	01/31/2019

Condition or disease

Hand Osteoarthritis

Intervention/treatment

Drug: Glucosamine Sulfate

Phase

Arm Groups

Arm	Intervention/treatment
Glucosamine Sulfate Group (GS Group) GS Group is treated for at least 6 consecutive months with a single daily dose of 1500 mg of crystalline GS (powder sachets), in addition to conventional therapy.
Control Group Control Group receive only usual care therapy. The conventional therapy includes exercise for HOA and treatment with acetaminophen or oral NSAIDs or COX-2 inhibitors (150 mg Diclofenac tablets, 20 mg Piroxicam tablets, 550 mg Naproxen tablets, 200 mg Aceclofenac, 600 mg Ibuprofen tablets, 200 mg Celecoxib tablets, 60 mg Etoricoxib tablets).

Eligibility Criteria

Ages Eligible for Study	45 Years To 45 Years
Sexes Eligible for Study	All
Sampling method	Probability Sample
Accepts Healthy Volunteers	Yes
Criteria	Inclusion Criteria: - Mono or bilateral primary HOA and concomitant knee OA, according to the American College of Rheumatology (ACR) criteria - Treatment for at least 6 consecutive months with crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone. - HOA symptoms duration for at least 3 months defined as global hand pain score superior to 40 mm on a 0-100 VAS and a FIHOA score of at least 6. - Radiographic evidence of HOA within the previous 6 months with a radiological score of II-III (using the Kellgren method). Exclusion Criteria: - Erosive Osteoarthritis of the hand - Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, monarticular post-traumatic OA of the finger, a history or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis. - Ongoing therapy with opioid analgesics and any kind of topical treatment - Therapy with SYSADOAs other than GS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months. - Contraindications or special warnings for GS presented in the data sheet.

Outcome

Primary Outcome Measures

1. Difference between the two groups in the change of the patient's assessment of global hand pain on a 0- 100 mm Visual Analogue Scale [Basal time; one month; three months; six months]

0-100 mm scale with 0 representing the absence of pain

Secondary Outcome Measures

1. Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score [Basal time; one month; three months; six months]

The FIHOA score represents a quantitative measure of functional disability of the hands; it contains 10 items and is an investigator-administered questionnaire. Patients are asked to answer each item using a four-point Likert scale: 0 = possible without difficulty, 1 = possible with slight difficulty, 2 = possible with considerable difficulty, 3 = impossible; the range of scores is 0-30 and the highest values indicate the worst functionality. The validate Italian version of FIHOA is used for the present study.

2. Health Assessment Questionnaire (HAQ) [Basal time; one month; three months; six months]

HAQ is a self administered questionnaire developed to measure disability consisting of 8 sections: dressing arising, eating, walking, hygiene, reach, grip, and activities and ranging from 0 to 3 with a higher score corresponding to worse disability

3. Medical Outcomes Study 36-Item Short Form (SF-36) [Basal time; one month; three months; six months]

SF-36 is a widely used measure of health and wellbeing, including two main domains, mental and physical component summary (MCS and PCS respectively), that investigates 8 different areas of perceived health, such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. Scores range from "0 to 100" where "0" indicates the worst condition and "100" indicates the best possible condition

4. NSAIDs and/or acetaminophen consumption [Basal time; one month; three months; six months]

The acetaminophen and NSAIDs/COX-2 inhibitors consumption was calculated asking the patients at each visit the number of tablets taken weekly.

Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

Keywords

oxygenase

glucosamine sulfate

inflammation

osteoarthritis

glucosamine

anti inflammatory