search
Back to results

Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage (msm)

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
MethylSulfonylMethane (MSM)
Placebo
Sponsored by
G.Papanikolaou Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring osteoarthritis, CAM treatments, MSM

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Knee and hip OA
  • men and women >45 years of age

Exclusion Criteria:

  • any other type of arthritis
  • chronic pain syndrome
  • arthroscopic surgery in the past 8 months
  • intra-articular corticosteroidsin the past 8 months
  • hyaluronic acid injections in the past 8 months
  • narcotic pain killers use
  • renal or hepatic disease
  • body mass index (BMI) >45 kg/m2
  • cancer

Sites / Locations

  • G. Papanikolaou HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSM group

Placebo Group

Arm Description

Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)

Placebo 3 gr twice a day for 26 weeks (6 gr/day total)

Outcomes

Primary Outcome Measures

Number of participants with improved Mobility
Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA were divided in 2 groups. Intervention was either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured were the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC)

Secondary Outcome Measures

Pain Scores on the Visual Analog Scale
On the same two groups (MSM and Placebo)we measured the improvement of quality of life through pain relief as measured by use of SF-36 (overall health-related quality of life)

Full Information

First Posted
March 13, 2013
Last Updated
April 17, 2013
Sponsor
G.Papanikolaou Research Group
search

1. Study Identification

Unique Protocol Identification Number
NCT01836757
Brief Title
Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage
Acronym
msm
Official Title
The Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Joint Cartilage Associated With the Degeneration of the Chondrocyte
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G.Papanikolaou Research Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To delineate the effect of MSM on osteoarthritis
Detailed Description
Objective: To delineate the effect of MSM on osteoarthritis of large joints. Design: Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA to be divided in 2 groups. Intervention is either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured are the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC), patient and physician assessments and SF-36 (overall health-related quality of life).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, CAM treatments, MSM

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MSM group
Arm Type
Experimental
Arm Description
Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo 3 gr twice a day for 26 weeks (6 gr/day total)
Intervention Type
Drug
Intervention Name(s)
MethylSulfonylMethane (MSM)
Intervention Description
Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of participants with improved Mobility
Description
Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA were divided in 2 groups. Intervention was either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured were the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC)
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
On the same two groups (MSM and Placebo)we measured the improvement of quality of life through pain relief as measured by use of SF-36 (overall health-related quality of life)
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Knee and hip OA men and women >45 years of age Exclusion Criteria: any other type of arthritis chronic pain syndrome arthroscopic surgery in the past 8 months intra-articular corticosteroidsin the past 8 months hyaluronic acid injections in the past 8 months narcotic pain killers use renal or hepatic disease body mass index (BMI) >45 kg/m2 cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Pagonis, MD, PhD
Phone
00306980488686
Email
iatros1@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pagonis, MD, PhD
Organizational Affiliation
Aristotle's University of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
G. Papanikolaou Hospital
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Givisis, MD, PhD
Phone
00306945264010
First Name & Middle Initial & Last Name & Degree
Thomas Pagonis, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage

We'll reach out to this number within 24 hrs