Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR20180770451482 Date of Approval: 26/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Glucosamine Sulfate, Chondrotin Sulfate, Methylsulfonylmethane Phonophoresis on Pain, Range of Motion, Position Sense and function in Knee Osteoarthritis
Official scientific title Glucosamine Sulfate, Chondrotin Sulfate, Methylsulfonylmethane Phonophoresis on Knee Osteoarthritis
Brief summary describing the background and objectives of the trial Glucosamine sulfate and chondroitin sulfate are believed to relieve pain, decrease joint narrowing, stimulate the production of new cartilage components, and help the body to repair damaged cartilage. Methylsulfonylmethane is an analgesic and anti-inflammatory drug is usually used with the previous drugs. Phonophoresis was believed to influence drug delivery by increasing cell permeability, causing particle oscillations within the tissue and drug milieu. This trial was designed to investigate the effect of Glucosamine sulfate, chondroitin sulfate and Methylsulfonylmethane Phonophoresis (PH) in knee osteoarthritis (OA).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 18/01/2018
Actual trial start date
Anticipated date of last follow up 30/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phonophoresis 3 sessions/week 12 weeks For PH group, pulsed ultrasound was used with frequency 1 MHz, intensity 1.5 W/cm², and (50% duty cycle) for 5 minutes /session. Drugs concentrations in gel were: GS 30mg/g CS 50mg/g and MSM 10mg/g gel were put on ultrasound head before application. 25
Experimental Group Topical drug application 3 sessions/week 12 weeks Topical application was done by applying of GS, CS and MSM gel on the head of US and moving it on the knee for 5 minutes with US where the device is off and all controls on zero. 23
Control Group Traditional exercise program 3 sessions/week 12 weeks The traditional exercise program in the form of: 1) Stretching of the hamstring muscles from supine lying position for 3 successive times, 30 seconds each with rest for 1 minute in between stretches, 2) Stretching of the calf muscles from supine lying position for 3 successive times, 30 seconds each with rest for 1 minute in between stretches, 3) Straight leg raising exercise in which the patients were positioned in the crook lying position with the unexercised limb is the flexed one then the patients was asked to contract the quadriceps muscle and elevate the limb to 45º and hold for 6 seconds, slowly lower the limb and then relax for 6 seconds, three sets of 10 repetitions were be done, 4) Isometric strengthening of the quadriceps muscle in the form of 3 sub maximal isometric contractions of increasing intensity followed by 6 maximal 5 seconds isometric contractions, the isometric contractions were repeated at multiple knee angles (30º–60º–90º) degrees respectively, each contraction was followed by 30 seconds rest period and each set of contractions at each knee angle was followed by 1 minute rest. 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility was defined as symptomatic knee OA for at least 6 months according to the clinical criteria of the American College of Rheumatology (ACR) Radiographic confirmed knee OA according to the Kellgren & Lawrence scale Exclusion criteria included acute septic arthritis; inflammatory arthritis; any other type of arthritis; history of knee buckling or recent knee injury; lack of physical or mental ability to perform or comply with the treatment procedure; diabetes mellitus; fibromyalgia or other chronic pain syndromes; concurrent anti-coagulant/anti-platelet drugs; arthroscopy or intra-articular injections in the previous 3 months Middle Aged: 45 Year(s)-64 Year(s) 47 Year(s) 59 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/01/2018 The Board Council of Higher Education of the School of Physical Therapy
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ElZayyat st., Dokki, Giza Cairo 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, Range of motion and position sense Baseline and after 12 weeks of treatment
Secondary Outcome Function of the knee Baseline and 12 weeks after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The out clinic of faculty of physical therapy Cairo University 7 Ahmed Elzayyat st., Dokki, Giza. Egypt. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Soheir 11 Ahmed ElTayeib st., Saint Theresa, Shubra, Egypt. Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soheir Samaan soheirsamaan@yahoo.com 01224003374 11 Ahmed ElZayyat., Shoubra, Egypt.
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Soheir Samaan soheirsamaan@yahoo.com 01224003374 11 Ahmed ElZayyat., Shoubra, Egypt.
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Soheir Samaan soheirsamaan@yahoo.com 01224003374 11 Ahmed ElTayeib, Shoubra, Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information