Condition category
Musculoskeletal Diseases
Date applied
08/04/2019
Date assigned
22/04/2019
Last edited
10/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Osteoarthritis (OA) is the commonest joint disorder that can cause pain, disability and affects the quality of life. There is conflicting evidence regarding the best management method for OA. The aim of this study is to assess the effect of PRP and hyaluronic acid intra articular knee injections on pain, function and quality of life, and to compare between them and a conventional physiotherapy program.

Who can participate?
Patients with chronic (at least 4 months) knee pain and x-ray evidence of OA

What does the study involve?
Participants are randomly allocated to one of the three groups. Detailed physical examinations are performed and an evaluation form is completed. Demographic features including age, occupation and level of education are recorded for each participant. Routine lab tests and blood tests are performed. Group I receive two PRP knee injections with a one-month interval. Group II receive four weekly knee injections of sodium hyaluronate. Group III receive 12 one-hour sessions (three per week) of a specialized exercise program supervised by a physiotherapist. All participants receive a home rehabilitation program and educational leaflet. All participants are evaluated initially, then after 2 and 6 months after treatment completion.

What are the possible benefits and risks of participating?
Participation may benefit future patients by showing the effectiveness of these treatments. Participation in this study is not expected to cause any risks greater than those encountered in everyday life, as these treatments are already currently used in daily practice for treating OA.

Where is the study run from?
Dubai and Rashid Hospitals (United Arab Emirates)

When is the study starting and how long is it expected to run for?
February 2016 to December 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Dr Sahar Khalil
sskhalil@dha.gov.ae
2. Dr Mohamed Abdulla
mmabdulla@dha.gov.ae

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sahar Khalil

ORCID ID

http://orcid.org/0000-0002-6615-3400

Contact details

Dubai Hospital- Diera- Al-Baraha area
Dubai
7272
United Arab Emirates
+971 (0)557557453
sskhalil@dha.gov.ae

Type

Scientific

Additional contact

Dr Mohamed Abdulla

ORCID ID

Contact details

Dubai Hospital- Diera- Al-Baraha area
Dubai
7272
United Arab Emirates
+971 (0)506584352
mmabdulla@dha.gov.ae

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

DSREC-12/2015-2016

Study information

Scientific title

Platelet rich plasma versus hyaluronic acid injections and conventional physical therapy in management of knee osteoarthritis

Acronym

Study hypothesis

Platelet rich plasma and hyaluronic acid injections are more effective than conventional physical therapy in management of knee osteoarthritis

Ethics approval

Approved 02/03/2016, Dubai scientific research ethical committee (DSREC) (Rashid Medical Library, Medical Education & Research Department, Dubai, UAE, P.O. 4545; Tel: +971 (0)4 219 1961; Email: DSREC@dha.gov.ae), ref: DSREC-12/2015-2016

Study design

Interventional single-blinded computer-generated random allocation multi-center study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format however contacting the author on email: sskhalil@dha.gov.ae, it can be sent upon request

Condition

Chronic knee pain associated with imaging findings of mild to moderate degenerative changes in the knee joint

Intervention

Randomization was performed using a computer-generated program. The enrolled patients were randomly distributed into three groups:

Group I included 20 patients who received two PRP intraarticular knee injections under ultrasound guidance. PRP was prepared using (Dr. PRP Kit [Rmedica, Seoul, Republic of Korea]) by the following method: 18 millilitres of the patient’s blood was collected and mixed with 2 mL ethylene di-amine tetra-acetic acid disodium anticoagulant (EDTA; Wako Pure Chemical Industries, Ltd.). Then, it was placed in a centrifuge first spin at a force of 3,000 RPM for 3 minutes to separate erythrocytes from the plasma. After that, the obtained plasma was centrifuged again for a second spin at a force of 3,200 RPM for another 6 minutes to separate the platelet poor plasma (PPP) from the platelet-rich plasma (PRP). PRP injections were given with a one-month interval.

Group II included 20 patients who received four weekly intraarticular knee injections of sodium hyaluronate 20 mg/2 mL (Hyalgan®, Fidia S.p.A, Abano Terme, Italy) under ultrasound guidance. Hyalgan is a viscous solution consisting of a high molecular weight (500,000–730,000 Da) fraction of purified natural sodium hyaluronate in buffered physiological sodium chloride, having a PH of 6.8–7.5. The sodium hyaluronate is extracted from rooster combs.

Group III included 20 patients who received 12 sessions (three per week), each last for one hour of a specialized exercise program supervised by the physiotherapist. They were asked to do their daily knee resistance and flexibility exercises in three sets of 10 repetitions and one set of five repetitions, respectively.

N.B: all patients of the three groups will receive a home rehabilitation program and educational leaflet

All patients were evaluated initially, then after 2 and 6 months after therapy completion. An independent physician who was blinded to patients’ group allocation throughout the study performed all evaluations. The subjects filled a questionnaire about their demographic data and medical history. They were evaluated by detailed physical examination, imaging techniques, grey-scale musculoskeletal ultrasound (MSUS) knee examination, and laboratory tests including complete blood count (CBC) to screen for inclusion and exclusion criteria.

The total duration of the trial is 7 months for each patient (1 month for therapeutic intervention and 6 months follow-up).

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Pain severity measured using Visual Analogue Scale (VAS) of shoulder pain initially, then after 2 and 6 months of therapy. Patients point to their amount of pain on a scale of zero (no pain) to 100 (agonizing severe pain), according to their subjective feelings on a 100-millimeter scale drawn on paper. In this scale, a higher score indicates much pain.

Secondary outcome measures

Measured initially, then after 2 and 6 months of therapy:
1. Physical knee examination: limitation in knee range of motion (ROM) and assessment of the presence of effusion
2. Western Ontario and McMaster Universities Arthritis Index (WOMAC): WOMAC comprises 24 multiple-choice items. Each item is scored using a 5-point scale (with 1 point indicating the best function and 5 points, the worst): aggregate scores for joint-specific pain (5 items), physical function (17 items), and stiffness (2 items) are calculated. Use of an overall score is not recommended.
3. Health-related quality of life measured by RAND 36-Item Short-Form Health Survey (SF-36): 36-Item SF-36 is a self-administered 36-item questionnaire comprising 8 health dimensions: physical function (PF), bodily pain (BP), role limitations related to physical health (PR), general health(GH), mental health (MH), role limitations related to emotional health (ER), vitality (VT) and social functioning (SF). Scoring for the eight dimensions ranges from 0 to 100 points, with higher scores indicating better health.
4. NSAIDs consumption: number of days over the past week the patient had consumed NSAID tablets
5. Patient satisfaction registered by means of five-point Likert Scale (not at all satisfied; slightly satisfied; somewhat satisfied; very satisfied; extremely satisfied)

Overall trial start date

03/02/2016

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. History of chronic (at least 4 months) pain or swelling of the knee
2. Imaging findings (radiography) of mild to moderate degenerative changes in the knee joint on Kellgren–Lawrence scale from I–III

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 patients

Participant exclusion criteria

1. Age >80 years
2. Rheumatic pathologies (rheumatoid, psoriatic and reactive arthritis, and seronegative spondyloarthritis)
3. Hematological diseases (coagulopathies)
4. Severe systemic diseases (renal, hepatic, cardiac, infections, endocrinopathies, malignancies)
5. Patients on therapy with anticoagulants–anti-aggregants
6. Use of NSAIDs within 5 days before blood procedure
7. Grade IV gonarthrosis
8. History of knee operarion, or recent knee trauma
9. Previous intra-articular injection with steroids, HA and/or PRP
10. Hb values<11 g/dl, and/or platelet values<150.000/mm3

Recruitment start date

20/03/2016

Recruitment end date

19/03/2017

Locations

Countries of recruitment

United Arab Emirates

Trial participating centre

Dubai Hospital - Rashid Hospital
Dubai Health Authority- Diera
Dubai
7272
United Arab Emirates

Sponsor information

Organisation

Dubai Health Authority

Sponsor details

Dubai Health Authority Building
Al Maktoum Bridge Street
Bur Dubai Area
Dubai
4545
United Arab Emirates
+971 (0)42198888
wasselsotak@dha.gov.ae

Sponsor type

Government

Website

https://www.dha.gov.ae

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results will be published as soon as they are ready.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository.

Intention to publish date

31/01/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/12/2019: The intention to publish date has been changed from 01/05/2019 to 31/01/2020. 17/04/2019: Trial's existence confirmed by Dubai scientific research ethical committee (DSREC).