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Comparison of Acetaminophen and PRP Therapy for Knee OA

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ClinicalTrials.gov Identifier: NCT01782885
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Mario Alberto Simental Mendia, M Sc, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Interventions Procedure: Intra-articular injection of PRP
Drug: Acetaminophen
Enrollment 543
Recruitment Details Patients diagnosed with degenerative osteoarthritis were recruited from May 2013 to November 2015 in the Service of Orthopedics and Traumatology at the University Hospital "Dr. José Eleuterio González" of the Autonomous University of Nuevo León in Monterrey, México.
Pre-assignment Details Only patients meeting inclusion criteria were assigned to a group (radiographic grade I and II osteoarthritis, mainly). Importantly, patients with previous surgical interventions, with concomitant diseases or with Hb values of <11 g/dL and platelet values of <150,000/µL were excluded prior to group assignment.
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks. Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Period Title: Overall Study
Started 36 39
Completed 32 33
Not Completed 4 6
Reason Not Completed
Lost to Follow-up             4             6
Arm/Group Title Acetaminophen Intra-articular Injection of PRP Total
Hide Arm/Group Description Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) during 6 weeks. Intra-articular injection of PRP: Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks treatment). Total of all reporting groups
Overall Number of Baseline Participants 32 33 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 33 participants 65 participants
55.6  (11.4) 57.2  (8.1) 56.4  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
Female
20
  62.5%
22
  66.7%
42
  64.6%
Male
12
  37.5%
11
  33.3%
23
  35.4%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 32 participants 33 participants 65 participants
29.5  (3.8) 32.2  (6.2) 30.9  (5.0)
Grade of Osteoarthritis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
Kellgren-Lawrence Grade I 12 11 23
Kellgren-Lawrence Grade II 20 22 42
[1]
Measure Description: Grade 0: No radiographic features of osteoarthritis, Grade I: Possible joint space narrowing and osteophyte formation, Grade II: Definite osteophyte formation with possible joint space narrowing, Grade III: Multiple osteophytes, definite joint space narrowing, sclerosis and possible bony deformity, Grade IV: Large osteophytes, marked joint space narrowing, severe sclerosis and definite bony deformity
Visual Analog Scale (VAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 32 participants 33 participants 65 participants
5.9  (2.2) 4.9  (2.4) 5.4  (2.3)
[1]
Measure Description: The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?
Western Ontario and McMaster Universities Arthritis Index (WOMAC)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 32 participants 33 participants 65 participants
35.5  (19.0) 35.7  (19.5) 35.6  (19.3)
[1]
Measure Description: The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
1.Primary Outcome
Title Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Hide Description The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame 0 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Stiffness (0 weeks) 3.0  (2.1) 2.9  (2.0)
Pain (0 weeks) 8.0  (4.3) 7.4  (4.0)
Functional capacity (0 weeks) 24.4  (13.7) 25.3  (14.3)
Total score (0 weeks) 35.5  (19.0) 35.7  (19.5)
2.Primary Outcome
Title Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Hide Description The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Stiffness (6 weeks) 2.3  (1.8) 1.1  (1.1)
Pain (6 weeks) 5.8  (2.9) 3.1  (2.6)
Functional capacity (6 weeks) 18.2  (12.0) 8.7  (8.0)
Total score (6 weeks) 26.2  (16.0) 12.8  (11.0)
3.Primary Outcome
Title Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Hide Description The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Stiffness (12 weeks) 2.2  (2.2) 0.9  (1.3)
Pain (12 weeks) 5.7  (4.1) 2.7  (2.4)
Functional capacity (12 weeks) 18.4  (13.1) 8.1  (7.2)
Total score (12 weeks) 26.3  (17.8) 12.0  (10.6)
4.Primary Outcome
Title Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Hide Description The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Stiffness (24 weeks) 1.9  (1.9) 0.8  (1.1)
Pain (24 weeks) 5.3  (3.9) 2.9  (2.2)
Functional capacity (24 weeks) 16.7  (13.3) 7.9  (7.7)
Total score (24 weeks) 23.5  (18.4) 11.7  (10.0)
5.Secondary Outcome
Title Change in Visual Analog Scale (VAS)
Hide Description The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?
Time Frame 0-24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: Centimeters
VAS (0 weeks) 5.9  (2.2) 4.9  (2.4)
VAS (6 weeks) 3.8  (2.2) 1.9  (1.6)
VAS (12 weeks) 4.1  (2.6) 1.9  (2.0)
VAS (24 weeks) 3.7  (2.7) 2.2  (2.1)
6.Other Pre-specified Outcome
Title Change in SF-12v2 Health Survey
Hide Description The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame 0 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mental Component Summary 50.8  (9.9) 44.2  (11.8)
Physical Component Summary 37.7  (9.3) 38.0  (8.0)
7.Other Pre-specified Outcome
Title Change in SF-12v2 Health Survey
Hide Description The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mental Component Summary 49.8  (9.3) 55.4  (8.7)
Physical Component Summary 41.1  (9.9) 47.6  (7.9)
8.Other Pre-specified Outcome
Title Change in SF-12v2 Health Survey
Hide Description The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mental Component Summary 50.7  (8.7) 55.9  (7.9)
Physical Component Summary 41.7  (8.5) 48.8  (7.9)
9.Other Pre-specified Outcome
Title Change in SF-12v2 Health Survey
Hide Description The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description:
Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
Overall Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mental Component Summary 52.3  (7.2) 54.3  (7.6)
Physical Component Summary 41.4  (7.4) 49.9  (8.1)
Time Frame 6 months
Adverse Event Reporting Description All patients were asked and evaluated for possibles adverse events at time-points of evaluation. Specific attention was provided for PRP treated patients.
 
Arm/Group Title Acetaminophen Intra-articular Injection of PRP
Hide Arm/Group Description Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks. Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
All-Cause Mortality
Acetaminophen Intra-articular Injection of PRP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Acetaminophen Intra-articular Injection of PRP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/33 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acetaminophen Intra-articular Injection of PRP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      4/33 (12.12%)    
Skin and subcutaneous tissue disorders     
Pain, inflammation * [1]  0/32 (0.00%)  0 4/33 (12.12%)  4
*
Indicates events were collected by non-systematic assessment
[1]
Some patients showed mild pain and inflammation at the site of injection after they were treated with PRP. These symptoms prevailed for 2-3 days after injection with spontaneous resolution.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M Sc Mario Simental-Mendía
Organization: Universidad Autónoma de Nuevo León
Phone: +52 (81) 8329 4174
EMail: mario.simental@gmail.com
Layout table for additonal information
Responsible Party: Mario Alberto Simental Mendia, M Sc, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01782885    
Other Study ID Numbers: BI13-001
First Submitted: January 30, 2013
First Posted: February 4, 2013
Results First Submitted: September 21, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015