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Safety and Efficacy of Botulinum Toxin A Injection in Patients With Painful Artificial Knee Arthroplasty (TKA)

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ClinicalTrials.gov Identifier: NCT00403273
Recruitment Status : Completed
First Posted : November 23, 2006
Results First Posted : November 18, 2016
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Arthritis Foundation
Information provided by (Responsible Party):
jasvinder singh, Minneapolis Veterans Affairs Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Pain
Interventions: Drug: Botulinum toxin A
Drug: Normal Saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of the 194 TKAs (188 patients) screened, 60 TKAs (54 patients) were recruited in the 6-month study. Main analyses were performed only on 49 TKAs, after excluding bilateral TKAs, to meet the assumption of independence of observations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No enrolled participants were excluded from analyses. Main analyses were done for Single TKA per patient, since 6 were bilateral TKAs; sensitivity analyses were done on all, regardless of unilateral or bilateral

Reporting Groups
  Description
Intra-articular Botulinum Toxin Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Intra-articular Placebo Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit

Participant Flow:   Overall Study
    Intra-articular Botulinum Toxin   Intra-articular Placebo
STARTED   25   29 
COMPLETED   22   25 
NOT COMPLETED   3   4 
Lost to Follow-up                3                2 
Physician Decision                0                1 
pt. wanted to have a surgical procedure                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intra-articular Botulinum Toxin Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Intra-articular Placebo Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Total Total of all reporting groups

Baseline Measures
   Intra-articular Botulinum Toxin   Intra-articular Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   29   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (10)   67  (12)   67  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  20.0%      3  10.3%      8  14.8% 
Male      20  80.0%      26  89.7%      46  85.2% 
Race/Ethnicity, Customized 
[Units: Participants]
     
caucasian   24   28   52 
Non-Caucasian   1   1   2 


  Outcome Measures

1.  Primary:   Participants With Clinically Meaningful Improvement in Pain Severity (0-10 cm; Higher Score on Pain Scale is Worse)   [ Time Frame: 2-month post-injection ]

2.  Secondary:   Mean Pain VAS (0-10)   [ Time Frame: 2-months post-injection ]

3.  Secondary:   Physician Global Assessment of Response to Treatment   [ Time Frame: 2-month (primary end-point) ]

4.  Secondary:   Physical Function Subscale of the WOMAC at 2-months   [ Time Frame: 2-month ]

5.  Secondary:   WOMAC Stiffness (0-100)   [ Time Frame: 2-months ]

6.  Secondary:   Timed Up-and-go (TUG) Test   [ Time Frame: 2-month ]

7.  Secondary:   QOL: SF-36 Score Physical Functioning Scale, a Generic Health Status Measure   [ Time Frame: 2-month ]

8.  Secondary:   Number of Participants With Occurrence of Joint Erythema, Warmth, Swelling or Tenderness   [ Time Frame: Upto 6 months ]

9.  Secondary:   Manual Muscle Strength Testing of Knee Flexion and Extension   [ Time Frame: Upto 6-months ]

10.  Secondary:   McGill Affective Dimension   [ Time Frame: 2-month ]

11.  Secondary:   Correlation of Change in Serum Cytokine (Interleukin 7) Levels With Improvement in Pain at 2-month Post-injection   [ Time Frame: Baseline to 2-months ]

12.  Secondary:   McGill Sensory Pain Score   [ Time Frame: 2-month ]

13.  Secondary:   Correlation of Change in Serum Cytokine (Interleukin 10) Levels With Improvement in Pain at 2-month Post-injection   [ Time Frame: Baseline to 2-months ]

14.  Secondary:   Correlation of Change in Serum Cytokine (Interleukin 12 p70) Levels With Improvement in Pain at 2-month Post-injection   [ Time Frame: Baseline to 2-months ]

15.  Secondary:   Correlation of Change in Serum Cytokine (Eotaxin) Levels With Improvement in Pain at 2-month Post-injection   [ Time Frame: Baseline to 2-months ]

16.  Secondary:   Correlation of Change in Serum Cytokine (Interferon Gamma) Levels With Improvement in Pain at 2-month Post-injection   [ Time Frame: Baseline to 2-months ]

17.  Secondary:   Correlation of Change in Serum Cytokine (Tumor Necrosis Factor Alpha) Levels With Improvement in Pain at 2-month Post-injection   [ Time Frame: Baseline to 2-months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: jasvinder singh
Organization: minneapolis VAMC
phone: 205-504-9559


Publications of Results:

Responsible Party: jasvinder singh, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00403273     History of Changes
Other Study ID Numbers: 1-singh
First Submitted: November 21, 2006
First Posted: November 23, 2006
Results First Submitted: April 21, 2012
Results First Posted: November 18, 2016
Last Update Posted: April 23, 2018