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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 : May 21, 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
Enrollment 54
Recruitment Details 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 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
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Period Title: Overall Study
Started 25 29
Completed 22 25
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             3             2
Physician Decision             0             1
pt. wanted to have a surgical procedure             0             1
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo Total
Hide Arm/Group Description Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit Total of all reporting groups
Overall Number of Baseline Participants 25 29 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 29 participants 54 participants
67  (10) 67  (12) 67  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 29 participants 54 participants
Female
5
  20.0%
3
  10.3%
8
  14.8%
Male
20
  80.0%
26
  89.7%
46
  85.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 29 participants 54 participants
caucasian 24 28 52
Non-Caucasian 1 1 2
1.Primary Outcome
Title Participants With Clinically Meaningful Improvement in Pain Severity (0-10 cm; Higher Score on Pain Scale is Worse)
Hide Description 2-point reduction in pain Visual Analog Scale (VAS) from baseline to the 2-month follow-up visit, which is considered clinically meaningful Change in Pain Severity; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain)
Time Frame 2-month post-injection
Hide Outcome Measure Data
Hide Analysis Population Description
all with follow-up data, allowing only single TKA per participant
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Measure Type: Number
Unit of Measure: participants
15 9
2.Secondary Outcome
Title Mean Pain VAS (0-10)
Hide Description VAS pain score at 2-month post-injection; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain) with higher score indicating worse pain
Time Frame 2-months post-injection
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing pain VAS data at 2-month FU visit
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: units on pain VAS scale
4.4  (2.5) 5.7  (2.9)
3.Secondary Outcome
Title Physician Global Assessment of Response to Treatment
Hide Description Physician global assessed on an ordinal scale with very much improved category as the outcome of interest (compared to all other categories of global assessment as reference category)
Time Frame 2-month (primary end-point)
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients did not have the outcome assessment; 1 lost to FU
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 20 26
Measure Type: Number
Unit of Measure: participants
6 0
4.Secondary Outcome
Title Physical Function Subscale of the WOMAC at 2-months
Hide Description Physical Function subscale score of the WOMAC at 2-months on a 0 (best physical function) to 100 (worst physical function), with higher score indicating worse physical function
Time Frame 2-month
Hide Outcome Measure Data
Hide Analysis Population Description
people providing data at 2-months
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.5  (14.1) 59.7  (17.4)
5.Secondary Outcome
Title WOMAC Stiffness (0-100)
Hide Description WOMAC stiffness subscale score on 0-100 scale at 2-month follow-up visit with scores ranging 0 (no joint stiffness) to 100 (worst joint stiffness), with higher score indicating worse joint stiffness
Time Frame 2-months
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing the data
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
51.8  (19.1) 60.4  (16.3)
6.Secondary Outcome
Title Timed Up-and-go (TUG) Test
Hide Description Time to get up from a chair, walk 3 meters turn back and sit in the chair in seconds at the 2-month visit (higher number is worse, i.e., taking a longer time to complete the task is worse)
Time Frame 2-month
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing data
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: seconds
17.2  (18.2) 9.6  (13.8)
7.Secondary Outcome
Title QOL: SF-36 Score Physical Functioning Scale, a Generic Health Status Measure
Hide Description Short Form (SF)-36 physical functioning subscale on 0-100, at 2-month FU visit, as a generic health status measure, with a score ranging from 0 (worst physical functioning) to 100 (best physical functioning), with higher score indicating better physical functioning (higher number is better)
Time Frame 2-month
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing data
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.7  (21.8) 23.6  (17.5)
8.Secondary Outcome
Title Number of Participants With Occurrence of Joint Erythema, Warmth, Swelling or Tenderness
Hide Description Occurence of any of the above clinical features (erythema, warmth, swelling or tenderness) as a new finding compared to the absence of the same feature at baseline
Time Frame Upto 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing data
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Manual Muscle Strength Testing of Knee Flexion and Extension
Hide Description Occurence of decrease in strength of knee flexion or extension at any of the follow-up visits, as measured by the Manual muscle strength testing (MMT) with scores ranging 0-5; 0 indicates None: No visible or palpable contraction; 1 indicates Trace: Visible or palpable contraction with no motion; 2 indicates Poor: Full range of motion (ROM) gravity eliminated; 3 indicates Fair: Full ROM against gravity; 4 indicates Good: Full ROM against gravity, moderate resistance; and 5 indicates Normal: Full ROM against gravity, maximal resistance
Time Frame Upto 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing the data
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title McGill Affective Dimension
Hide Description McGill Affective Dimension Score on 0-12 scale at 2-months (higher number is worse)
Time Frame 2-month
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing data
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.8  (3.1) 4.8  (3.4)
11.Secondary Outcome
Title Change in Serum Cytokine (Interleukin 7) Levels at 2-month Post-injection
Hide Description The change in serum interleukin 7 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 7. We compared the mean change in serum interleukin 7 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.
Time Frame Baseline to 2-months
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.
Arm/Group Title WOMAC Pain Responder WOMAC Pain Non-responder
Hide Arm/Group Description:
A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
Overall Number of Participants Analyzed 12 23
Mean (Standard Deviation)
Unit of Measure: pg/ml
1.07  (1.17) 0.08  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WOMAC Pain Responder, WOMAC Pain Non-responder
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments p-value not adjusted for multiple comparisons; the a priori threshold for statistical significance was <0.05
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title McGill Sensory Pain Score
Hide Description McGill Sensory pain score on 0-33 at 2-month FU visit (higher score is worse)
Time Frame 2-month
Hide Outcome Measure Data
Hide Analysis Population Description
patients providing data
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description:
Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.5  (8) 14.6  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intra-articular Botulinum Toxin, Intra-articular Placebo
Comments For primary outcome analysis, we compared the proportion of responders with clinically meaningful change [improvement] in 0-10 VAS Pain, i.e. those with 2-point reduction in 0-10 VAS pain score at 2-mths, in the 2 groups using comparison of proportions. Proportion of responders were also analyzed at all efficacy timepoints using generalized estimating equation (GEE) modeling. We used GEE for between-group comparisons in secondary outcomes at all efficacy endpoints, adjusted for baseline scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments No adjustment for multiple comparisons was made, since we analyzed only one primary outcome. 19 patients per group were needed for 80% power and 24 patients per group for 90% power to detect a difference of 43% in proportion with primary outcome
Method comparison of proportions
Comments compare proportion of patients with clinically meaningful change in 0-10 VAS pain (at least 2-point reduction on VAS pain) at 2-mths & all timepoints
Method of Estimation Estimation Parameter comparison of proportions
Estimated Value 0.65
Estimation Comments we hypothesized a greater proportion with meaningful reduction in pain on 0-10 scale in intervention versus placebo group.
13.Secondary Outcome
Title Change in Serum Cytokine (Interleukin 10) Levels at 2-month Post-injection
Hide Description The change in serum interleukin 10 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 10. We compared the mean change in serum interleukin 10 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.
Time Frame Baseline to 2-months
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.
Arm/Group Title WOMAC Pain Responder WOMAC Pain Non-responder
Hide Arm/Group Description:
A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
Overall Number of Participants Analyzed 12 23
Mean (Standard Deviation)
Unit of Measure: pg/ml
27.72  (21.56) 8.51  (20.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WOMAC Pain Responder, WOMAC Pain Non-responder
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Change in Serum Cytokine (Interleukin 12 p70) Levels at 2-month Post-injection
Hide Description The change in serum interleukin 12 p70 was defined as the difference between the follow-up (2-month) and the baseline value of serum interleukin 12 p70. We compared the mean change in serum interleukin 12 p70 levels between the WOMAC pain responders vs. the WOMAC pain non-responders.
Time Frame Baseline to 2-months
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.
Arm/Group Title WOMAC Pain Responder WOMAC Pain Non-responder
Hide Arm/Group Description:
A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
Overall Number of Participants Analyzed 12 23
Mean (Standard Deviation)
Unit of Measure: pg/ml
12.91  (9.60) 3.36  (8.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WOMAC Pain Responder, WOMAC Pain Non-responder
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title Change in Serum Cytokine (Eotaxin) Levels at 2-month Post-injection
Hide Description The change in serum Eotaxin was defined as the difference between the follow-up (2-month) and the baseline value of serum Eotaxin. We compared the mean change in serum Eotaxin levels between the WOMAC pain responders vs. the WOMAC pain non-responders.
Time Frame Baseline to 2-months
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.
Arm/Group Title WOMAC Pain Responder WOMAC Pain Non-responder
Hide Arm/Group Description:
A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
Overall Number of Participants Analyzed 12 23
Mean (Standard Deviation)
Unit of Measure: pg/ml
7.85  (12.28) -2.03  (13.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WOMAC Pain Responder, WOMAC Pain Non-responder
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Change in Serum Cytokine (Interferon Gamma) Levels at 2-month Post-injection
Hide Description The change in serum Interferon Gamma was defined as the difference between the follow-up (2-month) and the baseline value of serum Interferon Gamma. We compared the mean change in serum Interferon Gamma levels between the WOMAC pain responders vs. the WOMAC pain non-responders.
Time Frame Baseline to 2-months
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.
Arm/Group Title WOMAC Pain Responder WOMAC Pain Non-responder
Hide Arm/Group Description:
A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
Overall Number of Participants Analyzed 12 23
Mean (Standard Deviation)
Unit of Measure: pg/ml
15.61  (13.35) -1.24  (23.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WOMAC Pain Responder, WOMAC Pain Non-responder
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Change in Serum Cytokine (Tumor Necrosis Factor Alpha) Levels at 2-month Post-injection
Hide Description The change in serum tumor necrosis factor alpha was defined as the difference between the follow-up (2-month) and the baseline value of serum tumor necrosis factor alpha. We compared the mean change in serum tumor necrosis factor alpha levels between the WOMAC pain responders vs. the WOMAC pain non-responders.
Time Frame Baseline to 2-months
Hide Outcome Measure Data
Hide Analysis Population Description
This protocol modification was made in the middle of the trial conduct, based on a suggestion on the K-12 application. Therefore, the total number of patients with these data is smaller than the total number of participants.
Arm/Group Title WOMAC Pain Responder WOMAC Pain Non-responder
Hide Arm/Group Description:
A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
Overall Number of Participants Analyzed 12 23
Mean (Standard Deviation)
Unit of Measure: pg/ml
22.22  (24.65) 4.46  (21.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WOMAC Pain Responder, WOMAC Pain Non-responder
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6-months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intra-articular Botulinum Toxin Intra-articular Placebo
Hide Arm/Group Description Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
All-Cause Mortality
Intra-articular Botulinum Toxin Intra-articular Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intra-articular Botulinum Toxin Intra-articular Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/23 (13.04%)      9/26 (34.62%)    
Cardiac disorders     
Chest pain/new diagnosis of CAD   0/23 (0.00%)  0 3/26 (11.54%)  3
Supraventricular tachycardia   0/23 (0.00%)  0 1/26 (3.85%)  1
Subarachnoid hemorrhage   1/23 (4.35%)  1 0/26 (0.00%)  0
Immune system disorders     
Seafood allergy   1/23 (4.35%)  1 0/26 (0.00%)  0
Infections and infestations     
Influenza   0/23 (0.00%)  0 1/26 (3.85%)  1
Cellulitis and septic arthritis   0/23 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders     
Atypical chest pain   1/23 (4.35%)  1 0/26 (0.00%)  0
Gouty arthritis   0/23 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders     
Lethargy and decreased appetite   0/23 (0.00%)  0 1/26 (3.85%)  1
Psychiatric disorders     
Depression   2/23 (8.70%)  2 0/26 (0.00%)  0
Vascular disorders     
Deep vein thrombosis   0/23 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intra-articular Botulinum Toxin Intra-articular Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/23 (82.61%)      23/26 (88.46%)    
Musculoskeletal and connective tissue disorders     
Accidental injury  [1]  8/23 (34.78%)  11 6/26 (23.08%)  7
Pain in the study joint  [2]  6/23 (26.09%)  6 2/26 (7.69%)  2
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infections  [3]  10/23 (43.48%)  10 10/26 (38.46%)  10
Surgical and medical procedures     
Surgical procedure  [4]  3/23 (13.04%)  3 5/26 (19.23%)  5
Indicates events were collected by systematic assessment
[1]
Injury as a result of an accident
[2]
Pain reported in the joint that underwent injection
[3]
Infections of the upper respiratory tract
[4]
Scheduled surgical procedure
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
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: May 21, 2018