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Trial record 49 of 75 for:    "Collagen Disease" | "Triamcinolone"

Using Saline for Myofascial Pain Syndromes (USAMPS) (USAMPS)

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ClinicalTrials.gov Identifier: NCT02120261
Recruitment Status : Terminated (lack of activity, Primary researcher moved to another institution)
First Posted : April 22, 2014
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Roldan, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Myofascial Pain Syndrome
Interventions Drug: Normal Saline
Drug: Lidocaine Hydrochloride
Drug: Triamcinolone acetonide
Enrollment 51
Recruitment Details  
Pre-assignment Details 3 participants who were enrolled did not start the study.
Arm/Group Title TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Hide Arm/Group Description Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Period Title: Overall Study
Started 23 25
Completed 23 25
Not Completed 0 0
Arm/Group Title TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide Total
Hide Arm/Group Description Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. Total of all reporting groups
Overall Number of Baseline Participants 23 25 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
25
 100.0%
48
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
Female
17
  73.9%
18
  72.0%
35
  72.9%
Male
6
  26.1%
7
  28.0%
13
  27.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 23 participants 25 participants 48 participants
Hispanic
12
  52.2%
13
  52.0%
25
  52.1%
African American or Black
8
  34.8%
8
  32.0%
16
  33.3%
White
3
  13.0%
3
  12.0%
6
  12.5%
Asian
0
   0.0%
1
   4.0%
1
   2.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants 25 participants 48 participants
23
 100.0%
25
 100.0%
48
 100.0%
1.Primary Outcome
Title Pain Intensity
Hide Description The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Hide Arm/Group Description:
Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Overall Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.69  (1.87) 7.44  (2.04)
2.Primary Outcome
Title Pain Intensity
Hide Description The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.
Time Frame at discharge (a few minutes after receiving intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Hide Arm/Group Description:
Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Overall Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.52  (2.22) 1.76  (2.86)
3.Primary Outcome
Title Pain Intensity
Hide Description The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pain intensity was not measured in 6 subjects in the TPI with Normal Saline arm and 4 subjects in the TPI with Lidocaine & Triamcinolone Acetonide arm.
Arm/Group Title TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Hide Arm/Group Description:
Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.29  (3.66) 4.14  (3.17)
4.Secondary Outcome
Title Duration of Pain Relief
Hide Description If the patient experienced pain relief with the trigger point injection and the pain came back later, the number of days after the injection at which the pain had returned was recorded.
Time Frame 16 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Hide Arm/Group Description:
Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Overall Number of Participants Analyzed 23 25
Median (Full Range)
Unit of Measure: days
3
(1 to 16)
1
(0 to 15)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Hide Arm/Group Description

Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.

Normal Saline: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.

Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.

Lidocaine Hydrochloride: Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.

Triamcinolone acetonide: Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.

All-Cause Mortality
TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TPI With Normal Saline TPI With Lidocaine & Triamcinolone Acetonide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Carlos J. Roldan, MD
Organization: The University of Texas Health Science Center at Houston
Responsible Party: Carlos Roldan, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02120261     History of Changes
Other Study ID Numbers: HSC-MS-14-0072
First Submitted: April 14, 2014
First Posted: April 22, 2014
Results First Submitted: April 11, 2019
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019