Trial Outcomes & Findings for Using Saline for Myofascial Pain Syndromes (USAMPS) (NCT NCT02120261)

NCT ID: NCT02120261

Last Updated: 2019-05-01

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: baseline
• Results posted on: 2019-05-01

Participant Flow

3 participants who were enrolled did not start the study.

Participant milestones

Measure	TPI With 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. This will be performed by the treating physician under sterile technique with a 25 gauge needle.	TPI With Lidocaine & 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. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Overall Study STARTED	23	25
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Saline for Myofascial Pain Syndromes (USAMPS)

Baseline characteristics by cohort

Measure	TPI With Normal Saline n=23 Participants 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.	TPI With Lidocaine & Triamcinolone Acetonide n=25 Participants 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 n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American or Black	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

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.

Outcome measures

Measure	TPI With Normal Saline n=23 Participants 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.	TPI With Lidocaine & Triamcinolone Acetonide n=25 Participants 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.
Pain Intensity	7.69 units on a scale Standard Deviation 1.87	7.44 units on a scale Standard Deviation 2.04

PRIMARY outcome

Timeframe: at discharge (a few minutes after receiving intervention)

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.

Outcome measures

Measure	TPI With Normal Saline n=23 Participants 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.	TPI With Lidocaine & Triamcinolone Acetonide n=25 Participants 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.
Pain Intensity	1.52 units on a scale Standard Deviation 2.22	1.76 units on a scale Standard Deviation 2.86

PRIMARY outcome

Timeframe: 2 weeks

Population: 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.

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.

Outcome measures

Measure	TPI With Normal Saline n=17 Participants 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.	TPI With Lidocaine & Triamcinolone Acetonide n=21 Participants 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.
Pain Intensity	4.29 units on a scale Standard Deviation 3.66	4.14 units on a scale Standard Deviation 3.17

SECONDARY outcome

Timeframe: 16 days

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.

Outcome measures

Measure	TPI With Normal Saline n=23 Participants 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.	TPI With Lidocaine & Triamcinolone Acetonide n=25 Participants 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.
Duration of Pain Relief	3 days Interval 1.0 to 16.0	1 days Interval 0.0 to 15.0

Adverse Events

TPI With Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TPI With Lidocaine & Triamcinolone Acetonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carlos J. Roldan, MD

The University of Texas Health Science Center at Houston

Email: Carlos.J.Roldan@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place