Myofascial Pain SyndromePhase 4USAMPSNCT02120261
Using Saline for Myofascial Pain Syndromes (USAMPS)
A Phase 4 study testing Normal Saline, Lidocaine Hydrochloride and Triamcinolone acetonide in people with Myofascial Pain Syndrome, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Normal Saline, Lidocaine Hydrochloride and Triamcinolone acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.
Who cannot join
- Patients allergic to lidocaine and/or steroids.
- Pregnant women.
- Prisoners.
- Patients who are cognitively impaired and/or unable to consent for the study.
- Age < 18.
- Signs of localized infection or skin breakdown at the injection site.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, 77030
About this study
This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Normal Saline, Lidocaine Hydrochloride, Triamcinolone acetonide
- Keywords
- Myofascial Pain Syndrome, trigger point injection
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
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.
Lidocaine HydrochlorideDrug
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.
Triamcinolone acetonideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TPI with Normal Saline | Experimental | 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. Receives: Drug: Normal Saline |
| TPI with Lidocaine & Triamcinolone Acetonide | Active comparator | 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. Receives: Drug: Lidocaine Hydrochloride; Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
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.
Measured: baseline
Pain Intensity
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.
Measured: at discharge (a few minutes after receiving intervention)
Pain Intensity
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.
Measured: 2 weeks
Secondary outcomes (1)
Duration of Pain Relief
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.
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: lack of activity, Primary researcher moved to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Roldan, The University of Texas Health Science Center, Houston
- Investigators
- Carlos Roldan, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120261
- Sponsor's protocol ID
- HSC-MS-14-0072
- Acronym
- USAMPS
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2014
- Last updated
- 1 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Saline for Myofascial Pain Syndromes (USAMPS)
- ClinicalTrials.gov ID
- NCT02120261
- Acronym / sponsor ID
- USAMPS / HSC-MS-14-0072
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Myofascial Pain Syndrome, trigger point injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of activity, Primary researcher moved to another institution
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Posted 1 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPI with Normal Saline | Experimental | Drug: Normal SalineTrigger 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 | Active comparator | Drug: Lidocaine Hydrochloride, Drug: Triamcinolone acetonideTrigger 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.
Key exclusion criteria (6 listed)
- Patients allergic to lidocaine and/or steroids.
- Pregnant women.
- Prisoners.
- Patients who are cognitively impaired and/or unable to consent for the study.
- Age < 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineTrigger 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. | Drug | TPI with Normal Saline |
| Lidocaine HydrochlorideTrigger 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. | Drug | TPI with Lidocaine & Triamcinolone Acetonide |
| Triamcinolone acetonideTrigger 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. | Drug | TPI with Lidocaine & Triamcinolone Acetonide |
Primary outcome
Pain Intensity
Time frame: 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.
Pain Intensity
Time frame: 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.
Pain Intensity
Time frame: 2 weeks
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.
1 secondary outcome
Duration of Pain Relief
Time frame: 16 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Roldan, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline, Lidocaine Hydrochloride and Triamcinolone acetonide in people with Myofascial Pain Syndrome, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.