NCT04704297 · Madigan Army Medical Center
Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
(T-PIMPS)
What this study is about
Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back, accounts for approximately 2.63 million visits in the United States, or 2.3 percent of annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is lost from LBP. Approximately one-third of this is direct costs. Previous studies have established the safety of trigger point injections (TPI).
View original scientific description
Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back, accounts for approximately 2.63 million visits in the United States, or 2.3 percent of annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is lost from LBP. Approximately one-third of this is direct costs. Previous studies have established the safety of trigger point injections (TPI). However, the results of these studies are highly heterogeneous regarding TPI's ability to treat pain or improve functional outcomes. The two most promising TPI studies conducted in the ED have been published in the last two years. They both suffered from a small sample size. Additionally, they suffered from a combination of limitations including: lack of randomization, inconsistent medical management, lack of a follow-up assessment, and lack of patient centered functional outcomes. These studies were both two armed and either compared standard medical management to TPI with local anesthetic or TPI with local anesthetic to TPI with Normal Saline (NS). One of these studies concluded that TPI is generally beneficial. The other concluded that TPI with NS is superior. Research Hypothesis: The investigators hypothesize that standard therapy (ST) plus TPI with 8 mL of 0.5 percent Bupivacaine is superior to ST alone or ST plus TPI with 8 mL of NS for the treatment of the pain associated with MPS of the low back. Significance: This will be the first TPI study to compare ST, to TPI with local anesthetic, and TPI with NS for LBP conducted in an ED. It will also be the first TPI study to incorporate a patient centered functional outcome and patient follow-up after discharge from an ED. TPI's are a popular treatment modality for LBP among many Emergency Medicine Providers. However, to date, there is limited evidence for or against it. The investigators are hopeful that this study will answer whether or not trigger point injections are benefiting patients and, if so, which type of TPI is most beneficial.
Interventions
DRUG
Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.
We are testing which of the three arms is superior for the treatment of Myofascial Pain Syndrome of the Low Back. Pain will be measured using a 10 cm visual analogue scale (VAS) at baseline and 30-minutes after treatment.
DRUG
Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below.
Evaluation of functional ability using a patient centered functional score known as the MODI. The MODI will be scored at baseline and 30-minutes after treatment.
DRUG
Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.
60-72 after treatment in the Emergency Department, a member of the study team will follow up with participants to repeat a measurement of pain and functional ability on VAS and MODI respectively. This will be compared to baseline measurements.
Primary outcome measures
Pain reduction
Time frame: 30-minutes
To determine which of three treatments is the superior treatment for myofascial pain syndrome (MPS) of the low back. The three treatments are standard therapy (ST), ST plus trigger point injections (TPI) with 8 mL of 0.5% Bupivacaine, and ST plus TPI with 8 mL of normal saline NS. To reach superiority a treatment will have to decrease pain by 1.5 cm more than the other treatments, measured before treatment and 30-minutes following treatment on a 10 cm visual analog scale (VAS). The units of measurement are centimeters (cm) on a VAS.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years
- Must have at least 1 trigger point in low back paraspinal muscles.
- For exacerbations of chronic low back pain, the pain on presentation must be 1.5 cm above baseline pain on VAS
Exclusion criteria
- Allergy or inability to take study medications.
- New focal neurologic deficit in lower extremities.
- Known active malignancy with bony spinal metastases.
- Identifiable spinal, lumbosacral or hip fracture.
- History of Fibromyalgia, rheumatoid arthritis, ankylosing spondylitis.
- Current use of anticoagulation.
- Overlying cellulitis.
- Spinal, hip, or pelvic surgery within the past 6 months.
- Previous administration of trigger point injections for current episode.
- Sciatica-extending down the back of the leg to the heel.
- Alternate identifiable cause of participant's acute pain other than myofascial or musculoskeletal pain.
- Febrile patients.
- Unable to understand English or otherwise unable to provide informed consent (mental handicap, inability to understand instructions, risks, or benefits), or is an at risk population (wounded warrior, resident physicians, prisoners, cadets, midshipmen, or students).
Where
- Tacoma, Washington
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2021 · Source of record for eligibility and locations