Trigger point injections for low back pain relief

Trigger Point Injection for Myofascial Pain Syndrome in the Low Back (T-PIMPS): A Randomized Controlled Trial.

This study is testing whether trigger point injections can help people with lower back pain feel better and improve their ability to move after visiting the Emergency Department.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Madigan Army Medical Center (fed)
• Locations: 1 site (Tacoma, Washington)
• Trial ID: NCT04704297 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of trigger point injections (TPI) in treating myofascial pain syndrome in the lower back, particularly in patients presenting to the Emergency Department. The study aims to address the limitations of previous research by employing a randomized controlled design and focusing on patient-centered functional outcomes. Participants will be evaluated for pain relief and functional ability using the Modified Oswestry Disability Index, with follow-up assessments conducted 60-72 hours post-treatment. The trial seeks to provide clearer insights into the efficacy of TPI for low back pain management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have at least one trigger point in their low back paraspinal muscles and are experiencing exacerbations of chronic low back pain.

Not a fit: Patients with conditions such as fibromyalgia, rheumatoid arthritis, or those who have had recent spinal surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce low back pain and improve functional outcomes for patients suffering from myofascial pain syndrome.

How similar studies have performed: Previous studies on trigger point injections have shown mixed results, indicating a need for further investigation, making this approach both relevant and necessary.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Must have at least 1 trigger point in low back paraspinal muscles.
3. For exacerbations of chronic low back pain, the pain on presentation must be 1.5 cm above baseline pain on VAS

Exclusion Criteria:

1. Allergy or inability to take study medications.
2. New focal neurologic deficit in lower extremities.
3. Known active malignancy with bony spinal metastases.
4. Identifiable spinal, lumbosacral or hip fracture.
5. History of Fibromyalgia, rheumatoid arthritis, ankylosing spondylitis.
6. Current use of anticoagulation.
7. Overlying cellulitis.
8. Spinal, hip, or pelvic surgery within the past 6 months.
9. Previous administration of trigger point injections for current episode.
10. Sciatica-extending down the back of the leg to the heel.
11. Alternate identifiable cause of participant's acute pain other than myofascial or musculoskeletal pain.
12. Febrile patients.
13. Pregnant
14. 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 this trial is running

Tacoma, Washington

• Department of Emergency Medicine, Madigan Army Medical Center — Tacoma, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Joshua J Oliver, MD — Madigan AMC
• Study coordinator: Joshua J Oliver, MD

Conditions: Low Back Pain, Myofascial Pain Syndrome Lower Back, Trigger Point Injection, Myofascial Pain Syndrome, Emergency Department