Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial

NCT04704297 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 220042
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Myofascial Pain Syndrome Lower Back

Keywords

Trigger Point Injection; Low Back Pain; Myofascial Pain Syndrome; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  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.

  30-minutes

Secondary Outcomes (1)

• Functional Improvement

  30-minutes

Other Outcomes (2)

• Follow-up measurement of pain

  60-72 hours

• Follow-up measurement of function

  60-72 hours

Study Arms (3)

Standard Therapy (ST)

ACTIVE COMPARATOR

ST will consist of 975mg of Acetaminophen PO and either 30mg of Ketorolac IM or 15 mg IV. Upon discharge ST will consist of prescriptions for acetaminophen 650mg every 4 hours by mouth, Ibuprofen 400mg every 4 hours by mouth, and 10 mg of cyclobenzaprine nightly by mouth. Additionally, participants will be provided a handout going over these medications and the use of heat for low back pain and instructions on the performance of McKenzie stretching exercises for low back pain.4

Drug: Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.; 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.; 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.

ST plus Trigger Point Injections (TPI) with 8 mL of 0.5 percent Bupivacaine

ACTIVE COMPARATOR

ST plus TPI with 8 mL of 0.5 percent Bupivacaine

Drug: Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.; 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.; 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.

ST plus TPI with 8 mL of Normal Saline (NS)

ACTIVE COMPARATOR

ST plus TPI with 8 mL of Normal Saline

Drug: Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.; 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.; 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.

Interventions

Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below. DRUG

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.

Also known as: Ketorolac, acetaminophen, ibuprofen, cyclobenzaprine, bupivacaine, normal saline

ST plus TPI with 8 mL of Normal Saline (NS); ST plus Trigger Point Injections (TPI) with 8 mL of 0.5 percent Bupivacaine; Standard Therapy (ST)

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. DRUG

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.

Also known as: Ketorolac, acetaminophen, ibuprofen, cyclobenzaprine, bupivacaine, normal saline

ST plus TPI with 8 mL of Normal Saline (NS); ST plus Trigger Point Injections (TPI) with 8 mL of 0.5 percent Bupivacaine; Standard Therapy (ST)

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. DRUG

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.

Also known as: Ketorolac, acetaminophen, ibuprofen, cyclobenzaprine, bupivacaine, normal saline

ST plus TPI with 8 mL of Normal Saline (NS); ST plus Trigger Point Injections (TPI) with 8 mL of 0.5 percent Bupivacaine; Standard Therapy (ST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Pregnant
• 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).

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Department of Emergency Medicine, Madigan Army Medical Center

Tacoma, Washington, 98431, United States

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Low Back Pain; Myofascial Pain Syndromes; Emergencies

Interventions

Ketorolac; Acetaminophen; Ibuprofen; cyclobenzaprine; Bupivacaine; Saline Solution; Aftercare

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Joshua J Oliver, MD

  Madigan AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua J Oliver, MD

CONTACT

(360) 393-9024; joshua.j.oliver6.mil@mail.mil

Kyle S Couperus, MD

CONTACT

(315) 323-2029; kyle.s.couperus.mil@mail.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The two trigger point injection arms will be drawn-up and randomized by a research pharmacist prior to delivery to the Emergency Department. These two army will be Bupivacaine and Normal Saline, which are identical in appearence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Physician / Assistant Research Director Department of Emergency Medicine

Model Details: This will be a prospective three-armed randomized controlled trial. There will be no crossover. The first arm will be single blinded as it will be obvious to the investigators that it does not involve trigger point injections. The other two arms will be double blinded trigger point injections with either Bupivacaine or Normal Saline.

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 11, 2021
• Study Start: December 28, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)