Case Study:

Efficacy of EXO-MOVE ECM Therapy for Chronic Low Back Pain - 3 Participant Series with 12-Week Follow-Up

Author: Dr. Kade Hadley, DPM, DO

Affiliations: In collaboration with Utah Valley University – College of Health Science

Introduction

Background:

Chronic low back pain (CLBP) is a leading cause of disability worldwide and is often multifactorial in origin, including muscular dysfunction, degenerative disc disease, and soft tissue fibrosis. Conventional treatments such as analgesics, physical therapy, and injections frequently provide only symptomatic relief without addressing underlying structural deficits.

EXO-MOVE is a perinatal-derived extracellular matrix (ECM) flowable allograft intended to support musculoskeletal tissue repair and regeneration by providing a biologic scaffold for cellular attachment and migration, modulating inflammation, and promoting angiogenesis and remodeling.

Rationale:

Injection of EXO-MOVE ECM into soft tissue structures contributing to CLBP (e.g., paraspinal muscles, thoracolumbar fascia) may promote more complete healing, reduce pain, and improve function.

Objective

To evaluate the safety, tolerability, and preliminary efficacy of a single ultrasound-guided injection of EXO-MOVE ECM in patients with chronic low back pain with a 12-week follow-up.

Methods

1. Participant Selection

Inclusion criteria:

- Adults aged 30-65 years

- Chronic low back pain >3 months with soft tissue involvement

- Failure of conservative management (physical therapy, oral analgesics)

Exclusion criteria:

- Active infection

- Radicular pain due to a herniated disc requiring surgical intervention

- Recent corticosteroid injection <1 month

- Pregnancy or breastfeeding

2. Pre-Treatment Preparation

- Informed consent obtained

- Injection site prepped with chlorhexidine

- Optional local anesthetic administered

- Ultrasound guidance used to identify target structures (paraspinal musculature)

3. Treatment Protocol

- Product: EXO-MOVE ECM, 2-3 mL depending on extent of pathology

- Injection technique: Single ultrasound-guided injection into affected paraspinal muscles and / or thoracolumbar fascia

- Sterile technique adhered to throughout

4. Post-Procedure Care

- 15-minute observation for immediate reactions

- Aftercare instructions:

-- Mild soreness expected for 24-72 hours

-- Avoid strenuous activity for 3-5 days

-- No NSAIDs or alcohol for 72 hours post-injection

Secondary outcomes:

- Patient-reported improvement in function and activity tolerance

- Global satisfaction at 12 weeks

Results

Participant:

Participant 2:

Participant 3: xx [EXAMPLE (Age 65, KL grade II, baseline VAS 8): At 12 weeks, no adverse events. VAS improved to 2. Reported functional improvement though some evening pain persisted. Rated 'very satisfied.’]

Discussion

Safety:

EX: All 3 participants tolerated EXO-MOVE ECM injection without adverse events over 12 weeks.

Efficacy:

EX: Clinically meaningful reductions in pain and improvements in function capacity were observed.


These findings suggest that EXO-MOVE ECM may represent a promising biologic adjunct for patients with chronic tissue-related low back pain refractory to conservative care.

Limitation

- Small case series (n=3)

- Subjective self-reported outcomes

- No imaging

Conclusion

A single ultrasound-guided injection of EXO-MOVE ECM was safe, well-tolerated, and associated with clinically significant improvement in pain and function at 12 weeks in patients with chronic low back pain. Larger controlled studies with objective outcome measures are warranted.

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