Percutaneous Intradiscal Hydrogel Implantation Versus Sham Control for Chronic Discogenic Low Back Pain: A Randomized Controlled Double-Blind Trial.

BACKGROUND

Degenerative disc disease is a leading cause of low back pain. Conservative treatments like pain medication and exercise therapy have shown mixed results, while procedures like fusion surgery carry risks such as adjacent segment disorder and surgical morbidity. Therefore, there is a critical need for treatments that bridge the gap between conservative care and surgery.

OBJECTIVE

To assess the efficacy of intradiscal hydrogel implantation compared with sham treatment of intradiscal injection of saline in patients with chronic discogenic low back pain.

STUDY

DESIGN

Prospective, double-blind, randomized, controlled, multicenter trial.

SETTING

Two tertiary interventional pain care centers in Switzerland and in the Netherlands.

METHODS

Forty-nine patients with chronic discogenic low back pain unresponsive to conservative treatment were randomized to receive either intradiscal hydrogel implantation or a sham treatment. Control Group patients could cross over to hydrogel treatment after 6 months. The primary outcome was pain improvement at 6 months. Secondary outcomes included disability, quality of life, employment status, Patient Global Impression of Change score, analgesic use, disc space height, and disc degeneration. Adverse events were continually assessed.

RESULTS

At 6 months postprocedure, the Hydrogel Group patients had improved pain scores compared to Control Group patients, though not statistically significant (P = 0.070). Six out of 24 patients in the Hydrogel Group reported much improvement on their Patient Global Impression of Change scores, compared to 0 out of 25 in the Control Group (P = 0.008). Within-group disability improvements were statistically significant in the Hydrogel Group but not in the Control Group. No significant differences were found between groups in disability, quality of life, or employment status. Only one serious adverse event was reported-a patient from the Hydrogel Group was hospitalized due to a possible exacerbation of low back pain 6 days postprocedure.

LIMITATIONS: This trial's limitations include strict eligibility criteria and questions about the validity of intradiscal saline as a placebo.

CONCLUSIONS

This trial suggests that percutaneous intradiscal hydrogel implantation may reduce chronic discogenic pain and disability, with significant Patient Global Impression of Change improvements, though larger trials are needed to confirm efficacy.