Clinical Trials Logo
  1. Home
  2. Chronic Low Back Pain
  3. NCT04786145

Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain — COPE  

Chronic Low-back Pain Clinical Trial

Official title:
Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial

Clinical Trial Summary

This study will provide information on the effectiveness of cryoneurolysis for patients with facet joint pain syndrome, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.

Clinical Trial Description

Background: Low-back pain, including facet joint pain, accounts for up to 20 percent of all sick leaves in Denmark; among these are patients with facet joint pain syndrome. A proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome Methods: A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity >50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is a reduction in low-back pain intensity and an impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory). Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04786145
Study type Interventional
Source University of Aarhus
Contact
Status Active, not recruiting
Phase N/A
Start date February 15, 2020
Completion date October 1, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05963451 - Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Completed NCT04283370 - A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain N/A
Completed NCT04824547 - Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals N/A
Completed NCT04046419 - In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
Completed NCT04399772 - COgNitive FuncTional Therapy+ for Chronic Low Back paIn N/A
Recruiting NCT05780021 - Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation N/A
Completed NCT04555278 - Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain N/A
Completed NCT04530071 - Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain Phase 1/Phase 2
Not yet recruiting NCT06080464 - Clinician Satisfaction With the VERABAND™ N/A
Not yet recruiting NCT06347328 - The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain N/A
Not yet recruiting NCT04940715 - Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain N/A
Recruiting NCT04683718 - A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management N/A
Recruiting NCT05724160 - Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain N/A
Recruiting NCT06030128 - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults N/A
Recruiting NCT05846087 - Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia N/A
Active, not recruiting NCT05396014 - The BEST Trial: Biomarkers for Evaluating Spine Treatments Phase 4
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Completed NCT05512338 - Motivation and Adherence to Exercise Recommendations N/A
Recruiting NCT05021146 - Essential Oil for Chronic Low Back Pain N/A
Completed NCT05120921 - Osteopathic Single CAse Research for Patients With Chronic Low Back Pain N/A