Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Terminated

Conditions: Causalgia of Upper Limb; Dorsal Root Ganglion Stimulation; Pain in Limb, Hand, Foot, Fingers and Toes

Study type: Observational

Funder types: Other

Identifiers

NCT02553876

AMS-01-2015

Details and patient eligibility

About

There are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. The investigators propose to investigate the effect of dorsal root stimulation in patients with chronic hand or upper limb pain.

Full description

Dorsal Root Ganglion (DRG) stimulation is a form of Spinal Cord Stimulation (SCS), which has been available and used for the treatment of chronic pain in Europe since late 2011. Clinical practice and pre/post market studies have shown that stimulation of the DRG can significantly reduce chronic intractable pain of various aetiologies. However, there are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. Furthermore, there are very few studies of SCS generally, in an upper limb pain population, despite this being a group often referred for and treated with SCS in tertiary, interventional pain practices. Due to several limitations of traditional SCS systems, chiefly concerning the stability of stimulation induced paraesthesia, DRG stimulation is being increasingly utilised in its place for this condition.

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Subject is appropriate for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
• Subject is >18 to <75 years old.
• Subject is able and willing to comply with the follow-up schedule and protocol
• Subject has chronic (> 6 months) uni/bi-lateral pain, primarily in the upper limb(s)
• (Arm and/or Hand)
• Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
• Documented, successful paraesthesia mapping of transient stimulation over painful anatomy
• Subject is able to provide written informed consent

Exclusion criteria

• Subject has no other exclusion criteria for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
• Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
• Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
• Subject has participated in another clinical study within 30 days
• Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
• Subject has had a complete or partial amputation of the painful upper limb(s) and is experiencing phantom and/or stump pain post amputation

Trial design

5 participants in 1 patient group

Observational

Description:

All patients referred with pain in the hand and/or upper limb will be evaluated. Patients will first be assessed for suitability for neurostimulation implantation and then included in the study. Patients wiil fill in questionnaires (pain scores, Quality of Life and satisfaction) at baseline and post-operatively at regular intervals (as per standard of care in the Netherlands.)