A clinical study to evaluate HF10™ therapy in patients with chronic post-surgical shoulder pai

Not Applicable

Recruiting

• Conditions: Chronic post-surgical shoulder neuropathic pain; Nervous System Diseases

• Registration Number: ISRCTN12092812
• Lead Sponsor: evro Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-01
• Last Update Posted: 29 April 2019
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Chronic post-surgical pain, neuropathic in origin from joint surgery of the shoulder (e.g., arthroscopic stabilization, rotator cuff repair, arthroscopic acromioclavicular joint debridement, subacromial decompression, shoulder joint replacement), which has been refractory to conservative therapy for a minimum of 3 months and is >6 months post-surgery
2. Average pain intensity of =5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
3. Single or bilateral region joint post-surgery pain
4. Aged 18 years or older at time of enrollment
5. Neuropathic pain as clinically determined by the investigator or the DN4 questionnaire.
6. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the Baseline Visit
7. Meets the requirements for being an HF10 Therapy trial candidate as per the center’s practice which may include psychological evaluation
8. Willing and able to complete health questionnaires and pain scales as specified in the protocol
9. Capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English

Exclusion Criteria

1. Prosthesis failure for shoulder joint replacement patients, including, but not limited to structural, material and alignment conditions as determined by a qualified surgeon
2. Has plans to enroll in another clinical study during their participation in this study, or is currently enrolled in an interventional clinical study that could interfere in participation in this study or affect the scientific soundness of this study
3. Medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia)
4. Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by either the treating physician or a psychologist
5. Current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, and/or central deafferentation syndrome as determined by the Investigator
6. Current diagnosis of a coagulation disorder, bleeding diathesis that would put subject at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease, or uncontrolled diabetes mellitus as determined by the Investigator
7. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) or clinical back instability with surgically unstable spondylolisthesis that would disrupt/obliterate the posterior epidural space as determined by the Investigator
8. Condition currently requiring or likely to require the use of diathermy
9. Metastatic malignant disease or active local malignant disease
10. Life expectancy of less than 1 year
11. Active systemic or local infection

Study & Design

• Study Type: Observational
• Study Design: Not specified