High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients

A prospective, single-center, observational data collection study of high-frequency spinal cord stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000665639

Enrollment

100

Registered

2014-06-25

Start date

2013-11-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with persistent back pain and suspected mechanical instability are referred to spine surgeons for spine stability assessment and, if need be, stabilization surgery. A significant proportion of these patients fail however to derive adequate benefits from the surgery and these chronic pain patients are often left with few options. Traditional spinal cord stimulation (SCS) is a widely accepted, cost-effective therapy for patients with chronic pain, especially in patients with post-surgery back and leg pain. High-Frequency Spinal Cord Stimulation at 10 kHz (HF10 SCS) has established itself as a key treatment in treating patients with chronic back pain: data from European pain centers has shown that HF10 SCS is safe and effective at reducing pain, improving function and sleep, and reducing opioid in patients with predominant back pain. HF10 SCS has been used in Australia to treat chronic pain ever since its TGA approval, especially back and leg pain patients. The purpose of this non-interventional data collection study is to collect data on the improvement in pain relief and quality of life associated with HF10 SCS, as used in the clinic routine practice in patients with chronic back pain following back surgery.

Interventions

Twelve month observation of patients implanted with the Senza System for management of chronic back pain +/- leg pain following spinal surgery via spinal cord stimulation.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. undergone spine surgery that resulted in back pain. 2. => 18 years of age 3. Diagnosed with back pain or back pain plus leg pain for at least 6 months 4. Back pain intensity is at least 5 out of 10 5. Undergoing treatment for back pain or back pain plus leg pain 6. Meet the requirements for being an HF10 SCS trial candidate as per the center practice 7. Willing and able to complete protocol requirements including: a) Willing and able to complete health questionnaires and pain scales as specified in the protocol b) Willing and able to sign the study-specific Informed Consent form

Exclusion criteria

1. plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study

Outcome results