High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients
- Conditions
- Musculoskeletal - Other muscular and skeletal disordersNeurological - Other neurological disordersHigh-frequency spinal cord stimulation in patients with chronic back pain +/- leg pain following spine surgeryPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitation
- Registration Number
- ACTRN12614000665639
- Lead Sponsor
- Dr. Paul Verrills
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be degree of pain relief as determined by the patient via numerical rating scales for pain, as well as physician assessments.[A baseline assessment will be made prior to undergoing trial SCS implantation, followed by daily assessments during the temporary trial phase (6-14 days). Following permanent implantation, follow up assessments will be scheduled at 3, 6 and 12 months.]
- Secondary Outcome Measures
Name Time Method The secondary outcome measure will assess the impact of HF10 SCS on quality of life. This will be assessed via questionnaires addressing levels of depression, anxiety, stress, affected daily activities and daily analgesic use. Questionnaires will include medication use, DASS21, LANSS, ODI, GIC, SF-36 and Subject Satisfaction. <br>[A Baseline assessment will be made prior to undergoing trial SCS implantation, followed by an assessment at the end of the temporary trial phase (in 6-14 days). Following permanent implantation, assessments will be scheduled at 3, 6 and 12 months.]