Back pain - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

The Leeds Teaching Hospitals NHS Trust

Recruitment countries:

United Kingdom

Health condition studied:

Palliative Care

URL:

Link to the clinical trial website

About the trial

Interventions:

Device: Senza Spinal Cord Stimulation system

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  I. Patient is 18 years of age or older and has given written informed consent. II. Has
  persistent chronic predominant low back pain of neuropathic origin, with or with out
  radiculopathy, for a minimum of 6 months III. Visual Analogue Scale (VAS) back pain score
  of at least 50 mm at baseline IV. Confirmation of pain from neuropathic origin by SLANSS
  score (=12) AND PainDETECT score( =19) V. Total daily dose of opioids equivalent to =200mg
  of Morphine VI. No previous open spinal surgery (percutaneous procedures such as
  nucleoplasty are not considered as open surgical procedures) VII. Failed conservative
  therapies such as physiotherapy, chiropractor, hydrotherapy, TENS.
  
  VIII. MRI within the previous 18 months (as per standard care) IX. In the investigators
  opinion the patient is a suitable candidate for HF10
  
  Exclusion Criteria:
  
  I. Patient has mechanical spine instability based on flexion/extension testing of lumbar
  spine (documented in the last 6 months) II. Patient is pregnant, or pregnancy is suspected
  or planned within the first six months of the study timeframe.
  
  III. Patient has a cardiac pacemaker, automatic defibrillator, or any other implanted
  device, which will make the trial impossible. IV. Allergy to device components or drugs to
  be used in the intended procedure. V. Medical co-morbidities that preclude surgical
  intervention. VI. Patient is incapable of understanding or responding to the study
  questionnaires VII. Patient is incapable of understanding or operating the patient
  programmer handset.
  
  VIII. History of previous open spinal surgery (not percutaneous procedures) IX. Patient is
  morbidly obese (BMI = 40). X. Patient is simultaneously participating in another device or
  drug study within the last 30 days.
  
  XI. Patient has a spinal fracture, tumour or infection. XII. Clinical evidence of cauda
  equina syndrome. XIII. Progressive neurologic deficit.
  

• Age minimum: 18 Years
• Age maximum: 100 Years
• Gender: Both

Primary outcomes:

50% reduction in patient reported numerical rating score for pain
50% reduction in patient reported Visual analogue scale for pain

Secondary outcomes:

Target sample size:

25

Study type:

Interventional

Study design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Contacts:

• Name: G Baranidharan, MBBS
• Address:
• Phone:
• Email: g.baranidharan@nhs.net
• Affiliation:

• Name: R&I Administrator
• Address:
• Phone: 0113 392 0152
• Email: leedsth-tr.lthtresearch@nhs.net
• Affiliation:

Technical details

Scientific title:

Rospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT02689375

Secondary ID:

PM13/10904

Register:

ClinicalTrials.gov

Date of registration:

11/02/2025

Date of first enrollment:

February 2015

Last refreshed:

14 March 2024