Diabetic peripheral neuropathy treatment with dorsal root ganglion stimulation – the PENTAGONS trial
- Conditions
- Painful diabetic neuropathyNervous System Diseases
- Registration Number
- ISRCTN40062191
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 2
Current inclusion criteria as of 17/12/2018:
The participant may enter the trial if ALL of the following apply:
1. Participant is willing and able to give informed consent for participation in the trial
2. Male or Female, aged 18 years or above
3. Diagnosed with PDN of the feet, present for at least 6 months and scoring at least 50mm on a pain VAS despite medical treatment
4. Score of at least 2 out of 10 using the Michigan Neuropathy Screening Instrument for peripheral neuropathy (see Appendix D)
5. Participant has tried at least two first-line pharmacotherapy options and either is refractory to painkilling medication, or the required dose of medication to alleviate pain causes severe side effects. These should include at least one antiepileptic (gabapentin or pregabalin), and at least one antidepressant (amitriptyline or duloxetine)
6. Stable analgesic medication regimen for at least 4 weeks prior to trial entry. This includes patients not taking analgesics at all (either because they are refractory, or because side effects are too severe)
7. Female participants of child bearing potential must be willing to either state prior to enrolment that there is no chance that they could be pregnant, or if there is a chance that they might be pregnant, to undergo a pregnancy test. This is because the insertion of a DRGS system requires X-ray fluoroscopy that might be harmful to a developing foetus
8. If, in the Investigator’s opinion, the patient is able and willing to comply with all trial requirements
9. If, in the opinion of a consultant anaesthetist after review of case notes and medical history, there are no contraindications to DRGS surgery
10. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial
Previous inclusion criteria:
The participant may enter the trial if ALL of the following apply:
1. Participant is willing and able to give informed consent for participation in the trial
2. Male or Female, aged 18 years or above
3. Diagnosed with PDN of the feet, present for at least 6 months and scoring at least 50mm on a pain VAS despite medical treatment
4. Score of at least 2 out of 10 using the Michigan neuropathy screening instrument for peripheral neuropathy (see Appendix C)
5. Participant has tried at least two first-line pharmacotherapy options and either is refractory to painkilling medication, or the required dose of medication to alleviate pain causes severe side effects. These should include at least one antiepileptic (gabapentin or pregabalin), and at least one antidepressant (amitriptyline or duloxetine)
6. Stable analgesic medication regimen for at least 4 weeks prior to trial entry. This includes patients not taking analgesics at all (either because they are refractory, or because side effects are too severe)
7. Female participants of child bearing potential must be willing to either state prior to enrollment that there is no chance that they could be pregnant, or if there is a chance that they might be pregnant, to undergo a pregnancy test. This is because the insertion of a DRGS system requires X-ray fluoroscopy that might be harmful to a developing foetus
8. If, in the Investigator’s opinion, the patient is able and willing to comply with all trial requirements
9. If, in the opinion of a consultant anaesthetist after review of casenotes and medical history, there are no contraindications to DRGS surgery
10. Willing to allow his or her General Practi
Current exclusion criteria as of 17/10/2019:
The participant may not enter the trial if ANY of the following apply:
1. Female participant who is pregnant or planning pregnancy during the course of the trial.
2. Lack of good understanding of both written and spoken English. Most of the outcome measures, including the primary outcome measure, are in the form of questionnaires and these require good understanding of written English in order to provide valid measures. Fluent spoken English is needed during the implantation procedure when the participant is asked to confirm that the stimulation effect can be felt in the painful area.
3. Active infection other than viral infections that are mild and confidently expected to be self-limiting within two weeks (e.g. common colds)
4. Anticoagulant treatment or other coagulopathy
5. Diabetic ulcers at the time of, or in the 3 months prior to, recruitment
6. Participant rates their pain consistently as 10 out of 10, even on their best day. This indicates a failure to understand the principles of VAS use, or pain catastrophisation, either of which will confound pain scoring
7. Significant pain elsewhere in the body from any condition, which the participant is not easily able to rate separately from their foot pain. Participants must be able to clearly rate their foot pain alone and will be excluded if in the opinion of the Investigator they are unable to do so
8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
9. Opiate use greater than the maximum recommended amount for non-cancer pain (120mg morphine or equivalent per 24 hours)
10. Participation in a clinical trial of an investigational medicinal product (CTIMP) in the past 12 weeks
11. Previous lumbar spine surgery at or below the level of the third lumbar vertebra (L3). This is because the scarring following lumbar spine surgery frequently makes it impossible to pass a DRG wire
12. Previous failed Spinal Cord Stimulation therapy or other neuromodulation treatment
13. Previous lumbar or sacral radiofrequency nerve lesioning
14. Inability to have a preoperative MRI scan, either due to claustrophobia or due to the presence of a contraindication to MRI scanning
15. A previously performed MRI scan shows a contraindication to DRG lead insertion (if previous MRI scans are available they should be reviewed at this stage, prior to randomisation, to confirm no contraindication is present)
16. Body Mass Index (BMI) > 30
17. Patient is undergoing psychological therapy
Previous exclusion criteria as of 17/12/2018:
The participant may not enter the trial if ANY of the following apply:
1. Female participant who is pregnant or planning pregnancy during the course of the trial.
2. Lack of good understanding of both written and spoken English. Most of the outcome measures, including the primary outcome measure, are in the form of questionnaires and these require good understanding of written English in order to provide valid measures. Fluent spoken English is needed during the implantation procedure when the participant is asked to confirm that the stimulation effect can be felt in the painful area.
3. Active infection other than viral infections that are mild and confidently expected to be self-limiting within two weeks (e.g. common colds)
4. Anti
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method