Analgesic treatment of knee osteoarthritis and endometriosis Signs and Symptoms
Conditions
Interventions
Neurostimulation of a novel nerve target
Patients with knee pain due to knee OA and patients with pelvic pain due to endometriosis will have insertion of a commercially available stimulation device o
Sponsors
ABVF B.V.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for both knee and pelvic pain: 1. Agree to maintain a stable dose of analgesics 30 days prior to enrolment. 2. Willing to hold their usual analgesic medication constant throughout the study. 3. Able and willing to comply with the follow-up schedule and protocol. 4. Previously tried and failed at least one conservative treatment for chronic pain, including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for persistent pain. 5. Been deemed suitable for the study by the pain MDT. 6. Willing to provide informed consent. 7. Maximum daily dose of 90 mg morphine equivalents. If the patients are taking more than this dose, they will be offered a referral to an opioid reduction clinic to achieve the target opioid dose, and the baseline opioid will be taken as the dose on referral. 8. In the investigator’s opinion, the patient is a suitable candidate for LSC stimulation. 9. Participants diagnosed with persistent refractory pelvic pain secondary to endometriosis for at least 6 months OR knee pain secondary to OA for at least 6 months. 10. Subject is able to distinguish between primary pain (knee or pelvis) from other sources of pain. Inclusion criteria for knee pain secondary to osteoarthritis: 1. Male or non-pregnant female aged 30-75 years with chronic moderate to severe knee pain due to OA (baseline pain diary scores of = 6 of 10 on NRS for knee pain). 2. If female and of child-bearing age, willing to use contraception throughout the trial. Inclusion criteria for pelvic pain secondary to endometriosis: 1. Pre-menopausal women aged 18 to 50 years old. 2. If of childbearing age, willing to use contraception throughout the trial. 3. Recurrent symptoms suggestive of superficial peritoneal endometriosis (ASRM stage 1 or 2) identified during laparoscopy, confirmed via biopsy and performed within the last 5 years, who prefer not to undergo repeat surgery. OR Symptoms suggestive of ovarian endometrioma seen on ultrasound or MRI with cyst =3 cm in diameter. 4. If on hormonal therapies, they must be on a stable dose for at least 90 days prior to implant and agree to maintain a stable dose throughout the study. 5. Baseline pain diary scores of =6 of 10 on NRS for pelvic pain.
Exclusion criteria
Exclusion criteria: Exclusion criteria for both knee and pelvic pain: 1. Female participants of childbearing potential who are pregnant/nursing or plan to become pregnant during the course of the trial. 2. Escalating or changing pain condition within the past month as evidenced by investigator examination. 3. Has a psychiatric or psychological condition that would interfere with participation in the study. 4. Have a history of major depression, severe anxiety or post-traumatic stress disorder within 2 years of screening or a history of other major psychiatric disorders. 5. Chemical sympathectomy treatment within the past 6 months. 6. Currently has an active implantable device such as a pacemaker, spinal cord stimulator or intrathecal drug delivery system. 7. In the investigator’s opinion has an active infection. 8. Participated in another clinical investigation within 30 days. 9. Medical co-morbidities that preclude surgical intervention. 10. Patient is incapable of understanding or responding to the study questionnaires. 11. Patient is incapable of understanding or operating the patient programmer handset. 12. Patient has a BMI > 45kg/m2 with obesity related comorbidity. 13. Participant has a current or previous condition, which will probably require MRI investigation sometime in the following 2 years. 14. Participant has another predominant persistent painful condition other than persistent refractory pelvic pain or knee pain. 15. History of alcohol/IV drug abuse in the last 3 years. 16. History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders. 17. Any anxiolytic beta blocker dosage exceeding 40 mg/day. Dosage must be stable for at least 3 months prior to enrolment. 18. Known postural hypotension, bradycardia or cardiac arrhythmia. 19. History of refractory hypotension or vasovagal syncope. 20. Severe DASS-21 scores of =21 for depression, =15 for anxiety or =26 for stress. 21. Within the past 6 months have tried interventional pain procedures for persistent pain. Exclusion criteria for pelvic pain secondary to endometriosis: 1. Diagnosis of Irritable Bowel Syndrome (IBS) diagnosed by a qualified physician using the ROME 4 criteria, with the IBS identified as a predominant pain generator. 2. Diagnosis of Painful Bladder Syndrome as determined by O’Leary-Sant questionnaire with combined symptom and problem scores (symptoms + problem index) of =12. Exclusion criteria for knee pain: 1. Hip pain is greater than or equal to knee pain. 2. Previous joint replacement of the target knee(s) for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with knee OA: 1. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at 30, 60, 90 and 180 days. The WOMAC is a self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness, and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire that assesses the amount of pain experienced due to OA of an index joint (knee or hip) during the past 48 hours. It is calculated as the mean of scores from 5 questions, which may not be a whole (integer) number. Scores for each question on the WOMAC Pain subscale are scored on a five-point scale ranging from 0 (no pain) to 4 (extreme pain), where higher scores indicate higher pain. 2. Change from baseline in WOMAC Physical Function Subscale at 30, 60, 90 and 180 days. Physical function refers to the patient’s ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in an index joint (knee or hip) during the past 48 hours. It is calculated as a mean of the scores from 17 individual questions, which may not be a whole (integer) number. Scores for each question on the WOMAC physical function subscale are scored on a five-point scale ranging from 0 (no difficulty) to 4 (extreme difficulty), where higher scores indicate extreme difficulty/worse physical function. 3. Change from baseline in Knee Injury and OsteoArthritis Outcome Score (KOOS) at 30, 60, 90 and 180 days. 4. Change from baseline in the following tests: knee range of motion (ROM), knee swelling, and ambulation ability at 30, 60, 90 and 180 days. (These outcomes may be captured retroactively if the referring physician has captured these data as part of their standard of care). Patients with pelvic pain secondary to endometriosis: 1. Change from baseline in the Endopai | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactArun Sridhar
Outcome results
None listed