Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
Current interventions as of 01/06/2023:
Six research visits for pain-free healthy control pilot (baseline, 4 days intermittent theta-burst stimulation [TBS]/sham over 3-5 weeks).
Six research visits o
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/08/2023: 1. 18-75 years of age and able to consent 2. Chronic knee pain (minimum 6 months duration) with VAS score >=4/10 3. Able to accommodate the study visits without disruption to their jobs or other responsibilities and without experiencing excessive physical strain or other distress. Previous inclusion criteria from 01/06/2023 to 21/08/2023: 1. 18-75 years of age and able to consent 2. Chronic knee pain (minimum 6 months duration) with VAS score =4/10 3. Predominant knee pain 4. Able to accommodate the study visits without disruption to their jobs or other responsibilities and without experiencing excessive physical strain or other distress. Previous inclusion criteria: 1. 18-75 years of age 2. Chronic knee pain (minimum 6 months duration) with VAS score =4/10 3. Predominant knee pain 4. Reporting low mood, high anxiety or pain catastrophizing with scores above population average in one of three domains (mood, anxiety, PCS) 5. Able to accommodate the study visits without disruption to their jobs or other responsibilities 6. Able to come for the study visits without experiencing excessive physical strain or other distress. 7. Able to consent 8. No contraindication to MRI 9. No contraindication to TMS 10. Must be free from major medical or neurological conditions unrelated to the pain condition
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/08/2023: 1. Contraindication to MRI and TMS 2. Major medical or neurological conditions unrelated to the pain condition 3. Scheduled for total knee replacement surgery (TKR) within 1 month of study visits or other considerable treatment change 4. Change in pain medication in the past four weeks 5. On centrally active medication other than stable antidepressants or on opioidergic analgesic treatment 6. On medication, alcohol or recreational drugs thought to increase risk of seizure and/or syncope 7. Experiencing frequent headaches Previous exclusion criteria from 01/06/2023 to 21/08/2023: 1. Contraindication to MRI or contraindication to TMS 2. Major medical or neurological conditions unrelated to the pain condition 3. Scheduled for total knee replacement surgery (TKR) within 1 month of study visits or other considerable treatment change 4. Unstable pain medication over the past 4 weeks, or on centrally active medication other than stable antidepressants or on opioidergic analgesic treatment 5. Patients on medication, alcohol or recreational drugs, thought to increase risk of seizure and/or syncope 6. Patients experiencing frequent headaches Previous exclusion criteria: 1. Scheduled for total knee replacement surgery (TKR) within 1 month of study visits or other considerable treatment change 2. Claustrophobia 3. Safety concerns regarding TMS or MRI 4. Unstable pain medication over the past 4 weeks 5. Centrally active medication other than stable antidepressants or non-opioidergic analgesic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 04/05/2023: 1. Variance of changes in pre-selected neuroimaging functional markers of the descending pain modulatory system (MRI) at final (T6) vs baseline visit (T1) 2. Variance of change in conditioned pain modulation (pain intensity change with/without conditioned pain stimulus) (QST) at final vs baseline visit 3. Number of participants recruited and retained on the trial 4. Number of iTBS sessions completed at 80% RMT (TMS data collected T2-T4) Previous primary outcome measures: 1. Brain activity and connectivity changes in areas of the descending pain modulatory system measured using MRI (3Tesla): 0.5 – 1 hour duration (1.5 hours for controls), at baseline and 2 weeks 2. Extent of conditioned pain modulation (pain intensity change with/without conditioned pain stimulus): quantitative sensory testing for conditioned pain modulation (CPM) and temporal summation of pain (TSP) at baseline and 2 weeks 3. Number of participants recruited and retained on the trial, measured at the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/05/2023: 1. Variance of change in reported pain intensity, burden and catastrophizing (ICOAP, PCS) at final versus baseline study visit 2. Change in negative affect (HADS) at final versus baseline study visit 3. Variance in physiological and psychophysical changes (acute experimental pain) at final vs baseline study visit 4. Variance of PROMS (daily online recording pain, wellbeing, sleep) over 16 weeks from treatment versus enrolment-baseline Previous secondary outcome measures: 1. Physiological and psychophysical effects (acute experimental pain) measured at the final study visit 2. Reported pain intensity, burden and catastrophizing measured using Intermittent and Constant Osteoarthritis Pain (ICOAP), Pain Catastrophizing Scale (PCS) questionnaires at baseline and 2 weeks 3. Mood measured using Depression Anxiety Stress Scale-21 (DASS21) at baseline and 2 weeks 4. Anxiety measured using Hospital Anxiety and Depression Scale (HADS) at baseline and 2 weeks 5. Patient-Reported Outcome Measures (PROMs) (daily online recording pain, wellbeing, sleep) measured over 16 weeks from treatment versus enrolment-baseline 6. Pain phenotype measured using Quantitative Sensory Testing (QST) at baseline and 2 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed