Brain connectivity to optimise and assess noninvasive brain stimulation for central pain modulatio

Not Applicable

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases; Gonarthrosis [arthrosis of knee]

• Registration Number: ISRCTN15404076
• Lead Sponsor: niversity of Nottingham

Brief Summary

2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-073378 (added 17/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-24
• Last Update Posted: 30 October 2023
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 45

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified