## Protocol Section
### Identification Module
**NCT ID:** NCT03126279

**Brief Title:** fMRI and Central Sensitization in Chronic Knee Osteoarthritis. A Pre and Post TKR Study

**Official Title:** Predicting Chronic Post TKR Pain by Assessing Central Sensitisation Using Functional Brain MRI

#### Organization Study ID Info
**ID:** 10093
#### Organization
**Class:** OTHER
**Full Name:** University of Nottingham
### Status Module
#### Completion Date
**Date:** 2017-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-04-24

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-21

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-08

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2017-04-24
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-11
**Study First Submit QC Date:** 2017-04-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Aalborg University

**Class:** OTHER_GOV

**Name:** Medical Research Council

**Class:** OTHER

**Name:** Arthritis Research UK

**Class:** OTHER

**Name:** Royal College of Surgeons of Edinburgh

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Nottingham

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative temporal summation, a measure of central pain facilitation, has been shown to predict postoperative pain after total knee replacement surgery (TKR). The assessment of the brain's response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in identifying imaging biomarkers within the brain that map central sensitization changes seen in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop persistent post-operative pain. To test these concepts the study aims to functionally characterise the brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain and function will be performed 6 months post TKR surgery

### Conditions Module

**Conditions:**

- Osteoarthritis

- Pain

- Postoperative Pain

- Surgery

**Keywords:**

- Osteoarthritis

- Pain

- Postoperative Pain

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be recruited from orthopaedic preoperative clinics from those awaiting total knee replacement surgery.

**Intervention Names:**

- Procedure: Total Knee Replacement Surgery

**Label:** Preoperative Chronic Knee OA Patients

#### Arm Group 2

**Description:** Healthy volunteers will be recruited that are aged match to our OA patient cohort so meaningful comparisons regarding brain activity and pain sensitisation characteristics can be assessed.

**Label:** Healthy Volunteers

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Preoperative Chronic Knee OA Patients

**Description:** All chronic knee osteoarthritis patients will be recruited as they are on the NHS waiting list for a total knee replacement. Only this group will undergo the procedure

**Name:** Total Knee Replacement Surgery

**Other Names:**

- Total

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Using BOLD fMRI we aim to assess the difference in neural brain activity between patients with chronic knee OA pain and a group of healthy volunteers and to assess the reversal of this activity pattern 6 months post TKR surgery

**Measure:** Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer.

**Time Frame:** 6 months post total knee replacement surgery

#### Secondary Outcomes

**Description:** Pain using visual analogue scale

**Measure:** Assessment of knee pain using the Visual Analogue Scale for Pain (0-10)

**Time Frame:** 6 months post total knee replacement surgery

**Description:** pain and function outcome measure

**Measure:** Assessment of improvement in the Oxford Knee Score

**Time Frame:** 6 months post total knee replacement surgery

**Description:** quality of life index measure

**Measure:** Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire

**Time Frame:** 6 months post total knee replacement

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* OA Group

Unilateral Knee OA No previous knee surgery Able to give informed consent Age \> 40 years

- Healthy Volunteers Group

No OA or knee pain Able to give informed consent Age \> 40 years

Exclusion Criteria:

-OA Group

Major medical, psychiatric, neurological Cx Other chronic pain condition (fibromyalgia) Contraindications to MRI Active Cancer Neuropathic drug treatment

-Healthy Volunteers Group

Pregnancy Lower limb pain or previous knee surgery Contraindications to MRI Active Cancer Major medical, psychiatric, neurological condition

**Healthy Volunteers:** True

**Minimum Age:** 40 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with predominelaty unilateral knee osteoarthritis awaiting for total knee replacement surgery for pain will be included. Patients will recruited from Nottingham University Hospitals NHS Trust. Healthy volunteers will also be recruited as part of this study and they will be recruited from posters and advertisement within the university.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** thomas.kurien@nottingham.ac.uk

**Name:** Thomas Kurien, BMBS

**Role:** CONTACT

**Contact 2:**

**Email:** b.scammell@nottingham.ac.uk

**Name:** Brigitte E Scammell, FRCS

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nottingham

**Contacts:**

***Contact 1:***

- **Email:** thomas.kurien@nottingham.ac.uk

- **Name:** Thomas Kurien, MRCSEd

- **Role:** CONTACT

***Contact 2:***

- **Name:** Thomas Kurien, MRCSEd

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Brigitte E Scammell, FRCS

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Dorothee P Auer, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Kristian K Petersen, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Lars Ardent-Nielsen, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Thomas Graven-Nieslen, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** David A Walsh, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 9:***

- **Name:** Robert W Kerslake, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 10:***

- **Name:** Diane Reckziegel, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 11:***

- **Name:** Sarina Iwabuchi, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 12:***

- **Name:** William J Cottam, MSc

- **Role:** SUB_INVESTIGATOR

**Country:** United Kingdom

**Facility:** Academic Division of Trauma, Orthopaedics and Sports Medicine

**State:** Nottinghamshire

**Status:** RECRUITING

**Zip:** NG7 2UH

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Nottingham

**Name:** Dorothee P Auer, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: LOW

- As Found: Unknown

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000010149

- Term: Pain, Postoperative

### Misc Info Module

- Version Holder: 2024-05-24
