Neuroscience Education on Osteoarthritis

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Procedure: MT + NE; Procedure: MT + E

• Registration Number: NCT02246088
• Lead Sponsor: University of Valencia

Brief Summary

Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders).There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking.

The primary aim of this study is to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:

* Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;

* Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;

* Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.

Detailed Description

Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Pathophysiological mechanisms underlying central sensitisation are complex and numerous, but the net effect is an amplification of neural signaling within the CNS than elicits pain hypersensitivity. Central sensitization management is an area of great interest at least in a subgroup of patients with OA pain.

Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders). Moreover, some clinical guides to help clinicians to identify and explain central sensitization through NE, have been recently published. However, this kind of intervention has never been tested specifically for chronic pain related to OA.

Preoperative education centered on a biomedical model of anatomy and pathoanatomy as well as procedural information has limited effect in reducing postoperative pain after total hip arthroplasty and total hip arthroplasty surgeries. Preoperative educational sessions that aim to increase patient knowledge of pain science (i.e. NE) may be more effective in managing postoperative pain. NE is a cognitive-based educational intervention that aims to reduce pain and disability by helping patients gain an increased understanding of the biological processes underpinning their pain state. There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking.

Joint mobilization has been shown to be a useful modality to reduce pain related to osteoarthritis. Regarding the knee joint, two recent systematic reviews demonstrated the usefulness of manual therapy and exercise for the management of knee OA. Moreover, Deyle et al reported a preliminary clinical prediction rule which may help to identify the minority of knee OA patients who are unlikely to respond to this management approach.

The primary aim of this study is therefore to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:

* Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;

* Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;

* Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-19
• Last Update Submitted: 2014-09-19
• Study First Posted: 2014-09-22
• Last Update Posted: 2014-09-22
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. An established diagnosis of knee OA according to American College of Rheumatology criteria and Kellgreen/Lawrence scale grades.
2. To be in a waiting list and scheduled to undergo primary knee arthroplasty.
3. To have sufficient Spanish language skills to comprehend all explanations and to complete the assessment tools.

Exclusion Criteria

1. Previous knee joint replacement surgery of the affected joint or any other lower limb surgery within the past 6 months.
2. Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
3. Presence of co-morbidities associated with cognitive impairment.
4. Co-existing inflammatory, metabolic, neurological or severe medical conditions, defined as a diagnosis in the medical record severe enough that the patient cannot participate fully in the study procedures (i.e. cardiovascular disease).
5. Functional illiteracy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT + NE	MT + NE	A manual therapy (MT) intervention combined with neuroscience education (NE)
MT + E	MT + E	Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E)

Primary Outcome Measures

Name	Time	Method
Endogenous analgesia through the experimental protocol of conditioned pain modulation	Up to 3 months	For assessing endogenous analgesia, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation will be applied. Recently, the term conditioned pain modulation has been recommended to describe the psychophysical paradigm of Diffuse Noxious Inhibitory Control system in humans

Secondary Outcome Measures

Name	Time	Method
Chronic Pain Acceptance Questionnaire (Spanish version)	Up to 3 months
Central Sensitization Inventory	Up to 3 months	Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory
Pressure Pain Thresholds	Up to 3 months	Local and distant sites will be chosen for pressure pain threshold measurement. Regarding local sites, two points will be measured from the knee, 3 cm medial and lateral to the midpoint of the medial and lateral edge of patella, respectively. Regarding control site, a distant site will be used to assess systematic analgesic effect of NE at 5 cm distal to lateral epicondyle.
Goniometric assessment of knee flexion and extension range of motion	Up to 3 months
Tampa Scale of Kinesiophobia (TSK) (Spanish version)	Up to 3 months
Health-related quality of life using the self-reported Spanish version SF-36 questionnaire	Up to 3 months
Chronic Pain Coping Inventory-42 (Spanish version)	Up to 3 months
Strength of the hamstrings and quadriceps muscles	Up to 3 months
Timed "Up & Go" (TUG) Test	Up to 3 months	Participants will be required to rise from a standard arm chair, walk at a safe and comfortable pace to a mark 3 m away and then return to a sitting position in the chair. The outcome of the test will be the time to complete the task. Time will be measured on a stopwatch to the nearest one-hundredth of a second.
Pain at rest and in the last 24 hours	Up to 3 months	Participants will be asked to rate their pain at rest and in the last 24 hours on a horizontal 100-mm visual analogue scale (VAS). The horizontal line anchors will be "no pain" and "worst imaginable pain". The VAS is a valid and reliable instrument compared with other pain rating scales and has been well established in clinical practice and research for measuring pain levels in arthritis populations.
Western Ontario and McMaster osteoarthritis index (WOMAC scale)	Up to 3 months	WOMAC assesses pain, stiffness and physical function and can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.
Pain Catastrophization Scale (PCS) (Spanish version)	Up to 3 months

Trial Locations

Locations (1)

Hospital Universitario de La Ribera; 🇪🇸 Alcira, Valencia, Spain