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Neuroscience Education on Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MT + NE
MT + E
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Central Nervous System Sensitization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de La RiberaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MT + NE

MT + E

Arm Description

A manual therapy (MT) intervention combined with neuroscience education (NE)

Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E)

Outcomes

Primary Outcome Measures

Endogenous analgesia through the experimental protocol of conditioned pain modulation
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

Pain at rest and in the last 24 hours
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.
Pressure Pain Thresholds
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.
Western Ontario and McMaster osteoarthritis index (WOMAC scale)
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.
Health-related quality of life using the self-reported Spanish version SF-36 questionnaire
Tampa Scale of Kinesiophobia (TSK) (Spanish version)
Pain Catastrophization Scale (PCS) (Spanish version)
Chronic Pain Coping Inventory-42 (Spanish version)
Chronic Pain Acceptance Questionnaire (Spanish version)
Goniometric assessment of knee flexion and extension range of motion
Strength of the hamstrings and quadriceps muscles
Timed "Up & Go" (TUG) Test
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.
Central Sensitization Inventory
Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory

Full Information

First Posted
September 15, 2014
Last Updated
September 19, 2014
Sponsor
University of Valencia
Collaborators
Hospital de la Ribera
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1. Study Identification

Unique Protocol Identification Number
NCT02246088
Brief Title
Neuroscience Education on Osteoarthritis
Official Title
Effect of Neuroscience Education on Subjects With Chronic Knee Pain Related to Osteoarthritis : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Hospital de la Ribera

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Central Nervous System Sensitization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT + NE
Arm Type
Experimental
Arm Description
A manual therapy (MT) intervention combined with neuroscience education (NE)
Arm Title
MT + E
Arm Type
Active Comparator
Arm Description
Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E)
Intervention Type
Procedure
Intervention Name(s)
MT + NE
Intervention Description
Manual therapy will be applied using mobilization with movement (MWM) techniques. MWM will consist of a sustained manual glide of the tibia (either medial, lateral, anterior, posterior, or rotation) during active knee flexion and extension, depending on which are the limited/painful movements for each patient. The content and pictures of the neuroscience education (NE) will be based on the text "Explicando el dolor" (Spanish version of "Explain Pain").
Intervention Type
Procedure
Intervention Name(s)
MT + E
Intervention Description
Program of education based on the traditional biomedical model (i.e. through visualization of several videos related to anatomy, biomechanics and surgical procedure of the knee), plus the same manual treatment as per the MT+NE group
Primary Outcome Measure Information:
Title
Endogenous analgesia through the experimental protocol of conditioned pain modulation
Description
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
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Pain at rest and in the last 24 hours
Description
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.
Time Frame
Up to 3 months
Title
Pressure Pain Thresholds
Description
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.
Time Frame
Up to 3 months
Title
Western Ontario and McMaster osteoarthritis index (WOMAC scale)
Description
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.
Time Frame
Up to 3 months
Title
Health-related quality of life using the self-reported Spanish version SF-36 questionnaire
Time Frame
Up to 3 months
Title
Tampa Scale of Kinesiophobia (TSK) (Spanish version)
Time Frame
Up to 3 months
Title
Pain Catastrophization Scale (PCS) (Spanish version)
Time Frame
Up to 3 months
Title
Chronic Pain Coping Inventory-42 (Spanish version)
Time Frame
Up to 3 months
Title
Chronic Pain Acceptance Questionnaire (Spanish version)
Time Frame
Up to 3 months
Title
Goniometric assessment of knee flexion and extension range of motion
Time Frame
Up to 3 months
Title
Strength of the hamstrings and quadriceps muscles
Time Frame
Up to 3 months
Title
Timed "Up & Go" (TUG) Test
Description
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.
Time Frame
Up to 3 months
Title
Central Sensitization Inventory
Description
Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An established diagnosis of knee OA according to American College of Rheumatology criteria and Kellgreen/Lawrence scale grades. To be in a waiting list and scheduled to undergo primary knee arthroplasty. To have sufficient Spanish language skills to comprehend all explanations and to complete the assessment tools. Exclusion Criteria: Previous knee joint replacement surgery of the affected joint or any other lower limb surgery within the past 6 months. Stated inability to attend or complete the proposed course of intervention and follow-up schedule. Presence of co-morbidities associated with cognitive impairment. 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). Functional illiteracy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Aguilella, PhD
Phone
+34962458100
Email
luis.aguilella@comv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Lluch, PT
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Aguilella, PhD
Organizational Affiliation
Hospital Universitario de la Ribera, Alcira (Valencia)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de La Ribera
City
Alcira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Lluch, PT
First Name & Middle Initial & Last Name & Degree
Luis Aguilella, PhD

12. IPD Sharing Statement

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Neuroscience Education on Osteoarthritis

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