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Trial record 4 of 2880 for:    "Osteoarthritis"

Neuroscience Education on Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02246088
Recruitment Status : Unknown
Verified September 2014 by Enrique Lluch Girbés, University of Valencia.
Recruitment status was:  Recruiting
First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Collaborator:
Hospital de la Ribera
Information provided by (Responsible Party):
Enrique Lluch Girbés, 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.

Condition or disease Intervention/treatment
Osteoarthritis Procedure: MT + NE Procedure: MT + E

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Neuroscience Education on Subjects With Chronic Knee Pain Related to Osteoarthritis : a Randomized Controlled Trial
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: MT + NE
A manual therapy (MT) intervention combined with neuroscience education (NE)
Procedure: MT + NE

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").

Active Comparator: MT + E
Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E)
Procedure: MT + E
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 Measures :
  1. Endogenous analgesia through the experimental protocol of conditioned pain modulation [ Time Frame: 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 :
  1. Pain at rest and in the last 24 hours [ Time Frame: 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.

  2. Pressure Pain Thresholds [ Time Frame: 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.

  3. Western Ontario and McMaster osteoarthritis index (WOMAC scale) [ Time Frame: 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.

  4. Health-related quality of life using the self-reported Spanish version SF-36 questionnaire [ Time Frame: Up to 3 months ]
  5. Tampa Scale of Kinesiophobia (TSK) (Spanish version) [ Time Frame: Up to 3 months ]
  6. Pain Catastrophization Scale (PCS) (Spanish version) [ Time Frame: Up to 3 months ]
  7. Chronic Pain Coping Inventory-42 (Spanish version) [ Time Frame: Up to 3 months ]
  8. Chronic Pain Acceptance Questionnaire (Spanish version) [ Time Frame: Up to 3 months ]
  9. Goniometric assessment of knee flexion and extension range of motion [ Time Frame: Up to 3 months ]
  10. Strength of the hamstrings and quadriceps muscles [ Time Frame: Up to 3 months ]
  11. Timed "Up & Go" (TUG) Test [ Time Frame: 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.

  12. Central Sensitization Inventory [ Time Frame: Up to 3 months ]
    Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246088


Contacts
Contact: Luis Aguilella, PhD +34962458100 luis.aguilella@comv.es

Locations
Spain
Hospital Universitario de La Ribera Recruiting
Alcira, Valencia, Spain, 46600
Principal Investigator: Enrique Lluch, PT         
Principal Investigator: Luis Aguilella, PhD         
Sponsors and Collaborators
University of Valencia
Hospital de la Ribera
Investigators
Principal Investigator: Enrique Lluch, PT University of Valencia
Principal Investigator: Luis Aguilella, PhD Hospital Universitario de la Ribera, Alcira (Valencia)

Publications:

Responsible Party: Enrique Lluch Girbés, Physiotherapist, University of Valencia
ClinicalTrials.gov Identifier: NCT02246088     History of Changes
Other Study ID Numbers: EDUART13
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014

Keywords provided by Enrique Lluch Girbés, University of Valencia:
Osteoarthritis, Central Nervous System Sensitization

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases