We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Pain Neuroscience Education vs Biomedical Education for Patients Undergoing Surgery for Shoulder Pain

This study is not yet open for participant recruitment.
Verified November 2016 by Alejandro Luque-Suarez, University of Malaga
Sponsor:
ClinicalTrials.gov Identifier:
NCT02960477
First Posted: November 9, 2016
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alejandro Luque-Suarez, University of Malaga
  Purpose

BACKGROUND Shoulder pain is the third most common musculoskeletal disorder observed in primary care consultations after low back and neck pain. In the absence of successful outcome following a conservative intervention, shoulder surgery is the most common procedure conduct for a multitude of surgical indications, including rotator cuff tears, instability and stiffness. However, 22% of patients develop chronic shoulder pain (CSP) following shoulder surgery . The consequences of chronic or persistent postsurgical pain result in high socio-economic burden, not only in terms of suffering and reduced quality of life for the individual, but also, with considered the subsequent costs to healthcare and social services.

Pain neuroscience education (PNE) has been shown as an effective therapeutic strategy for increasing knowledge and understanding about neurobiology, neurophysiology and processing pain, changing pain beliefs, improving patient's skills and encouraging to do physical and social activities in different chronic pain conditions.

The primary aim of this study will be to evaluate whether perioperative PNE is more effective than classical biomedical education in reducing pain and disability in patients undergoing shoulder surgery. The secondary aim will be to analyse whether perioperative PNE is more effective than classical biomedical education in reducing postoperative healthcare costs and improving surgical experience in patients undergoing shoulder surgery .


Condition Intervention
Shoulder Pain Other: Pain Neuroscience education Other: Biomedical Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Pain Neuroscience Education vs Biomedical Education for Patients Undergoing Surgery for Shoulder Pain: Protocol for a Randomized Controlled Trial

Further study details as provided by Alejandro Luque-Suarez, University of Malaga:

Primary Outcome Measures:
  • "Change from Baseline pain and function at 6 months" [ Time Frame: 6 months ]
    This outcome will be measured with the shoulder pain and disability index (SPADI)


Secondary Outcome Measures:
  • "Change from Baseline patient's expectations of surgical experience at 6 months" [ Time Frame: 6 months ]
    To assess surgical experience, patients will be asked to indicate the level of agreement (on a numerical rating scale from 1 "minimal" to 10 "maximal agreement") with statements about their shoulder surgery/education experience: "I am glad I underwent surgery for my shoulder."; "I was fully prepared (physically, emotionally, and psychologically) for the surgery."; "The preoperative education I received prepared me well for the surgery."; "Knowing what I know now, I would do this again given the same choices." and "The surgery met my expectations.".

  • "Change from Baseline postoperative healthcare costs at 6 months" [ Time Frame: 6 months ]
    Postoperative healthcare costs include the number of days spent in hospital following surgery, medical tests related to postoperative surgery and any kind of postoperative treatments (e.g. pain killers, physiotherapy, psychotherapy, osteopathy).


Estimated Enrollment: 84
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain Neuroscience education
A PNE session covers the neurobiology, neurophysiology and processing of pain. Topics addressed during the educational sessions will include the characteristics of acute versus chronic pain; how pain becomes chronic (plasticity of the nervous system, modulation, modification, central sensitization, etc.); potential sustaining factors of central sensitization like emotions, stress, pain cognitions, and pain behaviour; the decision to have shoulder surgery; surgical experiences and environmental issues' effects on nerve sensitivity; recovery after shoulder surgery; scientific evidence for the PNE content; and the opportunity to reflect and write questions to ask the surgeon prior to surgery.
Other: Pain Neuroscience education
A PNE session covers the neurobiology, neurophysiology and processing of pain.
Active Comparator: Biomedical Education
A biomedical session covers the normal course of shoulder pain; anatomy, physiology and biomechanics of the shoulder; the expected course of postoperative shoulder pain; and the importance of self-care. Also, professional and leisure time activities will be discussed. Ergonomic advices will be given: e.g. how is the best way to catch a container, how I should move my shoulder in this sport/activity, what is a good work posture? The content of the biomedical education will be biomedically-/biomechanically-focussed.
Other: Biomedical Education
A biomedical session covers the normal course of shoulder pain, anatomy, physiology and biomechanics of the shoulder, the expected course of postoperative shoulder pain, and the importance of self-care.

Detailed Description:

The present study will be a 6-month randomized controlled trial that will be carried out between March 2017 and Aug 2017 in a regional hospital (secondary care setting ) of the province of Malaga, Spain. Participants scheduled for shoulder surgery and those that fulfil inclusion criteria will be asked for participating in this study. The outcomes will be assessed at baseline (in the week preceding surgery) and at 3 follow-ups times (1 week, 1 month and 6 months' post-surgery t1-t4 ).

All patients scheduled for shoulder surgery in the participating hospital and meeting the age criteria will be contacted by telephone and interviewed after having given consent. The initial telephone interview serves to provide a verbal description of the project and to screen potential study participants for in- and exclusion criteria (see above). People deemed likely to be eligible and willing to participate in the study will be scheduled for baseline assessments in the week before surgery. Furthermore, they will receive written information about the study via mail or e-mail. Prior to undertaking the baseline assessments, they will have the opportunity to ask questions and will be asked to provide written informed consent. Anonymized age, gender and visual analogue scale- verbal numerical rating scale (VAS-VNRS) for pain will be collected for those participants who decline to take part in the project, to assess the external validity of the recruited sample of participants.

Participants are not expected to start new treatments or medication other than their usual pre- and postoperative care 3 weeks prior to and during study participation. Participants will then complete several questionnaires at baseline, 1 week, 1 month and 6 months' post-intervention apart from biomedical education or PNE intervention. Retention of participants will be encouraged by researchers providing written feedback to all participants about the results of the "health screenings", maintaining the interest in the study through materials and mailings sent to participants during all the process and using reminders of the upcoming data collection. Participant data files will be stored in numerical order and in a secure and accessible place and manner. Participant files will be maintained in storage for a period of 3 years after completion of the study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients scheduled for shoulder surgery, willing to participate (including willingness to comply with the predetermined follow-ups).
  2. Participants scheduled for shoulder surgery due to partial or full thickness rotator cuff tear, tendon biceps tears, impingement syndrome, rotator cuff tendinopathy, adhesive capsulitis, rotator cuff tendinosis and labral pathologies will be included in this study. Diagnosis will be based on surgeon criteria and confirmed by MRI or US .
  3. Men / women aged between 18 and 70 years.

Exclusion Criteria:

  1. Chronic illness characterized by chronic pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma) or any other rheumatoid, endocrinological, neurological or psychiatric disorder.
  2. Patients with evidence of advanced osteoarthritis of the glenohumeral joint and inflammatory arthropathy .
  3. Shoulder pain considered to be originated from the cervical region and other traumas or if there is osteoporosis, haemophilia and / or cancer.
  4. Participants receiving shoulder surgery before the beginning of the study.
  5. Inability to provide informed consent and/or complete written questionnaires.
  Contacts and Locations
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): NCT02960477


Contacts
Contact: Javier Martinez Calderon, PhD student 655570595 ext +34 javier_martinez_calderon@hotmail.com
Contact: Alejandro Luque Suarez, PhD 606939920 ext +34 aluques@uma.es

Sponsors and Collaborators
University of Malaga
Investigators
Principal Investigator: Alejandro Luque Suarez, PhD University of Malaga
  More Information

Responsible Party: Alejandro Luque-Suarez, PhD, University of Malaga
ClinicalTrials.gov Identifier: NCT02960477     History of Changes
Other Study ID Numbers: University of Malaga
First Submitted: November 2, 2016
First Posted: November 9, 2016
Last Update Posted: September 12, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alejandro Luque-Suarez, University of Malaga:
Shoulder pain
Shoulder surgery
Pain neuroscience education
Chronic pain

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms