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

NCT02960477 | Unknown DMC

• 1 other identifier: University of Malaga
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Shoulder Pain

Keywords

Shoulder pain; Shoulder surgery; Pain neuroscience education; Chronic pain

Outcome Measures

Primary Outcomes (1)

• "Change from Baseline pain and function at 6 months"

  This outcome will be measured with the shoulder pain and disability index (SPADI)

  6 months

Secondary Outcomes (2)

• "Change from Baseline patient's expectations of surgical experience at 6 months"

  6 months

• "Change from Baseline postoperative healthcare costs at 6 months"

  6 months

Study Arms (2)

Pain Neuroscience education

EXPERIMENTAL

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

Biomedical Education

ACTIVE COMPARATOR

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

Interventions

Pain Neuroscience education OTHER

A PNE session covers the neurobiology, neurophysiology and processing of pain.

Pain Neuroscience education

Biomedical Education OTHER

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.

Biomedical Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for shoulder surgery, willing to participate (including willingness to comply with the predetermined follow-ups).
• 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 .
• Men / women aged between 18 and 70 years.

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Shoulder Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alejandro Luque Suarez, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Martinez Calderon, PhD student

CONTACT

655570595; javier_martinez_calderon@hotmail.com

Alejandro Luque Suarez, PhD

CONTACT

606939920; aluques@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share