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