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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: Protocol for a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02960477
Enrollment
84
Registered
2016-11-09
Start date
2019-11-30
Completion date
2020-08-31
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Shoulder pain, Shoulder surgery, Pain neuroscience education, Chronic pain

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 .

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.

Interventions

OTHERPain Neuroscience education

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

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.

Sponsors

University of Malaga
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline pain and function at 6 months6 monthsThis outcome will be measured with the shoulder pain and disability index (SPADI)

Secondary

MeasureTime frameDescription
Change from Baseline patient's expectations of surgical experience at 6 months6 monthsTo 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 months6 monthsPostoperative 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).

Contacts

Primary ContactJavier Martinez Calderon, PhD student
javier_martinez_calderon@hotmail.com655570595
Backup ContactAlejandro Luque Suarez, PhD
aluques@uma.es606939920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026