Shoulder PainNCT02960477
Effectiveness of Pain Neuroscience Education vs Biomedical Education for Patients Undergoing Surgery for Shoulder Pain
A study testing Pain Neuroscience education and Biomedical Education in people with Shoulder Pain, run by University of Malaga.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Pain Neuroscience education and Biomedical Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Pain Neuroscience Education vs Biomedical Education for Patients Undergoing Surgery for Shoulder Pain: Protocol for a Randomized Controlled Trial
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 .
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Pain Neuroscience education, Biomedical Education
- Keywords
- Shoulder pain, Shoulder surgery, Pain neuroscience education, Chronic pain
- Medical subject headings
- Shoulder Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience educationOther
A PNE session covers the neurobiology, neurophysiology and processing of pain.
Biomedical EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Biomedical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Change from Baseline pain and function at 6 months"
This outcome will be measured with the shoulder pain and disability index (SPADI)
Measured: 6 months
Secondary outcomes (2)
"Change from Baseline patient's expectations of surgical experience at 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.".
Measured: 6 months
"Change from Baseline postoperative healthcare costs at 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Luque-Suarez, University of Malaga
- Investigators
- Alejandro Luque Suarez, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960477
- Sponsor's protocol ID
- University of Malaga
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neuroscience Education vs Biomedical Education for Patients Undergoing Surgery for Shoulder Pain: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02960477
- Acronym / sponsor ID
- University of Malaga
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, Shoulder surgery, Pain neuroscience education, Chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience education | Experimental | Other: Pain Neuroscience educationA 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. |
| Biomedical Education | Active comparator | Other: Biomedical EducationA 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience educationA PNE session covers the neurobiology, neurophysiology and processing of pain. | Other | Pain Neuroscience education |
| Biomedical EducationA 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. | Other | Biomedical Education |
Primary outcome
"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)
2 secondary outcomes
"Change from Baseline patient's expectations of surgical experience at 6 months"
Time frame: 6 months
"Change from Baseline postoperative healthcare costs at 6 months"
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Luque Suarez, PhD principal investigator
University of Malaga
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience education and Biomedical Education in people with Shoulder Pain, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Martinez Calderon, PhD student (655570595 ext. +34, javier_martinez_calderon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Change from Baseline pain and function at 6 months" (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.