Clinical trial NCT05277077: Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair
Official title: The Effects of Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair on Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Tear
Pain, Shoulder
Keywords: Rotator Cuff Injuries
tear
pain
shoulder
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: Pain neuroscience education (PNE) aims to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. It has been demonstrated for musculoskeletal pain, PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement. Rotator cuff tears (RCT) often lead to pain aggrevation, deterioration of patients' functioning and considerable economic burden for health care resources requiring consultations, physiotherapy, radiological examinations and surgery. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, satisfactory results are scarce. The lack of satisfactory results at the end of all this effort suggests that some practices should be revised. Although PNE is likely to have beneficial effects on shoulder pathomechanics, to our knowledge, there is no randomized controlled research in the relevant literature investigating the effects of PNE in patients with an RCT. The present study aims to examine the effectiveness of PNE on clinical outcomes in a sample of patients with RCT.

Detailed description: Therapeutic interventions based on pain neuroscience education (PNE) have emerged as promising. It consists of educational sessions describing the neurobiology and neurophysiology of chronic pain and pain processing, with a particular focus on the role of the central nervous system on chronic pain and deemphasizing anatomical issues. PNE promotes the patients' understanding of chronic pain and changes maladaptive thoughts and cognitions (e.g. pain catastrophizing), which are important barriers to active therapy and exercise. Despite the apparent complexity of neuroscience education, patients are able to understand and remember it. Furthermore, there is evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophizing, and physical performance, especially if combined with exercise. Rotator cuff tears (RCT) often lead to pain aggrevation, deterioration of patients' functioning and considerable economic burden for health care resources requiring consultations, physiotherapy, radiological examinations and surgery. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, satisfactory results are scarce. The lack of satisfactory results at the end of all this effort suggests that some practices should be revised. Although PNE is likely to have beneficial effects on shoulder pathomechanics, to our knowledge, there is no randomized controlled research in the relevant literature investigating the effects of PNE in patients with an RCT. The present study aims to examine the effectiveness of PNE on clinical outcomes in a sample of patients with RCT.

Eligibility criteria: Inclusion Criteria:

* being in the age range of 18-65 years
* being diagnosed with a small and medium-sized RCT based on magnetic resonance imaging and clinical continuity tests
* history of arthroscopic rotator cuff repair (ARCR)
* having a good command of the Turkish language
* scoring above 24 in the Mini Mental State Test
* ≥80% compliance in completing the post-ARCR Phase 1 trainings
* volunteering to participate in the study.

Exclusion Criteria:

* diabetes mellitus
* neurological problems
* cervical disc herniation
* visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)
* osteoarthritis, rheumatoid arthritis or other systemic inflammatory problems
* hypermobility, trauma, and/or inflammation that could be a contraindication for mobilization
* former shoulder fractures on the affected side
* partial RCT
* former surgery on the affected side
* a history of adhesive capsulitis;
* traumatic shoulder instability (subluxation-dislocation)
* patients who are in stage 3 and above on the Goutallier classification system
* receiving a corticosteroid injection on the affected side within 6 weeks prior to diagnosis

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 6 weeks
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 6 weeks
measure: The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: 6 weeks
Secondary outcomes:
measure: Catastrophizing
timeFrame: 6 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 weeks
measure: Tampa-Scale of Kinesiophobia (TSK)
timeFrame: 6 weeks
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University
Study officials:
References:
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citation: Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
citation: Ryosa A, Laimi K, Aarimaa V, Lehtimaki K, Kukkonen J, Saltychev M. Surgery or conservative treatment for rotator cuff tear: a meta-analysis. Disabil Rehabil. 2017 Jul;39(14):1357-1363. doi: 10.1080/09638288.2016.1198431. Epub 2016 Jul 6.