Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-07-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rotator Cuff Injuries Tear Pain, Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

the double blinded study (assessor and statistician)

Study Groups

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Experimental Group

In addition to the conservative treatment, the experimental group will follow PNE sessions (one session per week over six consecutive weeks). Each session will take between 45 min and 1 h. The physiotherapist with 6 years of clinical and PNE experience will conduct all sessions. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience. The theoretical information will be complemented with pictures and diagrams based on previous procedures. A booklet with the contents of each session and containing a mixture of text, figures, and activities to perform between sessions will be developed for the purpose of this study and given to participants. Time devoted to PNE will decrease from session 1 (60 min) to session 6 (15 min).

Group Type EXPERIMENTAL

Pain neuroscience education

Intervention Type OTHER

The experimental group will follow a PNE protocol based on previous procedure for a whole period of 6 weeks in addition the conventional treatment.

Control Group

The control group will follow a conservative treatment. The 90-minute-long training sessions will be held 5 days per week. The training program will include the following exercises: cold-pack for 20 minutes; 20 minutes of Conventional TENS; 3 minutes of soft tissue massage for deltoid and biceps muscles; scapula and glenohumeral joint mobilizations; towel sliding and duster slide exercises on the wall; wand-assisted bilateral shoulder elevation; external rotation in increasing abduction angles, internal rotation in abduction, horizontal adduction and functional internal rotation exercises; strengthening exercises; finger ladder exercises; activation of deltoid, rotator cuff, and scapular muscles at chest level as the degree of active elevation increases; anterior elevation using an elastic band; strength training in "Full Can" position; closed kinetic chain trainings; isometric exercises of the periscapular muscles, deltoid and trapezius; and posterior capsule stretching.

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type OTHER

Patients from both groups will receive a conventional 6-week treatment programme (30 treatment sessions, five a week, for 90min duration).

Interventions

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Pain neuroscience education

The experimental group will follow a PNE protocol based on previous procedure for a whole period of 6 weeks in addition the conventional treatment.

Intervention Type OTHER

Conventional treatment

Patients from both groups will receive a conventional 6-week treatment programme (30 treatment sessions, five a week, for 90min duration).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No