Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair

NCT05277077 | Completed

• 1 other identifier: 2022100
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries; Tear; Pain, Shoulder

Keywords

Rotator Cuff Injuries; tear; pain; shoulder

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale (VAS)

  VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  6 weeks

• Shoulder Pain and Disability Index (SPADI)

  The SPADI is a 13 item self-reported questionnaire assessing pain and functional status. Each item is measured on a 0-10 scale and a 0-100 score calculated. Higher scores represent greater levels of pain and disability. The SPADI has been shown to have good test-re-test reliability and be sensitive to change.

  6 weeks

• The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

  DASH questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  6 weeks

Secondary Outcomes (4)

• Catastrophizing

  6 weeks

• Hospital Anxiety and Depression Scale (HADS)

  6 weeks

• Tampa-Scale of Kinesiophobia (TSK)

  6 weeks

• 12-Item Short-Form Health Survey (SF-12)

  6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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).

Other: Pain neuroscience education

Control Group

ACTIVE COMPARATOR

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.

Other: Conventional treatment

Interventions

Pain neuroscience education 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.

Experimental Group

Conventional treatment OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (6)

• Andias R, Neto M, Silva AG. The effects of pain neuroscience education and exercise on pain, muscle endurance, catastrophizing and anxiety in adolescents with chronic idiopathic neck pain: a school-based pilot, randomized and controlled study. Physiother Theory Pract. 2018 Sep;34(9):682-691. doi: 10.1080/09593985.2018.1423590. Epub 2018 Jan 10.

  PMID: 29319386 BACKGROUND

• Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.

  PMID: 29710099 BACKGROUND

• Wijma AJ, van Wilgen CP, Meeus M, Nijs J. Clinical biopsychosocial physiotherapy assessment of patients with chronic pain: The first step in pain neuroscience education. Physiother Theory Pract. 2016 Jul;32(5):368-84. doi: 10.1080/09593985.2016.1194651. Epub 2016 Jun 28.

  PMID: 27351769 BACKGROUND

• Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

  PMID: 22133255 BACKGROUND

• 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.

  PMID: 30178503 BACKGROUND

• 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.

  PMID: 27385156 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Lacerations; Shoulder Pain; Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the double blinded study (assessor and statistician)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Caner Karartı, Hacettepe University

Model Details: Randomized

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: March 31, 2022
• Primary Completion: June 12, 2023
• Study Completion: July 12, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)