Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair

Rotator Cuff Injuries Clinical Trial

Official title:

The Effects of Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair on Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277077
• Other study ID #: 2022100
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: July 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Shoulder
• Rotator Cuff Injuries
• Shoulder Pain
• Tear

Intervention

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

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University	Kirsehir

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. Erratum In: JAMA Neurol. 2019 Mar 1;76(3):373. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Catastrophizing	Pain Catastrophizing Scale (PCS) will be used to evaluate the patient's feelings, thoughts, and emotions related to cognitive characteristics of pain. It is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points.	6 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	HADS will be used to assess anxiety and depression. HADS consists of 7 items for anxiety and 7 for depression. The items are scored on a 4-point scale from 0 (not present) to 3 (considerable).	6 weeks
Secondary	Tampa-Scale of Kinesiophobia (TSK)	Participants will be assessed with Tampa-Scale of Kinesiophobia (TSK) in terms of presence of kinesiophobia. The TSK is a 17-item scale that measures the somatic focus of patients (beliefs about underlying and serious medical problems), and activity avoidance (beliefs about (re) injury or increased pain). The TSK has moderate construct, concurrent and predictive validity, good internal consistency, and a moderate to good retest reliability. Patients scoring high on the TSK, above 37 points, are likely to have fear of movement.	6 weeks
Secondary	12-Item Short-Form Health Survey (SF-12)	Participants will be assessed with 12-Item Short-Form Health Survey (SF-12) in terms of quality of life. It is a self-administered survey and two scores can be measured: the Physical Component and the Mental Component. In both, scores range from 0 to 100, with the highest scores associated with better levels of quality of life.	6 weeks