Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05277077
Other study ID # 2022100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT06070493 - The Effects of Myofascial Release Technique N/A
Completed NCT04541953 - TeleRehabilitation Following Arthroscopic Rotator Cuff Repair N/A
Completed NCT04944446 - Myofascial Release in Shoulder Pathologies N/A
Recruiting NCT06112444 - Validity And Reliability Study Of The Turkish Version Of Short Western Ontario Rotator Cuff Index
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Active, not recruiting NCT04686396 - Demineralized Bone Matrix Rotator Cuff Study N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Completed NCT04470167 - Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear Phase 1/Phase 2
Recruiting NCT05297305 - Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty N/A
Completed NCT02528084 - The Effects of Yoga on Patients With Rotator Cuff Injuries N/A
Recruiting NCT05011331 - The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome N/A
Recruiting NCT04209504 - Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Completed NCT03967574 - Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy N/A
Not yet recruiting NCT05906004 - Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch
Completed NCT04952623 - Online Education to Improve the Management of Rotator Cuff Related Shoulder Pain N/A
Recruiting NCT05344898 - Subscap Reverse Shoulder Arthroplasty N/A
Recruiting NCT04175184 - Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain N/A
Terminated NCT05215600 - Anaverseā„¢ Glenoid System and Its Instrumentation
Recruiting NCT05822414 - ESP vs STB for Pain and Diagraphragm Function for Shoulder Surgery N/A
Completed NCT04833244 - Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use N/A