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Clinical Trials/NCT06677450
NCT06677450
Completed
Not Applicable

Effectiveness of Pain Neuroscience Education in Rotator Cuff Related Shoulder Pain

Istanbul University - Cerrahpasa1 site in 1 country42 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Related Shoulder Pain
Sponsor
Istanbul University - Cerrahpasa
Enrollment
42
Locations
1
Primary Endpoint
Pain Intensity
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

The aim of this randomized controlled trial was to investigate the effects of pain neuroscience education added to exercise on pain intensity, disability, pain threshold, pain catastrophizing, pain beliefs, pain knowledge, and quality of life in rotator cuff related shoulder pain.

Detailed Description

Shoulder pain associated with rotator cuff injuries is a common clinical condition, with a global prevalence of 20.7%. Its etiology is multifaceted, and it is often reported that pain does not align with findings from diagnostic imaging. Recent studies have indicated that psychological factors, such as central sensitization and pain beliefs, play a significant role in patients with shoulder pain. Although exercise is recommended as the first-line treatment, approximately 50% of patients return with persistent pain complaints 6 to 12 months later. Treatments focused on the local tissue pathology-pain model are inadequate in addressing more complex and chronic pain issues related to central sensitization and neuroplasticity. There is a need for an approach that aims to desensitize the nervous system by focusing on neurophysiology and the representation and meaning of pain, rather than a traditional biomedical model. Pain neuroscience education is a treatment strategy that offers patients the opportunity to reconceptualize their ideas about pain, thereby changing negative beliefs and misconceptions regarding it. Recent literature has provided strong evidence that pain neuroscience education can alter pain intensity, pain knowledge, disability, and pain behaviors in patients with musculoskeletal pain. However, studies investigating patients' perceptions of pain neuroscience education in relation to rotator cuff related shoulder pain and the feasibility of implementing such education have emerged. Despite the limited existing evidence, the efficacy of pain neuroscience education combined with exercise for individuals with rotator cuff related shoulder pain has not been supported by a randomized controlled trial, indicating a need for further research in this area. Therefore, the aim of this study is to investigate the effects of pain neuroscience education, applied in addition to exercise, on pain intensity, disability, pain threshold, pain catastrophizing, pain beliefs, pain knowledge, and quality of life in individuals with rotator cuff related shoulder pain. Patients with rotator cuff related shoulder pain the ages of 40 and 65 will be randomly divided into two groups: Group 1 (pain neuroscience education + exercise) and Group 2 (exercise). Interventions will be applied for 12 sessions (twice a week for 6 weeks). The patients will be assessed at baseline and at the end of the 6-week intervention. After the demographic and clinical characteristics of the patients were evaluated with the demographic information form, pain intensity will be evaluated with the Numerical Pain Rating Scale (NPRS), disability with the Shoulder Pain and Disability Index (SPADI), pressure pain threshold with the Algometer, pain catastrophizing with the Pain Catastrophizing Scale, pain beliefs with the Pain Beliefs Scale, change in pain knowledge with the Revised Pain Neurophysiology Scale, quality of life with the Short Form-12 (SF-12), and patient satisfaction with the Global Change Rating Scale.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
November 1, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

Büşra Aksan Sadıkoğlu

MSc, PT

Istanbul University - Cerrahpasa

Eligibility Criteria

Inclusion Criteria

  • Being aged between 40 and 65 years
  • Presence of shoulder pain for at least 3 months
  • At least one positive finding in each of the following categories; 1) Painful arc finding during flexion or abduction, 2) Positive Neer's or Kennedy-Hawkins Tests, 3) Pain with resisted external rotation, abduction or empty can test
  • Pain level of at least 3 and at most 7 according to Visual Analogue Scale (VAS) at rest
  • Being literate

Exclusion Criteria

  • Systemic inflammatory shoulder pain
  • Having had a shoulder dislocation or fracture in the last 12 months
  • Having had a shoulder surgery
  • Having received physiotherapy or corticosteroid injection treatment for the shoulder in the last 3 months
  • Presence of adhesive capsulitis (passive shoulder ROM \<50%)
  • Presence of vision and hearing problems
  • Having been diagnosed a disease that may cause neurological-cognitive changes and prevents understanding the content of the ANE program

Outcomes

Primary Outcomes

Pain Intensity

Time Frame: At the baseline and end of 6-week intervention

The Numeric Pain Rating Scale (NPRS) will be used to evaluates pain levels. In the NPRS, participants are asked to verbally rate the intensity of their pain on a scale from 0 to 10.

Disability

Time Frame: At the baseline and end of 6-week intervention

The disability level of individuals will be measured with the Shoulder Pain and Disability Index (SPADI). SPADI is a 13-item scale, with 5 items measuring pain and 8 items measuring disability, for a total of 2 subscales to assess the level of perceived disability. The average of the 2 subscales out of 100 is taken for the total score; a higher score indicates greater disability.

Secondary Outcomes

  • Pressure Pain Threshold(At the baseline and end of 6-week intervention)
  • Pain Beliefs(At the baseline and end of 6-week intervention)
  • Pain Catastrophizing(At the baseline and end of 6-week intervention)
  • Pain Knowledge(At the baseline and end of 6-week intervention)
  • Health-Related Quality of Life(At the baseline and end of 6-week intervention)
  • Patient Satisfaction(End of the 6-week intervention)

Study Sites (1)

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