Clinical trial NCT06677450: Effectiveness of Pain Neuroscience Education in Rotator Cuff Related Shoulder Pain
Official title: Effectiveness of Pain Neuroscience Education in Rotator Cuff Related Shoulder Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Related Shoulder Pain
Impingement Syndrome
Shoulder Tendinopathy
Keywords: shoulder
pain
rotator cuff tear
pain neuroscience
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity
timeFrame: At the baseline and end of 6-week intervention
measure: Disability
timeFrame: At the baseline and end of 6-week intervention
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: At the baseline and end of 6-week intervention
measure: Pain Catastrophizing
timeFrame: At the baseline and end of 6-week intervention
measure: Pain Beliefs
timeFrame: At the baseline and end of 6-week intervention
measure: Pain Knowledge
timeFrame: At the baseline and end of 6-week intervention
measure: Health-Related Quality of Life
timeFrame: At the baseline and end of 6-week intervention
measure: Patient Satisfaction
timeFrame: End of the 6-week intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: