Effectiveness of Pain Neuroscience Education in Rotator Cuff Related Shoulder Pain

NCT06677450 | Completed

• 1 other identifier: IUC2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Related Shoulder Pain; Impingement Syndrome; Shoulder Tendinopathy

Keywords

shoulder; pain; rotator cuff tear; pain neuroscience

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  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.

  At the baseline and end of 6-week intervention

• Disability

  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.

  At the baseline and end of 6-week intervention

Secondary Outcomes (6)

• Pressure Pain Threshold

  At the baseline and end of 6-week intervention

• Pain Catastrophizing

  At the baseline and end of 6-week intervention

• Pain Beliefs

  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

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

Exercise program

Other: Exercise

Pain Neuroscience Education Group

EXPERIMENTAL

Pain neurosicence education with exercise program

Other: Pain neuoroscience education; Other: Exercise

Interventions

Pain neuoroscience education OTHER

Pain neurosicence education will be applied 1 day / 6 weeks at the beginning of one of the weekly exercise sessions in addition to the exercise program. The educations will include the definition and general characteristics of pain, pain physiology, peripheral neuropathic pain, the role of the brain in pain perception, tissue healing, peripheral and central sensitization, the effects of emotional, psychological and social factors on the pain process and pain coping strategies.

Pain Neuroscience Education Group

Exercise OTHER

Exercise program will be applied 2 days/week for 6 weeks and will consist of 3-phase stretching and motor control/progressive resistance exercises.

Exercise Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Rotator Cuff Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PT

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 6, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)