Rotator Cuff Related Shoulder PainNCT06677450
Effectiveness of Pain Neuroscience Education in Rotator Cuff Related Shoulder Pain
A study testing Pain neuoroscience education and Exercise in people with Rotator Cuff Related Shoulder Pain and Impingement Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Related Shoulder Pain, Impingement Syndrome, Shoulder Tendinopathy
- What is being tested?
- Pain neuoroscience education and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Pain neuoroscience education, Exercise
- Keywords
- shoulder, pain, rotator cuff tear, pain neuroscience
- Medical subject headings
- Pain, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuoroscience educationOther
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.
ExerciseOther
Exercise program will be applied 2 days/week for 6 weeks and will consist of 3-phase stretching and motor control/progressive resistance exercises.
ExerciseOther
Exercise program will be applied 2 days/week for 6 weeks and will consist of 3-phase stretching and motor control/progressive resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | Exercise program Receives: Other: Exercise |
| Pain Neuroscience Education Group | Experimental | Pain neurosicence education with exercise program Receives: Other: Pain neuoroscience education; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the baseline and end of 6-week intervention
Secondary outcomes (6)
Pressure Pain Threshold
A mechanical pressure algometer will be used to measure the pressure pain threshold of the muscles around the shoulder. The device consists of a 1 cm2 rubber disc connected to a manometer that displays the values in kg/cm2 (0 to 10 kg). The average of three trials will be calculated, allowing a 30-second rest period between each trial.
Measured: At the baseline and end of 6-week intervention
Pain Catastrophizing
The level of catastrophizing of individuals will be measured with the Pain Catastrophizing Scale. The 5-point scale, consisting of 13 items, assesses destructive thoughts and feelings related to pain. A score of 0 means "never" and a score of 4 means "always". A high score indicates the severity of pain.
Measured: At the baseline and end of 6-week intervention
Pain Beliefs
Individuals' pain beliefs will be measured with the Pain Beliefs Scale. It is a 12-question scale that evaluates organic and psychological belief status regarding the source and outcome of pain. There is an organic beliefs subtest consisting of eight items and a psychological beliefs subtest consisting of four items. Scoring for each item varies between 1-6.
Measured: At the baseline and end of 6-week intervention
Pain Knowledge
Pain knowledge will be measured with the Pain Neurophysiology Questionnaire (Revised-NPQ-TR) scale. It is a 12-item scale that patients can apply themselves and evaluates the level of knowledge about pain neurophysiology. Each item has the answer options "true-false-undecided". The scale is scored out of 12, with 1 point given for each correct answer. 0 points are given for wrong answers and undecided answers.
Measured: At the baseline and end of 6-week intervention
Health-Related Quality of Life
Health-related quality of life will be measured using the SF-12 (Short Form-12). The SF-12 provides two sub-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS is derived from the sub-dimensions of general health, physical functioning, physical role, and bodily pain, while the MCS is derived from the sub-dimensions of social functioning, emotional role, mental health, and energy.
Measured: At the baseline and end of 6-week intervention
Patient Satisfaction
Patient Satisfaction will be measured with the Global Rating Scale. It is a commonly used self-reported scale to measure a person's perceived change in health status and consists of a single question, 'How would you describe yourself compared to before treatment?', asking the patient to rate their change with respect to a specific condition over a specified period of time.
Measured: End of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Related Shoulder PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Aksan Sadıkoğlu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677450
- Sponsor's protocol ID
- IUC2025
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neuroscience Education in Rotator Cuff Related Shoulder Pain
- ClinicalTrials.gov ID
- NCT06677450
- Acronym / sponsor ID
- IUC2025
- Keywords
- shoulder, pain, rotator cuff tear, pain neuroscience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Other: ExerciseExercise program |
| Pain Neuroscience Education Group | Experimental | Other: Pain neuoroscience education, Other: ExercisePain neurosicence education with exercise program |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain neuoroscience educationPain 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. | Other | Pain Neuroscience Education Group |
| ExerciseExercise program will be applied 2 days/week for 6 weeks and will consist of 3-phase stretching and motor control/progressive resistance exercises. | Other | Exercise Group |
| ExerciseExercise program will be applied 2 days/week for 6 weeks and will consist of 3-phase stretching and motor control/progressive resistance exercises. | Other | Pain Neuroscience Education Group |
Primary outcome
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.
6 secondary outcomes
Pressure Pain Threshold
Time frame: At the baseline and end of 6-week intervention
Pain Catastrophizing
Time frame: At the baseline and end of 6-week intervention
Pain Beliefs
Time frame: At the baseline and end of 6-week intervention
Pain Knowledge
Time frame: At the baseline and end of 6-week intervention
Health-Related Quality of Life
Time frame: At the baseline and end of 6-week intervention
Patient Satisfaction
Time frame: End of the 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuoroscience education and Exercise in people with Rotator Cuff Related Shoulder Pain and Impingement Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: At the baseline and end of 6-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.