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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group | Active Comparator | Exercise program |
|
| Pain Neuroscience Education Group | Experimental | Pain neurosicence education with exercise program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the baseline and end of 6-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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 | 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. |
|
| 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. | 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. | 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. | 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. | 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. | End of the 6-week intervention |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |