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Logistic issues
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The aim of this randomized controlled trial is to evaluate the combined effects of pain neuroscience education plus exercise to exercise alone in the management of patients with chronic rotator cuff tendinopathy regarding pain, function, strength, kinesiophobia, and pain catastrophizing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain neuroscience education plus exercise | Experimental | Three sessions of pain neuroscience education plus exercise. |
|
| Exercise alone | Active Comparator | Exercise alone without pain neuroscience education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain neuroscience education | Other | Three sessions of pain neuroscience education based on explaining patients: characteristics of acute versus chronic pain, function of acute pain, how acute pain is originated within the nervous system, how acute pain progress to chronic pain, and factors that contribute to central sensitization (e.g., emotions, stress, disease and pain beliefs, behaviors regarding pain...). All the explanations will be conducted using easy-understandable examples and metaphors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity | Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain) | Baseline, change from baseline at 4-week, and change from baseline at 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder disability change | Shoulder disability measured with Shoulder Pain and Disability Index (SPADI). SPADI ranges from 0% (no disability) to 100% (maximum degree of disability). | Baseline, change from baseline at 4-week, and change from baseline at 12-week |
| Kinesiophobia change |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubรฉn Fernรกndez-Matรญas | Alcalรก de Henares | Madrid | 28805 | Spain |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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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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Researchers involved in recording outcome measures will not be aware of treatment allocation. Patients will be encouraged to not tell the evaluators about the received treatment.
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| Exercise | Other | Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions. |
|
Kinesiophobia measured with Tampa Scale for Kinesiophobia (TSK-11) which ranges from 0% (no kinesiophobia) to 100% (maximum degree of kinesiophobia). |
| Baseline, change from baseline at 4-week, and change from baseline at 12-week |
| Catastrophism change | Catastrophism measured with Pain Catastrophizing Scale (PCS) which ranges from 0% (no catastrophism) to 100% (maximum degree of catastrophism). | Baseline, change from baseline at 4-week, and change from baseline at 12-week |
| Strength change | Scaption strength at 90ยบ of elevation measured with a hand-held dynamometer | Baseline, change from baseline at 4-week, and change from baseline at 12-week |