PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy

NCT ID: NCT04985370

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-25

Study Completion Date

2029-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Tendinosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Pain neuroscience education plus exercise

Three sessions of pain neuroscience education plus exercise.

Group Type EXPERIMENTAL

Pain neuroscience education

Intervention Type 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.

Exercise

Intervention Type OTHER

Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.

Exercise alone

Exercise alone without pain neuroscience education.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.

Interventions

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Pain neuroscience education

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.

Intervention Type OTHER

Exercise

Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Shoulder pain due to rotator cuff tendinopathy lasting more than 6 months.
* Internal Rotation Resisted Strength Test positive.
* Test Item Cluster (Hawkins-Kennedy, painful arc, and infraspinatus test) positive.

Exclusion Criteria

* History of: tumors, metastasis, osteoporosis, shoulder fractures, shoulder luxation and/or instability, previous shoulder surgery, cervical radiculopathy, full-thickness rotator cuff tears, glenohumeral joint degeneration, inflammatory arthropathy, acromioclavicular joint arthrosis, and rotator cuff calcifications.
* Being treated by other physical therapy or medical treatment for their shoulder pain at the time of recruitment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruben Fernandez Matias

OTHER

Sponsor Role lead

Responsible Party

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Ruben Fernandez Matias

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rubén Fernández-Matías

Alcalá de Henares, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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2020/58

Identifier Type: -

Identifier Source: org_study_id

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