Back to resultsPNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy
Primary Purpose
Rotator Cuff Tendinosis
Status
Suspended
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pain neuroscience education
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tendinosis
Eligibility Criteria
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.
Sites / Locations
- Rubén Fernández-Matías
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pain neuroscience education plus exercise
Exercise alone
Arm Description
Three sessions of pain neuroscience education plus exercise.
Exercise alone without pain neuroscience education.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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).
Kinesiophobia change
Kinesiophobia measured with Tampa Scale for Kinesiophobia (TSK-11) which ranges from 0% (no kinesiophobia) to 100% (maximum degree of kinesiophobia).
Catastrophism change
Catastrophism measured with Pain Catastrophizing Scale (PCS) which ranges from 0% (no catastrophism) to 100% (maximum degree of catastrophism).
Strength change
Scaption strength at 90º of elevation measured with a hand-held dynamometer
Full Information
NCT ID
NCT04985370
First Posted
July 20, 2021
Last Updated
November 17, 2022
Sponsor
Ruben Fernandez Matias
1. Study Identification
Unique Protocol Identification Number
NCT04985370
Brief Title
PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy
Official Title
Pain Neuroscience Education Plus Exercise Versus Exercise Alone in the Management of Chronic Rotator Cuff Tendinopathy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Logistic issues
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruben Fernandez Matias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain neuroscience education plus exercise
Arm Type
Experimental
Arm Description
Three sessions of pain neuroscience education plus exercise.
Arm Title
Exercise alone
Arm Type
Active Comparator
Arm Description
Exercise alone without pain neuroscience education.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education
Intervention Description
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
Intervention Name(s)
Exercise
Intervention Description
Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)
Time Frame
Baseline, change from baseline at 4-week, and change from baseline at 12-week
Secondary Outcome Measure Information:
Title
Shoulder disability change
Description
Shoulder disability measured with Shoulder Pain and Disability Index (SPADI). SPADI ranges from 0% (no disability) to 100% (maximum degree of disability).
Time Frame
Baseline, change from baseline at 4-week, and change from baseline at 12-week
Title
Kinesiophobia change
Description
Kinesiophobia measured with Tampa Scale for Kinesiophobia (TSK-11) which ranges from 0% (no kinesiophobia) to 100% (maximum degree of kinesiophobia).
Time Frame
Baseline, change from baseline at 4-week, and change from baseline at 12-week
Title
Catastrophism change
Description
Catastrophism measured with Pain Catastrophizing Scale (PCS) which ranges from 0% (no catastrophism) to 100% (maximum degree of catastrophism).
Time Frame
Baseline, change from baseline at 4-week, and change from baseline at 12-week
Title
Strength change
Description
Scaption strength at 90º of elevation measured with a hand-held dynamometer
Time Frame
Baseline, change from baseline at 4-week, and change from baseline at 12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rubén Fernández-Matías
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy
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