Rotator Cuff TendinosisNCT04985370
PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy
A study testing Pain neuroscience education and Exercise in people with Rotator Cuff Tendinosis, run by Ruben Fernandez Matias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tendinosis
- What is being tested?
- Pain neuroscience education and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jul 2021to 1 Oct 2029
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Neuroscience Education Plus Exercise Versus Exercise Alone in the Management of Chronic Rotator Cuff Tendinopathy: a Randomized Controlled Trial
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.
- Conditions
- Rotator Cuff Tendinosis
- Being tested
- Pain neuroscience education, Exercise
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
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.
ExerciseOther
Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education plus exercise | Experimental | Three sessions of pain neuroscience education plus exercise. Receives: Other: Pain neuroscience education; Other: Exercise |
| Exercise alone | Active comparator | Exercise alone without pain neuroscience education. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Secondary outcomes (4)
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).
Measured: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Kinesiophobia change
Kinesiophobia measured with Tampa Scale for Kinesiophobia (TSK-11) which ranges from 0% (no kinesiophobia) to 100% (maximum degree of kinesiophobia).
Measured: 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).
Measured: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Strength change
Scaption strength at 90º of elevation measured with a hand-held dynamometer
Measured: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start25 Jul 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2029 (estimated)
Why it stopped: Logistic issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinosisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruben Fernandez Matias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruben Fernandez Matias, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985370
- Sponsor's protocol ID
- 2020/58
- Status last verified
- Nov 2022
- First submitted
- 20 Jul 2021
- Last updated
- 22 Nov 2022
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education Plus Exercise Versus Exercise Alone in the Management of Chronic Rotator Cuff Tendinopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04985370
- Acronym / sponsor ID
- 2020/58
- Conditions
- Rotator Cuff Tendinosis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Logistic issues
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ruben Fernandez MatiasUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 2 Aug 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education plus exercise | Experimental | Other: Pain neuroscience education, Other: ExerciseThree sessions of pain neuroscience education plus exercise. |
| Exercise alone | Active comparator | Other: ExerciseExercise alone without pain neuroscience education. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 neuroscience educationThree 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. | Other | Pain neuroscience education plus exercise |
| ExerciseProgressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions. | Other | Exercise alone, Pain neuroscience education plus exercise |
Primary outcome
Change in pain intensity
Time frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)
4 secondary outcomes
Shoulder disability change
Time frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Kinesiophobia change
Time frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Catastrophism change
Time frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Strength change
Time frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- 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 neuroscience education and Exercise in people with Rotator Cuff Tendinosis, run by Ruben Fernandez Matias at 1 site in Spain.
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 3 inclusion and 2 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: paused, as of the sponsor's last update on 22 Nov 2022. 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 Spain. 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?
Results are not available in the source record.
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?
Change in pain intensity (time frame: Baseline, change from baseline at 4-week, and change from baseline at 12-week). 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 22 Nov 2022.