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PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy

Pain Neuroscience Education Plus Exercise Versus Exercise Alone in the Management of Chronic Rotator Cuff Tendinopathy: a Randomized Controlled Trial

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04985370
Enrollment
52
Registered
2021-08-02
Start date
2021-07-25
Completion date
2029-10-01
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tendinosis

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.

Interventions

OTHERPain 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.

OTHERExercise

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

Sponsors

Ruben Fernandez Matias
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in pain intensityBaseline, change from baseline at 4-week, and change from baseline at 12-weekPain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)

Secondary

MeasureTime frameDescription
Shoulder disability changeBaseline, change from baseline at 4-week, and change from baseline at 12-weekShoulder disability measured with Shoulder Pain and Disability Index (SPADI). SPADI ranges from 0% (no disability) to 100% (maximum degree of disability).
Kinesiophobia changeBaseline, change from baseline at 4-week, and change from baseline at 12-weekKinesiophobia measured with Tampa Scale for Kinesiophobia (TSK-11) which ranges from 0% (no kinesiophobia) to 100% (maximum degree of kinesiophobia).
Catastrophism changeBaseline, change from baseline at 4-week, and change from baseline at 12-weekCatastrophism measured with Pain Catastrophizing Scale (PCS) which ranges from 0% (no catastrophism) to 100% (maximum degree of catastrophism).
Strength changeBaseline, change from baseline at 4-week, and change from baseline at 12-weekScaption strength at 90º of elevation measured with a hand-held dynamometer

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026