PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy

Rotator Cuff Tendinosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04985370
• Other study ID #: 2020/58
• Status: Suspended
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: October 1, 2029

Study information

• Verified date: November 2022
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 52
• Est. completion date: October 1, 2029
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tendinosis
• Tendinopathy

Intervention

Other:
• 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.
• Exercise
Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.

Locations

Country	Name	City	State
Spain	Rubén Fernández-Matías	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ruben Fernandez Matias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Kinesiophobia change	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
Secondary	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
Secondary	Strength change	Scaption strength at 90º of elevation measured with a hand-held dynamometer	Baseline, change from baseline at 4-week, and change from baseline at 12-week