NCT04985370

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
42mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jul 2021Oct 2029

First Submitted

Initial submission to the registry

July 20, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Expected
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

July 20, 2021

Last Update Submit

November 17, 2022

Conditions

Rotator Cuff Tendinosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Shoulder disability change

    Baseline, change from baseline at 4-week, and change from baseline at 12-week

  • Kinesiophobia change

    Baseline, change from baseline at 4-week, and change from baseline at 12-week

  • Catastrophism change

    Baseline, change from baseline at 4-week, and change from baseline at 12-week

  • Strength change

    Baseline, change from baseline at 4-week, and change from baseline at 12-week

Study Arms (2)

Pain neuroscience education plus exercise

EXPERIMENTAL

Three sessions of pain neuroscience education plus exercise.

Other: Pain neuroscience educationOther: Exercise

Exercise alone

ACTIVE COMPARATOR

Exercise alone without pain neuroscience education.

Other: Exercise

Interventions

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.

Pain neuroscience education plus exercise
ExerciseOTHER

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

Exercise alonePain neuroscience education plus exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rubén Fernández-Matías

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 20, 2021

First Posted

August 2, 2021

Study Start

July 25, 2021

Primary Completion

October 1, 2021

Study Completion (Estimated)

October 1, 2029

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)