Exercise Into Pain in Subacromial Shoulder Pain

August 1, 2024 updated by: Filip Struyf, Universiteit Antwerpen

Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial

The aim of the randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Exercise therapy is the first choice of treatment in the treatment of subacromial shoulder pain (SSP). Guidelines suggest exercise therapy for at least three months and research underlines the importance of progressive loaded exercise therapy at high dosage. However, it is not clear which is the best type of exercise and if pain should be provoked or avoided during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim is to investigate if one painful exercise can give better and faster results in the management of SSP than non-painful program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Physiotherapy private practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • shoulder pain for at least 3 months, elicited in the anterolateral shoulder region
  • at least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc, external resistance test
  • resting pain should be at 2/10 maximum on verbal numerical pain rating scale (NPRS)

Exclusion Criteria:

  • bilateral shoulder pain
  • corticosteroid injections 6 weeks prior to the study
  • pregnancy, inability to understand spoken or written Dutch
  • clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test)
  • evidence of adhesive capsulitis
  • previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
  • primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement; reproduction of shoulder pain with cervical rotation or axial compression
  • primary diagnosis of acromioclavicular pathology, shoulder instability
  • a radiologically confirmed fracture or previous medical imaging confirming the presence of calcification larger than 5 mm
  • presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness, osteoporosis, hemophilia, rheumatic polymyalgia)
  • more than 4h of training in sport overhead shoulder activities per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: exercising into pain
The participants will train during 12 with progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. One exercise will be performed with pain ranging between 4 and 7 on a NPRS (Numeric Pain Rating Scale) and the rest of the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. At week 9, patients will continue to exercise with pain between 0 and 2 in all exercises. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session.
Other: exercising into pain
the intervention consists in 4 strength exercises: one will be performed into pain (ranging between 4 and 7 on NPRS scale) and the rest between 0 adn 2 on a NPRS scale
Active Comparator: exercising with no/slight pain
The participants will train during 12 weeks with progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. All the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session.
Other: exercising with no/slight pain
the intervention consists in 4 strength exercises and all of them will be performed in no pain/slight pain (between 0 and 2 on NPRS scale)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: Change from baseline to 12 weeks
There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.
Change from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: Change from baseline to 6 months
There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.
Change from baseline to 6 months
Visual Analogue Scale (VAS)
Time Frame: Change from baseline to 6 months
It measures pain at rest, during activity, during night, in the past 24 hours. It is measured on a scale from 0 to 100, where 0=no pain, 100=worst imaginable pain.
Change from baseline to 6 months
Health-Related Quality of Life
Time Frame: Change from baseline to 12 weeks
It is measured with: 1) EQ-5D-5L (EuroQol-5 dimentions-5 levels) index: score range from less than 0 (0=value of health state equivalent to dead; negative values indicate state worse than dead) to 1 (the value of full health), with higher scores indicating higher health; 2) EQ-5D VAS (EuroQol-5 dimentions-Visual Analogue Scale), from 0 to 100 score, with 0=lowest health-related quality of life, 100=best health-related quality of life)
Change from baseline to 12 weeks
Health-Related Quality of Life
Time Frame: Change from baseline to 6 months
It is measured with: 1) EQ-5D-5L (EuroQol-5 dimentions-5 levels) index: score range from less than 0 (0=value of health state equivalent to dead; negative values indicate state worse than dead) to 1 (the value of full health), with higher scores indicating higher health; 2) EQ-5D VAS (EuroQol-5 dimentions-Visual Analogue Scale), from 0 to 100 score, with 0=lowest health-related quality of life, 100=best health-related quality of life)
Change from baseline to 6 months
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Change from baseline to 12 weeks
It consists of 16 items and it has 2 subscales: Physical Activity (FABQ-PA, range: 0-24) and Work (FABQ-W, range: 0-42) higher scores mean more fear avoidance beliefs affecting physical activity and/or work.
Change from baseline to 12 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Change from baseline to 6 months
It consists of 16 items and it has 2 subscales: Physical Activity (FABQ-PA, range: 0-24) and Work (FABQ-W, range: 0-42) higher scores mean more fear avoidance beliefs affecting physical activity and/or work.
Change from baseline to 6 months
Fear of Pain Questionnaire (FPQ-9)
Time Frame: Change from baseline to 12 weeks
It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45; higher scores mean more fear and anxiety associated with pain.
Change from baseline to 12 weeks
Fear of Pain Questionnaire (FPQ-9)
Time Frame: Change from baseline to 6 months
It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45; higher scores mean more fear and anxiety associated with pain.
Change from baseline to 6 months
Range of Movement (ROM) in internal rotation, external rotation, scaption
Time Frame: Change from baseline to 12 weeks
It is measured with the inclinometer. The unit of measure is degrees.
Change from baseline to 12 weeks
Range of Movement (ROM) in internal rotation, external rotation, scaption
Time Frame: Change from baseline to 6 months
It is measured with the inclinometer. The unit of measure is degrees.
Change from baseline to 6 months
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
Time Frame: Change from baseline to 12 weeks
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Change from baseline to 12 weeks
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
Time Frame: Change from baseline to 6 months
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Change from baseline to 6 months
Scapular Dyskinesis
Time Frame: Change from baseline to 12 weeks
It is measured with visual observation at rest and during movement (loaded and unloaded, in abduction and in flexion); the presence of winging, tilting or abnormal scapular movement determines the judgement about scapular dyskinesis (yes/no) at rest and during movement
Change from baseline to 12 weeks
Scapular Dyskinesis
Time Frame: Change from baseline to 6 months
It is measured with visual observation at rest and during movement (loaded and unloaded, in abduction and in flexion); the presence of winging, tilting or abnormal scapular movement determines the judgement about scapular dyskinesis (yes/no) at rest and during movement
Change from baseline to 6 months
Scapular Correction
Time Frame: Change from baseline to 12 weeks
it is measured with the reduction of symptoms during 2 tests: 2) the scapular assistance test (SAT); if the pain reduces after the SAT, the test is considered positive; 3) scapular retraction test (SRT); if the pain reduces after the SRT, the test is considered positive.
Change from baseline to 12 weeks
Scapular Correction
Time Frame: Change from baseline to 6 months
it is measured with the reduction of symptoms during 2 tests: 2) the scapular assistance test (SAT); if the pain reduces after the SAT, the test is considered positive; 3) scapular retraction test (SRT); if the pain reduces after the SRT, the test is considered positive.
Change from baseline to 6 months
Acromiohumeral Distance
Time Frame: Change from baseline to 12 weeks
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Change from baseline to 12 weeks
Acromiohumeral Distance
Time Frame: Change from baseline to 6 months
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Change from baseline to 6 months
Coracohumeral distance
Time Frame: Change from baseline to 12 weeks
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Change from baseline to 12 weeks
Coracohumeral distance
Time Frame: Change from baseline to 6 months
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Change from baseline to 6 months
Supraspinatus Tendon Thickness
Time Frame: Change from baseline to 12 weeks
it is measured with the Ultrasound in Crass position (in millimeters)
Change from baseline to 12 weeks
Supraspinatus Tendon Thickness
Time Frame: Change from baseline to 6 months
it is measured with the Ultrasound in Crass position (in millimeters)
Change from baseline to 6 months
Subscapularis Tendon Thickness
Time Frame: Change from baseline to 12 weeks
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Change from baseline to 12 weeks
Subscapularis Tendon Thickness
Time Frame: Change from baseline to 6 months
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Change from baseline to 6 months
Visual Analogue Scale (VAS)
Time Frame: Change from baseline to 12 weeks
It measures pain during activity, during night, in the past 24 hours. It is measured on a scale from 0 to 100, where 0=no pain, 100=worst imaginable pain.
Change from baseline to 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global perceived effect (GPE)
Time Frame: 12 weeks
It is measured on a 7-Likert Scale, ranging from 1 (way much better) to 7 (way much worse); higher scores mean worst global perceived effect.
12 weeks
Adherence
Time Frame: 12 weeks
It is analysed in terms of attendance to the physiotherapist-led sessions and adherence to the home-exercise protocol. Good level of adherence is defined by: attendance of 7/9 (80%) of physiotherapist led-sessions and 22/27 (80%) days of home-exercises completed.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiteit Antwerpen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southern Denmark
University of Malaga
Rotterdam University of Applied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Filip Struyf, Professor, Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18/34/379 (RCT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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