Effect of Isometric Exercise on Pain Perception in Rotator Cuff Related Shoulder Pain

April 29, 2021 updated by: Mercè Balasch i Bernat, University of Valencia

Effect of Isometric Exercise on Pain Perception in Subjects With Rotator Cuff Related Shoulder Pain

The aim of this study is to compare the immediate effects of an acute bout of isometric exercise of the shoulder external rotator muscles above and below pain threshold on pain intensity, pain threshold, conditioned pain modulation and pain free force in external rotation. To evaluate the results of the exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and after and 45 minutes after each experimental condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare the immediate effects of an acute bout of isometric exercise of the shoulder external rotator muscles above and below pain threshold on pain intensity, pain threshold, conditioned pain modulation and pain free force in external rotation.

It will consist of a randomized three-treatment parallel-design study. The sample will consist of subjects with rotator cuff related shoulder pain (RCRSP). Once the sample is selected, subjects will participate in three experimental sessions, which will occur in a randomized order: two exercise sessions (supra-threshold and infra-threshold isometric exercise) and one control session. In the first session, information regarding clinical and demographical aspects will be collected. A washout period of approximately 48 hours will separate each of the experimental sessions.

To evaluate the results of the exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and 45 minutes after each experimental condition. Pain intensity, Pressure Pain Thresholds (PPT), Conditioned Pain Modulation (CPM), maximal voluntary isometric contraction (MVIC) and pain free isometric strength (PFIS) will be measured.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • 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 Locations

  • Spain
      • Valencia, Spain, 46021
        • Mercè Balasch i Bernat
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46021
        • Mercè Balasch i Bernat

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18-80 years (likelihood of patients > 80 having degenerative changes in the shoulder is increased)
  • pain localised to the proximal anterolateral shoulder region
  • positive for pain on at least one of the following three impingement tests: Hawkins-Kennedy, Neer's, Jobe's
  • positive for pain on resisted external rotation and/or abduction.

Exclusion Criteria:

  • shoulder surgery within last 6 months
  • reasons to suspect systemic pathology including inflammatory disorders, cervical repeated movement testing affects shoulder pain and/or range of movement, passive external rotation deficit greater (less than 30º or a range of motion reduction of 50% or more as compared to the contralateral side), upper limb tension test A for cervical radiculopathy
  • atraumatic degenerative rotator cuff tear based on the cluster of clinical tests (painful arc, drop arm test, and marked weakness into ER all three positive)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supra-threshold isometric exercise
Participants will perform 10 isometric external rotation supra-threshold contractions of the affected shoulder, each held for 15 seconds, with resting intervals of 15 seconds between contractions.
Other: Supra-threshold isometric exercise
The supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).
Experimental: Infra-threshold isometric exercise
Participants will perform 10 isometric external rotation infra-threshold contractions of the affected shoulder, each held for 15 seconds, with resting intervals of 15 seconds between contractions.
Other: Infra-threshold isometric exercise
The infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).
No Intervention: Control
Participants will remain resting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Baseline
Pain intensity
Time Frame: Immediately post-intervention
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Immediately post-intervention
Pain intensity
Time Frame: 45 minutes post-intervention
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Lower values represent a better outcome (less pain).
45 minutes post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conditioned pain modulation (CPM)
Time Frame: Baseline
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Baseline
Pressure Pain Thresholds (PPT)
Time Frame: Baseline, immediately post-intervention and 45 minutes post-intervention
PPTs will be recorded using an electronic algometer at the ipsilateral m. infraspinatus, the contralateral resting m. infraspinatus and the contralateral resting m. quadriceps. Higher values represent a better outcome.
Baseline, immediately post-intervention and 45 minutes post-intervention
Pressure Pain Thresholds (PPT)
Time Frame: Immediately post-intervention
PPTs will be recorded using an electronic algometer at the ipsilateral m. infraspinatus, the contralateral resting m. infraspinatus and the contralateral resting m. quadriceps. Higher values represent a better outcome.
Immediately post-intervention
Pressure Pain Thresholds (PPT)
Time Frame: 45 minutes post-intervention
PPTs will be recorded using an electronic algometer at the ipsilateral m. infraspinatus, the contralateral resting m. infraspinatus and the contralateral resting m. quadriceps. Higher values represent a better outcome.
45 minutes post-intervention
Conditioned pain modulation (CPM)
Time Frame: Immediately post-intervention
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Immediately post-intervention
Conditioned pain modulation (CPM)
Time Frame: 45 minutes post-intervention
CPM will be tested using the upper extremity submaximal effort tourniquet test.
45 minutes post-intervention
Maximal voluntary isometric contraction (MVIC)
Time Frame: Baseline
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Baseline
Maximal voluntary isometric contraction (MVIC)
Time Frame: Immediately post-intervention and 45 minutes post-intervention
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Immediately post-intervention and 45 minutes post-intervention
Maximal voluntary isometric contraction (MVIC)
Time Frame: 45 minutes post-intervention
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
45 minutes post-intervention
Pain free isometric strength/threshold (PFIS)
Time Frame: Baseline
PFIS will be assessed at m. infraspinatus of the affected shoulder
Baseline
Pain free isometric strength/threshold (PFIS)
Time Frame: Immediately post-intervention
PFIS will be assessed at m. infraspinatus of the affected shoulder
Immediately post-intervention
Pain free isometric strength/threshold (PFIS)
Time Frame: 45 minutes post-intervention
PFIS will be assessed at m. infraspinatus of the affected shoulder
45 minutes post-intervention

Collaborators and Investigators

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

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Mercè Balasch i Bernat, PhD, Universitat de València

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2019

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1528701290644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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