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

Primary Purpose

Rotator Cuff Tendinitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supra-threshold isometric exercise
Infra-threshold isometric exercise
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinitis focused on measuring isometric exercise, rotator cuff, pain threshold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mercè Balasch i Bernat
  • Mercè Balasch i Bernat

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Supra-threshold isometric exercise

Infra-threshold isometric exercise

Control

Arm Description

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.

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.

Participants will remain resting.

Outcomes

Primary Outcome Measures

Pain intensity
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).
Pain intensity
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).
Pain intensity
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).

Secondary Outcome Measures

Pressure Pain Thresholds (PPT)
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.
Pressure Pain Thresholds (PPT)
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.
Pressure Pain Thresholds (PPT)
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.
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Maximal voluntary isometric contraction (MVIC)
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Maximal voluntary isometric contraction (MVIC)
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Maximal voluntary isometric contraction (MVIC)
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder

Full Information

First Posted
September 13, 2018
Last Updated
April 29, 2021
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03675399
Brief Title
Effect of Isometric Exercise on Pain Perception in Rotator Cuff Related Shoulder Pain
Official Title
Effect of Isometric Exercise on Pain Perception in Subjects With Rotator Cuff Related Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinitis
Keywords
isometric exercise, rotator cuff, pain threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Exercise sessions were delivered by a physiotherapist who was not involved in the assessments.
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supra-threshold isometric exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Infra-threshold isometric exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will remain resting.
Intervention Type
Other
Intervention Name(s)
Supra-threshold isometric exercise
Intervention Description
The supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).
Intervention Type
Other
Intervention Name(s)
Infra-threshold isometric exercise
Intervention Description
The infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).
Primary Outcome Measure Information:
Title
Pain intensity
Description
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).
Time Frame
Baseline
Title
Pain intensity
Description
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).
Time Frame
Immediately post-intervention
Title
Pain intensity
Description
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).
Time Frame
45 minutes post-intervention
Secondary Outcome Measure Information:
Title
Pressure Pain Thresholds (PPT)
Description
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.
Time Frame
Baseline, immediately post-intervention and 45 minutes post-intervention
Title
Pressure Pain Thresholds (PPT)
Description
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.
Time Frame
Immediately post-intervention
Title
Pressure Pain Thresholds (PPT)
Description
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.
Time Frame
45 minutes post-intervention
Title
Conditioned pain modulation (CPM)
Description
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time Frame
Baseline
Title
Conditioned pain modulation (CPM)
Description
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time Frame
Immediately post-intervention
Title
Conditioned pain modulation (CPM)
Description
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time Frame
45 minutes post-intervention
Title
Maximal voluntary isometric contraction (MVIC)
Description
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Time Frame
Baseline
Title
Maximal voluntary isometric contraction (MVIC)
Description
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Time Frame
Immediately post-intervention and 45 minutes post-intervention
Title
Maximal voluntary isometric contraction (MVIC)
Description
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Time Frame
45 minutes post-intervention
Title
Pain free isometric strength/threshold (PFIS)
Description
PFIS will be assessed at m. infraspinatus of the affected shoulder
Time Frame
Baseline
Title
Pain free isometric strength/threshold (PFIS)
Description
PFIS will be assessed at m. infraspinatus of the affected shoulder
Time Frame
Immediately post-intervention
Title
Pain free isometric strength/threshold (PFIS)
Description
PFIS will be assessed at m. infraspinatus of the affected shoulder
Time Frame
45 minutes post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercè Balasch i Bernat, PhD
Organizational Affiliation
Universitat de València
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercè Balasch i Bernat
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46021
Country
Spain
Facility Name
Mercè Balasch i Bernat
City
Valencia
ZIP/Postal Code
46021
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Isometric Exercise on Pain Perception in Rotator Cuff Related Shoulder Pain

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