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

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ClinicalTrials.gov Identifier: NCT03675399
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mercè Balasch i Bernat, University of Valencia

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tendinitis Other: Supra-threshold isometric exercise Other: Infra-threshold isometric exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Exercise sessions were delivered by a physiotherapist who was not involved in the assessments.
Primary Purpose: Treatment
Official Title: Effect of Isometric Exercise on Pain Perception in Subjects With Rotator Cuff Related Shoulder Pain
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supra-threshold isometric exercise
Participants will perform 5 isometric external rotation supra-threshold contractions of the affected shoulder, each held for 45 seconds, with resting intervals of 2 minutes 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 5 isometric external rotation infra-threshold contractions of the affected shoulder, each held for 45 seconds, with resting intervals of 2 minutes 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.



Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Conditioned pain modulation (CPM) [ Time Frame: Baseline ]
    CPM will be tested using the upper extremity submaximal effort tourniquet test.

  5. Conditioned pain modulation (CPM) [ Time Frame: Immediately post-intervention ]
    CPM will be tested using the upper extremity submaximal effort tourniquet test.

  6. Conditioned pain modulation (CPM) [ Time Frame: 45 minutes post-intervention ]
    CPM will be tested using the upper extremity submaximal effort tourniquet test.

  7. 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.

  8. 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.

  9. 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.

  10. Pain free isometric strength/threshold (PFIS) [ Time Frame: Baseline ]
    PFIS will be assessed at m. infraspinatus of the affected shoulder

  11. Pain free isometric strength/threshold (PFIS) [ Time Frame: Immediately post-intervention ]
    PFIS will be assessed at m. infraspinatus of the affected shoulder

  12. Pain free isometric strength/threshold (PFIS) [ Time Frame: 45 minutes post-intervention ]
    PFIS will be assessed at m. infraspinatus of the affected shoulder



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675399


Locations
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Spain
Mercè Balasch i Bernat Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46021
Contact: Mercè Balasch i Bernat, PhD    653507630    merce.balasch@uv.es   
Mercè Balasch i Bernat Recruiting
Valencia, Spain, 46021
Contact: Mercè Balasch i Bernat, PhD, PT    963983855 ext 51225    merce.balasch@uv.es   
Sub-Investigator: Lirios Dueñas Moscardó, PhD, PT         
Sub-Investigator: Enrique Lluch Girbés, PhD, PT         
Sponsors and Collaborators
University of Valencia
Investigators
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Principal Investigator: Mercè Balasch i Bernat, PhD Universitat de València
Publications of Results:

Other Publications:
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Responsible Party: Mercè Balasch i Bernat, PhD Professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03675399    
Other Study ID Numbers: H1528701290644
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mercè Balasch i Bernat, University of Valencia:
isometric exercise
rotator cuff
pain threshold
Additional relevant MeSH terms:
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Shoulder Pain
Tendinopathy
Rotator Cuff Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Rupture
Shoulder Injuries