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Completed

NCT Number: NCT03675399

Effect of Isometric Exercise on Pain Perception in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercè Balasch i Bernat, Valencia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Supra-threshold isometric exercise

Other

The supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).

Infra-threshold isometric exercise

Other

The infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 18, 2018
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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