An interventional study of Supra-threshold isometric exercise and Infra-threshold isometric exercise in Rotator Cuff Tendinitis, sponsored by University of Valencia. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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.
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.
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Exclusion Criteria:
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
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
Participants will remain resting.
The supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).
The infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).
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).
Time frame: Baseline
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).
Time frame: Immediately post-intervention
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).
Time frame: 45 minutes post-intervention
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.
Time frame: Baseline, immediately post-intervention and 45 minutes post-intervention
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.
Time frame: Immediately post-intervention
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.
Time frame: 45 minutes post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time frame: Baseline
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time frame: Immediately post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Time frame: 45 minutes post-intervention
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.
Time frame: Baseline
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.
Time frame: Immediately post-intervention and 45 minutes post-intervention
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.
Time frame: 45 minutes post-intervention
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Time frame: Baseline
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Time frame: Immediately post-intervention
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Time frame: 45 minutes post-intervention
Plan to share: No
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University of Valencia