An interventional study of Isokinetic dynamometer in Delayed Onset Muscle Soreness Experimentally Induced, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science
The purpose of this study is to characterize the clinical and radiological manifestations of delayed onset muscle soreness (DOMS) experimentally induced by an isokinetic eccentric contraction protocol targeting the shoulder rotator muscles in asymptomatic athletic subjects.
In recent years, an increasing number of young athletes have reported shoulder pain and weakness following intense physical activity, particularly strength training. These symptoms may sometimes suggest neurological conditions, such as suprascapular nerve involvement, but in most cases they correspond to delayed onset muscle soreness (DOMS), a common and benign response to unaccustomed or intense exercise. DOMS typically occurs between 12 and 48 hours after exercise and is characterized by diffuse muscle pain, transient loss of strength, tenderness to palpation, and reduced muscle flexibility. Despite its high prevalence, the clinical and imaging characteristics of DOMS affecting the shoulder rotator muscles remain insufficiently described, which may lead to diagnostic uncertainty and inappropriate management. To address this gap, this study is based on an experimental model designed to reproducibly induce DOMS in a controlled setting in healthy, physically active young adults.
Participants will undergo a standardized isokinetic exercise protocol targeting the internal and external rotator muscles of the shoulder. After an initial familiarization phase with the isokinetic device, participants will perform a structured exercise session consisting of 8 sets of 10 repetitions of eccentric contractions in both internal and external rotation. The protocol is designed to induce muscle fatigue and reproducible DOMS through controlled eccentric loading. Magnetic resonance imaging (MRI) of the shoulder will be performed at predefined time points during the study to assess muscle changes induced by the eccentric exercise. Particular attention will be paid to signal changes on fluid-sensitive sequences (T2/STIR), which are expected to reflect muscle edema and inflammation associated with DOMS.
In parallel, a comprehensive clinical and functional assessment will be conducted throughout the study. This includes evaluation of pain intensity using a visual analog scale (VAS), measurement of active and passive range of motion, assessment of muscle strength, and evaluation of functional impact using validated questionnaires such as the Shoulder Pain and Disability Index (SPADI) and the QuickDASH.
No invasive procedures or therapeutic interventions are involved in this study. The protocol relies exclusively on controlled mechanical (eccentric) muscle loading and non-invasive imaging.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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Exclusion Criteria:
Asymptomatic male athletes who have been performing upper-limb strength training at least once per week for the past 3 months.
Device: Isokinetic dynamometer
A standardized series of 8 sets of 10 repetitions of internal and external shoulder rotations performed under eccentric contractions.
Composite Clinical and MRI Assessment of DOMS Evolution in Shoulder Rotator Muscles
A composite endpoint combining quantitative clinical parameters and qualitative and semi-quantitative MRI parameters, allowing analysis of the temporal evolution of DOMS from baseline through the different follow-up phases.
Time frame: 3 months
Physical Impairment: numeric verbal scale of pain
self-evaluated numeric verbal scale of pain, ranging from 0 to 10 (lesser is better)
Time frame: Day4, Day9 to Day16, and 3 months
Physical Impairment : mobility of shoulder joints
Active and passive shoulder bilateral global mobility. Active and passive shoulder bilateral scapulohumeral mobility: Measured in antepulsion/ abduction in scapular plane/ lateral rotation and medial rotation
Time frame: Day4, Day9 to Day16, and 3 months
Self-administered questionnaire assessing quality of life of the upper limb
Assesses the ability to perform 23 activities, the severity of symptoms 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). In addition there are two optional modules of four questions each, sporting or instrumental and employment activity.
Time frame: Day4, Day9 to Day16, and 3 months
Shoulder Pain and Disability Index (SPADI)
Self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Total score ranging from 0 (best) to 100 (worst).
Time frame: Day4, Day9 to Day16, and 3 months
MRI Normalization Time
Qualitative and semi-quantitative assessment of MRI muscle abnormalities on sagittal, axial, and coronal T2 fat-saturated and T2 STIR sequences, including presence, intensity and distribution of muscle hyperintensity, number of muscles involved, and associated lesions.
Time frame: Day4, Day9 to Day16, and 3 months
Plan to share: No
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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