Clinical Trial Radar

Participant acceptance and satisfaction

Participant acceptance and satisfaction of the HIIT-session will be assessed with an adapted short questionnaire based on the total shoulder arthroplasty postoperative satisfaction questionnaire.

Immediately after the HIIT training session

HIIT protocol adherence

HIIT protocol adherence will be assessed by determining the percentage of HIIT-protocol completers and registration of protocol adjustments.

During the training session

Intrinsic motivation

Intrinsic motivation of the participants with shoulder pain will be assessed using the intrinsic motivation inventory (IMI). From this questionnaire only the following domains will be questioned: interest/enjoyment, effort, and value/usefulness. The questions will be adapted specific to the current study, as recommended.

Immediately after the training session

Study recruitment rate

Study recruitment rate will be determined by dividing the number of participants by the number of contacted individuals. Reasons for non-participation will be assessed with preset response options.

During the study period

Full protocol conduction

Assessment of full protocol conduction will be assessed by registering preparation time, protocol duration, and issues with equipment and location.

Immediately after the assessment and training session

Adverse events

The severity of the adverse event will be determine based on the Common Terminology Criteria for Adverse Events (CTCAE).

Up to 3 days after training and assessment

Shoulder pain and disability

The shoulder pain and disability index (SPADI) will be used, this is a self-reported index that consists of 13 items in two domains (pain (5 items) and disability (8 items)). A percentage ranging from 0 (no pain or disability) to 100 (worst pain or disability) will be used to present the pain and disability experienced by the participants. The SPADI has been found valid and reliable in evaluating pain and disability in shoulder disorders.

Baseline

Pain intensity

Pain intensity will be measured by a visual analogue scale. Participants will be asked to rate their pain on a 10 cm line by drawing a vertical mark on that line. The left end of the line represents 'No pain' (0 cm) and the right end 'Most severe pain' (10 cm). The scoring is the distance (in millimeter) from the left end of the line to the vertical mark of the participant. Participants must rate their shoulder pain for three moments: current and minimal and maximal pain during the last week. The VAS has been found valid and reliable.

Baseline

Health-related quality of life

Health-related quality of life will be assessed with the EQ-5D. The EQ-5D is a standardized, validated measure comprising five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level ordinal scale (from 'no problems' to 'extreme problems'), offering improved sensitivity and reduced ceiling effects compared to the earlier 3-level version. Additionally, the EQ-5D includes a visual analogue scale (EQ-VAS), on which participants rate their overall health on a scale ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The psychometric properties of the EQ-5D are excellent in a broad range of populations, conditions and settings. Utility scores will be calculated using the Dutch EQ-5D value set.

Baseline

C-reactive protein level

C-reactive protein (CRP) level will be measured by the QuikRead go easy CRP, a highly sensitive tool. With 10 μL blood (fingerprick) the level of CRP between 1 and 120 mg/L can be determined within 5 minutes. This tool has been found reliable.

Baseline

Adapted dietary inflammatory index

The adapted dietary inflammatory index (ADII) will be based on data acquired through the food frequency questionnaire (FFQ), as conducted previously. The ADII is a literature-derived index that summarizes an individual's diet on the continuum from maximally anti-inflammatory to maximally pro-inflammatory. ADII was calculated by multiplying the dietary inflammatory weights of the dietary components by the daily intake.

Baseline

Glycosylated hemoglobin

Glycosylated hemoglobin (HbA1c) will be measured with the A1CNOW+ tool. The A1CNOW+ is a tool that measures the A1c and total hemoglobin and determines the percentage HbA1c over the last 90 days, which is valid and reliable.

Baseline

Blood pressure

Blood pressure will be measured using an automated office blood pressure monitor in a seated position in a quit examination room. Both diastolic and systolic pressure will be recorded.

Baseline

Body composition

Body composition will be determined by the InBody 770® (InBodyUSA, Cerritos, CA), more specifically %body fat and fat free mass of the participants will be determined.

Baseline

Self-reported autonomic symptoms

Self-reported autonomic symptoms will be assessed by the composite autonomic symptom score 31 (COMPASS-31), which has 31 questions in six domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, constipation, bladder, and pupillomotor). Total score ranges from 0 to 100 because of summation of the six subdomains.

Baseline

Vasomotor function

Vasomotor function of the autonomic nervous system (parasympathetic branch) will be measured with the help of resting heart rate variability (HRV), which will be measured using a chest strap (polar H10). The root mean square of successive RR-interval differences (RRSMD), mean RR interval, standard deviation of all normal RR intervals (SDNN), and percentage of successive RR intervals that differ by more than 50 ms (pNN50) will be determined.

Baseline

Primary and secondary hyperalgesia

Primary and secondary hyperalgesia (in kg/cm2) will be assessed by pressure pain thresholds (PPTs). The PPTs will be determined at both affected and unaffected (shoulder pain group) and dominant and non-dominant (control group) shoulders and affected side (shoulder pain group) or dominant (control group) quadriceps muscle.

Baseline

Temporal summation

Temporal summation will be induced with a train of 10 repeated pressure stimuli at the quadriceps muscle at the affected (shoulder pain group) or dominant (control group) side using a digital algometer. Pressure will be applied with 2 kg/s with 1-second interstimulus intervals. The pressure for temporal summation will be the mean PPT previously determined for the quadriceps. Participants rate their pain intensity on a NRS (0-10) after the first, fifth, and tenth repetition of the train stimuli. Temporal summation is calculated as the difference in pain intensity between the tenth and the first pulse

Baseline

Conditioned pain modulation

The test stimulus consists of mechanical pressure pain elicited (PPT). The conditioning stimulus consists of ischemic occlusion and will be applied to the unaffected (shoulder pain group) or non-dominant (control group) arm with an inflatable air cuff (Boso Profitest). The absolute conditioned pain modulation effect will be calculated as the difference between the PPT at baseline and the PPT with conditioning stimulus, while the relative effect will be calculated as follows: (PPT at baseline - PPT with conditioning stimulus) / PPT at baseline.

Baseline