NCT Number: NCT07275164
This feasibility study investigates whether high-intensity interval training (HIIT) is feasible and acceptable for individuals with long-term shoulder pain where low-grade inflammation is suspected. Many patients do not recover fully with current local treatments, and systemic factors such as inflammation, and metabolic changes, additionally disturbances in the functioning of the nervous system often seem to play a role. HIIT is a time-efficient form of exercise that has been shown to improve inflammation and metabolic values and positively influence the balance of the nervous system. In this feasibility study, the investigators are enrolling 15 individuals with persistent shoulder pain (diagnosed with rotator cuff-related shoulder pain or frozen shoulder) with >3 months of symptoms, and 15 individuals without shoulder complaints. All participants will undergo measurements of inflammatory levels, glycosylated hemoglobin (HbA1c), blood pressure, body composition, pain sensitivity tests, and complete questionnaires about autonomic complaints and quality of life. Participants with shoulder pain will also perform one personalized HIIT session on a cycle ergometer. The investigators will assess whether participants accept a systemic intervention for their shoulder pain, if they are cooperative, and how they feel about the session; additionally, any side effects will be recorded. The aim is to determine whether HIIT is practically feasible and safe for this group and whether there are indications that systemic factors such as inflammation and nervous system function are associated with persistent shoulder pain. The outcome will determine whether follow-up research with a larger study is worthwhile.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Wilrijk, 2610, Belgium
Location status: Recruiting
An De Groef, PhD
SUB_INVESTIGATOR
Chloe Van Der Auwera
SUB_INVESTIGATOR
Jonas Verbrugghe, PhD
SUB_INVESTIGATOR
Lennert Moons
SUB_INVESTIGATOR
Levi Peeters
SUB_INVESTIGATOR
Lisa Van Hecke
SUB_INVESTIGATOR
Michel Mertens, PhD
CONTACT
Mira Meeus, PhD
SUB_INVESTIGATOR
Niels Polfliet
SUB_INVESTIGATOR
Sebastiaan Dalle, PhD
SUB_INVESTIGATOR
Tom Philips
SUB_INVESTIGATOR
Persistent musculoskeletal shoulder pain, such as rotator cuff-related complaints and frozen shoulder, is common and often leads to long-term limitations and reduced quality of life. Despite available treatment options, including exercise therapy, manual techniques and infiltrations, a significant group of patients do not experience full recovery. Growing scientific evidence suggests that chronic low-grade inflammation, metabolic disorders, such as insulin resistance or obesity, autonomic dysfunction, and changes in somatosensory processing contribute to the persistence of complaints. Within this framework, physical activity is receiving more attention as a systemic intervention. High-intensity interval training (HIIT) in particular appears to have a pronounced effect on inflammatory levels, metabolic parameters, cardiovascular function, and pain modulation in various populations. HIIT also offers practical advantages due to its short duration and higher efficiency compared to traditional endurance training. Therefore, the primary aim of the current study is to investigate the feasibility of a HIIT protocol in individuals with chronic inflammatory-driven shoulder pain. This investigation includes recruitment rate, adherence, acceptance, satisfaction, motivation, safety, and practical feasibility. A secondary aim of the current study is to explore differences between individuals with shoulder pain and asymptomatic controls in terms of inflammatory markers (C-Reactive Protein), metabolic parameters (HbA1c, blood pressure, body composition), autonomic functions (self-reported symptoms, heart rate variability) and somatosensory functions (pressure pain thresholds, temporal summation and conditioned pain modulation). This is a cross-sectional feasibility study with 30 participants (15 individuals with chronic shoulder pain and 15 asymptomatic controls). The individuals with shoulder pain participate in two sessions: a maximal exercise test on a cycle ergometer (to determine VO₂max and Wmax) and a combined assessment and HIIT session. Asymptomatic controls undergo a single assessment session. The HIIT protocol consists of five one-minute intervals of cycling at 100% of the individually determined VO₂max capacity, alternating with one minute of active rest at 50% of this capacity. The total exercise time is approximately 20 minutes. The session is supervised by an experienced physiotherapist in a research setting (MOVANT, University of Antwerp). Clinical parameters that will be assessed and stored in REDCap include demographics, shoulder pain and disability (SPADI), pain intensity (VAS), quality of life (EQ-5D), inflammation (c-reactive protein), nutrition-related inflammatory index, metabolic markers (glycosylated hemoglobin, blood pressure and body composition through bioelectrical impedance), autonomic functions (self-reported autonomic symptoms and Heart Rate Variability), and somatosensory processing (pressure pain thresholds, temporal summation, and conditioned pain modulation). Results are mainly reported descriptively, with confidence intervals to estimate effect sizes. As this is a pilot study, the design is not powered for formal hypothesis testing.The study aims to investigate whether HIIT is feasible and safe in this population and to provide initial indications of the role of systemic processes in the persistence of shoulder complaints. The results may form the basis for larger randomized studies and may contribute to a paradigm shift towards systemic approaches in the treatment of musculoskeletal pain.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Shoulder pain group
Control group
o Understanding Dutch in speaking and writing
Exclusion criteria
Shoulder pain group
Control group
One 20-minute HIIT session (5x1 min at VO₂max with 1 min recovery at 50% VO₂max) on cycle ergometer.
Time frame: Immediately after the HIIT training session
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.
Time frame: During the training session
HIIT protocol adherence will be assessed by determining the percentage of HIIT-protocol completers and registration of protocol adjustments.
Time frame: Immediately after the training session
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.
Time frame: During the study period
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.
Time frame: Immediately after the assessment and training session
Assessment of full protocol conduction will be assessed by registering preparation time, protocol duration, and issues with equipment and location.
Time frame: Up to 3 days after training and assessment
The severity of the adverse event will be determine based on the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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
Time frame: Baseline
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.
Time frame: Baseline
The gender of the participant
Time frame: Baseline
The age of the participant
Time frame: Baseline
The job status of the participant
Time frame: Baseline
The alcohol abuse status of the participant
Time frame: Baseline
Smoking status of the participant
Time frame: Baseline
Presence and type(s) of comorbidities of the participant
Time frame: Baseline
Characteristics of the disorder the participant presents with
Contact information is provided by the study sponsor or research team.
Michel Mertens, PhD
CONTACT
Mira Meeus, PhD
CONTACT
Universiteit Antwerpen
Other
Revolutionizing Musculoskeletal Shoulder Pain Management: High-intensity Interval Training as a Systemic Intervention. A Feasibility Study.
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.
Published trials that share one or more normalized conditions with this study.
NCT07607691
Arthralgia, Bursitis
Ankara, çankaya, Turkey (Türkiye)
View Trial DetailsNCT07392762
Arthralgia, Chronic Shoulder Pain
Middlesex, London, United Kingdom
View Trial DetailsNCT06854809
Arthralgia, Chronic Shoulder Pain
São Carlos, São Paulo, Brazil
View Trial DetailsNCT06661681
Arthralgia, Chronic Pain
João Pessoa, Paraíba, Brazil
View Trial Details