HIIT for Inflammatory-driven Shoulder Pain.

February 10, 2026 updated by: Michel GCAM Mertens, Universiteit Antwerpen

Revolutionizing Musculoskeletal Shoulder Pain Management: High-intensity Interval Training as a Systemic Intervention. A Feasibility Study.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Wilrijk, Belgium, 2610
        • Recruiting
        • Universiteit Antwerpen
        • Contact:
        • Sub-Investigator:
          • Mira Meeus, PhD
        • Sub-Investigator:
          • An De Groef, PhD
        • Sub-Investigator:
          • Jonas Verbrugghe, PhD
        • Sub-Investigator:
          • Sebastiaan Dalle, PhD
        • Sub-Investigator:
          • Lisa Van Hecke
        • Sub-Investigator:
          • Niels Polfliet
        • Sub-Investigator:
          • Chloe Van Der Auwera
        • Sub-Investigator:
          • Lennert Moons
        • Sub-Investigator:
          • Tom Philips
        • Sub-Investigator:
          • Levi Peeters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Shoulder pain group

  • Shoulder pain > 3 months
  • Diagnosis of rotator cuff related shoulder pain or frozen shoulder
  • Understanding Dutch in speaking and writing.

Control group

o Understanding Dutch in speaking and writing

Exclusion Criteria:

Shoulder pain group

  • <18 years
  • Shoulder surgery or trauma in past year
  • Neurological, cancer, or neuromuscular disease
  • Osteoarthritis, cervical or AC joint pathology
  • Heavy physical exertion <48h before testing

Control group

  • <18 years
  • recent or recurrent neck/shoulder pain
  • systemic or neurological disease
  • psychiatric disorders
  • pregnancy/breastfeeding
  • pain medication <48h before test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High intensity interval training (HIIT)
One 20-minute HIIT session (5x1 min at VO₂max with 1 min recovery at 50% VO₂max) on cycle ergometer
Other: High intensity interval training (HIIT)
One 20-minute HIIT session (5x1 min at VO₂max with 1 min recovery at 50% VO₂max) on cycle ergometer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant acceptance and satisfaction
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.
Immediately after the HIIT training session
HIIT protocol adherence
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.
During the training session
Intrinsic motivation
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.
Immediately after the training session
Study recruitment rate
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.
During the study period
Full protocol conduction
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.
Immediately after the assessment and training session
Adverse events
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).
Up to 3 days after training and assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shoulder pain and disability
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.
Baseline
Pain intensity
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.
Baseline
Health-related quality of life
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.
Baseline
C-reactive protein level
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.
Baseline
Adapted dietary inflammatory index
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.
Baseline
Glycosylated hemoglobin
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.
Baseline
Blood pressure
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.
Baseline
Body composition
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.
Baseline
Self-reported autonomic symptoms
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.
Baseline
Vasomotor function
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.
Baseline
Primary and secondary hyperalgesia
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.
Baseline
Temporal summation
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
Baseline
Conditioned pain modulation
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.
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Baseline
The gender of the participant
Baseline
Age
Time Frame: Baseline
The age of the participant
Baseline
Job status
Time Frame: Baseline
The job status of the participant
Baseline
Alcohol abuse
Time Frame: Baseline
The alcohol abuse status of the participant
Baseline
Smoking status
Time Frame: Baseline
Smoking status of the participant
Baseline
Comorbidities
Time Frame: Baseline
Presence and type(s) of comorbidities of the participant
Baseline
Disorder characteristics
Time Frame: Baseline
Characteristics of the disorder the participant presents with
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiteit Antwerpen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel Mertens, PhD, Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results of the food frequency questionnaire, which is part of the nutritional inflammatory index, will be shared with the developers of the questionnaire for optimization of the questionnaire. Furthermore, all data can be shared with other researchers upon reasonable request. Data will not be publicly available.

IPD Sharing Time Frame

It will only be available upon reasonable request.

IPD Sharing Access Criteria

The requested data will be send to the requester by the PI of the study and a data sharing agreement will be signed by both parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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