HIIT for Inflammatory-driven Shoulder Pain.

NCT07275164 | Recruiting DMC

• 1 other identifier: 7796
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Shoulder Pain; Rotator Cuff Related Shoulder Pain; Frozen Shoulder; Shoulder Adhesive Capsulitis; Shoulder Pain

Keywords

low-grade inflammation; chronic shoulder pain; autonomic dysfunction; metabolic syndrome; frozen shoulder; rotator cuff related shoulder pain; high intensity interval training

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (13)

• Shoulder pain and disability

  Baseline

• Pain intensity

  Baseline

• Health-related quality of life

  Baseline

• C-reactive protein level

  Baseline

• Adapted dietary inflammatory index

  Baseline

Other Outcomes (7)

• Gender

  Baseline

• Age

  Baseline

• Job status

  Baseline

Study Arms (1)

High intensity interval training (HIIT)

EXPERIMENTAL

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)

Interventions

High intensity interval training (HIIT) OTHER

One 20-minute HIIT session (5x1 min at VO₂max with 1 min recovery at 50% VO₂max) on cycle ergometer.

High intensity interval training (HIIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

Universiteit Antwerpen

Wilrijk, 2610, Belgium

RECRUITING

MeSH Terms

Conditions

Bursitis; Shoulder Pain; Primary Dysautonomias; Metabolic Syndrome

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michel Mertens, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Mertens, PhD

CONTACT

+32 3 265 89 76; michel.mertens@uantwerpen.be

Mira Meeus, PhD

CONTACT

mira.meeus@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Only the group with shoulder pain will receive one intervention session. The asymptomatic controls are recruited for comparing baseline values.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 10, 2025
• Study Start: December 10, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: It will only be available upon reasonable request.
• 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.

Locations

BE (1)