HIIT for Inflammatory-driven Shoulder Pain.

NCT ID: NCT07275164

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2026-10-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High intensity interval training (HIIT)

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

Group Type: EXPERIMENTAL

High intensity interval training (HIIT)

Intervention Type: OTHER

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

Interventions

High intensity interval training (HIIT)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Michel GCAM Mertens

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Mertens, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

Universiteit Antwerpen

Wilrijk, , Belgium

Countries

Belgium

Central Contacts

Michel Mertens, PhD

Role: CONTACT

michel.mertens@uantwerpen.be

+32 3 265 89 76

Mira Meeus, PhD

Role: CONTACT

mira.meeus@uantwerpen.be

Facility Contacts

Michel Mertens, PhD

Role: primary

michel.mertens@uantwerpen.be

+32 3 265 89 76

Other Identifiers

7796

Identifier Type: -

Identifier Source: org_study_id