Revolutionizing Musculoskeletal Shoulder Pain Management: High-intensity Interval Training as a Systemic Intervention. A Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Participant acceptance and satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High intensity interval training (HIIT)
One 20-minute HIIT session (5x1 min at VO₂max with 1 min recovery at 50% VO₂max) on cycle ergometer
干预措施: High intensity interval training (HIIT) (Other)
结局指标
主要结局
Participant acceptance and satisfaction
时间窗: 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.
HIIT protocol adherence
时间窗: During the training session
HIIT protocol adherence will be assessed by determining the percentage of HIIT-protocol completers and registration of protocol adjustments.
Intrinsic motivation
时间窗: 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.
Study recruitment rate
时间窗: 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.
Full protocol conduction
时间窗: 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.
Adverse events
时间窗: 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).
次要结局
- Shoulder pain and disability(Baseline)
- Pain intensity(Baseline)
- Health-related quality of life(Baseline)
- C-reactive protein level(Baseline)
- Adapted dietary inflammatory index(Baseline)
- Glycosylated hemoglobin(Baseline)
- Blood pressure(Baseline)
- Body composition(Baseline)
- Self-reported autonomic symptoms(Baseline)
- Vasomotor function(Baseline)
- Primary and secondary hyperalgesia(Baseline)
- Temporal summation(Baseline)
- Conditioned pain modulation(Baseline)
研究者
Michel GCAM Mertens
Dr.
Universiteit Antwerpen
