Acute Effects of a High Intensity Training Protocol on Pain Processing and Inflammatory Parameters in Persons With Chronic Nonspecific Low Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- blood sample (evaluation of inflammatory markers) - IL-6 concentration
研究概览
简要总结
A multitude of exercise therapy modalities are effective in improving daily physical function and relieving pain in various forms of chronic musculoskeletal pain (CMP) such as chronic neck pain, osteoarthritis, fibromyalgia, and chronic low back pain. However, the inital pain response to physical exercise can be variable in populations with CMP. Indeed, some studies show no change or even brief exacerbations in pain in individuals with CMP in response to exercise. These pain flare-ups in chronic pain populations are believed to be associated with increased pain sensitivity after exercise.
The magnitude of "exercise-induced hypoalgesia" or the EIH response (i.e., the short-term endogenous pain-suppressing response after exercise) is believed to depend on several training factors, including exercise intensity. Currently, there is limited understanding of the optimal intensity of exercise for producing hypoalgesic effects on different types of pain stimuli. Nevertheless, several indications have been found for a dose-response effect in exercise and the amount of EIH that can be expected. However, very few studies have specifically examined EIH in people with chronic low back pain, although exercise is recommended in national and international guidelines as a basic treatment for the treatment of this condition.
Relevant studies have also shown that exercise can induce an extensive inflammatory response in CMP, which may contribute to the disrupted EIH production. In addition, it is stated that this inflammatory response in CMP is also influenced by psychosocial factors.
Therefore, the aim of the current cross-sectional cohort study is to expand the knowledge of the pain processing and inflammatory response to acute physical exertion in persons with chronic low back pain through evaluation responses of persons with this disorder to a high intensity training protocol. It is also investigated whether their EIH response is dependent on psychosocial factors.
详细描述
Chronic musculoskeletal pain (CMP) currently affects up to 20% of all people or about 1.5 billion persons worldwide, and these numbers continue to increase steadily. CMP can have a significant impact on both the physical and psychological functioning of an individual with consequences including recurring health care costs, limitation of participation in society, and long-term absenteeism. This makes CMP a pervasive medical problem that consumes a huge amount of healthcare resources.
Regular physical activity and exercise can impact many aspects of a person's general health through improving both physical functioning (e.g. cardiorespiratory fitness), as well as psychological functioning (e.g. mental health). Moreover, many common forms of exercise therapy have been studied and shown to be effective in relieving pain. These include amongst others running, walking, resistance training, water training and Tai Chi. As a result, more and more studies are referring to exercise therapy as an accessible, cost-effective and cost-effective therapeutic modality for the treatment of almost all types of musculoskeletal disorders. For example, substantial evidence already supports that exercise therapy can be effective in improving daily physical function and relieving pain in individuals with chronic neck pain, osteoarthritis, fibromyalgia and chronic low back pain.
While exercise therapy thus has clear benefits in persons with CMP, pain response to exercise can be variable in these populations, especially in the initial stages of therapy. Indeed, some studies show no change or even brief exacerbations of pain in persons with CMP in response to exercise. These 'flare-ups' of acute pain during exercise are believed to be related to increased chronic pain sensitivity.
The effect of "exercise-induced hypoalgesia" or EIH (i.e., the short-term endogenous pain-inhibiting response after exercise) is well documented in healthy subjects. The magnitude of the EIH response is believed to depend on several factors, including the type, dose, and intensity of the exercise. While the EIH response, measured as a change in the pain threshold after exercise, can be assess with quantitative sensory tests (ie a panel of diagnostic tests used to assess somatosensory function), there is currently only limited understanding of the optimal exercise intensity to produce hypoalgesic effects on different types of pain stimuli. Nevertheless, several indications of a dose-response effect in exercise and the amount of EIH that can be expected have been found. Studies have also shown that EIH can be affected in a variety of musculoskeletal pain disorders, including whiplash, knee osteoarthritis, or shoulder pain. This may explain the varied response to exercise and may have important implications for exercise prescription. However, very few studies have examined the relationship between exercise modalities and EIH in people with chronic low back pain, although exercise is recommended in national and international guidelines as a basic treatment for the treatment of this condition.
Furthermore, research has also shown that exercise can induce an extensive inflammatory response in persons with CMP (by drastically changing levels of inflammatory markers at various sites in the nervous system), which may heavily contribute to the disrupted production of EIH. Specifically, the effect of interleukin-6 (IL-6) during physical performance as a potential local "pain trigger" is gaining more and more attention. Recently, several pathological pain models have shown significantly increased expression levels of IL-6 and its receptor in the spinal cord and dorsal root ganglia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for group 1 (persons with chronic low back pain)
- •Primary complaint: non-specific chronic low back pain.
- •Low back pain is defined as pain in the area between the lower ribs and the upper buttock crease, with or without radiation in the leg
- •Chronic: current episode > 12 weeks, mean pain intensity between 3-8/10
- •Non-specific: the main pain cannot be traced back to a known pathology
- •Age: 18-65 years
- •Acute pain intensity at the time of testing between 3-8/10 (i.e. a pain intensity within this range is necessary to obtain a correct estimate of the pain response)
- •Understanding of the Dutch language (written and spoken)
- •Inclusion criteria for group 2 (healthy persons)
- •No acute or chronic musculoskeletal complaints (i.e. VAS> 2/10 in the last 24 hours)
- •Age: 18-65 years
- •Understanding of the Dutch language (written and spoken)
排除标准
- •for both group 1 and 2
- •Invasive spinal surgery within the last 18 months (arthrodesis will always be excluded, microsurgery is allowed)
- •Radiculopathy (uni- or bilateral) of the lower extremities
- •Comorbidities: paresis and sensory disturbances with a neurological cause in the lower extremities, diabetes mellitus, rheumatoid arthritis, autoimmune disorders etc.
- •Pregnancy
- •Ongoing compensation complaints and/or incapacity for work > 6 months
- •Previous active rehabilitation (i.e. exercise therapy) for low back pain in the last 6 months.
结局指标
主要结局
blood sample (evaluation of inflammatory markers) - IL-6 concentration
时间窗: Day 7
Two venous blood sample (serum) will be collected (one blood sample before the first QST protocol and one after the cardiorespiratory exercise protocol) by venous puncture. All samples are kept at room temperature for two hours. Afterwards, they are centrifuged at 1300 g for 15 minutes, transferred to cryovials (4 cryovials of 500µl), and stored at -80 ° C in the University Biobank Limburg (UBiLim) until further processing and analysis. Inflammatory markers will be assayed via bead-based multiplex assay using flow cytometry i.e. LegendPlex Multiplex Assay, inflammation panel 1. Absorbance is measured with an automated Microplate Reader. With this panel plasma IL-6 concentration (pg/ml) will be evaluated.
QST protocol (evaluation of pain processing) - widespread mechanical hyperalgesia
时间窗: day 7
Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing before and after the cardiorespiratory exercise protocol. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. A standardized 20-minute test protocol serves as the basis. Widespread mechanical hyperalgesia (1 protocol, 3 scores for each leg displayed in Newton) will be measured by determining the Cuff pressure pain threshold (cPPT), cuff pressure pain tolerance (cPTT), and cuff pressure pain tolerance limit (cPTL) during increased cuff pressure with a rate of 1 kPa/s by a computer-controlled cuff pressure algometer (NociTech, Denmark, and Aalborg University, Denmark) at the level of the left and right leg (calve).
blood sample (evaluation of inflammatory markers) - TNF-α concentration
时间窗: Day 7
Two venous blood sample (serum) will be collected (one blood sample before the first QST protocol and one after the cardiorespiratory exercise protocol) by venous puncture. All samples are kept at room temperature for two hours. Afterwards, they are centrifuged at 1300 g for 15 minutes, transferred to cryovials (4 cryovials of 500µl), and stored at -80 ° C in the University Biobank Limburg (UBiLim) until further processing and analysis. Inflammatory markers will be assayed via bead-based multiplex assay using flow cytometry i.e. LegendPlex Multiplex Assay, inflammation panel 1. Absorbance is measured with an automated Microplate Reader. With this panel plasma TNF-α concentration (pg/ml) will be evaluated.
QST protocol (evaluation of pain processing) - local pressure pain thresholds
时间窗: day 7
Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing before and after the cardiorespiratory exercise protocol. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. A standardized 20-minute test protocol serves as the basis. Two local pressure pain thresholds scores, displayed as kilogram-force (or KgF), 1 at the left and 1 at the right level of the lower back (at the subjective pain level) will be determined using a manual algometer (Force Ten FDX 50; Wagner Instruments, Greenwich, CT). Pressure will be applied at a constant rate of approximately 1 kg/s. Measurements at each side are performed twice with 5 minutes of rest apart. The highest score is used for analysis.
QST protocol (evaluation of pain processing) - temporal summation
时间窗: day 7
Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing before and after the cardiorespiratory exercise protocol. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. A standardized 20-minute test protocol serves as the basis. Temporal summation of pain (1 protocol, 10 scores displayed in Newton) will be measured by determining pressure pain thresholds during 10 repeated cuff pressure stimulations (2-second duration and 1-second interval between stimuli) by a computer-controlled cuff pressure algometer (NociTech, Denmark, and Aalborg University, Denmark) at the level of the dominant leg (calve).
QST protocol (evaluation of pain processing) - conditioned pain modulation
时间窗: day 7
Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing before and after the cardiorespiratory exercise protocol. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. A standardized 20-minute test protocol serves as the basis. Conditioned pain modulation ('CPM', 1 protocol, 3 scores for the dominant leg displayed in Newton) will be explored to evaluate the endogenous analgesic system by examining the change in the Cuff pressure pain threshold (cPPT), cuff pressure pain tolerance (cPTT), and cuff pressure pain tolerance limit (cPTL) seen in one body area ('test stimulus') due to pain induced in another body area ('conditioned stimulus') by a computer-controlled cuff pressure algometer (NociTech, Denmark, and Aalborg University, Denmark) at the level of the dominant leg (calve) for the test stimulus and the non-dominant leg for the conditioning stimulus.
次要结局
- The Brief Pain Inventory short form (BPI-sf)(day 7)
- Depression Anxiety Stress Scale (DASS-21)(day 7)
- Modified Oswestry Disability Index (MODI)(day 7)
- International Physical Activity Questionnaire short form (IPAQ)(day 7)
- Fear-Avoidance Components Scale (FACS)(day 7)
- Short form Health Survey (SF-36)(day 7)
- Pittsburg Sleep Quality Index (PSQI)(day 7)
研究者
Annick Timmermans
Principal Investigator
Hasselt University