Acute Effects of High Intensity Training on Pain Processing and Inflammation in Chronic Low Back Pain.
NCT ID: NCT04902196
Last Updated: 2023-04-05
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-02-24
2022-12-31
Brief Summary
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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.
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Detailed Description
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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.
In addition, these inflammatory responses and EIH are said to be influenced by psychosocial factors in chronic pain disorders. For example, higher anxiety and catastrophe resulted in an enhanced pro-inflammatory response in fibromyalgia and osteoarthritis. Likewise, sleep disturbances resulted in higher IL-6 levels in CLBP. As such, these results suggest that EIH can be affected by multiple cellular and molecular events in the pain process as well as individual responses to specific situations.
The objective of this study is to expand the knowledge of the pain processing and inflammatory response to acute physical exertion of persons with chronic low back pain. This study will also investigate whether these responses are dependent on psychosocial factors. The information provided by this study may contribute to a better understanding of the mechanisms that lead to varied responses to exercise in people with chronic low back pain. This allows therapy protocols to be adapted and the worsening of symptoms in some people with chronic low back pain to be counteracted by these therapy protocols.
Primary research questions:
* Question 1: To what extent does a single high or moderately intensive cardiorespiratory exercise protocol have an acute effect on pain processing and the inflammatory response in persons with chronic low back pain?
* Question 2: To what extent is the acute effect of a single high or moderately intensive cardiorespiratory exercise protocol on pain processing and the inflammatory response correlated with differences in psychosocial parameters in persons with chronic low back pain?
* Question 3: To what extent is the acute effect of a single high or moderately intensive cardiorespiratory exercise protocol on pain processing and the inflammatory response in subjects with chronic low back pain different from healthy subjects?
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
group 2: 2 testmoments, min. 7 days and max. 14 days in between them. During the first testmoment, a maximum exercise test is performed (to establish the exercise protocol that will be used during the second testmoment). The design and content of the second test moment is identical to that of group 1 with the exception of 1) only performing a HIT protocol and 2) not completing the questionnaires only applicable for persons with low back pain (i.e. ODI, BPI).
TREATMENT
NONE
Study Groups
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Group 1
persons with chronic low back pain of an non-specific origin
high intensity cardiorespiratory exercise protocol
During the high intensive cardiorespiratory exercise protocol, a bicycle ergometer (eBike Basic, General Electric GmbH, Bitz, Germany) with pulmonary gas exchange analysis (MetaMax 3B, Cortex Biophysik GmbH, Leipzig, Germany) will be used. Oxygen uptake (VO2max), expiratory volume (VE) and respiratory exchange rate (RER) will be tracked every breath and an average will be taken every 10s. Heart rate is continuously monitored using a heart rate chest strap (Polar Electro Inc., Finland). After a five-minute warm-up, a high-intensity interval protocol is started, consisting of five one-minute bouts (110 reps/minute at 100% VO2max workload), separated by one minute of active rest (75 reps per minute at 50% VO2max workload).
moderate intensity cardiorespiratory exercise protocol
During the moderate intensive cardiorespiratory exercise protocol, a bicycle ergometer (eBike Basic, General Electric GmbH, Bitz, Germany) with pulmonary gas exchange analysis (MetaMax 3B, Cortex Biophysik GmbH, Leipzig, Germany) will be used. Oxygen uptake (VO2max), expiratory volume (VE) and respiratory exchange rate (RER) will be tracked every breath and an average will be taken every 10s. Heart rate is continuously monitored using a heart rate chest strap (Polar Electro Inc., Finland). After a five-minute warm-up, participants begin a moderately-intensive continuous 14-minute exercise protocol at a stable resistance (90 repetitions per minute at 60% VO2max workload).
Group 2 (Control group)
"healthy" persons (pain-free)
high intensity cardiorespiratory exercise protocol
During the high intensive cardiorespiratory exercise protocol, a bicycle ergometer (eBike Basic, General Electric GmbH, Bitz, Germany) with pulmonary gas exchange analysis (MetaMax 3B, Cortex Biophysik GmbH, Leipzig, Germany) will be used. Oxygen uptake (VO2max), expiratory volume (VE) and respiratory exchange rate (RER) will be tracked every breath and an average will be taken every 10s. Heart rate is continuously monitored using a heart rate chest strap (Polar Electro Inc., Finland). After a five-minute warm-up, a high-intensity interval protocol is started, consisting of five one-minute bouts (110 reps/minute at 100% VO2max workload), separated by one minute of active rest (75 reps per minute at 50% VO2max workload).
Interventions
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high intensity cardiorespiratory exercise protocol
During the high intensive cardiorespiratory exercise protocol, a bicycle ergometer (eBike Basic, General Electric GmbH, Bitz, Germany) with pulmonary gas exchange analysis (MetaMax 3B, Cortex Biophysik GmbH, Leipzig, Germany) will be used. Oxygen uptake (VO2max), expiratory volume (VE) and respiratory exchange rate (RER) will be tracked every breath and an average will be taken every 10s. Heart rate is continuously monitored using a heart rate chest strap (Polar Electro Inc., Finland). After a five-minute warm-up, a high-intensity interval protocol is started, consisting of five one-minute bouts (110 reps/minute at 100% VO2max workload), separated by one minute of active rest (75 reps per minute at 50% VO2max workload).
moderate intensity cardiorespiratory exercise protocol
During the moderate intensive cardiorespiratory exercise protocol, a bicycle ergometer (eBike Basic, General Electric GmbH, Bitz, Germany) with pulmonary gas exchange analysis (MetaMax 3B, Cortex Biophysik GmbH, Leipzig, Germany) will be used. Oxygen uptake (VO2max), expiratory volume (VE) and respiratory exchange rate (RER) will be tracked every breath and an average will be taken every 10s. Heart rate is continuously monitored using a heart rate chest strap (Polar Electro Inc., Finland). After a five-minute warm-up, participants begin a moderately-intensive continuous 14-minute exercise protocol at a stable resistance (90 repetitions per minute at 60% VO2max workload).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Jessa Hospital
OTHER
Hasselt University
OTHER
Responsible Party
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Annick Timmermans
Principal Investigator
Principal Investigators
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Annick Timmermanst, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Jonas Verbrugghe, dr.
Role: STUDY_CHAIR
Hasselt University
Locations
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Jessa Ziekenhuis
Hasselt, , Belgium
Countries
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References
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McBeth J, Jones K. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):403-25. doi: 10.1016/j.berh.2007.03.003.
Cimmino MA, Ferrone C, Cutolo M. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):173-83. doi: 10.1016/j.berh.2010.01.012.
Woolf AD, Erwin J, March L. The need to address the burden of musculoskeletal conditions. Best Pract Res Clin Rheumatol. 2012 Apr;26(2):183-224. doi: 10.1016/j.berh.2012.03.005.
March L, Smith EU, Hoy DG, Cross MJ, Sanchez-Riera L, Blyth F, Buchbinder R, Vos T, Woolf AD. Burden of disability due to musculoskeletal (MSK) disorders. Best Pract Res Clin Rheumatol. 2014 Jun;28(3):353-66. doi: 10.1016/j.berh.2014.08.002. Epub 2014 Nov 18.
Moore, G., Durstine, J. L., Painter, P., & American College of Sports Medicine. (2016). Acsm's exercise management for persons with chronic diseases and disabilities, 4E. Human Kinetics.
Manley, A. F. (1996). Physical activity and health: A report of the Surgeon General.
Booth J, Moseley GL, Schiltenwolf M, Cashin A, Davies M, Hubscher M. Exercise for chronic musculoskeletal pain: A biopsychosocial approach. Musculoskeletal Care. 2017 Dec;15(4):413-421. doi: 10.1002/msc.1191. Epub 2017 Mar 30.
Smith BE, Hendrick P, Bateman M, Holden S, Littlewood C, Smith TO, Logan P. Musculoskeletal pain and exercise-challenging existing paradigms and introducing new. Br J Sports Med. 2019 Jul;53(14):907-912. doi: 10.1136/bjsports-2017-098983. Epub 2018 Jun 20. No abstract available.
Wilson, F., Gormley, J., & Hussey, J. (Eds.). (2011). Exercise therapy in the management of musculoskeletal disorders. Wiley-Blackwell.
O'Riordan C, Clifford A, Van De Ven P, Nelson J. Chronic neck pain and exercise interventions: frequency, intensity, time, and type principle. Arch Phys Med Rehabil. 2014 Apr;95(4):770-83. doi: 10.1016/j.apmr.2013.11.015. Epub 2013 Dec 12.
Hunter DJ, Eckstein F. Exercise and osteoarthritis. J Anat. 2009 Feb;214(2):197-207. doi: 10.1111/j.1469-7580.2008.01013.x.
Fink, L., & Lewis, D. (2017). Exercise as a treatment for fibromyalgia: a scoping review. The Journal for Nurse Practitioners, 13(8), 546-551.
Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.
Lima LV, Abner TSS, Sluka KA. Does exercise increase or decrease pain? Central mechanisms underlying these two phenomena. J Physiol. 2017 Jul 1;595(13):4141-4150. doi: 10.1113/JP273355. Epub 2017 May 26.
Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.
Naugle KM, Fillingim RB, Riley JL 3rd. A meta-analytic review of the hypoalgesic effects of exercise. J Pain. 2012 Dec;13(12):1139-50. doi: 10.1016/j.jpain.2012.09.006. Epub 2012 Nov 8.
Naugle KM, Naugle KE, Fillingim RB, Samuels B, Riley JL 3rd. Intensity thresholds for aerobic exercise-induced hypoalgesia. Med Sci Sports Exerc. 2014 Apr;46(4):817-25. doi: 10.1249/MSS.0000000000000143.
Polaski AM, Phelps AL, Kostek MC, Szucs KA, Kolber BJ. Exercise-induced hypoalgesia: A meta-analysis of exercise dosing for the treatment of chronic pain. PLoS One. 2019 Jan 9;14(1):e0210418. doi: 10.1371/journal.pone.0210418. eCollection 2019.
Georgopoulos V, Akin-Akinyosoye K, Zhang W, McWilliams DF, Hendrick P, Walsh DA. Quantitative sensory testing and predicting outcomes for musculoskeletal pain, disability, and negative affect: a systematic review and meta-analysis. Pain. 2019 Sep;160(9):1920-1932. doi: 10.1097/j.pain.0000000000001590.
Kuithan P, Heneghan NR, Rushton A, Sanderson A, Falla D. Lack of Exercise-Induced Hypoalgesia to Repetitive Back Movement in People with Chronic Low Back Pain. Pain Pract. 2019 Sep;19(7):740-750. doi: 10.1111/papr.12804. Epub 2019 Jul 7.
van den Berg R, Jongbloed EM, de Schepper EIT, Bierma-Zeinstra SMA, Koes BW, Luijsterburg PAJ. The association between pro-inflammatory biomarkers and nonspecific low back pain: a systematic review. Spine J. 2018 Nov;18(11):2140-2151. doi: 10.1016/j.spinee.2018.06.349. Epub 2018 Jun 28.
Kawi J, Lukkahatai N, Inouye J, Thomason D, Connelly K. Effects of Exercise on Select Biomarkers and Associated Outcomes in Chronic Pain Conditions: Systematic Review. Biol Res Nurs. 2016 Mar;18(2):147-59. doi: 10.1177/1099800415599252. Epub 2015 Aug 14.
Svensson CI. Interleukin-6: a local pain trigger? Arthritis Res Ther. 2010;12(5):145. doi: 10.1186/ar3138. Epub 2010 Oct 28.
Zhou YQ, Liu Z, Liu ZH, Chen SP, Li M, Shahveranov A, Ye DW, Tian YK. Interleukin-6: an emerging regulator of pathological pain. J Neuroinflammation. 2016 Jun 7;13(1):141. doi: 10.1186/s12974-016-0607-6.
Munneke W, Ickmans K, Voogt L. The Association of Psychosocial Factors and Exercise-Induced Hypoalgesia in Healthy People and People With Musculoskeletal Pain: A Systematic Review. Pain Pract. 2020 Jul;20(6):676-694. doi: 10.1111/papr.12894. Epub 2020 May 15.
Lazaridou A, Martel MO, Cahalan CM, Cornelius MC, Franceschelli O, Campbell CM, Haythornthwaite JA, Smith M, Riley J, Edwards RR. The impact of anxiety and catastrophizing on interleukin-6 responses to acute painful stress. J Pain Res. 2018 Mar 28;11:637-647. doi: 10.2147/JPR.S147735. eCollection 2018.
Heffner KL, France CR, Trost Z, Ng HM, Pigeon WR. Chronic low back pain, sleep disturbance, and interleukin-6. Clin J Pain. 2011 Jan;27(1):35-41. doi: 10.1097/ajp.0b013e3181eef761.
Vaegter HB, Hoeger Bement M, Madsen AB, Fridriksson J, Dasa M, Graven-Nielsen T. Exercise increases pressure pain tolerance but not pressure and heat pain thresholds in healthy young men. Eur J Pain. 2017 Jan;21(1):73-81. doi: 10.1002/ejp.901. Epub 2016 Jun 5.
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
Graven-Nielsen T, Vaegter HB, Finocchietti S, Handberg G, Arendt-Nielsen L. Assessment of musculoskeletal pain sensitivity and temporal summation by cuff pressure algometry: a reliability study. Pain. 2015 Nov;156(11):2193-2202. doi: 10.1097/j.pain.0000000000000294.
Other Identifiers
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LPB-QST-001
Identifier Type: -
Identifier Source: org_study_id
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