Acute Effects of High Intensity Training on Pain Processing and Inflammation in Chronic Low Back Pain.

NCT04902196 | Completed

• 1 other identifier: LPB-QST-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Inflammation

Outcome Measures

Primary Outcomes (12)

• blood sample (evaluation of inflammatory markers) - IL-6 concentration

  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.

  baseline

• blood sample (evaluation of inflammatory markers) - TNF-α concentration

  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.

  baseline

• blood sample (evaluation of inflammatory markers) - IL-6 concentration

  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.

  Day 7

• blood sample (evaluation of inflammatory markers) - TNF-α concentration

  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.

  Day 7

• QST protocol (evaluation of pain processing) - local pressure pain thresholds

  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.

  Baseline

• QST protocol (evaluation of pain processing) - widespread mechanical hyperalgesia

  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).

  Baseline

• QST protocol (evaluation of pain processing) - temporal summation

  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).

  Baseline

• QST protocol (evaluation of pain processing) - conditioned pain modulation

  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.

  Baseline

• QST protocol (evaluation of pain processing) - local pressure pain thresholds

  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.

  day 7

• QST protocol (evaluation of pain processing) - widespread mechanical hyperalgesia

  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).

  day 7

• QST protocol (evaluation of pain processing) - temporal summation

  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).

  day 7

• QST protocol (evaluation of pain processing) - conditioned pain modulation

  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.

  day 7

Secondary Outcomes (14)

• The Brief Pain Inventory short form (BPI-sf)

  Baseline

• The Brief Pain Inventory short form (BPI-sf)

  day 7

• Modified Oswestry Disability Index (MODI)

  Baseline

• Modified Oswestry Disability Index (MODI)

  day 7

• International Physical Activity Questionnaire short form (IPAQ)

  Baseline

Study Arms (2)

Group 1

EXPERIMENTAL

persons with chronic low back pain of an non-specific origin

Other: high intensity cardiorespiratory exercise protocol; Other: moderate intensity cardiorespiratory exercise protocol

Group 2 (Control group)

ACTIVE COMPARATOR

"healthy" persons (pain-free)

Other: high intensity cardiorespiratory exercise protocol

Interventions

high intensity cardiorespiratory exercise protocol OTHER

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).

Also known as: physical perfomance intervention

Group 1; Group 2 (Control group)

moderate intensity cardiorespiratory exercise protocol OTHER

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).

Also known as: physical perfomance intervention

Group 1

Eligibility Criteria

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

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

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MeSH Terms

Conditions

Low Back Pain; Inflammation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Annick Timmermanst, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Jonas Verbrugghe, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: group 1: 2 testmoments, min. 7 days and max. 14 days in between them. Both have exactly the same design and the same content of measurements, with the exception of the intensity of the performed exercise protocol. The correct wattage for the exercise protocols is extracted from a previous maximum exercise test at the Jessa Hospital. By means of a randomized cross-over design, participants from group 1 will undergo both a moderately intensive cardiorespiratory protocol (MIT) and a high-intensity cardiorespiratory protocol (HIT). 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).

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 26, 2021
• Study Start: February 24, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

BE (1)