Healthy Clinical Trial
Official title:
Pro-Nociceptive and Anti-Nociceptive Mechanisms Across an Episode of Recurrent Low Back Pain
NCT number | NCT03463759 |
Other study ID # | N-20170034 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 10, 2018 |
Est. completion date | December 14, 2019 |
Verified date | December 2020 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates psychophysical measures of pain inhibition and facilitation, along with cortical responses to different sensory stimuli, in patients with recurrent low back pain and matched healthy individuals.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 14, 2019 |
Est. primary completion date | December 14, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion: - Healthy men and women - Aged 18-60 years - No previous back pain OR >1 previous episode of low back pain in past 12 months - No current back pain OR Pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at time of recruitment lasting >24 hours - Able to speak, read and understand English Exclusion: - Pregnancy - First episode of low back pain - Low back pain associated with menstruation - Chronic low back pain (continuous pain episode for >3 months) - Currently seeking active treatment for low back pain - Red flags symptoms - Drug addiction defined as the use of cannabis, opioids or other drugs - Current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial - Current or previous chronic or recurrent pain condition other than low back pain - Current regular use of analgesic or other medication which may affect the trial - Lack of ability to cooperate - Recent history of acute pain particularly in the lower limbs (unless related to LBP) - Abnormally disrupted sleep in 24 hours preceding experiment |
Country | Name | City | State |
---|---|---|---|
Denmark | CNAP, SMI, Aalborg University | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Affective Regulation | Pressure pain ratings pre, during and post affective image set | Day 0 vs. Day 28 | |
Other | Attentional Regulation | Pressure pain ratings pre, during and post computerised attention-demanding task | Day 0 vs. Day 28 | |
Primary | Conditioned Pain Modulation | Pressure pain threshold (kPa) as test stimulus before compared to during a pressure conditioning stimulus on the lower leg | Day 0 vs. Day 28 | |
Primary | Temporal Summation of Pain | Pain rating (VAS) change over a series of 10 repeated mechanical stimuli | Day 0 vs. Day 28 | |
Secondary | Pressure Pain Thresholds | Threshold of pain detection (kPa) with handheld algometry over the low back and distant sites | Day 0 vs. Day 28 | |
Secondary | Thermal Pain Thresholds | Hot and cold pain detection thresholds (degrees) | Day 0 vs. Day 28 | |
Secondary | Two Point Discrimination | The smallest distance (mm) for which two separate points can be distinguished over the low back | Day 0 vs. Day 28 | |
Secondary | Proprioceptive Weighting | Center of pressure displacement during 1-minute of quiet standing | Day 0 vs. Day 28 | |
Secondary | Sensory Evoked Potentials | EEG signals recorded in response to laser and electrical stimuli applied to the back | Day 0 vs. Day 28 |
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