Clinical trial NCT04193969: Changes in Radicular Pain and Pain Modulation
Official title: The Association Between Changes in Radicular Pain and Pain Modulation Among Patients With Lumbar Radiculopathy: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Back Pain With Radiation
Keywords: low back pain
radiculopathy
conditioned pain modulation
temporal summation
Lead sponsor: Spine Centre of Southern Denmark
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has a cohort design and will include a patient group (male and female) attending a treatment program at the Spine Centre of Southern Denmark and an equally large control group matched on age and gender.
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of this study are: 1)To investigate the difference in pain modulatory mechanisms using quantitative sensory testing (QST) between healthy controls and patients with radicular leg pain due to nerve root compression. 2) To investigate the association between changes in radiating leg pain and pain modulation among the patient group.

Detailed description: Few studies have investigated pain modulatory mechanisms using QST in patients with lumbar radiculopathy due to nerve root compression. Knowledge about the association between changes in the experience of pain and changes measures of pain modulation is to our knowledge limited. The results could potentially contribute to knowledge about mechanisms involved in lumbar radiculopathy and facilitate future studies. The hypotheses of the study are: 1) Measures of pain modulation will be less efficient among patients with lumbar radiculopathy showing reduced pain inhibition and facilitated temporal summation compared to healthy controls. 2) Improvements in pain modulation will be associated with improvements in clinical pain outcomes

Eligibility criteria: Inclusion Criteria:

Patient group

* Radiating leg pain due to nerve root compression verified by MRI
* Clinical findings in accordance with MRI findings
* Average leg pain ≥ 3/10 on a numeric pain rating scale Controls
* No current or previous history of ongoing musculoskeletal pain

Exclusion Criteria:

Applies for both groups.

* Other specific medical conditions e.g. rheumatologic disease, diabetes or vascular diseases.
* Pregnancy

Primary outcomes:
measure: Cuff sensitivity, measured with computer-controlled cuff algometry
timeFrame: At baseline and at discharge from treatment throughout study completion, an average of 6 months. The timeframe between the baseline test and follow up test for controls will be matched the patient group.
measure: Temporal summation of pain (increase in pain during repeated pain stimuli at same intensity) measured with computer-controlled cuff algometry
timeFrame: At baseline and at discharge from treatment throughout study completion, an average of 6 months. The timeframe between the baseline test and follow up test for controls will be matched the patient group.
measure: Conditioned pain modulation (change in pain sensitivity during a competing pain stimulus) measured with computer-controlled cuff algometry
timeFrame: At baseline and at discharge from treatment throughout study completion, an average of 6 months. The timeframe between the baseline test and follow up test for controls will be matched the patient group.
Secondary outcomes:
measure: Leg pain (measured on the low back pain rating scale)
timeFrame: At baseline and at discharge from treatment throughout study completion, an average of 6 months.
measure: Back pain and leg pain (measured on the low back pain rating scale)
timeFrame: At baseline and at discharge from treatment throughout study completion, an average of 6 months.
measure: Disability (Measured on the Oswestry Disability index)
timeFrame: At baseline and at discharge from treatment throughout study completion, an average of 6 months.
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: Spine Centre of Southern Denmark
Study officials:
affiliation: Research department of Spine Center of Southern Denmark
name: Berit Schiøtzz-Christensen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaegter HB, Palsson TS, Graven-Nielsen T. Facilitated Pronociceptive Pain Mechanisms in Radiating Back Pain Compared With Localized Back Pain. J Pain. 2017 Aug;18(8):973-983. doi: 10.1016/j.jpain.2017.03.002. Epub 2017 Mar 24.
citation: Mehta V, Snidvongs S, Ghai B, Langford R, Wodehouse T. Characterization of peripheral and central sensitization after dorsal root ganglion intervention in patients with unilateral lumbosacral radicular pain: a prospective pilot study. Br J Anaesth. 2017 Jun 1;118(6):924-931. doi: 10.1093/bja/aex089.
citation: Yarnitsky D. Role of endogenous pain modulation in chronic pain mechanisms and treatment. Pain. 2015 Apr;156 Suppl 1:S24-S31. doi: 10.1097/01.j.pain.0000460343.46847.58.
citation: Graven-Nielsen T, Izumi M, Petersen KK, Arendt-Nielsen L. User-independent assessment of conditioning pain modulation by cuff pressure algometry. Eur J Pain. 2017 Mar;21(3):552-561. doi: 10.1002/ejp.958. Epub 2016 Nov 11.
citation: 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.