Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2019-11-01
2021-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Radiculopathy due to nerve root compression
Participants with radicular leg pain due to lumbar disc herniation or to foraminal- or recess stenosis.
Baseline assessments of pain intensities are performed through questionnaires prior to protocol. Data regarding initial pain, function, age, gender, pain-duration, weight and height is retrieved from the clinical registry SpineData.
Pain sensitivity, temporal summation and conditioned pain modulation are assessed at the first visit in the treatment program. The protocol is repeated at the last visit in the treatment program.
Pressure pain assessment using computer controlled cuff algometry
Pressure pain sensitivity is assessed. The pressure is gradually increased and pain is rated by the participant on an electronic visual analogue pain rating scale (VAS) which is connected to the equipment. The assessment is performed on the lower leg and the upper arm. The pain free leg and the left upper arm is used in the patient group. The leg used in the control group will be chosen in a balanced manner meaning that half will receive pressure on the left leg and the other half on the right leg. The pain detection threshold (PDT), pain pressure tolerance threshold (PPT) and pressure pain intensity perceived as 6 on the VAS (VAS6) at the leg site is registered. The PDT and PPT on the arm site is registered.
Temporal summation (TS)
10 repeated inflations on the lower leg with a 1 sec interval. The pressure used at each pressure is equivalent the PPT measured at baseline. Each inflation is rated on the VAS. TS is registered as the increase pain intensity.
Conditioned pain modulation (CPM)
The cuff on the upper arm is inflated until 70% of the PPT is reached. While the pressure on the arm is kept constant the cuff on the leg is inflated. PDT, PPT and VAS6 pressure at the leg site is registered during the tonic stimulation (pressure on the left arm). The procedure on the leg is repeated within 30 seconds after the pressure is released on the arm site.
Low back pain rating scale (LBPRS-pain)
A questionnaire measuring the intensities of low back pain and leg pain currently, on average the last two weeks and the worst pain within the same period.
Oswestry Disability Index
A questionnaire measuring the disability in relation to low back pain and leg pain.
Healthy controls
Healthy controls Healthy age and gender-matched controls. Gender, weight and height are registered on questionnaires prior to protocol.
Pain sensitivity, temporal summation and conditioned pain modulation are assessed at the first visit. The tests are repeated at the next visit. The interval between the two sessions will be determined by the averaged interval between tests in the patient group.
Pressure pain assessment using computer controlled cuff algometry
Pressure pain sensitivity is assessed. The pressure is gradually increased and pain is rated by the participant on an electronic visual analogue pain rating scale (VAS) which is connected to the equipment. The assessment is performed on the lower leg and the upper arm. The pain free leg and the left upper arm is used in the patient group. The leg used in the control group will be chosen in a balanced manner meaning that half will receive pressure on the left leg and the other half on the right leg. The pain detection threshold (PDT), pain pressure tolerance threshold (PPT) and pressure pain intensity perceived as 6 on the VAS (VAS6) at the leg site is registered. The PDT and PPT on the arm site is registered.
Temporal summation (TS)
10 repeated inflations on the lower leg with a 1 sec interval. The pressure used at each pressure is equivalent the PPT measured at baseline. Each inflation is rated on the VAS. TS is registered as the increase pain intensity.
Conditioned pain modulation (CPM)
The cuff on the upper arm is inflated until 70% of the PPT is reached. While the pressure on the arm is kept constant the cuff on the leg is inflated. PDT, PPT and VAS6 pressure at the leg site is registered during the tonic stimulation (pressure on the left arm). The procedure on the leg is repeated within 30 seconds after the pressure is released on the arm site.
Interventions
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Pressure pain assessment using computer controlled cuff algometry
Pressure pain sensitivity is assessed. The pressure is gradually increased and pain is rated by the participant on an electronic visual analogue pain rating scale (VAS) which is connected to the equipment. The assessment is performed on the lower leg and the upper arm. The pain free leg and the left upper arm is used in the patient group. The leg used in the control group will be chosen in a balanced manner meaning that half will receive pressure on the left leg and the other half on the right leg. The pain detection threshold (PDT), pain pressure tolerance threshold (PPT) and pressure pain intensity perceived as 6 on the VAS (VAS6) at the leg site is registered. The PDT and PPT on the arm site is registered.
Temporal summation (TS)
10 repeated inflations on the lower leg with a 1 sec interval. The pressure used at each pressure is equivalent the PPT measured at baseline. Each inflation is rated on the VAS. TS is registered as the increase pain intensity.
Conditioned pain modulation (CPM)
The cuff on the upper arm is inflated until 70% of the PPT is reached. While the pressure on the arm is kept constant the cuff on the leg is inflated. PDT, PPT and VAS6 pressure at the leg site is registered during the tonic stimulation (pressure on the left arm). The procedure on the leg is repeated within 30 seconds after the pressure is released on the arm site.
Low back pain rating scale (LBPRS-pain)
A questionnaire measuring the intensities of low back pain and leg pain currently, on average the last two weeks and the worst pain within the same period.
Oswestry Disability Index
A questionnaire measuring the disability in relation to low back pain and leg pain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Other specific medical conditions e.g. rheumatologic disease, diabetes or vascular diseases.
* Pregnancy
18 Years
60 Years
ALL
Yes
Sponsors
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Spine Centre of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Berit Schiøtzz-Christensen, Professor
Role: PRINCIPAL_INVESTIGATOR
Research department of Spine Center of Southern Denmark
Locations
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Spine Centre of Southern Denmark
Middelfart, , Denmark
Countries
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References
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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.
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.
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.
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.
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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S-20190091
Identifier Type: -
Identifier Source: org_study_id
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