Changes in Radicular Pain and Pain Modulation

Not Applicable

Completed

• Conditions: Back Pain; Back Pain With Radiation
• Interventions: Diagnostic Test: Pressure pain assessment using computer controlled cuff algometry; Diagnostic Test: Temporal summation (TS); Diagnostic Test: Conditioned pain modulation (CPM); Diagnostic Test: Low back pain rating scale (LBPRS-pain); Diagnostic Test: Oswestry Disability Index

• Registration Number: NCT04193969
• Lead Sponsor: Spine Centre of Southern Denmark

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

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-12-08
• Study First Posted: 2019-12-11
• Primary Completion: 2021-07-01
• Study Completion: 2021-09-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiculopathy due to nerve root compression	Low back pain rating scale (LBPRS-pain)	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.
Radiculopathy due to nerve root compression	Oswestry Disability Index	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.
Healthy controls	Conditioned pain modulation (CPM)	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.
Radiculopathy due to nerve root compression	Conditioned pain modulation (CPM)	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.
Radiculopathy due to nerve root compression	Pressure pain assessment using computer controlled cuff algometry	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.
Radiculopathy due to nerve root compression	Temporal summation (TS)	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.
Healthy controls	Pressure pain assessment using computer controlled cuff algometry	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.
Healthy controls	Temporal summation (TS)	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.

Primary Outcome Measures

Name	Time	Method
Conditioned pain modulation (change in pain sensitivity during a competing pain stimulus) measured with computer-controlled cuff algometry	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.	Change in pain intensity between baseline and follow-up. Cuff is placed on the lower leg. In patients the non-painful leg is used, in healthy controls, half of the participants will be tested on the left leg and half on the right leg. 10 painful stimuli are performed with a one-second interval in between. After each stimulus, the participant rates the pain intensities using an electronic VAS ( 0=No pain, 10=worst pain imaginable pain). The increase in pain intensity is defined as temporal summation.
Cuff sensitivity, measured with computer-controlled cuff algometry	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.	Change in pain sensitivity between baseline and follow-up. Cuff is placed around the lower leg and on the upper arm and gradually inflated (1kPa/sec) on each location separately. In patients, the cuff is placed on the non-painful leg and left upper arm, in healthy controls, half of the participants the cuff is placed on the left leg and half on the right leg, while the other cuff is placed on the left upper arm. First, the pressure needed to evoke an onset of pain (pain detection threshold, PDT), the pressure at pain intensity VAS 6 (Measured on an electronic visual analogue scale: 0=No pain, 10=worst pain imaginable pain) and pain tolerance threshold (PTT) is assessed on the lower leg. Secondly, the PDT and the PTT is assessed on the left upper arm.
Temporal summation of pain (increase in pain during repeated pain stimuli at same intensity) measured with computer-controlled cuff algometry	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.	Change in pain intensity between baseline and follow-up. Cuff is placed on the lower leg. In patients the non-painful leg is used, in healthy controls, half of the participants will be tested on the left leg and half on the right leg. 10 painful stimuli are performed with a one-second interval in between. After each stimulus, the participant rates the pain intensities using an electronic VAS ( 0=No pain, 10=worst pain imaginable pain). The increase in pain intensity is defined as temporal summation.

Secondary Outcome Measures

Name	Time	Method
Leg pain (measured on the low back pain rating scale)	At baseline and at discharge from treatment throughout study completion, an average of 6 months.	Change in pain between post-treatment and pre-treatment. The average pain during the last two weeks, the worst pain experienced during the same period and current pain is rated by the patient. Range 0-30. 0=no pain, 30= Worst pain imaginable.
Back pain and leg pain (measured on the low back pain rating scale)	At baseline and at discharge from treatment throughout study completion, an average of 6 months.	Change in pain between post-treatment and pre-treatment. Low back pain rating scale (LBPRS - pain): Two questionnaires with three numeric 11-point box scales (0-10) regarding low back pain and leg pain respectively. The average pain during the last two weeks, the worst pain experienced during the same period and current pain is rated by the patient. Range 0-60. 0=no pain, 60= Worst pain imaginable.
Disability (Measured on the Oswestry Disability index)	At baseline and at discharge from treatment throughout study completion, an average of 6 months.	Change in disability between post-treatment and pretreatment. Range 0-100, 0= No disability, 100 maximum disability possible.

Trial Locations

Locations (1)

Spine Centre of Southern Denmark; 🇩🇰 Middelfart, Denmark