Changes in Radicular Pain and Pain Modulation

NCT04193969 | Completed

• 1 other identifier: S-20190091
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Back Pain With Radiation

Keywords

low back pain; radiculopathy; conditioned pain modulation; temporal summation

Outcome Measures

Primary Outcomes (3)

• Cuff sensitivity, measured with computer-controlled cuff algometry

  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.

  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.

• Temporal summation of pain (increase in pain during repeated pain stimuli at same intensity) measured with computer-controlled cuff algometry

  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.

  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.

• Conditioned pain modulation (change in pain sensitivity during a competing pain stimulus) measured with computer-controlled cuff algometry

  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.

  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 (3)

• 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.

• 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.

• Disability (Measured on the Oswestry Disability index)

  At baseline and at discharge from treatment throughout study completion, an average of 6 months.

Study Arms (2)

Radiculopathy due to nerve root compression

EXPERIMENTAL

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.

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

Healthy controls

EXPERIMENTAL

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.

Diagnostic Test: Pressure pain assessment using computer controlled cuff algometry; Diagnostic Test: Temporal summation (TS); Diagnostic Test: Conditioned pain modulation (CPM)

Interventions

Pressure pain assessment using computer controlled cuff algometry DIAGNOSTIC_TEST

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.

Also known as: Assessment of pain sensitivity

Healthy controls; Radiculopathy due to nerve root compression

Temporal summation (TS) DIAGNOSTIC_TEST

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.

Also known as: Repeated pressure pain

Healthy controls; Radiculopathy due to nerve root compression

Conditioned pain modulation (CPM) DIAGNOSTIC_TEST

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.

Also known as: Pain inhibition

Healthy controls; Radiculopathy due to nerve root compression

Low back pain rating scale (LBPRS-pain) DIAGNOSTIC_TEST

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.

Also known as: Pain intensity

Radiculopathy due to nerve root compression

Oswestry Disability Index DIAGNOSTIC_TEST

A questionnaire measuring the disability in relation to low back pain and leg pain.

Also known as: Disability

Radiculopathy due to nerve root compression

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Applies for both groups.
• Other specific medical conditions e.g. rheumatologic disease, diabetes or vascular diseases.
• Pregnancy

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead

Study Sites (1)

Spine Centre of Southern Denmark

Middelfart, 5500, Denmark

Location

Related Publications (5)

• 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.

  PMID: 28344100 BACKGROUND

• 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.

  PMID: 28575334 BACKGROUND

• 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.

  PMID: 25789433 BACKGROUND

• 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.

  PMID: 27859944 BACKGROUND

• 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.

  PMID: 26172551 BACKGROUND

MeSH Terms

Conditions

Back Pain; Low Back Pain; Radiculopathy

Interventions

Postsynaptic Potential Summation; Pain Measurement; Disability Evaluation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Synaptic Transmission; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Synaptic Potentials; Membrane Potentials; Cell Physiological Phenomena; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Berit Schiøtzz-Christensen, Professor

  Research department of Spine Center of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are not informed about test results during or after the sessions. The test equipment is computer controlled and user independent.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: December 11, 2019
• Study Start: November 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: September 21, 2021
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)