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Changes in Radicular Pain and Pain Modulation

Primary Purpose

Back Pain, Back Pain With Radiation

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Pressure pain assessment using computer controlled cuff algometry

Temporal summation (TS)

Conditioned pain modulation (CPM)

Low back pain rating scale (LBPRS-pain)

Oswestry Disability Index

About this trial

This is an interventional basic science trial for Back Pain focused on measuring low back pain, radiculopathy, conditioned pain modulation, temporal summation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Spine Centre of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Radiculopathy due to nerve root compression

Healthy controls

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

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.

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

Secondary Outcome Measures

Leg pain (measured on the low back pain rating scale)

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)

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)

Change in disability between post-treatment and pretreatment. Range 0-100, 0= No disability, 100 maximum disability possible.

Full Information

NCT ID

NCT04193969

First Posted

November 24, 2019

Last Updated

May 6, 2022

Sponsor

Spine Centre of Southern Denmark

1. Study Identification

Unique Protocol Identification Number

NCT04193969

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

July 1, 2021 (Actual)

Study Completion Date

September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spine Centre of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain, Back Pain With Radiation

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

Participant

Masking Description

The participants are not informed about test results during or after the sessions. The test equipment is computer controlled and user independent.

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiculopathy due to nerve root compression

Arm Type

Experimental

Arm Description

Arm Title

Healthy controls

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Pressure pain assessment using computer controlled cuff algometry

Other Intervention Name(s)

Assessment of pain sensitivity

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Temporal summation (TS)

Other Intervention Name(s)

Repeated pressure pain

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Conditioned pain modulation (CPM)

Other Intervention Name(s)

Pain inhibition

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Low back pain rating scale (LBPRS-pain)

Other Intervention Name(s)

Pain intensity

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Oswestry Disability Index

Other Intervention Name(s)

Disability

Intervention Description

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

Primary Outcome Measure Information:

Title

Cuff sensitivity, measured with computer-controlled cuff algometry

Description

Time Frame

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.

Title

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

Description

Time Frame

Title

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

Description

Time Frame

Secondary Outcome Measure Information:

Title

Leg pain (measured on the low back pain rating scale)

Description

Time Frame

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

Title

Back pain and leg pain (measured on the low back pain rating scale)

Description

Time Frame

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

Title

Disability (Measured on the Oswestry Disability index)

Description

Change in disability between post-treatment and pretreatment. Range 0-100, 0= No disability, 100 maximum disability possible.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Berit Schiøtzz-Christensen, Professor

Organizational Affiliation

Research department of Spine Center of Southern Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spine Centre of Southern Denmark

City

Middelfart

ZIP/Postal Code

5500

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28344100

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.

Results Reference

background

PubMed Identifier

28575334

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.

Results Reference

background

PubMed Identifier

25789433

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.

Results Reference

background

PubMed Identifier

27859944

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.

Results Reference

background

PubMed Identifier

26172551

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.

Results Reference

background

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Changes in Radicular Pain and Pain Modulation

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