CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Pressure pain assessment using computer controlled cuff algometry +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04193969
NCT04193969N/ACompleted

The Association Between Changes in Radicular Pain and Pain Modulation Among Patients With Lumbar Radiculopathy: A Pilot Study.

Spine Centre of Southern Denmark·interventional·Posted Dec 11, 2019·Updated May 9, 2022

In Brief

A clinical study evaluating Pressure pain assessment using computer controlled cuff algometry, Temporal summation (TS), and 3 other interventions for Back Pain and Back Pain With Radiation. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 11, 2019
Enrollment StartNov 1, 2019
Primary CompletionJul 1, 2021
Study CompletionSep 21, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.6 years ago

Interventions

Pressure pain assessment using computer controlled cuff algometryother

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)other

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)other

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)other

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 Indexother

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