CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
Quantitative Sensory Testingother
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/NCT03972332
NCT03972332N/ACompleted

Pain Experience in Individuals With Chronic Low Back Pain: a Cohort Study

University of Nottingham·observational·Posted Jun 3, 2019·Updated Mar 25, 2020

In Brief

An observational study evaluating Quantitative Sensory Testing for Low Back Pain. Completed, enrolled 97 participants across 1 site.

Detailed Summary

Low back pain is a very common musculoskeletal condition that affects many people each year regardless of age, gender, and ethnicity. Most people get better however, some continue suffering from painful episodes despite treatment. Self-management strategies for the management of chronic low back pain are very important to patients as they help them develop skills to manage their pain more effectively. However, self-management strategies are not always effective as expected. It is possible that the brain has become very sensitive to signals coming from peripheral parts of the body (e.g. low back) affecting the ability of patients to self-manage their condition. The aim of this study is to establish whether central sensitisation (sensitivity of the brain to peripheral signals) predicts how effective self-management approaches will be. On three different occasions, scheduled sessions will include a clinical assessment session and completion of a questionnaire booklet. The clinical assessment will measure three features of central sensitisation: 1) sensitivity to blunt pressure on the forearm, 2) changes in pain, felt during repeated light pricking of the forearm skin, and 3) reduction in pain that accompanies inflation of a blood pressure cuff on the opposite arm. Participant involvement at each session is expected to last for 70 minutes. Individuals over 18, diagnosed with chronic low back pain and enlisted to follow a pain management program are eligible to participate. The clinical assessments, questionnaire completion and subsequent statistical analysis are expected to be completed within 18 months of study commencement. Based on our findings, future research may use similar clinical assessment to identify people who might be helped to self-manage by using treatment that reduces central sensitisation.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 3, 2019
Enrollment StartJul 27, 2018
Primary CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.1 years ago

Interventions

Quantitative Sensory Testingother

PPT: An electronic data collection unit will be used featuring an electronic algometer connected with a laptop where the amount of pressure will be displayed on the screen. When the pressure pain detection threshold is reached (the point where the pressure sensation starts to be experienced as pain), the individual will press a button at a handheld device, that will automatically store the pressure value in the system and serve as an indication, for the examiner, to stop the testing. TS: A pinprick stimulator (Weight: 256mNewton) will be used. The examiner will apply the pen that features a retractable blunt needle in a repetitive manner (once per second for ten seconds). The individual will be asked for the intensity of pain (NRS) at the first and at the last time and the given score will be noted. CPM: A manual blood pressure sphygmomanometer will be used in conjunction with the electronic algometer described above (PPT).