Tactile Acuity in Experimentally Induced Acute Low Back Pain

Low Back Pain Clinical Trial

Official title: Lumbar Tactile Acuity in Experimentally Induced Acute Low Back Pain

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether experimentally induced acute low back pain might lead to alteration in lumbar tactile acuity measured in region affected by pain compared to pain-free side and pain-free controls.

Clinical Trial Description

Healthy male participants will be recruited at the Academy of Physical Education in Katowice. Each participant will be assessed only once. All participants will be asked to provide written informed consent for participation prior to the experimental procedure and will be naïve to the experimental hypothesis. The plan for this research project has been previously approved by the local bioethical committee.

Between-subject (real-injection, sham-injection and control group) and within-subject (assessment 1 versus assessment 2 and 3) design will be used for the purpose of this experiment. After the screening procedure and preparation phase, participants will be randomly assigned to one of three groups: control, saline injection or sham-injection. Groups will differ only in terms of the specific manipulation: the experimental group will receive intra-muscular saline injection, the sham-injection group will be stimulated by pinprick sensation produced by a PinPrick device. No manipulation will take place in the control group allowing to control for the learning effect. In fact, participants will be informed that the study includes only two branches so they can be assigned either to the group with pain evoked as a result of an injection or to the control group without any noxious stimuli. Not revealing the sham-injection condition will allow for comparison between nociceptive (injection) and non-nociceptive (sham-injection) condition.

Because no previous studies have investigated tactile acuity changes in acute low back pain, the sample size calculation was based on the data from our own systematic review and meta-analysis (Adamczyk et al., under review) and previous cross-sectional data among healthy controls (Adamczyk et al., 2016). Based on reported mean difference of 9.49mm between chronic low back pain patients and healthy controls and standard deviation of 9.90mm, a total sample size of 57 participants (19 per group) is required to detect a significant effect. Power calculation was performed for specific planned-comparison tests that were described in detailed under 'statistical analysis' section below. Calculation was performed in G*Power (G*Power 3.1.9.2 statistical software) with the alpha level set at =0.05 and 80% power.

Baseline differences in descriptive statistics will be analysed by one-way analysis of variance (ANOVA) with 'group' as the between-subject factor. Further statistical comparisons will be performed using a repeated-measures ANOVA design, with 'group' (real-injection, sham-injection, and control group) as between-subject factor and repeated measures (assessment 1, 2 and 3) as a within-subject factor. In order to test hypothesis on tactile acuity alteration during pain induction, F-tests will be followed by planned comparisons on data from assessment 1 versus assessment 2 in experimental group. To determine whether the magnitude of tactile acuity alteration has differed between the groups, planned comparisons will be performed on the difference in tactile acuity (assessment 1 vs. assessment 2) between real-injection and sham-injection group and between real-injection and control group. Bonferroni correction will be used for multiple planned comparisons. Forward, stepwise multiple regression will be performed to determine the degree to which tactile acuity change is predicted by either pain intensity or the size of its distribution. All the analyses will be conducted using the STATISTICA data analysis software, version 12 (StatSoft Inc., Tulsa, OK, USA). The level of significance will be set at p < 0.05. ;

Related Conditions & MeSH terms

• Acute Pain
• Back Pain
• Low Back Pain

• NCT number: NCT03021278
• Study type: Interventional
• Source: The Jerzy Kukuczka Academy of Physical Education in Katowice
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Completion date: July 2017