CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 132 enrolled
Drug / intervention
Spinal manipulationother
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/NCT04086667
NCT04086667N/ACompleted

What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial

Spine Centre of Southern Denmark·interventional·Posted Sep 11, 2019·Updated Sep 11, 2019

In Brief

A clinical study evaluating Spinal manipulation for Low Back Pain and Pain, Chronic. Completed, enrolled 132 participants across 1 site.

Detailed Summary

Introduction Several treatment methods have been proposed to ease the burden of low back pain (LBP) but none are clearly superior. Spinal manipulative therapy (SMT) is a guideline recommended treatment, but the effect is moderate to low. Previous publications suggest that acute LBP patients with who are more stiff are more likely to improve with SMT. However, as LBP persists changes in the central nervous system which modulates the pain experience becomes hypersensitive and possible stiffness is not as important an factor. Experimentally SMT may have a reversible effect of this sensitization. Objective The primary objective of this study is, to examine whether SMT is more effective in regards to short term pain relief when directed at level in the lower back characterized by spinal stiffness or pain hypersensitivity in persistent LBP. Methods A double blinded randomized clinical trial of up to 155 participants with persistent LBP included at a multidisciplinary Spinecenter. spinal stiffness (Global Stiffness Score) is measured using the VerteTracker, a novel device that can quantify stiffness. Pain sensitivity is measured as pain threshold, tolerance, temporal summation (TS) and conditioned pain modulation(CPM). Participants receive SMT at either "the stiffest" or "the most sensitive" segment, a total of four times over a 14-day period. The quantitative measures are recorded at baseline, post treatment and at 4-weeks follow-up along with a numerical pain rating (NRS) and the a disability index (ODI). Discussion These novel findings could improve clinical decision rules - specifically at which level in the lower back to direct SMT. Furthermore, the results will potentially shed light on the underlying mechanisms of SMT - are treatment effects mediated primarily by changes in stiffness or central hypersensitivity?

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2019
Enrollment StartNov 1, 2017
Primary CompletionFeb 1, 2019
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.8 years ago

Interventions

Spinal manipulationother

Spinal manipulation: The patient is placed in the side-position and a standard manipulation lumbar-roll technique will be applied at the indicated segment dependent on the subgroup indication.