NCT04086667: POPS

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

Completed NA Last updated 11 September 2019

What this trial tests

NA trial testing Spinal manipulation in Low Back Pain in 132 participants. Completed in 1 March 2019.

Timeline

1 November 2017

Primary endpoint
1 February 2019

1 March 2019

Quick facts

Lead sponsor	Spine Centre of Southern Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	132
Start date	1 November 2017
Primary completion	1 February 2019
Estimated completion	1 March 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Spinal manipulation

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →
• Pain, Chronic — all drugs for Pain, Chronic →

Sponsor

Spine Centre of Southern Denmark

Who can join

Adults 18 to 60, any sex, with Low Back Pain or Pain, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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?

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effect on clinical outcomes when targeting spinal manipulation at stiffness or pain sensitivity: a randomized trial.
   Nim CG, Kawchuk GN, Schiøttz-Christensen B, O'Neill S. · · 2020 · cited 29× · PMID 32884045 · DOI 10.1038/s41598-020-71557-y
2. Spinal manipulation and modulation of pain sensitivity in persistent low back pain: a secondary cluster analysis of a randomized trial.
   Nim CG, Weber KA, Kawchuk GN, O'Neill S. · · 2021 · cited 11× · PMID 33627163 · DOI 10.1186/s12998-021-00367-4
3. Changes in pain sensitivity and spinal stiffness in relation to responder status following spinal manipulative therapy in chronic low Back pain: a secondary explorative analysis of a randomized trial.
   Nim CG, Kawchuk GN, Schiøttz-Christensen B, O'Neill S. · · 2021 · cited 11× · PMID 33407345 · DOI 10.1186/s12891-020-03873-3
4. Self-reports vs. physical measures of spinal stiffness.
   Nielsen J, Glissmann Nim C, O'Neill S, Boyle E, et al · · 2020 · cited 5× · PMID 33354411 · DOI 10.7717/peerj.9598