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

NCT04086667 | Completed

• 1 other identifier: POPS
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Low Back Pain; Pain, Chronic

Keywords

LBP; SMT

Outcome Measures

Primary Outcomes (1)

• Subjective low back pain

  Pain: will be measured by the Low Back Pain Rating scale (NRS) consisting of an 11-point box score. Changes in pain will be measured at each time point

  Baseline (day 0), Post treatment(day 14), Follow-up(28 days)

Secondary Outcomes (5)

• Disability

  Baseline (day 0), Post treatment(day 14), Follow-up(28 days)

• Low back stiffness (Global stiffness)

  Baseline (day 0), Post treatment(day 14), Follow-up(28 days)

• Low back pressure pain threshold

  Baseline (day 0), Post treatment(day 14), Follow-up(28 days)

• Quantitative sensory testing

  Baseline (day 0), Post treatment(day 14), Follow-up(28 days)

• Heat pain threshold

  Baseline (day 0), Post treatment(day 14), Follow-up(28 days)

Other Outcomes (1)

• Intervention information

  Session 1(Baseline/day 0), session 2(Ultimo - week 1), session 3(Primo week 2), session 4(post treatment/dasy 14)

Study Arms (2)

Pain group

EXPERIMENTAL

The segment on the lower back marked as "most painful"

Other: Spinal manipulation

Stiff group

EXPERIMENTAL

The segment on the lower back marked as "most stiff"

Other: Spinal manipulation

Interventions

Spinal manipulation OTHER

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.

Pain group; Stiff group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be enrolled in the study, the participant must fulfill the following:
• Informed written consent
• Have the ability to speak and read Danish.
• Between the age of 18 and 60.
• Body mass index \< 35
• LBP \> 3 months, defined as pain on the posterior aspect of the body between the 12th thoracic vertebrae and the gluteal folds.
• No previous back surgery and must not have had surgery in general in the last 4 months.
• Must not have received spinal manipulation in the last month.
• Must not take other pain medication than paracetamol, NSAIDs or weak synthetic opioids
• Not have radiculopathy: dermatomal leg pain and a positive straight-leg-raise test \<60 degrees.
• Not have problems regarding deep vein thrombosis, circulatory issues in the under extremity, compartment syndrome or severe lung diseases
• No competing diagnoses which could a) confound the diagnosis of NSLBP e.g. osteoporosis, cancer, fibromyalgia etc. b) interfere with the allocated treatment or c) interfere with QST and VT testing

You may not qualify if:

• Participants will be excluded during the study if:
• Not completing the allocated intervention (minimum 75% of scheduled treatments).
• Receiving other treatment than that administered as part of the study
• Deviate from the agreed upon medication at baseline measures within the treatment period.
• Inability to hold breath for 10 seconds

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• Berit Schiøttz-Christensen: collaborator
• Søren O'Neill: collaborator
• Gregory Kawchuk: collaborator

Study Sites (1)

Spine Centre of Southern Denmark

Middelfart, 5500, Denmark

Location

Related Publications (21)

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MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Berit Schiøttz-Christensen, PhD

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Ph.D student

Model Details: Segments chosen for intervention The most painful segment will be chosen from the MPA findings and the stiff segment from VT. It is possible to measure the absolute values of both, but it might be that there is a natural difference between segments, especially for stiffness. Therefore, the stiffness and pain sensitivity for each individual (0-100%) will be normalized. For each segment we calculate the normalized difference: norm\_diff(segment) = (segment\_indent - min\_indent) / (max\_indent - min\_indent) - (segment\_pain - min\_pain) / (max\_pain - min\_pain) This will determine the biggest difference between stiffness and pain sensitivity and each segment will be chosen according to this. The lowest limit would equal the stiffest segment, while the highest limit would indicate the most painful segment.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 11, 2019
• Study Start: November 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Ultimo 2021 and for 5 years
• Access Criteria: Permission

Locations

DK (1)