Status:
COMPLETED
What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial
Lead Sponsor:
Spine Centre of Southern Denmark
Collaborating Sponsors:
Berit Schiøttz-Christensen
Søren O'Neill
Conditions:
Low Back Pain
Pain, Chronic
Eligibility:
All Genders
18-60 years
Phase:
NA
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 treatmen...
Detailed Description
1.0 Background 1.1 Treatment of persistent low back pain Low back pain (LBP) is one of the leading causes of years lived with disability. In Denmark, many patients are treated conservatively in privat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04086667
Start Date
November 1 2017
End Date
March 1 2019
Last Update
September 11 2019
Active Locations (1)
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1
Spine Centre of Southern Denmark
Middelfart, Denmark, 5500