A Randomized Controlled Double Blind Study on the Pragmatic Application of a Clinical Prediction Rule in Primary Care to Treat Low Back Pain Patients With a Brief Spinal Manipulation Intervention: a Validation Study

The purpose of this study is:

• To validate or not the interest of the classification using the pragmatic application of clinical predictive rule for low back pain to identify patients with good prognosis following a brief spinal manipulation intervention.

Patients (n = 100 to 150) :

Recruited from emergency department of Saint-Luc hospital by medical doctors

Inclusion criteria:

A. Non-specific (No red flags) acute low back with mobility deficit (limitation in bending) and a pain duration < 16 days and no symptoms distal to the knees, male and female patients aged 19-55 years.

Exclusion criteria:

• Specific LBP (red flags) and radiating beyond the knee
• Low Back Pain Non-specific subacute and chronic
• Recurrent low back pain (more than 3 painful episodes)
• Lumbar instability or hyper laxity (instability catch, active straight leg raise (SLR) > 90°, aberrant movement,range of motion (ROM) of le lower lumbar spine > 50° during standing flexion), pregnancy and post-partum status
• High irritability = necessity of opioid medication or intravenous injection of medication in the emergency department
• previous history of surgical intervention in the low back area

Intervention:

• 3 sessions within one week of spinal manipulation (thrusts, grade V)

comparison:

• 3 sessions of false/sham manipulation (placebo) in side lying on thoraco-lumbar hinge in a grade II

Co-intervention similar in both group:

= traditional medical care (TMC)

• Reassure patients, avoid bed rest, advise them to stay active and to take analgesics (if needed such as paracetamol) (European Guidelines for non-specific acute low back pain ; van Tulder et al. 2006 ; Koes et al. 2010).

Outcomes:

Use of effect sizes by standardized mean of difference. ANOVA one and Two Way, number needed to treat (NNT) analysis and intention to treat analysis on all outcome variables:

• Primary: Kinematic Variables: two indices, logit score for the amplitude and velocity (Hidalgo et al., 2012) and patient's expectation from manual therapy (MT) treatment to improve his LBP
• Secondary: Pain in the presentation with visual analogical scale (VAS) and the repartition (body diagram), Oswestry Disability Index (ODI, questionnaire on pain and function), patient specific function (PSF), fear avoidance beliefs questionnaire (FABQ), Start back tool, physical examination, medication use, return to work and treatment side effects, patient's belief in a real MT intervention or not (at the end of the follow-up)

Study design:

• Double blind ie: patients and assessors blind.
• The methodological quality of the study is the 8-9/10 on the PEDro scale, we will strictly follow the CONSORT statement and will be register in clinical.trials gov

Evaluators:

Christine Detrembleur (PT-PhD-UCL), Maxime Gilliaux (PT-PhD-student-UCL)

Responsible for the study: Henri Nielens (MD-PhD-UCL)

Practitioner and investigator:

Benjamin Hidalgo PE, PT-MT, DO, PhD-student Certificate in Orthopedic Manual Therapy (Manual Concepts, Curtin University) Assistant-Professor Faculty of Physical therapy (FSM-UCL) Belgium

International collaborator:

Timothy Flynn (PT-PhD), Regis University, Denver, USA