TerminatedNot Applicable

Study of the Efficacy of Manual Therapy for a Subgroup of Acute Non-specific Low Back Pain

Stopped: problem of recruitment (not enough patients)

Belgium100 participantsStarted 2013-05

Plain-language summary

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

Who can participate

Age range

19 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * non specific acute low back pain \< 16 days, * no pain below the knee, * mobility deficit Exclusion Criteria: * specific low back pain (red flags), * subacute or chronic non-specific LBP, * previous history of surgery, * high irritability, * hyperlaxity - aberrant movement when standing flexion, * post part um and pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Kinematic spine model (Hidalgo et al. 2012 Journal of Rehabilitation medicine)

Timeframe: Change from baseline and 1 week after discharge of treatment

Trial details

NCT IDNCT01801553

SponsorUniversité Catholique de Louvain

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

View on ClinicalTrials.gov More Low Back Pain trials