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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Kinematic spine model (Hidalgo et al. 2012 Journal of Rehabilitation medicine)
Study Overview
Brief 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
Detailed Description
INTRODUCTION:
Non-specific low back pain is a high prevalence within musculoskeletal disorders in industrialized countries (Waddell 2004). Many treatments are available with different degrees of effectiveness (Delitto et al. 2012). Many experts agree that sub-groups exist within the large category of patients diagnosed with non-specific LBP. The difficulty in identifying pathoanatomical causes in most patients combined with the high false positive rates of imaging studies have led many to further conclude that meaningful sub-groups should be based on patient's symptoms and clinical presentation (Fritz et al; 2005; Hidalgo et al. 2012, 2013a,b). The identification of subgroups could improve the outcomes of clinical care by establishing more accurate prognoses, efficiently directing patients to therapies most likely to benefit their particular sub-group (Fritz et al. 2005; Delitto et al. 2012).
Orthopaedic Manual Therapy (OMT) plays an increasingly important role in the treatment of back pain, especially in patients with factors predicting a favorable response to the TMO (Delitto et al. 2012, Fritz et al. 2005).
One proposed subgroup among non-specific LBP people that has been identified is patients who respond rapidly to spinal manipulation when positive on clinical predictive rule (4-5/ 5 criteria) (Flynn et al. 2002, Child et al. 2004, Fritz et al. 2005). However common sense, as well as research evidence recognizes that not all patients with LBP should expected to respond to a manipulation intervention. The efficiency of primary care management of patients with LBP could be improved if a pragmatic tool could help to identify those patients with LBP who are likely to respond to this hands on approach.
In the study of Fritz et al. 2005, authors demonstrated that 2 easy clinical criteria are sufficient to identify this subgroup among non-specific LBP (duration of symptom <16 days and distribution of symptoms : not having symptoms distal to the knees).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
spinal manipulation intervention group
Spinal manipulation: 3 sessions within one week of true lumbopelvic manipulation
Intervention: Usual medical care (Other)
spinal manipulation intervention group
Spinal manipulation: 3 sessions within one week of true lumbopelvic manipulation
Intervention: Spinal manipulation (Other)
Spinal manipulation control group
Sham spinal manipulation: 3 sessions within one week of sham lumbopelvic manipulation
Intervention: sham spinal manipulation (Other)
Spinal manipulation control group
Sham spinal manipulation: 3 sessions within one week of sham lumbopelvic manipulation
Intervention: Usual medical care (Other)
Outcomes
Primary Outcomes
Kinematic spine model (Hidalgo et al. 2012 Journal of Rehabilitation medicine)
Time Frame: Change from baseline and 1 week after discharge of treatment
Use of quantitative variables for ROM and SPEED using two Logit Score Index (ROM and SPEED)
Secondary Outcomes
- physical examination(During the 2 sessions of treatment within one week)
- Oswestry Disability questionnaire(change from baseline until 1 month after discharge of treatment)
- Start back tool (screening questionnaire)(change from baseline until 1 month after discharge of treatment)
- Fear avoidance belief questionnaire(change from baseline until 1 month after discharge of treatment)
- present pain with visual analog scale (VAS)(change from baseline until 1 month after discharge of treatment)
- medication consumption / return to work / side effects(change from baseline until 1 week after discharge of treatment)
- body diagram/chart of pain symptoms(change from baseline until 1 month after discharge of treatment)
- patient specific functional scale PSFs(change from baseline until 1 month after discharge of treatment)
- Patient's belief that spinal manipulation will improve the LBP status / Patient's belief that he received an effective spinal manipulation treatment ?(baseline and after 1 week (discharge of treatment))
Investigators
Benjamin Hidalgo
PhD-student, assistant of teaching
Université Catholique de Louvain