Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000684224
Ethics application status
Approved
Date submitted
16/04/2018
Date registered
26/04/2018
Date last updated
27/05/2020
Date data sharing statement initially provided
27/05/2020
Date results information initially provided
27/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Short time effects in pain of mechanical flexion-distraction technique compared to lumbar manipulation techniques in patients with low back pain
Scientific title
Short time effects in pain of mechanical flexion-distraction technique compared to lumbar manipulation techniques in patients with low back pain
Secondary ID [1] 294571 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 307350 0
Condition category
Condition code
Musculoskeletal 306454 306454 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 306455 306455 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 3 x 10 minute session (each one separated for five days, total duration of 12 days) of manual therapy (finger compression on trigger points) at quadratus lumborum and psoas muscles and 3x10 minute session of flexion-distraction technique (5x10 repetitions followed by one minute of rest per session). Flexion-distraction technique consist on a two-leaves table with a engine that mobilize one of the leaves respect to the other in flexion by bending it in vertical way. This movement is respectful with physiology of the low back

The intervention will be administered by a physiotherapist with over 10 years of experience.
To monitor the adherence to the intervention, a session attendance checklist will be used.
Intervention code [1] 300915 0
Rehabilitation
Comparator / control treatment
Arm 2: 3 x 10 minute session (each one separated for five days, total duration of 12 days) of manual therapy (finger compression on trigger points) at quadratus lumborum and lumbar spine manipulation by high velocity and short amplitud technique on L3-L4. High velocity technique will consist on a lumbar roll, which requires upper-lumbar spine rotation to one side and lower lumbar spine rotation (with hip and knee flexion of the upper leg) to the opposite side on lying position. The impulsed movement will be a short increasing on upper-lumbar spine rotation.

The treatment will be administered by a physiotherapist with over 10 years of experience.
To monitor the adherence to the intervention, a session attendance checklist will be used.
Control group
Active

Outcomes
Primary outcome [1] 305487 0
Pain measured with Visual Analogue Scale
Timepoint [1] 305487 0
Just before first session of treatment and just after the last session of treatment
Primary outcome [2] 305488 0
Lumbar function with Oswestry Scale
Timepoint [2] 305488 0
Just before first session of treatment and just after the last session of treatment
Secondary outcome [1] 345433 0
Lumbar movement by Schober Test
Timepoint [1] 345433 0
Just before first session of treatment and just after the last session of treatment
Secondary outcome [2] 345434 0
Lumbar movement by "Fingers to floor distance" test
Timepoint [2] 345434 0
Just before first session of treatment and just after the last session of treatment

Eligibility
Key inclusion criteria
People diagnosed of lumbar pain with minimum three weeks of pain
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Acute lumbar pain of less than three weeks of pain
-People who had undergone another treatment for lumbar pain in the last month
-People who had undergone any spine surgery
-People who suffer any radiculopathy to lower limbs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Kolmogorov-Smirnov test will be performed to analyse the normality of the continuous variables.
The paired t-test will be used to analyse any change in group scores. In order to analyse the differences between the groups, we will calculate the change scores by subtracting the baseline scores to those obtained throughout the follow-up process. Afterwards, between-groups differences in change scores will be analysed using the t-test for independent samples.
Cohen’s d, calculated as the difference of means between groups divided by the combined standard deviation, will be chosen to measure effect size (ES). The ES will be interpreted as follows: ES <0.2 shows negligible effect; = 0.2 to = 0.5 small effect; = 0.5 to = 0.8 medium effect and ES> 0.8 reflects large effect.
Data will be analysed using the Statistical Package for the Social Sciences version 19.0 for Windows (SPSS Inc., Chicago, IL, USA) and MedCalc Statistical Software version 17.9.7 (MedCalc Software bvba, Ostend, Belgium; 2014). We will work with a 95% confidence level (p <0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2018
Actual
24/09/2018
Date of last participant enrolment
Anticipated
1/10/2018
Actual
1/10/2018
Date of last data collection
Anticipated
13/10/2018
Actual
13/10/2018
Sample size
Target
171
Accrual to date
Final
171
Recruitment outside Australia
Country [1] 10289 0
Spain
State/province [1] 10289 0
JAEN

Funding & Sponsors
Funding source category [1] 299188 0
University
Name [1] 299188 0
Universidad de Jaen
Country [1] 299188 0
Spain
Primary sponsor type
University
Name
Universidad de Jaén
Address
Universidad de Jaen
Edificio B3, Despacho 270
23071 Paraje de las Lagunillas, Jaen
Country
Spain
Secondary sponsor category [1] 298451 0
None
Name [1] 298451 0
Address [1] 298451 0
Country [1] 298451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300113 0
Ethics Committee of Universidad de Jaén
Ethics committee address [1] 300113 0
Universidad de Jaen
Comité Ético de Investigación
Facultad de Ciencias de la Salud
Edificio B3, Paraje de las Lagunillas s/n
23071 JAEN
Ethics committee country [1] 300113 0
Spain
Date submitted for ethics approval [1] 300113 0
27/03/2018
Approval date [1] 300113 0
27/04/2018
Ethics approval number [1] 300113 0
ABR.18/2TES

Summary
Brief summary
Lower back pain is one of the most important cause of laboral absenteeism. Among 70% and 80% of population have ever feel lower back pain. Depending on its etiology, could be classificated as:
-Mechanic lower back pain: 90% of all cases, it differs from the others because patient only feel pain in lumbar spine without irradiation to lower limb.
-Lumbo-ciatalgya: when pain at lower limb is worse than in lumbar spine.
-Reflex lower back pain: irradiated pain to lower limb from the lumbar spine.

Flexion-distraction technique: the first time this technique was developed was in 1909 by the osteopath McManis. He prepared a table to carry it out. The technique consisted basically of placing the patient in the prone position, with the feet off the table tied at the ankles. The arms are stretched towards the cranial margin of the table until they can be held with the hands in an accessory. In this position, flexion-extension, lateral bending and circumduction movements are applied, taking as a reference the horizontal midline and always by the lower lever.
At the end of the 70s, A. Stoddart developed the technique of manual vertebral traction and a few years later, James Cox made a series of modifications to the Mc Manis technique. The patient's position is the same as before, the difference was in the treatment protocol applied by Cox. He despises the extension of the lumbar spine above the horizontal line. Small flexion-extension movements were made from a flexion position that was applied to the lower lever.

The effects of the flexion-distraction technique are the following:
- It increases the interdiscal somatic space, decreasing the intradiscal pathogenic pressure, facilitating the reduction of the herniated disc.
- Produces a suction effect that tends to suck the disc and reintegrates it in its space.
- Create a disc edema that fights against the edema and rehydrates the disc.
- It decreases the tensions on the posterior common vertebral ligament and moves the disc away from the sensitive structures.
- Decompress and stretch the joint capsules. The traction stretches the capsule rhythmically and stimulates the mechanoreceptors during each phase of traction, thus producing an analgesic and lowering of muscle tone.
- The traction inhibits the spasm of the transverse thorns responsible for a part of the pain. Golgi receptors and neuromuscular spindles cause reflex inhibition that boxes muscle tone.
- The capsule stretching activate the control-gate system. The large fibers that transmit the proprioceptive information about the movement, saturate the marrow in such a way that it closes the door to the painful information of the small fibers. This explains the analgesic action of this technique.

The aim of this study is to compare the effects of flexion distraction technique with high velocity and low amplitud lumbar manipulation, treatment which has shown good results in immediate reduction of lower back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82610 0
Mr Francisco Carrasco Martinez
Address 82610 0
Universidad de Jaén
Edificio B3, despacho 270
Paraje de las Lagunillas s/n
23071 JAEN
Country 82610 0
Spain
Phone 82610 0
+34953213519
Fax 82610 0
Email 82610 0
ajibanez@ujaen.es
Contact person for public queries
Name 82611 0
Dr Alfonso Ibañez
Address 82611 0
Universidad de Jaén
Edificio B3, despacho 270
Paraje de las Lagunillas s/n
23071 JAEN
Country 82611 0
Spain
Phone 82611 0
+34953213519
Fax 82611 0
Email 82611 0
ajibanez@ujaen.es
Contact person for scientific queries
Name 82612 0
Dr Alfonso Ibáñez
Address 82612 0
Universidad de Jaén
Edificio B3, despacho 270
Paraje de las Lagunillas s/n
23071 JAEN
Country 82612 0
Spain
Phone 82612 0
+34953213519
Fax 82612 0
Email 82612 0
ajibanez@ujaen.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.