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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

Pain measured with Visual Analogue Scale

Timepoint [1]

Just before first session of treatment and just after the last session of treatment

Primary outcome [2]

Lumbar function with Oswestry Scale

Timepoint [2]

Just before first session of treatment and just after the last session of treatment

Secondary outcome [1]

Lumbar movement by Schober Test

Timepoint [1]

Just before first session of treatment and just after the last session of treatment

Secondary outcome [2]

Lumbar movement by "Fingers to floor distance" test

Timepoint [2]

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?

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]

Spain

State/province [1]

JAEN

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universidad de Jaen

Address [1]

Universidad de Jaen
Edificio B3, Despacho 270
23071 Paraje de las Lagunillas, Jaen

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Universidad de Jaén

Ethics committee address [1]

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]

Spain

Date submitted for ethics approval [1]

27/03/2018

Approval date [1]

27/04/2018

Ethics approval number [1]

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

Mr Francisco Carrasco Martinez

Address

Universidad de Jaén
Edificio B3, despacho 270
Paraje de las Lagunillas s/n
23071 JAEN

Country

Spain

Phone

+34953213519

Fax

[email protected]

Contact person for public queries

Name

Alfonso Ibañez

Address

Universidad de Jaén
Edificio B3, despacho 270
Paraje de las Lagunillas s/n
23071 JAEN

Country

Spain

Phone

+34953213519

Fax

[email protected]

Contact person for scientific queries

Name

Alfonso Ibáñez

Address

Universidad de Jaén
Edificio B3, despacho 270
Paraje de las Lagunillas s/n
23071 JAEN

Country

Spain

Phone

+34953213519

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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