ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000200482

Ethics application status

Approved

Date submitted

1/12/2015

Date registered

15/02/2016

Date last updated

15/02/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of neurodynamic mobilization and motor control training on pain and mechanosensitivity in patients with lumbosacral disc herniation and sciatica

Scientific title

Effect of neurodynamic mobilization and motor control training on pain and mechanosensitivity in patients with lumbar disc herniation and sciatica

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

sciatica pain

lumbar disc herniation

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In the experimental group a physiotherapist will teach motor control exercise in lumbopelvic region. In addition, patients will receive neurodynamic mobilization of sciatic nerve.
Sessions will be individual (one-on-one consultation), and the frequency will be 1 half-hour session per week for 8 weeks.
Patients will be treated with mobilization of sciatic nerve, using oscilatory movements with knee extension, hip flexion and ankle dorsiflexion. Physiotherapist could use hip abduction and adduction if necessary.
Motor control exercises will be taught by physiotherapist. He´ll teach the isolated transverse abdominal muscle contraction to the patients. After that patients will learn multifidus contraction too. Then, patients will perform some exercises simultaneously contracting these deep muscles.
Patients will receive some information about the exercise in order to perform these exercises all the week, between every session. Participants are asked to practice the exercises at home once daily for 20 minutes over the 8 week intervention period.
There are not strategies used to monitor adherence to the intervention

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

In the control group a physiotherapist will teach only motor control exercises in lumbopelvic region.
Sessions will be individual (one-on-one consultation), and the frecuency will be 1 half-hour session per week for 8 weeks.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of participants with a reduction in pain measured with Visual Analogic Scale and LANSS Questionnaire

Timepoint [1]

LANSS Questionnaire will be used at the beggining of the trial, at the middle (4 weeks) and at the end of the intervention (8 weeks). It will be used also 2 months post intervention completion.
Visual Analogic Scale will be used each weekly session (before and after each session) and it will be used also 2 months post intervention completion

Primary outcome [2]

Proportion of participants with a reduction in mechanosensitivity in lower limbs nerves (preassure pain threshold) measured with an algometer

Timepoint [2]

The weekly assessment occur before and after each weekly session. Algometry will be used 2 months after intervention completion too

Secondary outcome [1]

Proportion of participants with a reduction in low back pain disability, measured with Rolland Morris questionnaire

Timepoint [1]

At the beggining of the intervention, 4 weeks, at the end of the intervention and 2 months post intervention completion

Eligibility

Key inclusion criteria

Patients aged between 18 and 60 years old.
L4-L5-S1 disc herniation with pain in lower limb.
At least 3 months with pain
Positive Straight Leg Raise Test
No additional treatment while study is carrying out

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Disc herniations in other spinal levels
Other spinal pathologies like tumours or spondylolisthesis
Acute pain
Patients treated with other treatments.

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)

central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2016

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Burgos

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Ignacio Cancela Cilleruelo

Address [1]

Calle Sol de las Moreras 28

Country [1]

Spain

Primary sponsor type

Individual

Name

Gustavo Plaza

Address

Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid
Plaza Ramon y Cajal. Ciudad Universitaria. 28040 Madrid

Country

Spain

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical committee of investigation and animal experimentation of Alcala de Henares University

Ethics committee address [1]

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

22/11/2015

Approval date [1]

23/11/2015

Ethics approval number [1]

Summary

Brief summary

Radicular pain originated in lumbar and sacral plexus is a common problem in clinical practice. It is usually related with problems in lumbar spine, specially with disc herniations which induce compression in nerve roots. There are some techniques and methods aimed to reduce low back pain and sciatica pain, like physical therapy, exercises or pharmacologic treatment. Physical exercise,  and mainly motor control training in lumbopelvic region has shown great effects in lumbar spine problems like chronic low back pain. 
Among the techniques of physiotherapy for neuropathic pain, neurodinamic mobilization seems to be an useful technique in order to reduce pain and other symptoms.
The objective of the this trial is measure changes in patients treated with both techniques  in some parameters: pain (assessed with Visual Analogic Scale), neuropathic pain characteristics (LANSS Questionnarire), nerve mechanosensitivity or algometry (pain threshold pressure and Straight Leg Raise Test) and low back pain disability (Roland Morris Questionnaire).
Trial will be carried out with around 30 patients with radicular pain in lower limb (sciatica) and with lumbar or sacral disc herniation in L4-L5-S1 level. Patients will be allocated in two groups, the control group (n=15) which receive a motor control training for lumbopelvic region, and the experimental group (n=15) which receive the same training and they will receive also neurodinamic mobilization in lower limb nerves. Both groups treatments will be given for 2 months, one session per week.
Some measurements will be carried out previous and after session (VAS, Straight Leg Raise Test and algometry). In addition, LANSS Questionnaire and Roland-Morris will be carried out previous to the beginning of the intervention, at the middle and after the intervention. It will be measured again 2 months after the end of the treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Ignacio Cancela Cilleruelo

Address

Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid
Plaza Ramon y Cajal. Ciudad Universitaria. 28040 Madrid

Country

Spain

Phone

+34 628234514

Fax

ignaciocancela@gmail.com

Contact person for public queries

Name

Ignacio Cancela Cilleruelo

Address

Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid
Plaza Ramon y Cajal. Ciudad Universitaria. 28040 Madrid

Country

Spain

Phone

+34 628234514

Fax

ignaciocancela@gmail.com

Contact person for scientific queries

Name

Gustavo Plaza Manzano

Address

Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid
Plaza Ramon y Cajal. Ciudad Universitaria. 28040 Madrid

Country

Spain

Phone

+34 628234514

Fax

ignaciocancela@gmail.com

No information has been provided regarding IPD availability

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.

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