Trial Review

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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] 288049 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sciatica pain 296913 0
lumbar disc herniation 296914 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297149 297149 0 0
Physiotherapy
Musculoskeletal 297532 297532 0 0
Other muscular and skeletal disorders
Neurological 297533 297533 0 0
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] 293371 0
Rehabilitation
Intervention code [2] 293653 0
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] 296766 0
Proportion of participants with a reduction in pain measured with Visual Analogic Scale and LANSS Questionnaire
Timepoint [1] 296766 0
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] 296767 0
Proportion of participants with a reduction in mechanosensitivity in lower limbs nerves (preassure pain threshold) measured with an algometer
Timepoint [2] 296767 0
The weekly assessment occur before and after each weekly session. Algometry will be used 2 months after intervention completion too
Secondary outcome [1] 319292 0
Proportion of participants with a reduction in low back pain disability, measured with Rolland Morris questionnaire
Timepoint [1] 319292 0
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?
No
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
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 7390 0
Spain
State/province [1] 7390 0
Burgos

Funding & Sponsors
Funding source category [1] 292488 0
Self funded/Unfunded
Name [1] 292488 0
Ignacio Cancela Cilleruelo
Country [1] 292488 0
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] 291199 0
None
Name [1] 291199 0
Address [1] 291199 0
Country [1] 291199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293954 0
Ethical committee of investigation and animal experimentation of Alcala de Henares University
Ethics committee address [1] 293954 0
Ethics committee country [1] 293954 0
Spain
Date submitted for ethics approval [1] 293954 0
22/11/2015
Approval date [1] 293954 0
23/11/2015
Ethics approval number [1] 293954 0

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 61918 0
Mr Ignacio Cancela Cilleruelo
Address 61918 0
Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid
Plaza Ramon y Cajal. Ciudad Universitaria. 28040 Madrid
Country 61918 0
Spain
Phone 61918 0
+34 628234514
Fax 61918 0
Email 61918 0
[email protected]
Contact person for public queries
Name 61919 0
Mr Ignacio Cancela Cilleruelo
Address 61919 0
Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid
Plaza Ramon y Cajal. Ciudad Universitaria. 28040 Madrid
Country 61919 0
Spain
Phone 61919 0
+34 628234514
Fax 61919 0
Email 61919 0
[email protected]
Contact person for scientific queries
Name 61920 0
Dr Gustavo Plaza Manzano
Address 61920 0
Departamento de Medicina Fisica y Rehabilitacion. Facultad de Medicina. Universidad Complutense de Madrid
Plaza Ramon y Cajal. Ciudad Universitaria. 28040 Madrid
Country 61920 0
Spain
Phone 61920 0
+34 628234514
Fax 61920 0
Email 61920 0
[email protected]

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

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