Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000523303
Ethics application status
Approved
Date submitted
12/01/2017
Date registered
10/04/2017
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of motor control exercise combined with manual therapy in patients with low back pain classified in directional patterns of instability
Scientific title
Effectiveness of motor control exercise combined with manual therapy in patients with low back pain classified in directional patterns of instability
Secondary ID [1] 290732 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 301312 0
Condition category
Condition code
Musculoskeletal 301065 301065 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301466 301466 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 5 subgroups (directional patterns of instability), within motor control impairment group, These are: flexion, flexion/lateral shifting, active extension, pasive extension and multidirectional patterns. We will focus only in flexor pattern.
First, Directional pattern will be evaluated with 4 specific functional motor control tests to both groups for flexion pattern, Only flexion patterns will be selected for our study.
Then, patients will be divided in intervention and control groups.
Experimental group will perform a specific exercise for their flexion pattern of lumbar instability.
Exercises will be controlled movements where they will activate Multifidus, Psoas Major, spinal erectors muscles, and we will instruct that these exercises will be done with slowness and attention.
Exercises examples for flexion pattern are:
- In supine position; Anterior pelvic tilt; hip flexion maintening neutral lordosis of low back.
- In sit position: anterior bend of trunk keeping neutral lordisis of low back
- In quadruped position: hips double flexion towards heels keeping neutral lordosis of low back.
- To do Squats, maintening neutral lordosis
Exercises examples for extension pattern are (this exercises are only an explication for contrary pattern, futhermore these exercises are out of protocol, it is for show the difference):
-Posterior pelvic tilt in supine position with 45 degrees flexion hip and 45 degrees flexion knee .
-In supine position, with 45 degrees flexion hip and 45 degrees flexion knee; to flex hip to 90 degrees without separate lumbar segment of ground (neutral lordosis of low back).
One example for passive extension, (these exercises are out of protocol);
-In sedestation position, to perform a hip flexion, tilting the trunk forward without losing lordosis of low back.
We will be 3 physiotherapists that will be in normal rehabilitation service working with patients, one by one.
Patients will be 2 weeks (5 sessions/week; 45 minutes/ session) doing the supervised exercises at hospital and then, they will continue exercises at home during one month more (5 session/ week) at least.
Home exercises will be same that performed at hospital, with equal duration.
Adherence will not be assessed; we will say to patient the recomendation to continue exercise at least one month more with same frecuency.
Intervention code [1] 296633 0
Rehabilitation
Intervention code [2] 296968 0
Treatment: Other
Comparator / control treatment
Control group will receive the regular hospital rehabilitation treatment;. general strengthening exercise and stretching of lumbar spine 5 sessions/week during 2 weeks at hospital, then patients will go on exercises at home 5 sessions/ week during one month more.
Control group
Active

Outcomes
Primary outcome [1] 300487 0
Disability with Roland Morris questionnaire (RMQ)
Timepoint [1] 300487 0
Baseline, 2 weeks, 6 weeks, 3 and 9 months post commencement of intervention.
Secondary outcome [1] 330076 0
Pressure pain threshold with algometer,
Pain numeric scale,
Timepoint [1] 330076 0
Baseline, 2 weeks, 6 weeks, 3 and 9 months commencement of intervention.
Secondary outcome [2] 330077 0
Kinesiophobia with Tampa scale
Timepoint [2] 330077 0
Baseline, 2 weeks, 6 weeks, 3 and 9 months commencement of intervention.

Eligibility
Key inclusion criteria
Subjects with low back pain, 3 month with pain ,lumbar instability flexion pattern, mechanic pain
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Another patterns of lumbar instability (for example: active and passive extension), diseases like cancer, infections, inflamatory diseases, fractures,psychiatric diseases,MODIC changes, neurologic diseases, or pregancy.

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)
Computer allocation
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


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/05/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 8477 0
Spain
State/province [1] 8477 0
Madrid

Funding & Sponsors
Funding source category [1] 295162 0
Hospital
Name [1] 295162 0
Hospital clinico San Carlos
Country [1] 295162 0
Spain
Primary sponsor type
Individual
Name
Hospital clinico San Carlos
Address
Calle del Profesor Martin Lagos, s/n, 28040 Madrid
Country
Spain
Secondary sponsor category [1] 293997 0
None
Name [1] 293997 0
Address [1] 293997 0
Country [1] 293997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296520 0
CEIC Hospital Clinico San Carlos
Ethics committee address [1] 296520 0
Calle Doctor Martin Lagos, s/n. Madrid 28040
Ethics committee country [1] 296520 0
Spain
Date submitted for ethics approval [1] 296520 0
08/11/2016
Approval date [1] 296520 0
16/11/2016
Ethics approval number [1] 296520 0
internal code 16/476-E

Summary
Brief summary
Specific treatment is based in classification of patients depending of their painful or unsuccessful movements of their lumbar spine.
This movements are recognised by therapist and clasiffied in 4 directional patterns (flexion, extension, lateral, and multidirectional) and according to these, therapist choices an specifics exercises for retrain these movements and enhanced the lumbar muscle.
Normal treatment in almost every hospital or clinics is working general strengthening and stretching of lumbar spine.
Main hypothesis is patients with low back pain classified, in our study as flexion pattern , and receiving specific exercises for their specific instability directional pattern of pain and movement, will obtain better improvements in terms of pain and disability.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1365 1365 0 0
/AnzctrAttachments/371495-16.476-E Aprob. Ceic.pdf (Ethics approval)

Contacts
Principal investigator
Name 69038 0
Dr Gustavo Plaza-Manzano
Address 69038 0
Departamento de Medicina Fisica y Rehabilitacion
Facultad de Medicina
Universidad Complutense de Madrid
Avenida Complutense s/n
28440 Madrid
Country 69038 0
Spain
Phone 69038 0
+34609578380
Fax 69038 0
Email 69038 0
[email protected]
Contact person for public queries
Name 69039 0
Mr Emmanuel R. Moreno-Palancas Platero
Address 69039 0
Departamento de Medicina Fisica y Rehabilitacion
Facultad de Medicina
Universidad Complutense de Madrid
Avenida Complutense s/n
28440 Madrid
Country 69039 0
Spain
Phone 69039 0
+34647968442
Fax 69039 0
Email 69039 0
[email protected]
Contact person for scientific queries
Name 69040 0
Dr Gustavo Plaza-Manzano
Address 69040 0
Departamento de Medicina Fisica y Rehabilitacion
Facultad de Medicina
Universidad Complutense de Madrid
Avenida Complutense s/n
28440 Madrid
Country 69040 0
Spain
Phone 69040 0
+34609578380
Fax 69040 0
Email 69040 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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