Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001328369
Ethics application status
Approved
Date submitted
9/08/2017
Date registered
15/09/2017
Date last updated
24/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Dejarnette’s Blocks on chronic back pain
Scientific title
Impact of Dejarnette's Blocks on low back pain and strength of stabilising muscles in dancers.
Secondary ID [1] 292562 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic low back pain 304229 0
Condition category
Condition code
Musculoskeletal 303578 303578 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is performed by a physiotherapist.
The experimental group will be the placement of the blocks, 5 minutes in flexion and 5 minutes en extension. The base of the blocks are placed on the hip joints and the tips of the blocks towards the navel to bring the pelvis to flexion. To carry the pelvis to extension the base of the blocks is placed on the iliac crests and the tips towards the pubis.
The treatment is administered once in each participant.
The control group will remain without intervention for 10 minutes lying on the stretcher in the prone position. Once the study for the control group was concluded, the same treatment as that applied to the experimental group was obtained.
With the technique of blocks we intend to normalize the movements of the iliac crests, L4, L5 and sacrum and reduce the pain that is directly related by joints, ligaments, muscles and nerves.
The tests of orthopedic strength of the pyramidal muscles, gluteal medius, gluteus maximus and psoas-iliac according to Daniels will be used as diagnostic maneuvers. They will be measured with the force dynamometer by performing 3 repetitions of each test and obtaining the average value. The duration of each test will be 5 seconds.
The tests will be performed before and after the placement of the Dejarnette blocks and one week later of placement of the bloks.
Intervention code [1] 298852 0
Treatment: Devices
Comparator / control treatment
The control group will be left without intervention for 10 minutes lying on the stretcher in prone position. Once the study for the control group was concluded the same treatment as that applied to the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 303042 0
Perceived lumbar pain by Visual Analogue Scale
Timepoint [1] 303042 0
Before, immediately following treatment
Primary outcome [2] 303181 0
Test maximal and mean strength of the pyramidal, gluteus medius, gluteus maximus and psoas-iliac muscles bilaterally using The Lafayette Manual Muscle Testing (MMT) System
Timepoint [2] 303181 0
Before treatment and immediately following treatment
Primary outcome [3] 303182 0
The Roland Morris Questionnaire
Timepoint [3] 303182 0
Before treatment and one week after treatment.
Secondary outcome [1] 337759 0
Perceived lumbar pain by Visual Analogue Scale
Timepoint [1] 337759 0
One week after treatment
Secondary outcome [2] 338152 0
Test maximal and mean strength of the pyramidal, gluteus medius, gluteus maximus and psoas-iliac muscles bilaterally using The Lafayette Manual Muscle Testing (MMT) System
Timepoint [2] 338152 0
One week after treatment

Eligibility
Key inclusion criteria
-All participants are dancers.
- That the parents or guardians give written consent for the minor children to be part of the study.
- With low non-specific lower back pain of less than 3 months
- No diagnosed disc pathologies.
- No surgical interventions in the lower limbs or rachis.
- No pathology of dental or bite occlusion.
Minimum age
14 Years
Maximum age
26 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women with low non-specific lower back pain of less than 3 months.
- That we have received osteopathic treatment in the last 3 months.
- That they were medicated low-back pain, at least two months in advance, for the same pathology.
- That was done with pathologies of graves diagnosed in the feet, knees or hips.
- Those who have not taken medication during the 72 hours prior to the study.
- Pregnant at the time of study.
- That they present some type of contraindication to the therapy with wedges of Dejarnette.
- Women with plantar supports.
- That suffered cervical whiplash or traffic accident or trauma.

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)
In the first consultation of the first patient and once decided their participation in the study, the assignment of subjects is selected using the random number software www.randomizer.org.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The subjects of the study are dancers with low non-specific low back pain of more than three months and recruited from different dance schools and conservatories of Valencia.
It is intended to create two groups of 20 subjects each.
A repeated measures ANOVA will be carried out

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2017
Actual
Date of last participant enrolment
Anticipated
21/11/2017
Actual
Date of last data collection
Anticipated
22/12/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 9141 0
Spain
State/province [1] 9141 0
valencia

Funding & Sponsors
Funding source category [1] 297317 0
Self funded/Unfunded
Name [1] 297317 0
Francisco Selva
Country [1] 297317 0
Primary sponsor type
Individual
Name
Francisco Selva
Address
Department of Physiotherapy, University of Valencia, Calle Gascó Oliag 3, Valencia, 46010, Spain.
Country
Spain
Secondary sponsor category [1] 296287 0
None
Name [1] 296287 0
Address [1] 296287 0
Country [1] 296287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298311 0
Commission of ethics in experimental research. University of Valencia, Spain
Ethics committee address [1] 298311 0
Ethics committee country [1] 298311 0
Spain
Date submitted for ethics approval [1] 298311 0
04/09/2017
Approval date [1] 298311 0
07/09/2017
Ethics approval number [1] 298311 0
H1504616010653

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76670 0
Dr Francisco Selva
Address 76670 0
Department of Physiotherapy, University of Valencia, Calle Gascó Oliag 3, Valencia, 46010, Spain.
Country 76670 0
Spain
Phone 76670 0
+34634590640
Fax 76670 0
Email 76670 0
[email protected]
Contact person for public queries
Name 76671 0
Francisco Selva
Address 76671 0
Department of Physiotherapy, University of Valencia, Calle Gascó Oliag 3, Valencia, 46010, Spain.
Country 76671 0
Spain
Phone 76671 0
+34634590640
Fax 76671 0
Email 76671 0
[email protected]
Contact person for scientific queries
Name 76672 0
Francisco Selva
Address 76672 0
Department of Physiotherapy, University of Valencia, Calle Gascó Oliag 3, Valencia, 46010, Spain.
Country 76672 0
Spain
Phone 76672 0
+34 963983855
Fax 76672 0
Email 76672 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

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

Documents added automatically
No additional documents have been identified.