Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000506695
Ethics application status
Approved
Date submitted
30/04/2014
Date registered
13/05/2014
Date last updated
13/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Short term changes in algometry, inclinometry, stabilometry and urinary pH analysis after a thoracolumbar junction manipulation in patients with kidney stones: a randomized controlled trial
Scientific title
Short term changes in spinous process and muscular algometry, thoracolumbar junction inclinometry and stabilometry parameters and urinary pH analysis after a bilateral rotational, end range, thoracolumbar junction manipulation versus manual placebo in patients with a diagnosis of kidney stones diagnosed following the criteria of the European Association of Urology
Secondary ID [1] 284513 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nephrolithiasis 291774 0
Condition category
Condition code
Alternative and Complementary Medicine 292134 292134 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 292135 292135 0 0
Other physical medicine / rehabilitation
Renal and Urogenital 292136 292136 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Semi-direct thrust technique in lumbar roll on T12 (bilateral)
The approximate duration of the intervention is 90 seconds.
The intervention is performed once only and is administered by an osteopath.
Intervention code [1] 289274 0
Treatment: Other
Intervention code [2] 289275 0
Rehabilitation
Comparator / control treatment
Placebo (manual placement of hands on the sacrum and mid-thoracic region without performing any action for 90 sec).
The placebo treatment is administered to participants on a single occasion only.
Control group
Placebo

Outcomes
Primary outcome [1] 292015 0
urinary pH
Timepoint [1] 292015 0
The sample will be taken about 1 hour after intervention/placebo
Secondary outcome [1] 308000 0
pressure pain threshold at both quadratus lumborum muscles and T10 to L1 spinous processes measured by dynamometer (algometry)
Timepoint [1] 308000 0
at baseline and at short term (immediately after the intervention)
Secondary outcome [2] 308001 0
back range of motion at T12-L1 level assessed by digital inclinometry
Timepoint [2] 308001 0
at baseline and at short term (immediately after the intervention)
Secondary outcome [3] 308002 0
postural control and postural balance measured by a stabilometry platform
Timepoint [3] 308002 0
at baseline and at short term (immediately after the intervention)

Eligibility
Key inclusion criteria
(a) Diagnosis of urolithiasis by a nephrologist (following the criteria of the European Association of Urology); (b) ages between 25 and 55 (c) not taking anti-anxiety drugs in the last month; (d) sign the informed consent.
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) have suffered bone or nerve tumors; (b) inflammatory rheumatism; (c) ongoing infectious diseases; (d) spondylolysis / spondylolisthesis; (e) ongoing pregnancy; (f) suffering from peripheral or central neurological disease; (g) suffer or have suffered from pathologies that course with balance disorders; (h) developing disorders captors pathologies or postural related diseases (i) inability to maintain upright position more than 1 minute; (j) attention difficulties; (k) traumatic injuries in the last year to lower limbs or spine or sequels of traumatic injuries in such areas; (l) patients with respiratory disorders capable of causing alterations in urinary pH; (m) have other non lithiasic nephropathy; (n) present any contraindication to intervention technique or received osteopathic treatment in the last month.

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)
An external consultant prevented access to the sequence for those participating in the study (holder of the allocation schedule)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomised number table designed by an Internet website (randomized.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 6025 0
Spain
State/province [1] 6025 0
Valencia

Funding & Sponsors
Funding source category [1] 289156 0
Self funded/Unfunded
Name [1] 289156 0
Country [1] 289156 0
Primary sponsor type
University
Name
Universidad de Sevilla
Address
C/ S. Fernando, 4, C.P. 41004-Sevilla, Espana.
Country
Spain
Secondary sponsor category [1] 287821 0
None
Name [1] 287821 0
Address [1] 287821 0
Country [1] 287821 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290929 0
Comision etica de la escuela de osteopatia de Madrid
Ethics committee address [1] 290929 0
C/ San Felix de Alcala 4. 28807 Alcala de Henares. Madrid
Ethics committee country [1] 290929 0
Spain
Date submitted for ethics approval [1] 290929 0
Approval date [1] 290929 0
23/09/2013
Ethics approval number [1] 290929 0

Summary
Brief summary
The aim of this study was to evaluate the immediate effect of manipulation in the thoracolumbar junction in pressure pain thresholds, back range of motion, postural control and postural balance and in urinary pH in patients with kidney stones.

The main hypothesis of the study is that bilateral semidirect thrust technique in lumbar roll with thumb on T12 in patients with kidney stones will cause a change in the increased mobility of the spine in flexion, a change in the sensitivity of the trigger points muscles of both quadratus lumborum and T10 to L1 lumbar spinous processes, a change in stabilometric parameters and urinary pH.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48026 0
Dr Cleofas Rodriguez Blanco
Address 48026 0
Universidad de Sevilla
C/ S. Fernando, 4, C.P. 41004-Sevilla, Espana
Country 48026 0
Spain
Phone 48026 0
+ 34 955486510
Fax 48026 0
+ 34 955486527
Email 48026 0
[email protected]
Contact person for public queries
Name 48027 0
Dr Cleofas Rodriguez Blanco
Address 48027 0
Universidad de Sevilla
C/ S. Fernando, 4, C.P. 41004-Sevilla, Espana
Country 48027 0
Spain
Phone 48027 0
+ 34 955486510
Fax 48027 0
+ 34 955486527
Email 48027 0
[email protected]
Contact person for scientific queries
Name 48028 0
Dr Cleofas Rodriguez Blanco
Address 48028 0
Universidad de Sevilla
C/ S. Fernando, 4, C.P. 41004-Sevilla, Espana
Country 48028 0
Spain
Phone 48028 0
+ 34 955486510
Fax 48028 0
+ 34 955486527
Email 48028 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
SourceTitleYear of PublicationDOI
EmbaseShort-term changes in algometry, inclinometry, stabilometry, and urinary pH analysis after a thoracolumbar junction manipulation in patients with kidney stones.2017https://dx.doi.org/10.1089/acm.2017.0041
N.B. These documents automatically identified may not have been verified by the study sponsor.