Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000352505
Ethics application status
Approved
Date submitted
14/02/2015
Date registered
17/04/2015
Date last updated
20/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate changes in pain thresholds, lumbopelvic mobility and posture in functional chronic constipation patients after a visceral manual therapy technique: a randomized controlled trial.
Scientific title
Short term changes in pain thresholds, lumbopelvic mobility and posture after a visceral manual therapy intervention called modified abdominal hemodynamics maneuver compared to manual placebo in patients with a diagnosis of functional chronic constipation
Secondary ID [1] 286176 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional chronic constipation 294204 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294516 294516 0 0
Physiotherapy
Oral and Gastrointestinal 294517 294517 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Modified abdominal hemodynamics maneuver applied over the whole abdominal visceral mass performed in three phases. In the first phase, the therapist places the ulnar border of both hands on hypogastric region asking the patient breathe widely so that in the inspiratory phase the therapist pulls the visceral mass towards its head. In the second and third phases, the therapist contacts with both hands respectively in the right and left patient iliac fossa and follows the procedure described above, so that in the inspiratory phase the therapist pulls the visceral mass to the left shoulder of the patient in the second phase and to the right shoulder in the third phase.
The intervention will be performed by a qualified physiotherapist with over 6 years of experience in the field of manual therapy. The intervention will be conducted in one session, performing 10 repetitions in each of the phases.
Intervention code [1] 291181 0
Rehabilitation
Intervention code [2] 291182 0
Treatment: Other
Comparator / control treatment
Placebo: Manual placement of one hand over the epigastric region without performing any action while the patient performs 30 deep diaphragmatic breaths. The placebo therapy will be conducted in one session (approximately 60 seconds)
Control group
Placebo

Outcomes
Primary outcome [1] 294299 0
Pressure pain thresholds (algometry): patellar tendons, tibialis anterior muscles, ulnar nerves and C7,T3, T10, T11 and T12 spinous processes .
Timepoint [1] 294299 0
at baseline and inmediately after the intervention was applied
Secondary outcome [1] 312988 0
Back range of motion at T12-L1 and at sacrum level using digital inclinometer (BASELINE model)
Timepoint [1] 312988 0
at baseline and immediately after the intervention was applied
Secondary outcome [2] 312989 0
Lower limbs extensibility measured by a Baseline (Registered Trademark) Sit-and-reach Trunk Flexibility Box
Timepoint [2] 312989 0
at baseline and at short term (immediately after the intervention)
Secondary outcome [3] 312990 0
Postural changes measured by photogrammetry (SAPO posture assessment software (v. 0.68)).
Timepoint [3] 312990 0
at baseline and immediately after the intervention was applied

Eligibility
Key inclusion criteria
(a) Diagnosis of functional chronic constipation (following the Rome III criteria, specifically the symptom-based diagnostic criteria of functional constipation; and the Bristol scale on stool form); (b) ages between 18 and 50 (c) sign the informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) have suffered some abdominal and/or lumbar surgery, (b) ongoing pregnancy, (c) suffering from rheumatism, spinal stenosis, cancer infectious and/or neurological diseases, (d) have suffered any trauma to the chest or abdominal cavity in the last 6 months, (e) suspected aortic aneurysm and/or psychiatric illness (f) in the past 72 hours have taken medications that may interfere with the measurements, (g) receiving osteopathic / visceral manual therapy in the last month (h) present any disability that prevent the performance of the required evaluations or (i) present any contraindication to intervention technique

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 (holder of the allocation schedule) prevented access to the sequence for those participating in the study.
The allocation involved contacting the holder of the allocation schedule who was at central administration site.
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
Completed
Date of first participant enrolment
Anticipated
8/05/2015
Actual
8/05/2015
Date of last participant enrolment
Anticipated
Actual
15/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
62
Recruitment outside Australia
Country [1] 6659 0
Spain
State/province [1] 6659 0

Funding & Sponsors
Funding source category [1] 290745 0
Self funded/Unfunded
Name [1] 290745 0
Country [1] 290745 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] 289429 0
None
Name [1] 289429 0
Address [1] 289429 0
Country [1] 289429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292376 0
Comision etica de la escuela de osteopatia de Madrid
Ethics committee address [1] 292376 0
Ethics committee country [1] 292376 0
Spain
Date submitted for ethics approval [1] 292376 0
Approval date [1] 292376 0
20/01/2015
Ethics approval number [1] 292376 0

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

Contacts
Principal investigator
Name 54886 0
Dr Angel Oliva Pascual-Vaca
Address 54886 0
Universidad de Sevilla
C/ S. Fernando, 4, C.P. 41004-Sevilla, Espana.
Country 54886 0
Spain
Phone 54886 0
+ 34 954482168
Fax 54886 0
+ 34 955486527
Email 54886 0
[email protected]
Contact person for public queries
Name 54887 0
Angel Oliva Pascual-Vaca
Address 54887 0
Universidad de Sevilla
C/ S. Fernando, 4, C.P. 41004-Sevilla, Espana.
Country 54887 0
Spain
Phone 54887 0
+ 34 954482168
Fax 54887 0
+ 34 955486527
Email 54887 0
[email protected]
Contact person for scientific queries
Name 54888 0
Angel Oliva Pascual-Vaca
Address 54888 0
Universidad de Sevilla
C/ S. Fernando, 4, C.P. 41004-Sevilla, Espana.
Country 54888 0
Spain
Phone 54888 0
+ 34 954482168
Fax 54888 0
+ 34 955486527
Email 54888 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.