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
ACTRN12617000760370
Ethics application status
Approved
Date submitted
2/06/2016
Date registered
23/05/2017
Date last updated
23/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Manual therapy technique on the sacrum for people with muscular dysfunction in the pelvic floor, and urinary incontinence
Scientific title
Efficacy of manual therapy on the sacrum for patients with pelvic floor dystonia
Secondary ID [1] 288431 0
None
Universal Trial Number (UTN)
U1111-1178-7628
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor dystonia 297450 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297640 297640 0 0
Other physical medicine / rehabilitation
Musculoskeletal 297641 297641 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:

- Kegel exercises: at the end of each weekly session supervised by the osteopath and at the participant's home 3 times a week.
Slow-Twitch Exercise: the pelvic floor muscle hold for a slow count of 5 seconds, relax 5 seconds, and repeat again for a total of 10 contractions. 3 sets.

Fast-Twitch Exercise: Quickly contract the pelvic floor muscle 5 times and relax 5 seconds and repeat again for a total of 10 times. 3 sets.

- Global pelvis technique

Patient: Right lateral decubitus.
Osteopath: at the level of the patient's pelvis.
Hands: We place our right knee on the left knee of the patient, for the kick. Left hand controls the patient's pectoralis. Right hand contact on the iliac crest.
Technique: Right lower extremity in extension. The lower left limb in flexion. Introduce very little rotation of the spine. Anterior slip of Anterosuperior iliac spine until fold is formed at the waist. We bring the elbow to our hip. We then rotated the patient to open the lumbo sacra veneer.
The thrust is performed by simultaneously increasing these three parameters, with kick and joint compression.

- Sacrum technique with wedges

It is done in two stages:

1. For the previous sacral base:
Patient: Prone prone, resting on wedges.
Osteopath: Standing at the level of the patient's pelvis.
Placement of the wedges: underneath the anterior superior iliac Spines, which makes the two wedges form a V of inferior point, this allows to place the pelvis in retroversion and to correct the relative position for anteriority of the base.
Contacts: The correction later consists of taking a pisiform contact or with the heel of the hand on the apex of the sacrum reinforced by the other hand.
Technique: The patient is asked to take a deep breath. In inspiration, we are going to push the pelvis in the direction of the floor, in the exhalation the correction is maintained. This correction is performed on about 10 respiratory cycles.

2. For the posterior sacral base:

Patient: prone position
Osteopath: Standing at the level of the patient's pelvis.
Placement of the wedges: The wedge is placed under the greater trochanter, which makes the two wedges now make a V of the upper tip.
Contacts: The therapist makes a contact on the sacral base, the position of the wedges makes an anteversion that corrects the relative posterior position of the base of the sacrum.
Technique: The patient is asked to take a deep breath. In exhalation, the sacral base is anteriorized, in inspiration, It is maintained.

All of the techniques described are performed at each session (25 minutes).
Who will deliver the intervention is an osteopath with 6 years experience.
The mode of delivery: face to face, manually and individually in a private clinic 3 sessions, once a week for 3 weeks.
In addition, patients must do 3 sets of Kegel exercises at home daily.
Intervention code [1] 293750 0
Treatment: Other
Intervention code [2] 293751 0
Rehabilitation
Comparator / control treatment
Intervention:

- Kegel exercises and Global pelvis technique, but not Sacrum technique with wedges
Control group
Active

Outcomes
Primary outcome [1] 298216 0
Brief pain inventory test
Timepoint [1] 298216 0
At the beginning of the first session and at the end of the last session.
Primary outcome [2] 300320 0
ICIQ-SF TEST. International Consultation on Incontinence questionnaire
Timepoint [2] 300320 0
At the beginning of the first session and at the end of the last session.
Primary outcome [3] 300321 0
The Short Form (36) Health Survey SF36
Timepoint [3] 300321 0
At the beginning of the first session and at the end of the last session.
Secondary outcome [1] 323554 0
Perineometer: used for assessing the strength of the pelvic floor muscles
Timepoint [1] 323554 0
At the beginning and end of each session. Total 6 times.
Secondary outcome [2] 329683 0
EMG Biofeedback: to measure the muscle activity and to improve muscle conditioning of the pelvic floor muscles.
Timepoint [2] 329683 0
At the beginning and end of each session. Total 6 times.

Eligibility
Key inclusion criteria
Women with pelvic floor dysfunction and urinary incontinence
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women with previous treatment for urinary incontinence and medical contraindications

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 http://www.randomization.com
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 assessing the outcomes
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
1/06/2017
Actual
Date of last participant enrolment
Anticipated
23/06/2017
Actual
Date of last data collection
Anticipated
1/10/2017
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 7864 0
Spain
State/province [1] 7864 0
GRANADA

Funding & Sponsors
Funding source category [1] 293539 0
Self funded/Unfunded
Name [1] 293539 0
Unfunded
Country [1] 293539 0
Primary sponsor type
Individual
Name
Ana Dominguez Segura
Address
Clinica Centro: Osteopatia y Fisioterapia.
C/ Catalanes No. 2
18.600 Motril - Granada - Spain
Country
Spain
Secondary sponsor category [1] 292354 0
None
Name [1] 292354 0
Address [1] 292354 0
Country [1] 292354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294982 0
Scientific European Federation Osteopaths
Ethics committee address [1] 294982 0
Ethics committee country [1] 294982 0
Date submitted for ethics approval [1] 294982 0
06/05/2016
Approval date [1] 294982 0
10/09/2016
Ethics approval number [1] 294982 0

Summary
Brief summary
In this study, we want to investigate whether the sacrum technique with wedges have an efficacy and improves the urinary incontinence, pelvic floor muscle and patients' quality of life much more than with the global pelvic technique and kegel exercises because exist a relation between the good movement of sacrum bone and the good job of pelvic floor muscle. This relation is for nerves, ligaments and muscle insertions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63058 0
Miss Dominguez Segura, Ana
Address 63058 0
Professional address:
Clinica Centro: Osteopatia y Fisioterapia
C/Catalanes, 2
18600- Motril (Granada) Spain
Country 63058 0
Spain
Phone 63058 0
+34645519715
Fax 63058 0
Email 63058 0
[email protected]
Contact person for public queries
Name 63059 0
Miss Ana Dominguez Segura
Address 63059 0
Professional address:
C/Catalanes, 2
18600- Motril (Granada) Spain

The work organisation: School of osteopathy of Madrid.
Country 63059 0
Spain
Phone 63059 0
+34645519715
Fax 63059 0
Email 63059 0
[email protected]
Contact person for scientific queries
Name 63060 0
Miss Ana Dominguez Segura
Address 63060 0
Professional address:
C/Catalanes, 2
18600- Motril (Granada) Spain

The work organisation: School of osteopathy of Madrid.
Country 63060 0
Spain
Phone 63060 0
+34645519715
Fax 63060 0
Email 63060 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.