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Trial registered on ANZCTR


Registration number
ACTRN12611001195943
Ethics application status
Approved
Date submitted
14/11/2011
Date registered
18/11/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate effect of a global pelvic manipulation technique on lumbar pain in patients with primary dysmenorrhea: a randomized controlled trial
Scientific title
Immediate effect of a global pelvic manipulation technique versus a placebo technique on lumbar pain measured with a visual analogue scale, the pressure pain threshold in sacroiliac joints and the body's response to pain following a catecholamine and serotonine release in 40 patients with primary dismenorrhea: a double blind randomized controlled trial.
Secondary ID [1] 273391 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure pain treshold in sacroiliac joints 279169 0
Self-perceived pain in lumbo-pelvic area 279186 0
Condition category
Condition code
Anaesthesiology 279364 279364 0 0
Pain management
Physical Medicine / Rehabilitation 279385 279385 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will receive a global pelvic manipulation (gpm) technique.

The patient will lie in lateral position. The therapist stands in front of the patient. The therapist will then flex the top leg until there is movement at the selected segment interspace (L5 fifth lumbar vertebrae -S1 first sacral segment) and place the patient's foot in the popliteal fossa of the bottom leg. Next the therapist grasps the patient's bottom shoulder and arm and introduces left trunk sidebending and right rotation until motion is felt at the selected interspace. This interspace will be controlled by therapist's both hands adding a small traction.
Finally the therapist will apply a high velocity, low amplitude thrust of the pelvis in an anterior direction.

the whole technique lasts for two minutes and will be performed just once. The technique is harmless and painless
Intervention code [1] 283723 0
Rehabilitation
Comparator / control treatment
the control group will be placed in a similar position but with no intended manipulation or thrust technique for the same estimated period of time.

A sham procedure will take place, so the technique will appear to happen, but with no real pressure
Control group
Placebo

Outcomes
Primary outcome [1] 285953 0
- To quantitatively assess the effect of global pelvic manipulation (GPM) on lumbo-pelvic self-perceived pain using VAS scores.
Timepoint [1] 285953 0
Before and After the intervention procedure
Secondary outcome [1] 294844 0
- To explore differences in Pressure pain threshold (PPT) in sacroiliac joints (SIJ) with an algometer (FXP 25, Wagner Instruments), predicting an improvent in mechanosensibility in at least a 10%
Timepoint [1] 294844 0
Before and After the intervention procedure
Secondary outcome [2] 294845 0
- To assess body's endogenous response to pain following a catecholamine and serotonin release. A blood test will be done to measure the catecholamine / serotonin levels with an expected variability of 15%
Timepoint [2] 294845 0
Before and After the intervention procedure

Eligibility
Key inclusion criteria
(i) age between 18 and 60 years old
(ii) regular menstruation intervals
(iii) willing to participate in the study
Minimum age
18 Years
Maximum age
60 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) to wear a intrauterine device (IUD)
(ii) to suffer from secondary dysmenorrhea
(iii) previous gynecologic surgeries
(iv) Any contraindication to a spinal manipulation technique
(v) to have received any kind of manipulative treatment in the two months prior to the inclusion in the study
(vi) to show any fear to blood test or manipulative techniques

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 phone

Subjects have been selected from one hundred clinical histories from one of the researcher's clinical practice. The subjects should have shown low back pain and medical diagnosis of primary dysmenorrhea.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer


(http://www.randomized.com/)
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
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3949 0
Spain
State/province [1] 3949 0

Funding & Sponsors
Funding source category [1] 284206 0
University
Name [1] 284206 0
Universidad de Sevilla
Address [1] 284206 0
Avicena s/n 41009 Sevilla (Spain)
Country [1] 284206 0
Spain
Primary sponsor type
University
Name
Universidad de Sevilla
Address
Avicena s/n 41009 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 269163 0
None
Name [1] 269163 0
Address [1] 269163 0
Country [1] 269163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286167 0
Comite Etico de Experimentacion de la Universidad de Sevilla
Ethics committee address [1] 286167 0
Paseo de las Delicias s/n 41013 Sevilla (Spain)
Ethics committee country [1] 286167 0
Spain
Date submitted for ethics approval [1] 286167 0
Approval date [1] 286167 0
27/10/2011
Ethics approval number [1] 286167 0
NONE

Summary
Brief summary
Primary dysmenorrhea (PD) is a gynecological disorder common in women of childbearing age. The premenstrual symptoms are the following: the most common is pain in the lower abdomen, followed by lumbo-pelvic pain together with other less frequent symptoms. Due to the high frequency of women suffering from PD, it could be considered as a problem of public health. With manipulative techniques we can deal with pain of visceral origin, so our hypothesis is to provide an objective view of how lumbo-pelvic pain improves after applying a manual therapy technique.

The main goal of the study is to quantitatively assess the effect of global pelvic manipulation technique on lumbar pain in patients with primary dysmenorrhea. The following parameters will be measured pre / post intervention in both, control and experimental groups, trough several parameters: (i) lumbo-pelvic pain using Visual Analogue Scale scores, (ii) the pressure pain threshold in sacroiliac joints and (iii) the body’s endogenous response to pain following a catecholamine and serotonin release.
Trial website
Trial related presentations / publications
Molins-Cubero, S., Rodriguez-Blanco, C., Oliva-Pascual-Vaca, A., Heredia-Rizo, A. M., Bosca-Gandia, J. J. and Ricard, F. (2014), Changes in Pain Perception after Pelvis Manipulation in Women with Primary Dysmenorrhea: A Randomized Controlled Trial. Pain Medicine. doi: 10.1111/pme.12404
Public notes

Contacts
Principal investigator
Name 33392 0
Dr Cleofas Rodriguez-Blanco
Address 33392 0
C/ Avicena s/n 41009, Sevilla, University of Sevilla
Country 33392 0
Spain
Phone 33392 0
(+34 954486528)
Fax 33392 0
Email 33392 0
cleofas@us.es
Contact person for public queries
Name 16639 0
Dr ALBERTO MARCOS HEREDIA RIZO
Address 16639 0
DEPARTMENT OF PHYSIOTHERAPY. FACULTY OF NURSING, PHYSIOTHERAPY AND PODIATRICS. UNIVERSIDAD DE SEVILLA

C/ Avicena s/n 41009 Sevilla
Country 16639 0
Spain
Phone 16639 0
(+34)687823894
Fax 16639 0
(+34)954486527
Email 16639 0
amheredia@us.es
Contact person for scientific queries
Name 7567 0
Dr ALBERTO MARCOS HEREDIA RIZO
Address 7567 0
Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatrics. Universidad de Sevilla

C/ Avicena s/n 41009 Sevilla
Country 7567 0
Spain
Phone 7567 0
(+34)687823894
Fax 7567 0
(+34)954486527
Email 7567 0
amheredia@us.es

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary