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Trial registered on ANZCTR


Registration number
ACTRN12616001481460
Ethics application status
Approved
Date submitted
28/07/2016
Date registered
24/10/2016
Date last updated
24/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of physiotherapy intervention in symptoms of dysmenorrhea.
Scientific title
Impact of physiotherapy intervention in symptoms of dysmenorrhea.
Secondary ID [1] 289786 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysmenorrhea. 299683 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299619 299619 0 0
Physiotherapy
Reproductive Health and Childbirth 300197 300197 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suboccipital inhibition technique: Subject supine, physiotherapist sitting at the bedside with his elbows on the surface of the table. The physiotherapist places both hands below the patient’s occipital with his palms facing up. The occipital is placed first on the palms of the hands and the fingers take on a position at right angles so that clearly pointing anteriorly for 5 minutes of pressure. The fingertips touch the bottom edge of the occipital.
3 sessions will be performed, respectively on the 7th, 14th and 21st day of the menstruation. Participants will receive two cycles of treatment
Intervention code [1] 295453 0
Treatment: Other
Comparator / control treatment
Uterus’ external manipulation technique: Subject supine with the lower limb triple flexion, physiotherapist standing next to the patient. The physiotherapist hand picks patient’s knees and puts hand head above patient’s lower abdominal area, taking with thumb and index finger ends uterus’ fundal. The technique involves slow exert transverse movements to mobilize and slide the uterus and its fascia, for a time of 3 minutes per fundal. In while moving toward the opposite side the lower limbs of the patient to be able to reach all the ROM.
3 sessions will be performed, respectively on the 7th, 14th and 21st day of the menstruation. Participants will receive two cycles of treatment
Control group
Active

Outcomes
Primary outcome [1] 299091 0
Determine the impact of physical therapy in improving the symptoms of dysmenorrhea by subjective symptoms (Lattinen Index), using an inhibition suboccipital technique and an external manipulation of uterus. Lattinen Index is an instrument of measurement widely used in the area of the treatment and investigation of the chronic pain. We used also the Lattinen scale composed of 5 categories: pain intensity, patient activity, pain frequency, use of analgesics, and hours of sleep. Each category comprises 5 items scored from 0 (better) to 5 (worse). Maximum score of the Lattinen scale is 20; a decrease in score indicates an improvement in patient status. Pain alleviation scores on the scale of 0 to 4 were: 0 (no alleviation), 1 (slight alleviation), 2 (moderate alleviation), 3 (considerable alleviation), 4 (complete alleviation).
Timepoint [1] 299091 0
Pre-treatment, last day of treatment and first two days of menstruation
Primary outcome [2] 299682 0
Determine the impact of physical therapy in improving the symptoms of dysmenorrhea by the pain related to the vertebral pressure on the uterine innervation’s trigger points by algometer, using an inhibition suboccipital technique and an external manipulation of uterus.
Timepoint [2] 299682 0
Pre-treatment, last day of treatment and first two days of menstruation
Secondary outcome [1] 326119 0
Determine the impact of physical therapy in improving the symptoms of dysmenorrhea by pain location with a graphic, using an inhibition suboccipital technique and an external manipulation of uterus.
Timepoint [1] 326119 0
Pre-treatment, last day of treatment and first two days of menstruation
Secondary outcome [2] 327843 0
Determine the impact of physical therapy in improving the symptoms of dysmenorrhea by the index scale of pain, using an inhibition suboccipital technique and an external manipulation of uterus.
Timepoint [2] 327843 0
Pre-treatment, last day of treatment and first two days of menstruation

Eligibility
Key inclusion criteria
Inclusion criteria will be nulliparous women aged between 18 to 35, with dysmenorrhea for at least 3 months, BMI <30, informed consent signed.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects presenting the following could not participate in the study:
(i) Previous surgery in the lumbar-pelvic area. (ii) Previous serious injuries (<3 months). (iii) Cervical arthrosis / instability of the cervical ligament. (iv) Vertebrobasilar artery syndrome. (v) physiotherapy-osteopathic pretreatment (<1 month). (vi) IUD use. (vii) Thyroid problems. (viii) Infection and inflammation in acute stage.

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)
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
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 8058 0
Spain
State/province [1] 8058 0
Madrid

Funding & Sponsors
Funding source category [1] 294169 0
University
Name [1] 294169 0
University Camilo Jose Cela
Country [1] 294169 0
Spain
Primary sponsor type
University
Name
University Camilo Jose Cela
Address
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country
Spain
Secondary sponsor category [1] 293001 0
None
Name [1] 293001 0
Address [1] 293001 0
Country [1] 293001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295576 0
Camilo Jose Cela University
Ethics committee address [1] 295576 0
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Ethics committee country [1] 295576 0
Spain
Date submitted for ethics approval [1] 295576 0
22/06/2016
Approval date [1] 295576 0
26/07/2016
Ethics approval number [1] 295576 0

Summary
Brief summary
Dysmenorrhoea is defined as the presence of pain during the menstrual cycle. The objective of our study will be to determine the impact of physical therapy on the improvement of this condition, using a suboccipital inhibition technique and an external manipulation of the uterus. We’ll enrol patients aged between 18-35 years old, nulliparous and presented with dysmenorrhoea. We`ll divide them into two groups: group 1 received the suboccipital inhibition technique and group 2 an external manipulation of the uterus. Three sessions were performed, respectively on the 7th, 14th and 21st day of the menstruation. The outcomes will be evaluated before and after the intervention and collected in the first two days of menstruation. The variables analysed will be: the subjective symptoms, the pain location, the Lattinen test, the index scale of pain and the pain related to the vertebral pressure on the uterine innervation’s trigger points. 12 patients will receive two cycles of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67814 0
Miss Sara Fiscon
Address 67814 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 67814 0
Spain
Phone 67814 0
+39 3383074797
Fax 67814 0
Email 67814 0
[email protected]
Contact person for public queries
Name 67815 0
Dr ELENA RODRIGUEZ LOPEZ
Address 67815 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 67815 0
Spain
Phone 67815 0
+34679336394
Fax 67815 0
Email 67815 0
[email protected]
Contact person for scientific queries
Name 67816 0
Dr ELENA RODRIGUEZ LOPEZ
Address 67816 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country 67816 0
Spain
Phone 67816 0
+34679336394
Fax 67816 0
Email 67816 0
[email protected]

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