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Trial registered on ANZCTR


Registration number
ACTRN12616000170426
Ethics application status
Approved
Date submitted
7/01/2016
Date registered
10/02/2016
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Dry needling in myofascial trigger points of rectus abdominis for the treatment of pain in primary dysmenorrhoea
Scientific title
Dry needling in myofascial trigger points of rectus abdominis for the treatment of pain in primary dysmenorrhoea
Secondary ID [1] 288257 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary dysmenorrhea 297201 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297412 297412 0 0
Physiotherapy
Reproductive Health and Childbirth 297413 297413 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three groups of 15 people each one: intervention, control and placebo control.
0.25mm thickness and 40 or 50mm length needle depending on the anatomical characteristics of each patient will be introduced. Placed the patient in supine position, the needle is inserted horizontally into the lateral edge of the rectus abdominis, burying the part of the abdominal wall that is next to the rectus sheath. Once the first local twitch response appears, the needle will be handled with longitudinal movements of 2 to 3mm, without rotation, at approximately 1Hz for 25-30 seconds. Only one needle will be inserted.
This technique is applied by a physiotherapist only once, taking place two weeks before menstruation.
All groups will perform stretching exercises at home. Cuadratus lumborum and rectus abdominis will be stretched for 30-60 seconds each one three times a day until three months after the intervention..
There are not strategies to monitor adherence to exercises.
Intervention code [1] 293548 0
Treatment: Other
Comparator / control treatment
There are two control groups: placebo control and control.
People in control group will only complete the paper with questions about pain and medication and SF-36 questionnaire.
For placebo group, a false needle whose mechanism is identical to the Streitberger needle is used, but without base.
To counter this lack of base we´ll use the fingers that we take on the patient's skin to hold the needle while the other hand manipulate the handle after applying pressure to the skin with the help of the guide tube, but without entering the needle. The placebo needles give a mechanical feeling to the tissue without perforating the skin. The patient will feel pressure in the area, but will not know if it has been punctured or not.
Control group
Placebo

Outcomes
Primary outcome [1] 296968 0
Dysmenorrhea pain in lower abdomen will be assessed by VAS
Timepoint [1] 296968 0
Two times: First one month after intervention Second two months after intervention
Primary outcome [2] 296969 0
Quality of life will be assessed by SF-36 questionnaire
Timepoint [2] 296969 0
Two times: First one month after intervention Second two months after intervention
Secondary outcome [1] 319783 0
Dysmenorrhea pain duration (days) in lower abdomen assessed by subjetive patient data
Timepoint [1] 319783 0
Two times: First one month after intervention Second two months after intervention
Secondary outcome [2] 319784 0
Analgesic medication used to decrease the studied pain assessed by patient data (number of tablets)
Timepoint [2] 319784 0
Two times: First one month after intervention Second two months after intervention

Eligibility
Key inclusion criteria
To participate in the study, women must suffer primary dysmenorrhoea diagnosed by a doctor. The pain should be moderate or severe calculated by the visual analog scale (VAS): moderate pain which is greater than 3, and severe when excedd 7.
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who suffer from secondary dysmenorrhoea or having signs to suffer it, women that have been mothers or have suffered abortion or women who suffer fear of needles are not included in the study

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/02/2016
Date of last participant enrolment
Anticipated
29/02/2016
Actual
11/04/2016
Date of last data collection
Anticipated
Actual
5/10/2016
Sample size
Target
45
Accrual to date
Final
51
Recruitment outside Australia
Country [1] 7501 0
Spain
State/province [1] 7501 0
Madrid

Funding & Sponsors
Funding source category [1] 292642 0
University
Name [1] 292642 0
Universidad Alcala de Henares
Country [1] 292642 0
Spain
Primary sponsor type
Individual
Name
Alberto Gaubeca
Address
Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid
Country
Spain
Secondary sponsor category [1] 291358 0
None
Name [1] 291358 0
None
Address [1] 291358 0
None
Country [1] 291358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294118 0
Comite de etica de la investigacion y de experimentacion animal de la Universidad de Alcala
Ethics committee address [1] 294118 0
Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid
Ethics committee country [1] 294118 0
Spain
Date submitted for ethics approval [1] 294118 0
26/06/2015
Approval date [1] 294118 0
23/11/2015
Ethics approval number [1] 294118 0
CEIM/HU/2015/22

Summary
Brief summary
The aim of this pilot study is to quantify the effectiveness of the dry needling technique of myofascial trigger points in the abdominal wall along with performing a stretching program for the treatment of pain in young women or adolescents with primary dysmenorrhoea.
In this randomized clinical trial (RCT), the treatment with dry needling is compared with the results obtained by administering a placebo puncture in another group of patients and with the normal pain development in another one group. Patients will be randomly assigned to the experimental, placebo and control groups, so that groups will be parallel, similar in characteristics, known prognostic factors, other treatments received, etc., except for the intervention they receive.
The target population will consist of women between 18 and 25 years, residing in Madrid and diagnosed primary dysmenorrhoea by a doctor. To participate in the study, women must undergo primary dysmenorrhea moderate or severe level the score calculated by the visual analog scale (VAS)
We will measure: VAS, medication and SF-36 questionnaire.
Three groups of 15 women each one: treatment, placebo and control.
Dry needling in the treatment group will be apply in the active trigger points of rectus abdominis muscle. In the case of performing the placebo treatment, a false needle whose mechanism is identical to the needle Streitberger be used, but without base. In both groups it will take place two weeks before menstruation. In the control group only they have to fill the data being measured. All women should do stretching exercises at home.
The reassessment will be performed a month and at 3 months after intervention.
Our hypothesis is that the performance of the technique of deep dry needling deep in active myofascial trigger points of the rectus abdominis muscle along with the completion of a program of stretching reduces pain in patients with primary dysmenorrhoea.
H0: pre-puncture pain is equal to post-puncture pain
H1: pre-puncture pain is greater than post-puncture pain
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62542 0
Mr Alberto Gaubeca Gilarranz
Address 62542 0
Universidad de Alcala (Madrid)
Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid
Country 62542 0
Spain
Phone 62542 0
+34 637717252
Fax 62542 0
Email 62542 0
[email protected]
Contact person for public queries
Name 62543 0
Alberto Gaubeca Gilarranz
Address 62543 0
Universidad de Alcala (Madrid)
Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid
Country 62543 0
Spain
Phone 62543 0
+34 637717252
Fax 62543 0
Email 62543 0
[email protected]
Contact person for scientific queries
Name 62544 0
Alberto Gaubeca Gilarranz
Address 62544 0
Universidad de Alcala (Madrid)
Plaza de San Diego, s/n, 28801 Alcala de Henares, Madrid
Country 62544 0
Spain
Phone 62544 0
+34 637717252
Fax 62544 0
Email 62544 0
[email protected]

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