Immediate effect of a global pelvic manipulation technique on lumbar pain in patients with primary dysmenorrhea: a randomized controlled trial

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001195943

Enrollment

Registered

2011-11-18

Start date

2011-11-02

Completion date

2012-09-18

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

(i) age between 18 and 60 years old (ii) regular menstruation intervals (iii) willing to participate in the study

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

Outcome results