Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00740818 |
| Other study ID # |
SR1120070131 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
August 21, 2008 |
| Last updated |
August 22, 2008 |
| Start date |
July 2008 |
| Est. completion date |
November 2008 |
Study information
| Verified date |
August 2008 |
| Source |
Logan College of Chiropractic |
| Contact |
Patrick Montgomery, DC |
| Phone |
636-230-2100 |
| Email |
patrick.montgomery[@]logan.edu |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine the effects of Logan Basic Technique on symptoms
of dysmenorrhea.
Description:
Dysmenorrhea, also known in the public realm as the dreaded painful period, is a common
condition plaguing millions of women. The familiar symptoms of dysmenorrhea include but are
not limited to muscle cramping of the lower abdominal muscles, mood swings, breast
tenderness, and heavy flow just to name a few. These common complaints can range from a
minor annoyance to debilitating. The allopathic model of medicine has offered up several
solutions to this problem most women face during their reproductive phase of life. However,
even with these options for menstrual discomfort relief, the problem still remains in
overwhelming numbers. The rationale of this study is to possibly provide another safer and
more effective treatment using protocols of chiropractic medicine.
According to Merck, dysmenorrhea is simplified as pelvic pain during menses. This condition
can also be broken down into two forms-primary dysmenorrhea and secondary dysmenorrhea.
Primary dysmenorrhea tends to begin in adolescence with the onset of menses. This form is
attributed to histological and hormonal changes to the female reproductive system. The
symptoms tend to subside with age and pregnancy. Secondary dysmenorrhea is seen to develop
in the adult female and is linked to structural anomalies of the pelvic region. Although
both of these cause discomfort to several women, the main focus of this study is on
treatment of primary dysmenorrhea as treatment of the secondary form involves addressing the
underlying structural dysfunction causing the symptoms. This is out of the scope of this
study.
Medical treatment of dysmenorrhea involves a few different facets. The first approach is to
treat the symptoms of dysmenorrhea with the use of analgesics which is usually the most
popular and convenient option. These medications are over-the-counter and are often
effective treatment in mild cases. Another option commonly pursued in the medical realm is
addressing the hormonal imbalances involved in symptomatology. This is done by prescribing
the use of low dose oral contraceptives. This treatment is popular as it provides a
convenient preventative measure for pregnancy in addition to symptom relief in some cases.
Surgery, an extreme and last resort, involves anywhere from partial to a complete
hysterectomy. With partial hysterectomies, there is a higher risk that symptoms will still
be present following surgery. However, following a full hysterectomy the patient is subject
to the adverse effects of post menopause including but not limited to increased bone loss.
Although effective in the treatment of dysmenorrhea, the medical options can produce adverse
effects on the body. Chiropractic treatment offers a mode of care with limited risks and
many benefits to the patient. It is the goal of this study to aid in the support of this
statement. It has been documented that spinal manipulation using Flexion-Distraction
technique combined with Manual Trigger Point therapy has positive results with short-term
relief of symptomatology and disability related to chronic pelvic pain syndrome, which is
defined as noncyclic pain in the pelvis lasting longer than three months. Although this
condition is separate from dysmenorrhea it can provide some insight into symptomatology
affecting this region. The Toftness system has also demonstrated significant improvement in
subjects suffering from primary dysmenorrhea when compared to those subjects receiving sham
adjustments. Gauntt demonstrated the benefits of Logan Basic Technique and Soft Tissue
Manipulation in decreasing the symptoms of painful periods. The combination of these
treatments establishes "great promise" in intervention of dysmenorrhea. The goal of this new
study is to build on Gauntt's work by possibly duplicating these results. This study also
aims to explore the efficacy of utilizing auxiliary abdominal contacts in addition to the
Logan Basic Protocols.
Logan Basic Methods of adjusting addresses the correction of the base of the spine, the
sacrum. By contacting the sacrotuberous ligament on the side of the anteriorly and
inferiorly misaligned sacrum, the doctor corrects the said misalignment to help restore
proper function to the affected sacroiliac joint. Furthermore, correction of the foundation
of the spine, according to Logan Basic Methods, restores optimum function to the entire
spine. To increase the efficacy of this procedure, known as the apex contact, one can also
utilize auxiliary contacts. Auxiliary contacts are administered during the apex contact.
Specifically, auxiliary abdominal contacts address hollow organ spasms. This may be
beneficial in addressing the uterine muscle spasms commonly associated with menses.
Logan Basic encompasses a low force adjusting protocol which can be helpful in treatment of
all types of patients. This technique is essentially safe for everyone with no known
contraindications. However, with any adjusting technique there are adverse reactions to
treatment, although usually minor. Patients can experience increased perspiration with their
first few adjustments. Following adjustments, the patient can experience pain associated
with muscle soreness, which can be treated with the use of cold compresses for twenty
minutes on then twenty minutes off for the first 48 hours after treatment. Muscle soreness
usually subsides within a day or two and its occurrence decreases with subsequent
treatments. Some patients may experience a toxic reaction to treatment that is described as
nausea and/or vomiting. This occurs in individuals with increased exposure to drugs and/or a
poor diet. However, it is believed that though this reaction has occurred, these patients
were in need of this intervention to eliminate toxins from the body.
For this study, a menstrual distress questionnaire will be utilized to objectively analyze
subjective complaints of subjects in this study. This method of analyzing symptoms has been
used in past studies including Snyder's study on the Toftness system and dysmenorrhea as
well as in Gauntt's study on Logan Basic, Soft Tissue Manipulation, and dysmenorrhea. Moos
provides an overview of the utilization of this questionnaire. It has been shown to be quite
useful in studies with menstrual distress.
Through the exploration of Logan Basic Methods and auxiliary abdominal contacts in the
treatment of dysmenorrhea, it is the hope of the investigators to provide some insight into
this common condition affecting and disabling women. This investigation aims to build on
previous studies showing the efficacy of chiropractic care in the treatment of menstrual
distress. Through investigation of primary dysmenorrhea, this study can hopefully assist in
opening the scientific community as well as the females of the current society to safer
options in treatment of this common condition.
