Menstrual Distress (Dysmenorrhea)Phase 2NCT00740818
Logan Basic and Dysmenorrhea
A Phase 2 study testing Logan Basic adjustment in people with Menstrual Distress (Dysmenorrhea), run by Logan College of Chiropractic at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of Logan Basic Technique on symptoms of dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menstrual Distress (Dysmenorrhea)
- What is being tested?
- Logan Basic adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Logan students, staff, or faculty
- Minimum of 18 years
- No chiropractic adjustments below T12 throughout the duration of the study
- Suffering from primary dysmenorrhea
Who cannot join
- Pregnancy
- Endometriosis (if known to have)
- Reproductive cancer of any kind
- NSAIDs and/or any other medical or herbal treatments for symptoms of dysmenorrhea. Oral contraception use for this purpose will not be excluded from the study; however, usage will be noted in the final reporting of this study's results.
- Menopause
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan University, College of Chiropractic
Chesterfield, Missouri, 63017
About this study
Official title: A Pilot Study: Logan Basic Technique and Auxiliary Abdominal Contacts for Reducing Symptomatology of Primary Dysmenorrhea
The purpose of this study is to determine the effects of Logan Basic Technique on symptoms of dysmenorrhea.
Read the detailed 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.
- Conditions
- Menstrual Distress (Dysmenorrhea)
- Being tested
- No Intervention, Sham Logan Basic Adjustment, Logan Basic adjustment
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
The patient will lay prone on the adjustment table 5 minutes, the approximate equivalency of a Logan Basic adjustment. Table will be in proper position according to Logan Basic protocol.
Sham Logan Basic AdjustmentProcedure or surgery
A thumb contact will be used against the sacrotuberous ligament as opposed to underneath the ligament. Auxiliary contacts will also be sham adjustments; the spine will be contacted but no force applied.
Logan Basic adjustmentProcedure or surgery
Logan Basic adjustment, as well as auxiliary and abdominal contacts, based on the Logan Basic protocol.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | The patient will lay prone on the adjustment table 5 minutes, the approximate equivalency of a Logan Basic adjustment. Table will be in proper position according to Logan Basic protocol. Receives: Other: No Intervention |
| B | Sham comparator | A thumb contact will be used against the sacrotuberous ligament as opposed to underneath the ligament. Auxiliary contacts will also be sham adjustments; the spine will be contacted but no force applied. Receives: Procedure: Sham Logan Basic Adjustment |
| C | Experimental | Logan Basic adjustment, as well as auxiliary and abdominal contacts, based on the Logan Basic protocol. Receives: Procedure: Logan Basic adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Distress Questionnaire
Measured: Before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Distress (Dysmenorrhea)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740818
- Sponsor's protocol ID
- SR1120070131
- Status last verified
- Aug 2008
- First submitted
- 21 Aug 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Logan Basic Technique and Auxiliary Abdominal Contacts for Reducing Symptomatology of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00740818
- Acronym / sponsor ID
- SR1120070131
- Conditions
- Menstrual Distress (Dysmenorrhea)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of Logan Basic Technique on symptoms of dysmenorrhea.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | Other: No InterventionThe patient will lay prone on the adjustment table 5 minutes, the approximate equivalency of a Logan Basic adjustment. Table will be in proper position according to Logan Basic protocol. |
| B | Sham comparator | Procedure: Sham Logan Basic AdjustmentA thumb contact will be used against the sacrotuberous ligament as opposed to underneath the ligament. Auxiliary contacts will also be sham adjustments; the spine will be contacted but no force applied. |
| C | Experimental | Procedure: Logan Basic adjustmentLogan Basic adjustment, as well as auxiliary and abdominal contacts, based on the Logan Basic protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female Logan students, staff, or faculty
- Minimum of 18 years
- No chiropractic adjustments below T12 throughout the duration of the study
- Suffering from primary dysmenorrhea
Key exclusion criteria (5 listed)
- Pregnancy
- Endometriosis (if known to have)
- Reproductive cancer of any kind
- NSAIDs and/or any other medical or herbal treatments for symptoms of dysmenorrhea. Oral contraception use for this purpose will not be excluded from the study; however, usage will be noted in the final reporting of this study's results.
- Menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThe patient will lay prone on the adjustment table 5 minutes, the approximate equivalency of a Logan Basic adjustment. Table will be in proper position according to Logan Basic protocol. | Other | A |
| Sham Logan Basic AdjustmentA thumb contact will be used against the sacrotuberous ligament as opposed to underneath the ligament. Auxiliary contacts will also be sham adjustments; the spine will be contacted but no force applied. | Procedure or surgery | B |
| Logan Basic adjustmentLogan Basic adjustment, as well as auxiliary and abdominal contacts, based on the Logan Basic protocol. | Procedure or surgery | C |
Primary outcome
Menstrual Distress Questionnaire
Time frame: Before and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
Related trials for Menstrual Distress (Dysmenorrhea)
Not yet recruiting
Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement
Primary Dysmenorrhea (PD)
RecruitingObservational study
Menstrual Cycle Symptoms and Female Health
Menstrual Cycle, Menstrual Distress (Dysmenorrhea)
Recruiting
Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms
Premenstrual Syndrome, Menstrual Cycle
Active, not recruitingObservational study
Menstrual Complaints in Adolescents and Adults
Dysmenorrhea, Heavy Menstrual Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Logan Basic adjustment in people with Menstrual Distress (Dysmenorrhea), run by Logan College of Chiropractic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Montgomery, DC (636-230-2100 ext. 1931, patrick.montgomery@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Distress Questionnaire (time frame: Before and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.