Multiple SclerosisNCT03213522
Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy
A study testing Pelvic Floor Physical Therapy and Craniosacral Therapy in people with Multiple Sclerosis and Bladder Dysfunction, run by CentraState Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of CST for the treatment of LUTS in patients with MS and evaluate the acute effects compared to PFPT. A. Objectives To examine the effect of CST as compared to PFPT on QOL, SEMG resting biofeedback readings, and PVR ultrasonography measures in patients with MS and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Bladder Dysfunction, Urinary Incontinence
- What is being tested?
- Pelvic Floor Physical Therapy and Craniosacral Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 9 Apr 2018
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Multiple Sclerosis
- Currently have the following symptoms for at least three (3) months or longer: frequent urination, increased urge to urinate, nighttime urination, loss/leakage of urine with or without activity, and/or problems emptying your bladder.
Who cannot join
- Unable or unwilling to give consent to be treated
- Unable or unwilling to cover your portion of physical therapy treatment (i.e. co-pays and/or deductibles)
- Cannot speak or read English
- Have NOT had any urinary symptoms for at least three (3) months
- Do not have Multiple Sclerosis; or have NOT been diagnosed with Multiple Sclerosis
- Take medication to treat your urinary symptoms; or have taken medication in the past three (3) months to treat your urinary symptoms
Show all 11Show fewer
- Use an indwelling catheter (i.e. tube inserted into your bladder for continuous urine drainage); or you require intermittent catheterization
- Currently are experiencing any of the following: shooting or radiating pain in your back or abdomen; pain that is not relieved with body position and/or medication; nausea; decreased appetite; pain with bowel movements or urination; and/or any symptom that is new and/or of unexplained onset (i.e. you do not know why it started or when it started)
- Currently have cancer/tumors (i.e. tumors in the spine, brain, pelvis, etc.) and/or aneurysms (i.e. abdominal aortic aneurysm)
- Received Botox injections in the past three (3) months
- Received Pelvic Floor Physical Therapy and/or Craniosacral Therapy in the past three (3) months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CentraState Medical Center
Freehold, New Jersey, 07728
Danielle T Robbins, DPT, 732-294-2700, drobbins@centrastate.com
Emily Bessemer, DPT, 7322942700, ebesseme@centrastate.com
About this study
Official title: A Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy for the Treatment of Lower Urinary Tract Dysfunction in People With Multiple Sclerosis: A Pilot Study
The purpose of this study is to determine the efficacy of CST for the treatment of LUTS in patients with MS and evaluate the acute effects compared to PFPT.
- Objectives To examine the effect of CST as compared to PFPT on QOL, SEMG resting biofeedback readings, and PVR ultrasonography measures in patients with MS and LUTS.
- Hypotheses / Research Question(s) It is hypothesized that patients who receive CST will demonstrate improved QOL, bladder control and ability to empty bladder as compared to those who receive PFPT.
Read the detailed description
The purpose of this study is to determine if Craniosacral Therapy is an effective therapy for treating bladder dysfunction in patients with Multiple Sclerosis (MS). It will be compared to standard care for the treatment of bladder dysfunction, which is Pelvic Floor Physical Therapy. Bladder dysfunctions are extremely common in patients with Multiple Sclerosis. One of the most common symptoms of bladder dysfunction is called over-active bladder. Over- active bladder can be described by increased urges to urinate and frequency of urination, especially at night. Other common symptoms are: leakage of urine, with or without activity; inability to hold urine; and a decreased ability to empty bladder when urinating.
- Being tested
- Pelvic Floor Physical Therapy, Craniosacral Therapy
- Medical subject headings
- Multiple Sclerosis, Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Physical TherapyProcedure or surgery
Also called Bladder training, Pelvic floor muscle training, Prompted voiding
Educating the PFPT group on therapeutic exercise, which includes, but not limited to, the pelvic brace, pelvic floor muscle exercise, and diaphragmatic breathing. If the patient is presenting with hypertonia of lower extremity muscles and/or muscles connecting to or part of the pelvic floor, the patient may be instructed on gentle static stretching and/or treated with passive stretching and diaphragmatic breathing.
Craniosacral TherapyProcedure or surgery
Also called Osteopathic manipulation, Visceral manipulation
Modified Upledger Institute 10-step protocol.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Physical Therapy | Active comparator | PFPT group will be treated/educated with/on therapeutic exercise, which includes, but not limited to, the pelvic brace, pelvic floor muscle exercise, and diaphragmatic breathing. If the patient is presenting with hypertonia of lower extremity muscles and/or muscles connecting to or part of the pelvic floor, the patient may be instructed on gentle static stretching and/or treated with passive stretching and diaphragmatic breathing. Receives: Procedure: Pelvic Floor Physical Therapy |
| CranioSacral Therapy | Active comparator | Modified Upledger Institute 10-step protocol. Sequence of hand placements (for this protocol)/type of intervention which will mirror many of the treatment sequences described in the systematic review by Jakel and von Hauenschild (2012). Receives: Procedure: Craniosacral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFDI-20
Pelvic floor distress inventory self-report questionnaire
Measured: Change from baseline PFDI-20 after six weeks of intervention
PFIQ-7
Pelvic floor incontinence questionnaire self-report
Measured: Change from baseline PFIQ-7 after six weeks of intervention
Secondary outcomes (9)
MSQOL-54
Multiple Sclerosis Quality of Life self-report questionnaire
Measured: Change from baseline MSQOL-54 after six weeks of intervention
Post void residual volume
PVR measurement
Measured: Change from baseline PVR after six weeks of intervention
Resting SEMG
surface electromyographic reading, resting only
Measured: Change from baseline Resting SEMG after six weeks of intervention
Systolic BP
blood pressure
Measured: Change from baseline Systolic BP after six weeks of intervention
Systolic BP
blood pressure
Measured: Change from pre-intervention to post-intervention at each of six intervention sessions
Diastolic BP
blood pressure
Measured: Change from baseline Diastolic BP after six weeks of intervention
Diastolic BP
blood pressure
Measured: Change from pre-intervention to post-intervention at each of six intervention sessions
Pulse
pulse
Measured: Change from pre-intervention to post-intervention at each of six intervention sessions
Pulse
pulse
Measured: Change from baseline Pulse after six weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start10 Apr 2017
- Primary completion9 Apr 2018 (estimated)
- Study completion9 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CentraState Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle T Robbins, DPT, Principal investigator, CentraState Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213522
- Sponsor's protocol ID
- CSMC 2016-14
- Status last verified
- Jul 2017
- First submitted
- 17 Apr 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy for the Treatment of Lower Urinary Tract Dysfunction in People With Multiple Sclerosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03213522
- Acronym / sponsor ID
- CSMC 2016-14
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CentraState Medical CenterUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 9 Apr 2018 (estimated)
- Study completion
- 9 Apr 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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 efficacy of CST for the treatment of LUTS in patients with MS and evaluate the acute effects compared to PFPT.
- Objectives To examine the effect of CST as compared to PFPT on QOL, SEMG resting biofeedback readings, and PVR ultrasonography measures in patients with MS and LUTS.
- Hypotheses / Research Question(s) It is hypothesized that patients who receive CST will demonstrate improved QOL, bladder control and ability to empty bladder as compared to those who receive PFPT.
Detailed description
The purpose of this study is to determine if Craniosacral Therapy is an effective therapy for treating bladder dysfunction in patients with Multiple Sclerosis (MS). It will be compared to standard care for the treatment of bladder dysfunction, which is Pelvic Floor Physical Therapy. Bladder dysfunctions are extremely common in patients with Multiple Sclerosis. One of the most common symptoms of bladder dysfunction is called over-active bladder. Over- active bladder can be described by increased urges to urinate and frequency of urination, especially at night. Other common symptoms are: leakage of urine, with or without activity; inability to hold urine; and a decreased ability to empty bladder when urinating.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Physical Therapy | Active comparator | Procedure: Pelvic Floor Physical TherapyPFPT group will be treated/educated with/on therapeutic exercise, which includes, but not limited to, the pelvic brace, pelvic floor muscle exercise, and diaphragmatic breathing. If the patient is presenting with hypertonia of lower extremity muscles and/or muscles connecting to or part of the pelvic floor, the patient may be instructed on gentle static stretching and/or treated with passive stretching and diaphragmatic breathing. |
| CranioSacral Therapy | Active comparator | Procedure: Craniosacral TherapyModified Upledger Institute 10-step protocol. Sequence of hand placements (for this protocol)/type of intervention which will mirror many of the treatment sequences described in the systematic review by Jakel and von Hauenschild (2012). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Multiple Sclerosis
- Currently have the following symptoms for at least three (3) months or longer: frequent urination, increased urge to urinate, nighttime urination, loss/leakage of urine with or without activity, and/or problems emptying your bladder.
Key exclusion criteria (11 listed)
- Unable or unwilling to give consent to be treated
- Unable or unwilling to cover your portion of physical therapy treatment (i.e. co-pays and/or deductibles)
- Cannot speak or read English
- Have NOT had any urinary symptoms for at least three (3) months
- Do not have Multiple Sclerosis; or have NOT been diagnosed with Multiple Sclerosis
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 |
|---|---|---|
| Pelvic Floor Physical TherapyAlso: Bladder training, Pelvic floor muscle training, Prompted voidingEducating the PFPT group on therapeutic exercise, which includes, but not limited to, the pelvic brace, pelvic floor muscle exercise, and diaphragmatic breathing. If the patient is presenting with hypertonia of lower extremity muscles and/or muscles connecting to or part of the pelvic floor, the patient may be instructed on gentle static stretching and/or treated with passive stretching and diaphragmatic breathing. | Procedure or surgery | Pelvic Floor Physical Therapy |
| Craniosacral TherapyAlso: Osteopathic manipulation, Visceral manipulationModified Upledger Institute 10-step protocol. | Procedure or surgery | CranioSacral Therapy |
Primary outcome
PFDI-20
Time frame: Change from baseline PFDI-20 after six weeks of intervention
Pelvic floor distress inventory self-report questionnaire
PFIQ-7
Time frame: Change from baseline PFIQ-7 after six weeks of intervention
Pelvic floor incontinence questionnaire self-report
9 secondary outcomes
MSQOL-54
Time frame: Change from baseline MSQOL-54 after six weeks of intervention
Post void residual volume
Time frame: Change from baseline PVR after six weeks of intervention
Resting SEMG
Time frame: Change from baseline Resting SEMG after six weeks of intervention
Systolic BP
Time frame: Change from baseline Systolic BP after six weeks of intervention
Systolic BP
Time frame: Change from pre-intervention to post-intervention at each of six intervention sessions
Diastolic BP
Time frame: Change from baseline Diastolic BP after six weeks of intervention
Diastolic BP
Time frame: Change from pre-intervention to post-intervention at each of six intervention sessions
Pulse
Time frame: Change from pre-intervention to post-intervention at each of six intervention sessions
Pulse
Time frame: Change from baseline Pulse after six weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Danielle T Robbins, DPT principal investigator
CentraState Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Physical Therapy and Craniosacral Therapy in people with Multiple Sclerosis and Bladder Dysfunction, run by CentraState Medical Center 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 2 inclusion and 11 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 11 Jul 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Danielle T Robbins, DPT (7322942700, drobbins@centrastate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFDI-20 (time frame: Change from baseline PFDI-20 after six weeks of intervention). The study lists 2 primary outcomes in all. 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 11 Jul 2017.