Multiple Sclerosis Clinical Trial

Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

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 LUTS.

B. 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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

30

Study ID:

NCT03213522

Recruitment Status:

Unknown status

Sponsor:

CentraState Medical Center

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There is 1 Location for this study

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CentraState Medical Center
Freehold New Jersey, 07728, United States More Info
Danielle T Robbins, DPT
Contact
732-294-2700
[email protected]
Emily Bessemer, DPT
Contact
7322942700
[email protected]
Danielle T Robbins, DPT
Principal Investigator
Emily Bessemer, DPT
Sub-Investigator
Deborah Pearce, DPT
Sub-Investigator
Ilyasah Byfield, MSN
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

30

Study ID:

NCT03213522

Recruitment Status:

Unknown status

Sponsor:


CentraState Medical Center

How clear is this clinincal trial information?

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