Clinical trial NCT03213522: Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Bladder Dysfunction
Urinary Incontinence
Overactive Bladder
Lead sponsor: CentraState Medical Center
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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

Primary outcomes:
measure: PFDI-20
timeFrame: Change from baseline PFDI-20 after six weeks of intervention
measure: PFIQ-7
timeFrame: Change from baseline PFIQ-7 after six weeks of intervention
Secondary outcomes:
measure: MSQOL-54
timeFrame: Change from baseline MSQOL-54 after six weeks of intervention
measure: Post void residual volume
timeFrame: Change from baseline PVR after six weeks of intervention
measure: Resting SEMG
timeFrame: Change from baseline Resting SEMG after six weeks of intervention
measure: Systolic BP
timeFrame: Change from baseline Systolic BP after six weeks of intervention
measure: Systolic BP
timeFrame: Change from pre-intervention to post-intervention at each of six intervention sessions
measure: Diastolic BP
timeFrame: Change from baseline Diastolic BP after six weeks of intervention
measure: Diastolic BP
timeFrame: Change from pre-intervention to post-intervention at each of six intervention sessions
measure: Pulse
timeFrame: Change from pre-intervention to post-intervention at each of six intervention sessions
measure: Pulse
timeFrame: Change from baseline Pulse after six weeks of intervention
Other outcomes:
Locations:
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
Study officials:
affiliation: CentraState Medical Center
name: Danielle T Robbins, DPT
role: PRINCIPAL_INVESTIGATOR
References: