Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2018-04-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Multiple Sclerosis Bladder Dysfunction Urinary Incontinence Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pelvic Floor Physical Therapy

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.

Group Type ACTIVE_COMPARATOR

Pelvic Floor Physical Therapy

Intervention Type PROCEDURE

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 Therapy

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).

Group Type ACTIVE_COMPARATOR

Craniosacral Therapy

Intervention Type PROCEDURE

Modified Upledger Institute 10-step protocol.

Interventions

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Pelvic Floor Physical Therapy

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.

Intervention Type PROCEDURE

Craniosacral Therapy

Modified Upledger Institute 10-step protocol.

Intervention Type PROCEDURE

Other Intervention Names

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Bladder training Pelvic floor muscle training Prompted voiding Osteopathic manipulation Visceral manipulation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No