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Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

Primary Purpose

Multiple Sclerosis, Bladder Dysfunction, Urinary Incontinence

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pelvic Floor Physical Therapy

Craniosacral Therapy

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CentraState Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Pelvic Floor Physical Therapy

CranioSacral Therapy

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

PFDI-20

Pelvic floor distress inventory self-report questionnaire

PFIQ-7

Pelvic floor incontinence questionnaire self-report

Secondary Outcome Measures

MSQOL-54

Multiple Sclerosis Quality of Life self-report questionnaire

Post void residual volume

PVR measurement

Resting SEMG

surface electromyographic reading, resting only

Systolic BP

blood pressure

Systolic BP

blood pressure

Diastolic BP

blood pressure

Diastolic BP

blood pressure

Pulse

pulse

Pulse

pulse

Full Information

NCT ID

NCT03213522

First Posted

April 17, 2017

Last Updated

July 7, 2017

Sponsor

CentraState Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03213522

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 10, 2017 (Actual)

Primary Completion Date

April 9, 2018 (Anticipated)

Study Completion Date

April 9, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CentraState Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Bladder Dysfunction, Urinary Incontinence, Overactive Bladder

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pelvic Floor Physical Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

CranioSacral Therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Pelvic Floor Physical Therapy

Other Intervention Name(s)

Bladder training, Pelvic floor muscle training, Prompted voiding

Intervention Description

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

Intervention Name(s)

Craniosacral Therapy

Other Intervention Name(s)

Osteopathic manipulation, Visceral manipulation

Intervention Description

Modified Upledger Institute 10-step protocol.

Primary Outcome Measure Information:

Title

PFDI-20

Description

Pelvic floor distress inventory self-report questionnaire

Time Frame

Change from baseline PFDI-20 after six weeks of intervention

Title

PFIQ-7

Description

Pelvic floor incontinence questionnaire self-report

Time Frame

Change from baseline PFIQ-7 after six weeks of intervention

Secondary Outcome Measure Information:

Title

MSQOL-54

Description

Multiple Sclerosis Quality of Life self-report questionnaire

Time Frame

Change from baseline MSQOL-54 after six weeks of intervention

Title

Post void residual volume

Description

PVR measurement

Time Frame

Change from baseline PVR after six weeks of intervention

Title

Resting SEMG

Description

surface electromyographic reading, resting only

Time Frame

Change from baseline Resting SEMG after six weeks of intervention

Title

Systolic BP

Description

blood pressure

Time Frame

Change from baseline Systolic BP after six weeks of intervention

Title

Systolic BP

Description

blood pressure

Time Frame

Change from pre-intervention to post-intervention at each of six intervention sessions

Title

Diastolic BP

Description

blood pressure

Time Frame

Change from baseline Diastolic BP after six weeks of intervention

Title

Diastolic BP

Description

blood pressure

Time Frame

Change from pre-intervention to post-intervention at each of six intervention sessions

Title

Pulse

Description

pulse

Time Frame

Change from pre-intervention to post-intervention at each of six intervention sessions

Title

Pulse

Description

pulse

Time Frame

Change from baseline Pulse after six weeks of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Danielle T Robbins, DPT

Phone

7322942700

drobbins@centrastate.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danielle T Robbins, DPT

Organizational Affiliation

CentraState Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

CentraState Medical Center

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danielle T Robbins, DPT

Phone

732-294-2700

drobbins@centrastate.com

First Name & Middle Initial & Last Name & Degree

Emily Bessemer, DPT

Phone

7322942700

ebesseme@centrastate.com

First Name & Middle Initial & Last Name & Degree

Danielle T Robbins, DPT

First Name & Middle Initial & Last Name & Degree

Emily Bessemer, DPT

First Name & Middle Initial & Last Name & Degree

Deborah Pearce, DPT

First Name & Middle Initial & Last Name & Degree

Ilyasah Byfield, MSN

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

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