Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

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.

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Overactive Bladder; Urinary Incontinence; Bladder Dysfunction
• Intervention / Treatment: Procedure: Pelvic Floor Physical Therapy; Procedure: Craniosacral Therapy

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Recruiting
      • CentraState Medical Center
      • Contact: Danielle T Robbins, DPT; Phone Number: 732-294-2700; Email: drobbins@centrastate.com
      • Contact: Emily Bessemer, DPT; Phone Number: 7322942700; Email: ebesseme@centrastate.com
      • Principal Investigator: Danielle T Robbins, DPT
      • Sub-Investigator: Emily Bessemer, DPT
      • Sub-Investigator: Deborah Pearce, DPT
      • Sub-Investigator: Ilyasah Byfield, MSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: Pelvic floor muscle training; Bladder training; Prompted voiding
Active Comparator: 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).	Procedure: Craniosacral Therapy; Modified Upledger Institute 10-step protocol.; Other Names: Osteopathic manipulation; Visceral manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFDI-20	Pelvic floor distress inventory self-report questionnaire	Change from baseline PFDI-20 after six weeks of intervention
PFIQ-7	Pelvic floor incontinence questionnaire self-report	Change from baseline PFIQ-7 after six weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSQOL-54	Multiple Sclerosis Quality of Life self-report questionnaire	Change from baseline MSQOL-54 after six weeks of intervention
Post void residual volume	PVR measurement	Change from baseline PVR after six weeks of intervention
Resting SEMG	surface electromyographic reading, resting only	Change from baseline Resting SEMG after six weeks of intervention
Systolic BP	blood pressure	Change from baseline Systolic BP after six weeks of intervention
Systolic BP	blood pressure	Change from pre-intervention to post-intervention at each of six intervention sessions
Diastolic BP	blood pressure	Change from baseline Diastolic BP after six weeks of intervention
Diastolic BP	blood pressure	Change from pre-intervention to post-intervention at each of six intervention sessions
Pulse	pulse	Change from pre-intervention to post-intervention at each of six intervention sessions
Pulse	pulse	Change from baseline Pulse after six weeks of intervention

Collaborators and Investigators

• Sponsor: CentraState Medical Center
• Investigators: Principal Investigator: Danielle T Robbins, DPT, CentraState Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Anticipated): April 9, 2018
• Study Completion (Anticipated): April 9, 2018

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Multiple Sclerosis; Sclerosis; Urinary Bladder, Overactive; Urinary Incontinence
• Other Study ID Numbers: CSMC 2016-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No