Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

Not Applicable

• Conditions: Overactive Bladder; Multiple Sclerosis; Bladder Dysfunction; Urinary Incontinence
• Interventions: Procedure: Pelvic Floor Physical Therapy; Procedure: Craniosacral Therapy

• Registration Number: NCT03213522
• Lead Sponsor: CentraState Medical Center

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.

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-04-17
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-07
• Last Update Submitted: 2017-07-07
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Physical Therapy	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.
CranioSacral Therapy	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).

Primary Outcome Measures

Name	Time	Method
PFDI-20	Change from baseline PFDI-20 after six weeks of intervention	Pelvic floor distress inventory self-report questionnaire
PFIQ-7	Change from baseline PFIQ-7 after six weeks of intervention	Pelvic floor incontinence questionnaire self-report

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CentraState Medical Center; 🇺🇸 Freehold, New Jersey, United States