Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03213522
• Other study ID #: CSMC 2016-14
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2017
• Last updated: July 7, 2017
• Start date: April 10, 2017
• Est. completion date: April 9, 2018

Study information

• Verified date: July 2017
• Source: CentraState Medical Center
• Contact: Danielle T Robbins, DPT
• Phone: 7322942700
• Email: drobbins[@]centrastate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Dysfunction
• Enuresis
• Multiple Sclerosis
• Overactive Bladder
• Sclerosis
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

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.
• Craniosacral Therapy
Modified Upledger Institute 10-step protocol.

Locations

Country	Name	City	State
United States	CentraState Medical Center	Freehold	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
CentraState Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFDI-20	Pelvic floor distress inventory self-report questionnaire	Change from baseline PFDI-20 after six weeks of intervention
Primary	PFIQ-7	Pelvic floor incontinence questionnaire self-report	Change from baseline PFIQ-7 after six weeks of intervention
Secondary	MSQOL-54	Multiple Sclerosis Quality of Life self-report questionnaire	Change from baseline MSQOL-54 after six weeks of intervention
Secondary	Post void residual volume	PVR measurement	Change from baseline PVR after six weeks of intervention
Secondary	Resting SEMG	surface electromyographic reading, resting only	Change from baseline Resting SEMG after six weeks of intervention
Secondary	Systolic BP	blood pressure	Change from baseline Systolic BP after six weeks of intervention
Secondary	Systolic BP	blood pressure	Change from pre-intervention to post-intervention at each of six intervention sessions
Secondary	Diastolic BP	blood pressure	Change from baseline Diastolic BP after six weeks of intervention
Secondary	Diastolic BP	blood pressure	Change from pre-intervention to post-intervention at each of six intervention sessions
Secondary	Pulse	pulse	Change from pre-intervention to post-intervention at each of six intervention sessions
Secondary	Pulse	pulse	Change from baseline Pulse after six weeks of intervention