Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

CentraState Medical Center

Status: Unknown

Conditions: Multiple Sclerosis; Urinary Incontinence; Overactive Bladder; Bladder Dysfunction

Treatments: Procedure: Craniosacral Therapy; Procedure: Pelvic Floor Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03213522

CSMC 2016-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Pelvic Floor Physical Therapy

Active Comparator group

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.

Treatment:

Procedure: Pelvic Floor Physical Therapy

CranioSacral Therapy

Active Comparator group

Description:

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).

Treatment:

Procedure: Craniosacral Therapy