Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

NCT03213522 | Unknown

• 1 other identifier: CSMC 2016-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Bladder Dysfunction; Urinary Incontinence; Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• MSQOL-54

  Change from baseline MSQOL-54 after six weeks of intervention

• Post void residual volume

  Change from baseline PVR after six weeks of intervention

• Resting SEMG

  Change from baseline Resting SEMG after six weeks of intervention

• Systolic BP

  Change from baseline Systolic BP after six weeks of intervention

• Systolic BP

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

Study Arms (2)

Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

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

CranioSacral Therapy

ACTIVE COMPARATOR

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

Interventions

Pelvic Floor Physical Therapy PROCEDURE

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.

Also known as: Bladder training, Pelvic floor muscle training, Prompted voiding

Pelvic Floor Physical Therapy

Craniosacral Therapy PROCEDURE

Modified Upledger Institute 10-step protocol.

Also known as: Osteopathic manipulation, Visceral manipulation

CranioSacral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CentraState Medical Center: lead

Study Sites (1)

CentraState Medical Center

Freehold, New Jersey, 07728, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Incontinence; Urinary Bladder, Overactive

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Danielle T Robbins, DPT

  CentraState Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle T Robbins, DPT

CONTACT

7322942700; drobbins@centrastate.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: July 11, 2017
• Study Start: April 10, 2017
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)