Recruiting

Craniosacral Therapy vs. Pelvic Floor Physical Therapy

Sponsor:

CentraState Medical Center

Code:

NCT03213522

Conditions

Multiple Sclerosis

Bladder Dysfunction

Urinary Incontinence

Overactive Bladder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic Floor Physical Therapy

Craniosacral Therapy

Study Details

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

Study ID

NCT03213522

Start date

Apr 10, 2017

Status verified date

Jul, 2017

Completion date

Apr 9, 2018

Anticipated

Primary completion date

Apr 9, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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).

Interventions

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.

Primary outcome measure

  • PFDI-20 [ Time Frame: Change from baseline PFDI-20 after six weeks of intervention ]
  • PFIQ-7 [ Time Frame: Change from baseline PFIQ-7 after six weeks of intervention ]

Central Contacts and Locations

Central contacts

Danielle T Robbins, DPT

7322942700drobbins@centrastate.com

Locations

CentraState Medical Center

Recruiting

Freehold, New Jersey, United States, 07728

Contacts

Danielle T Robbins, DPT

732-294-2700drobbins@centrastate.com

Emily Bessemer, DPT

7322942700ebesseme@centrastate.com

Principal Investigator:

Danielle T Robbins, DPT

More Information

Sponsor

CentraState Medical Center

Last update posted

Jul 11, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CentraState Medical Center on 2017-07-11.