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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MSQOL-54 | Multiple Sclerosis Quality of Life self-report questionnaire | Change from baseline MSQOL-54 after six weeks of intervention |
| Post void residual volume | PVR measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle T Robbins, DPT | Contact | 7322942700 | drobbins@centrastate.com |
| Name | Affiliation | Role |
|---|---|---|
| Danielle T Robbins, DPT | CentraState Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CentraState Medical Center | Recruiting | Freehold | New Jersey | 07728 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Craniosacral Therapy | Procedure | Modified Upledger Institute 10-step protocol. |
|
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| Change from baseline PVR after six weeks of intervention |
| Resting SEMG | surface electromyographic reading, resting only | Change from baseline Resting SEMG after six weeks of intervention |
| Systolic BP | blood pressure | Change from baseline Systolic BP after six weeks of intervention |
| Systolic BP | blood pressure | Change from pre-intervention to post-intervention at each of six intervention sessions |
| Diastolic BP | blood pressure | Change from baseline Diastolic BP after six weeks of intervention |
| Diastolic BP | blood pressure | Change from pre-intervention to post-intervention at each of six intervention sessions |
| Pulse | pulse | Change from pre-intervention to post-intervention at each of six intervention sessions |
| Pulse | pulse | Change from baseline Pulse after six weeks of intervention |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D012046 | Rehabilitation |