Biopsychosocial and Conventional Approach in Bladder Pain Syndrome
NCT ID: NCT05155384
Last Updated: 2022-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-11-12
2022-10-15
Brief Summary
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Individuals who meet the inclusion criteria and agree to participate will be randomly assigned into one of the two research arms: biopsychosocial approach group or conventional approach group. A biopsychosocial approach, which is a holistic approach that includes pain neuroscience education, relaxation training and cognitive exercises, will be applied to the patients in the first research arm for the treatment of chronic pain symptoms. For the patients in the second research arm, a conventional approach including pelvic floor stretching exercises and Transcutaneous Electrical Nerve Stimulation (TENS) will be applied for the treatment of chronic pain complaints. Treatments will be lasted for a total of six weeks, with two sessions per week. Participants will be evaluated at the baseline (before treatments) and at the end of the 6th week (after treatments). In the evaluations, information about the demographic and physical characteristics, medical and surgical background, medications and lifestyle characteristics (water, tea, coffee, alcohol, cigarette consumption, the presence constipation and physical activity level) of the individuals will be recorded. For primary or secondary outcome measures, Interstitial Cystitis Symptom and Problem Index, Visual Analog Scale, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, 3-day voiding diary, Pain Disability Index, Hospital Anxiety and Depression Scale, and Short Form-36 will be used. The present study is planned to be carried out with a total of 60 individuals, 30 for each study group based on a sample size analysis.
After reaching required sample for the present study, in patients with bladder pain syndrome/interstitial cystitis, the effects of biopsychosocial and conventional approach on symptom and problem severity, pain parameters, disability, psychological status and quality of life will be analyzed using (2\*2) two-way ANOVA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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biopsychosocial model-based treatment
Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training.
Pain Neuroscience Education
main topics of pain neuroscience education; neurophysiology of the nervous system, protective mechanism of pain, acute pain formation and chronic pain, factors that increase/reduce pain, central sensitization mechanism, neuroplasticity and treatment strategies in chronic pain.
Relaxation exercises
Relaxation exercises are a training based on deep relaxation techniques and visual imagery. Relaxation exercises will be applied at the end of the training sessions.
Cognition target exercise
Cognition target exercises are a time-based approach that is not symptom-conditioned (not based on fatigue or pain). It includes functional and dynamic exercises.
Conventional physiotherapy
Conventional physiotherapy will be applied including standard exercises and electrical stimulation.
Pelvic floor stretching exercises
Pelvic floor stretching exercises; consists of stretching exercises involving the pelvic floor muscles and surrounding group muscles (such as piriformis, hamstring, adductor group muscles and lumbar extensors).
Transcutaneous electrical nerve stimulation
It will be used with superficial electrodes attached to the suprapubic region of the patients for 20 minutes in each session.
Interventions
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Pain Neuroscience Education
main topics of pain neuroscience education; neurophysiology of the nervous system, protective mechanism of pain, acute pain formation and chronic pain, factors that increase/reduce pain, central sensitization mechanism, neuroplasticity and treatment strategies in chronic pain.
Relaxation exercises
Relaxation exercises are a training based on deep relaxation techniques and visual imagery. Relaxation exercises will be applied at the end of the training sessions.
Cognition target exercise
Cognition target exercises are a time-based approach that is not symptom-conditioned (not based on fatigue or pain). It includes functional and dynamic exercises.
Pelvic floor stretching exercises
Pelvic floor stretching exercises; consists of stretching exercises involving the pelvic floor muscles and surrounding group muscles (such as piriformis, hamstring, adductor group muscles and lumbar extensors).
Transcutaneous electrical nerve stimulation
It will be used with superficial electrodes attached to the suprapubic region of the patients for 20 minutes in each session.
Eligibility Criteria
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Inclusion Criteria
* with chronic symptoms (more than 6 months)
* Bladder pain severity in the last week should be at least 3/10 according to the Visual Analogue Scale (VAS)
* Stable medication schedule
* Individuals over the age of 18 (individuals over 65 years of age with a Mini Mental Test score ≥ 24) voluntarily to participate in the study will be included.
Exclusion Criteria
* Stones in the bladder, ureter, or urethra in the last 3 months
* Having an ulcer appearance on cystoscopy
* For women: during pregnancy and/or breastfeeding
* Previous history of urological and/or pelvic malignancy
* Congenital anomaly of the upper and/or lower urinary tract
* who have started a new drug treatment in the last 3 months, or undergoing implantation operation of neuromodulation devices
* Diagnosed with opioid dependence
* Neurogenic bladder dysfunction or concomitant neurologic conditions
* Not cooperating with assessment and/or treatment, and illiterate individuals
18 Years
ALL
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Ceren Gursen
Doc. Dr.
Principal Investigators
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Ceren Gürşen, PhD
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University
Locations
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Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, , Turkey (Türkiye)
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, , Turkey (Türkiye)
Hacettepe University
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
Von Korff M, Jensen MP, Karoly P. Assessing global pain severity by self-report in clinical and health services research. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3140-51. doi: 10.1097/00007632-200012150-00009. No abstract available.
Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.
Other Identifiers
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KA- 21109
Identifier Type: -
Identifier Source: org_study_id
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