Biopsychosocial and Conventional Approach in Bladder Pain Syndrome

NCT05155384 | Unknown

• 1 other identifier: KA- 21109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of the present study is to compare the effects of biopsychosocial and conventional approach on symptom severity, pain parameters (pain intensity and pain cognitions), disability, psychological distress and quality of life in patients who are suffering from bladder pain syndrome/interstitial cystitis. The study is designed as a randomized clinical trial including two parallel arms. 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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

chronic pain; pain neuroscience education; Bladder Pain Syndrome; Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• severity of symptoms

  The Interstitial Cystitis Symptom and Problem Index will be used to assess the severity of symptoms. This scale consists of two separate parts as symptom and problem index, both of which are four questions. Participants will be asked to fill in both parts.

  change in severity of symptoms from baseline up to end of 6th week

Secondary Outcomes (6)

• severity of pain

  change in severity of pain from baseline up to end of 6th week

• Pain cognitions

  change in pain cognitions from baseline up to end of 6th week

• urinary symptoms

  change in urinary symptoms from baseline up to end of 6th week

• severity of disability

  change in severity of disability from baseline up to end of 6th week

• psychological distress

  change in psychological distress from baseline up to end of 6th week

Study Arms (2)

biopsychosocial model-based treatment

EXPERIMENTAL

Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training.

Other: Pain Neuroscience Education; Other: Relaxation exercises; Other: Cognition target exercise

Conventional physiotherapy

ACTIVE COMPARATOR

Conventional physiotherapy will be applied including standard exercises and electrical stimulation.

Other: Pelvic floor stretching exercises; Device: Transcutaneous electrical nerve stimulation

Interventions

Pain Neuroscience Education OTHER

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.

biopsychosocial model-based treatment

Relaxation exercises OTHER

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.

biopsychosocial model-based treatment

Cognition target exercise OTHER

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.

biopsychosocial model-based treatment

Pelvic floor stretching exercises OTHER

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).

Conventional physiotherapy

Transcutaneous electrical nerve stimulation DEVICE

It will be used with superficial electrodes attached to the suprapubic region of the patients for 20 minutes in each session.

Conventional physiotherapy

Eligibility Criteria

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

You may qualify if:

• Diagnosed with Bladder Pain Syndrome/Interstitial Cystitis
• 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.

You may not qualify if:

• Acute disease state (with ongoing urinary tract infection, active vaginitis, active Herpes infection)
• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (3)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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.

  PMID: 9146003 BACKGROUND

• 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.

  PMID: 11124730 BACKGROUND

• 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.

  PMID: 25558568 BACKGROUND

• 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.

  PMID: 16446108 BACKGROUND

• 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.

  PMID: 6240632 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 11124729 BACKGROUND

• 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.

  PMID: 23234638 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ceren Gürşen, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ceren Gursen, PhD

CONTACT

+905380644120; cerengursen@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doc. Dr.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 13, 2021
• Study Start: November 12, 2021
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)