Pain Neuroscience Education and Basic Body Awareness Therapy in Women With Chronic Pelvic Pain

Официальное название

Investigation of the Effects of Pain Neuroscience Education and Basic Body Awareness Therapy on Pain, Autonomic Nervous System Responses, and Pelvic Floor Muscle Activity in Women With Chronic Pelvic Pain

Обзор

This randomized controlled trial aims to investigate the effects of Pain Neuroscience Education and Basic Body Awareness Therapy, when added to standard physiotherapy and rehabilitation, on pain, autonomic nervous system responses, and pelvic floor muscle activity in women with chronic pelvic pain. A total of 45 women diagnosed with chronic pelvic pain will be randomly allocated into three groups: (1) standard physiotherapy and rehabilitation, (2) standard physiotherapy plus Pain Neuroscience Education, and (3) standard physiotherapy plus Basic Body Awareness Therapy. The study will assess pain intensity (algometry, NRS, SF-MPQ), pain catastrophizing, autonomic responses (electrodermal activity), pelvic floor muscle activation (EMG), and related psychological, cognitive, and body awareness parameters. Secondary outcomes will include sexual function, quality of life, and patient satisfaction. The aim is to compare two awareness-based interventions-one primarily mind-to-body (Pain Neuroscience Education) and the other body-to-mind (Basic Body Awareness Therapy)-to determine their relative and complementary effects on pain perception and physiological regulation in women with chronic pelvic pain.

Вмешательства

• Поведенческое Standard Physiotherapy and Rehabilitation
  The interventions will be conducted over 8 weeks, with sessions held twice per week. The Standard Physiotherapy and Rehabilitation program includes pelvic floor muscle relaxation, myofascial release, stretching, breathing and relaxation exercises, and aerobic training.
• Поведенческое Pain Neuroscience Education
  The Pain Neuroscience Education (PNE) group will receive the same physiotherapy program plus weekly educational sessions focused on pain neurophysiology, central sensitization, and cognitive reframing strategies, delivered by a physiotherapist trained in Pain Neuroscience Education.
• Поведенческое Basic Body Awareness Therapy
  The Basic Body Awareness Therapy (BBAT) group will receive the same physiotherapy program plus weekly body awareness sessions emphasizing postural alignment, movement control and breathing. Exercises will be practiced in supine, sitting, and standing positions to enhance body-mind awareness. All interventions will be supervised by an experienced pelvic floor physiotherapist at Istinye University.

Первичные конечные точки

• Pressure Pain Threshold and Pain Tolerance [Срок оценки: Baseline and up to 8 weeks]
• Pain Intensity and Characteristics (Short Form McGill Pain Questionnaire) [Срок оценки: Baseline and up to 8 weeks]
• Pain Catastrophizing (Pain Catastrophizing Scale) [Срок оценки: Baseline and up to 8 weeks]
• Autonomic Nervous System Responses - Tonic Skin Conductance Level (SCL) [Срок оценки: Baseline and up to 8 weeks]
• Autonomic Nervous System Responses- Phasic Skin Conductance Response (SCR) Amplitude [Срок оценки: Baseline and up to 8 weeks]
• Autonomic Nervous System Responses- Skin Conductance Response Frequency [Срок оценки: Baseline and up to 8 weeks]
• Autonomic Nervous System Responses- Skin Conductance Response Latency [Срок оценки: Baseline and up to 8 weeks]
• Resting Pelvic Floor Muscle Activity (Resting sEMG) (Surface Electromyography) [Срок оценки: Baseline and up to 8 weeks]
• Minimum Pelvic Floor Muscle Activation (Minimum sEMG) (Surface Electromyography) [Срок оценки: Baseline and up to 8 weeks]
• Maximum Voluntary Contraction of Pelvic Floor Muscles (MVC) (Surface Electromyography) [Срок оценки: Baseline and up to 8 weeks]

Вторичные конечные точки (8)

• Pain-Related Beliefs (Pain Beliefs Questionnaire) [Срок оценки: Baseline and up to 8 weeks]
• Pelvic Floor Symptoms (Global Pelvic Floor Bother Questionnaire) [Срок оценки: Baseline and up to 8 weeks]
• Female Sexual Function (Female Sexual Function Index) [Срок оценки: Baseline and up to 8 weeks]
• Depression, Anxiety, and Stress Levels (Depression Anxiety Stress Scale-21) [Срок оценки: Baseline and up to 8 weeks]
• Interoceptive Awareness (Multidimensional Assessment of Interoceptive Awareness II) [Срок оценки: Baseline and up to 8 weeks]
• Quality of Life (WHOQOL-BREF) [Срок оценки: Baseline and up to 8 weeks]
• Quality of Life (Pelvic Pain Impact Questionnaire) [Срок оценки: Baseline and up to 8 weeks]
• Patient Satisfaction (Numeric Rating Scale) [Срок оценки: After 8 weeks of intervention]

Критерии участия

Критерии включения

• Women with any type of chronic pelvic pain, including pelvic floor muscle dysfunction, endometriosis, vulvodynia, genito-pelvic pain/penetration disorder, or bladder pain syndrome, with pain persisting for six months or longer.

Критерии исключения

• Presence of pelvic infections, inflammatory conditions, or pelvic malignancy.
• Pregnancy.
• History of urogynecological surgery within the last six months.
• Presence of advanced pelvic organ prolapse.
• Patients currently receiving chemotherapy or radiotherapy.
• Patients whose primary complaint is not chronic pelvic pain.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07328672 · DrThesis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗