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

Official title

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

Overview

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.

Interventions

• Behavioral 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.
• Behavioral 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.
• Behavioral 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.

Primary outcome measures

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

Secondary outcome measures (8)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07328672 · DrThesis

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗