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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sena Öndeş
- Enrollment
- 45
- Primary Endpoint
- Pressure Pain Threshold and Pain Tolerance
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pain Neuroscience Education + Standard Physiotherapy and Rehabilitation
Participants receive the standard physiotherapy and rehabilitation program in addition to structured Pain Neuroscience Education sessions.
Intervention: Standard Physiotherapy and Rehabilitation (Behavioral)
Pain Neuroscience Education + Standard Physiotherapy and Rehabilitation
Participants receive the standard physiotherapy and rehabilitation program in addition to structured Pain Neuroscience Education sessions.
Intervention: Pain Neuroscience Education (Behavioral)
Basic Body Awareness Therapy + Standard Physiotherapy Group
Participants receive the standard physiotherapy and rehabilitation program in addition to Basic Body Awareness Therapy sessions focusing on posture, movement and breathing.
Intervention: Standard Physiotherapy and Rehabilitation (Behavioral)
Basic Body Awareness Therapy + Standard Physiotherapy Group
Participants receive the standard physiotherapy and rehabilitation program in addition to Basic Body Awareness Therapy sessions focusing on posture, movement and breathing.
Intervention: Basic Body Awareness Therapy (Behavioral)
Standard Physiotherapy and Rehabilitation Group
Participants receive standard pelvic physiotherapy and rehabilitation interventions, including relaxation training, myofascial release, stretching, breathing, and aerobic exercises.
Intervention: Standard Physiotherapy and Rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Pressure Pain Threshold and Pain Tolerance
Time Frame: Baseline and up to 8 weeks
Pressure pain threshold and tolerance will be assessed using a Baseline® manual algometer. Standardized measurement points will be located in the abdominal and pelvic regions (15 points in total). Pressure will be applied perpendicularly at a rate of 1 kg/s until the participant reports the first pain sensation and maximum tolerable pain. The mean of two measurements per site will be used for analysis. Distal control points (C5-C6 zygapophyseal level, second metacarpal, and tibialis anterior muscle) will be included to evaluate widespread pressure sensitivity as an indicator of central sensitization.
Pain Intensity and Characteristics (Short Form McGill Pain Questionnaire)
Time Frame: Baseline and up to 8 weeks
Pain intensity and characteristics will be assessed using the Short Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ evaluates both sensory (11 items) and affective (4 items) dimensions of pain through 15 descriptors rated on a 4-point scale (0 = none to 3 = severe). It also includes a Visual Analog Scale (VAS) and a 6-point Likert scale assessing overall pain intensity (0 = no pain to 5 = unbearable pain). Total scores will be calculated for sensory, affective, and overall dimensions.
Pain Catastrophizing (Pain Catastrophizing Scale)
Time Frame: Baseline and up to 8 weeks
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item self-report questionnaire developed by Sullivan et al. to measure negative cognitive and emotional responses to pain. Each item is rated on a 5-point Likert scale (0 = not at all, 4 = all the time), with total scores ranging from 0 to 52. Higher scores indicate greater levels of catastrophizing. The PCS includes three subscales: rumination, magnification, and helplessness.
Autonomic Nervous System Responses - Tonic Skin Conductance Level (SCL)
Time Frame: Baseline and up to 8 weeks
Resting tonic skin conductance level will be recorded using the Shimmer3 GSR+ device with electrodes placed on the hypothenar region. Higher SCL indicates increased sympathetic arousal.
Autonomic Nervous System Responses- Phasic Skin Conductance Response (SCR) Amplitude
Time Frame: Baseline and up to 8 weeks
Phasic SCR amplitude will be recorded during painful pressure stimuli applied at the Pfannenstiel incision point. This parameter reflects rapid sympathetic responses to pain.
Autonomic Nervous System Responses- Skin Conductance Response Frequency
Time Frame: Baseline and up to 8 weeks
The total number of phasic responses during the stimulus period will be counted to quantify response frequency.
Autonomic Nervous System Responses- Skin Conductance Response Latency
Time Frame: Baseline and up to 8 weeks
Latency from stimulus onset to the first SCR will be measured to assess autonomic response timing.
Resting Pelvic Floor Muscle Activity (Resting sEMG) (Surface Electromyography)
Time Frame: Baseline and up to 8 weeks
Resting pelvic floor muscle activity will be recorded using surface electromyography (NeuroTrac® MyoPlus PRO). Electrodes will be placed bilaterally in the perianal region. Mean resting µV value across trials will be used for analysis.
Minimum Pelvic Floor Muscle Activation (Minimum sEMG) (Surface Electromyography)
Time Frame: Baseline and up to 8 weeks
Minimum muscle activation during contraction attempts will be recorded in µV. The lowest activation value across the contraction-relaxation cycles will be used.
Maximum Voluntary Contraction of Pelvic Floor Muscles (MVC) (Surface Electromyography)
Time Frame: Baseline and up to 8 weeks
MVC will be assessed during five maximal pelvic floor contractions. Values will be expressed as percent activation relative to baseline.
Pelvic Floor Muscle Relaxation Time (Surface Electromyography)
Time Frame: Baseline and up to 8 weeks
Relaxation time will be measured as the time required for sEMG amplitude to return from peak activation to baseline following a contraction.
Secondary Outcomes
- Pain-Related Beliefs (Pain Beliefs Questionnaire)(Baseline and up to 8 weeks)
- Pelvic Floor Symptoms (Global Pelvic Floor Bother Questionnaire)(Baseline and up to 8 weeks)
- Female Sexual Function (Female Sexual Function Index)(Baseline and up to 8 weeks)
- Depression, Anxiety, and Stress Levels (Depression Anxiety Stress Scale-21)(Baseline and up to 8 weeks)
- Interoceptive Awareness (Multidimensional Assessment of Interoceptive Awareness II)(Baseline and up to 8 weeks)
- Quality of Life (WHOQOL-BREF)(Baseline and up to 8 weeks)
- Quality of Life (Pelvic Pain Impact Questionnaire)(Baseline and up to 8 weeks)
- Patient Satisfaction (Numeric Rating Scale)(After 8 weeks of intervention)
Investigators
Sena Öndeş
Lecturer
Atlas University