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

NCT07328672 | Not Yet Recruiting

• 1 other identifier: DrThesis
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pelvic Pain Syndrome; Female

Keywords

Body Awareness; Basic Body Awareness Therapy; Pelvic Floor Muscle Activity; Autonomic Nervous System; Physiotherapy; Rehabilitation; Chronic Pelvic Pain; Pelvic Floor Muscles; Pain Neuroscience Education

Outcome Measures

Primary Outcomes (11)

• Pressure Pain Threshold and Pain Tolerance

  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.

  Baseline and up to 8 weeks

• Pain Intensity and Characteristics (Short Form McGill Pain Questionnaire)

  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.

  Baseline and up to 8 weeks

• Pain Catastrophizing (Pain Catastrophizing Scale)

  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.

  Baseline and up to 8 weeks

• Autonomic Nervous System Responses - Tonic Skin Conductance Level (SCL)

  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.

  Baseline and up to 8 weeks

• Autonomic Nervous System Responses- Phasic Skin Conductance Response (SCR) Amplitude

  Phasic SCR amplitude will be recorded during painful pressure stimuli applied at the Pfannenstiel incision point. This parameter reflects rapid sympathetic responses to pain.

  Baseline and up to 8 weeks

• Autonomic Nervous System Responses- Skin Conductance Response Frequency

  The total number of phasic responses during the stimulus period will be counted to quantify response frequency.

  Baseline and up to 8 weeks

• Autonomic Nervous System Responses- Skin Conductance Response Latency

  Latency from stimulus onset to the first SCR will be measured to assess autonomic response timing.

  Baseline and up to 8 weeks

• Resting Pelvic Floor Muscle Activity (Resting sEMG) (Surface Electromyography)

  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.

  Baseline and up to 8 weeks

• Minimum Pelvic Floor Muscle Activation (Minimum sEMG) (Surface Electromyography)

  Minimum muscle activation during contraction attempts will be recorded in µV. The lowest activation value across the contraction-relaxation cycles will be used.

  Baseline and up to 8 weeks

• Maximum Voluntary Contraction of Pelvic Floor Muscles (MVC) (Surface Electromyography)

  MVC will be assessed during five maximal pelvic floor contractions. Values will be expressed as percent activation relative to baseline.

  Baseline and up to 8 weeks

• Pelvic Floor Muscle Relaxation Time (Surface Electromyography)

  Relaxation time will be measured as the time required for sEMG amplitude to return from peak activation to baseline following a contraction.

  Baseline and up to 8 weeks

Secondary Outcomes (8)

• 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

Study Arms (3)

Pain Neuroscience Education + Standard Physiotherapy and Rehabilitation

EXPERIMENTAL

Participants receive the standard physiotherapy and rehabilitation program in addition to structured Pain Neuroscience Education sessions.

Behavioral: Standard Physiotherapy and Rehabilitation; Behavioral: Pain Neuroscience Education

Basic Body Awareness Therapy + Standard Physiotherapy Group

EXPERIMENTAL

Participants receive the standard physiotherapy and rehabilitation program in addition to Basic Body Awareness Therapy sessions focusing on posture, movement and breathing.

Behavioral: Standard Physiotherapy and Rehabilitation; Behavioral: Basic Body Awareness Therapy

Standard Physiotherapy and Rehabilitation Group

ACTIVE COMPARATOR

Participants receive standard pelvic physiotherapy and rehabilitation interventions, including relaxation training, myofascial release, stretching, breathing, and aerobic exercises.

Behavioral: Standard Physiotherapy and Rehabilitation

Interventions

Standard Physiotherapy and Rehabilitation BEHAVIORAL

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.

Basic Body Awareness Therapy + Standard Physiotherapy Group; Pain Neuroscience Education + Standard Physiotherapy and Rehabilitation; Standard Physiotherapy and Rehabilitation Group

Pain Neuroscience Education BEHAVIORAL

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.

Pain Neuroscience Education + Standard Physiotherapy and Rehabilitation

Basic Body Awareness Therapy BEHAVIORAL

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.

Basic Body Awareness Therapy + Standard Physiotherapy Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Only women diagnosed with chronic pelvic pain will be eligible to participate in this study. Male participants are excluded because the interventions and outcome measures are specifically designed for female pelvic floor function and related disorders.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sena Öndeş: lead
• Istinye University: collaborator

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 9, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12