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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-65
SponsorSena Öndeş

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Pain Neuroscience Education + Standard Physiotherapy and RehabilitationExperimental treatment 2 interventions
Group B: Basic Body Awareness Therapy + Standard Physiotherapy GroupExperimental treatment 2 interventions
Group C: Standard Physiotherapy and Rehabilitation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and up to 8 weeks
2

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.

Time frame
Baseline and up to 8 weeks
3

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.

Time frame
Baseline and up to 8 weeks
4

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.

Time frame
Baseline and up to 8 weeks

Secondary outcomes

1

Pain-Related Beliefs (Pain Beliefs Questionnaire)

Pain-related cognitive beliefs will be assessed using the Pain Beliefs Questionnaire (PBQ), which evaluates individuals' beliefs about the causes, meaning, and controllability of pain. The PBQ consists of two subscales: organic beliefs (the idea that pain indicates tissue damage) and psychological beliefs (the idea that pain is influenced by emotional and mental processes). Each item is rated on a 6-point Likert scale (1 = never, 6 = always), with higher scores indicating stronger beliefs in each domain. The questionnaire will be used to assess changes in pain-related cognitions and cognitive restructuring following the interventions.

Time frame
Baseline and up to 8 weeks
2

Pelvic Floor Symptoms (Global Pelvic Floor Bother Questionnaire)

Pelvic floor dysfunction-related symptoms will be assessed using the Global Pelvic Floor Bother Questionnaire (PFBQ). This questionnaire evaluates the severity of pelvic floor symptoms and their impact on daily life, including stress urinary incontinence, urinary frequency, urgency, urge incontinence, voiding difficulty, pelvic organ prolapse, obstructive defecation, fecal incontinence, and dyspareunia. Each symptom is answered as "Yes/No," and if "Yes," participants rate the bother level from 1 (not at all) to 5 (a lot). The total score ranges from 0 to 45, with higher scores indicating greater symptom severity or bother.

Time frame
Baseline and up to 8 weeks
3

Female Sexual Function (Female Sexual Function Index)

Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated, multidimensional questionnaire developed by Rosen et al. It consists of 19 items rated on a 5-point Likert scale and evaluates six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2.0 to 36.0, with higher scores indicating better sexual function. A cutoff score of 26.55 differentiates between normal and dysfunctional sexual function.

Time frame
Baseline and up to 8 weeks
4

Depression, Anxiety, and Stress Levels (Depression Anxiety Stress Scale-21)

Depression, anxiety, and stress levels will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21), a reliable 21-item self-report questionnaire developed by Lovibond \& Lovibond and validated in Turkish by Yılmaz et al. (2017). The scale includes three subscales-depression, anxiety, and stress-each with seven items rated on a 4-point Likert scale (0 = did not apply to me at all to 3 = applied to me very much). Higher scores indicate greater emotional distress. Severity for each subscale is categorized as normal, mild, moderate, severe, or extremely severe.

Time frame
Baseline and up to 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Sena Öndeş

Lead sponsor

Atlas University

Sponsor institution

Istinye University

Collaborator

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