Graded Motor Imagery for Primary Dysmenorrhea

Официальное название

Effect of Graded Motor Imagery on Pressure Pain Threshold and Pain Intensity in Women With Primary Dysmenorrhea: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if graded motor imagery can reduce pain sensitivity and period pain in women with primary dysmenorrhea (painful periods with no medical cause). The main questions it aims to answer are: 1. Is there a decrease in pressure pain threshold (increased pain sensitivity) with graded motor imagery? 2. Is the intensity of menstrual pain reduced by graded motor imagery? 3. Is GMI helpful to reduce menstrual symptoms and pain catastrophizing (negative thinking about pain)? Researchers will compare full GMI (active intervention), a sham GMI(inactive intervention), and a wait-list (no intervention) to see if GMI works better than the alternatives. Participants will: 1. Take part in a 6-week graded motor imagery program, sham program, or no intervention control. 2. Do laterality recognition, motor imagery, and mirror therapy exercises in the graded motor imagery group. 3. Complete pain and symptom assessments before and after the program, and again at follow-up.

Подробное описание

Women with primary dysmenorrhea have decreased pressure pain threshold (PPT) at local abdominal and lumbar sites and at remote sites (tibialis anterior). This is indicative of central sensitization, rather than just peripheral, prostaglandin-driven pain. This sensitization extends out of the menstrual window and is associated with increased pain catastrophizing (a cognitive-affective amplifier of central pain processing). All of these factors contribute to primary dysmenorrhea being an appropriate target for brain-directed intervention.

Graded Motor Imagery (GMI) is a three-phase physiotherapy program aimed at restoring the normal representation of pain in the cortex and reducing movement-related threat appraisal. Phases progress from implicit motor imagery using left/right body-part recognition tasks, followed by explicit mental rehearsal of pain-free movement. The third phase involves mirror therapy with visual feedback of normal movement. This sequenced approach targets the two measurable mechanisms underlying central sensitization in dysmenorrhea: altered pressure pain sensitivity and elevated pain catastrophizing. GMI has proven to be effective in complex regional pain syndrome, phantom limb pain, and genito-pelvic pain. However, it has not been specifically tested in primary dysmenorrhea.

This three-arm randomized controlled trial compares full GMI, sham GMI, and a wait-list control over six weeks of online-delivered sessions. The sham program is identical to GMI in terms of therapist contact time and structure of sessions, but employs non-pelvic imagery content (to control for non-specific effects of attention and engagement). The outcome is measured at baseline, 6 and 10 weeks by a blinded assessor.

Вмешательства

• Поведенческое Graded Motor Imagery (GMI)
  The intervention will be a structured 6-week graded motor imagery program focused on the modulation of pain processing and sensorimotor representation in women with primary dysmenorrhea. It will consist of three sequential steps. Firstly, laterality recognition training with pelvic and abdominal body images. Secondly, explicit motor imagery with pain-free abdominal and pelvic movements. Finally, mirror therapy/visual feedback for normal pain-free movement. The program will be delivered online by
• Поведенческое Sham Graded Motor Imagery
  The intervention will be a sham 6-week graded motor imagery program in which the participants will undergo a program of the same amount of contact time as well as duration over 6 weeks with the same number of sessions. The sham intervention will consist of three phases. Sham laterality discrimination tasks will be performed with distal body parts only (e.g., hands and feet) and without pelvic content. Moreover, the sham general relaxation imagery will have peaceful scenes rather than body moveme

Первичные конечные точки

• Pain Pressure Threshold [Срок оценки: Baseline, post-intervention at 6 weeks, and 4-week follow-up.]
• Menstrual pain intensity [Срок оценки: Baseline, 6 weeks post-intervention, and 4-week follow-up.]

Вторичные конечные точки (2)

• Menstrual symptom severity [Срок оценки: Baseline, 6 weeks post-intervention, and 4-week follow-up.]
• Pain Catastrophizing [Срок оценки: Baseline, 6 weeks post-intervention, and 4-week follow-up.]

Критерии участия

Критерии включения

• Female sex (aged 18-30 years)
• Diagnosis of primary dysmenorrhea confirmed by a physician (painful menstruation for ≥6 consecutive cycles, in the absence of identifiable pelvic pathology on clinical and/or ultrasound evaluation)
• Pain ≥4/10 NRS experienced during the last period.
• Confirmed altered pressure pain threshold: PPT ≥2 standard deviations below published norms for age-matched healthy women, measured at baseline assessment
• Regular menstrual cycle (21-35 days)
• Capable of engaging in virtual video sessions and taking online tests.
• Consent to withhold new analgesic or hormonal treatments during the study period.

Критерии исключения

• Secondary dysmenorrhea (endometriosis, adenomyosis, fibroids, pelvic inflammatory disease, ovarian cysts ≥3 cm confirmed on imaging)
• Current use of hormonal contraceptives (which alter prostaglandin levels and pain processing)
• Pregnancy or lactation
• Concurrent chronic pain condition (fibromyalgia, CRPS, chronic low back pain, chronic pelvic pain unrelated to menstruation)
• Neurological or psychiatric disorder that would impair motor imagery ability (stroke, schizophrenia, active psychosis)
• Cognitive impairment affecting informed consent capacity
• Participation in another clinical trial within 4 weeks before enrollment
• Previous exposure to graded motor imagery or mirror therapy
• Regular use of NSAIDs or opioids for non-menstrual indications

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Dr. Saqib Rabbani — Lahore

Идентификаторы

NCT: NCT07618832 · UHS/DUGS-26/1959

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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