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Graded Motor Imagery for Primary Dysmenorrhea

30 maggio 2026 aggiornato da: Dr. Mehak Naeem

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

81

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54782

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Female sex (aged 18-30 years)
  2. 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)
  3. Pain ≥4/10 NRS experienced during the last period.
  4. Confirmed altered pressure pain threshold: PPT ≥2 standard deviations below published norms for age-matched healthy women, measured at baseline assessment
  5. Regular menstrual cycle (21-35 days)
  6. Capable of engaging in virtual video sessions and taking online tests.
  7. Consent to withhold new analgesic or hormonal treatments during the study period.

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Graded Motor Imagery Protocol
Participants in this arm will be engaged in a 6-week graded motor imagery program, consisting of two supervised sessions per week and daily home practice. The intervention will have three phases: laterality recognition training with images of the pelvis and abdomen, explicit motor imagery of pain-free abdominal and pelvic movements, and mirror therapy/visual feedback with a mirror box to produce the illusion of normal and pain-free lower abdominal movement. A trained physiotherapist will deliver online sessions, and participants will complete about 15 minutes of home practice each day, which will be recorded in a diary.
Comportamentale: 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 a trained physiotherapist with two supervised sessions per week as well as daily home practice. This intervention is different from usual exercise or education because it mainly focuses on the cortical and sensorimotor mechanisms rather than only physical conditioning.
Comparatore fittizio: Sham Graded Motor Imagery

Participants in the sham group 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 movement. Lastly, sham mirror exposure will be done by looking at a mirror showing the contralateral hand but not at the pelvic area.

The sham protocol aims to control non-specific effects of therapist contact, attention, and imagery engagement, and to remove the pelvic-specific cortical engagement as occurred in the active component of GMI.
Comportamentale: 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 movement. Lastly, sham mirror exposure will be done by looking at a mirror showing the contralateral hand but not at the pelvic area. The sham protocol aims to control non-specific effects of therapist contact, attention, and imagery engagement, and to remove the pelvic-specific cortical engagement as occurred in the active component of GMI.
Nessun intervento: Wait-List Control
Participants in the wait-list group will receive no intervention throughout the 10-week study. They will be given standard written information regarding menstrual health and will be allowed to use analgesics as needed, which will be noted as a covariate.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Pressure Threshold
Lasso di tempo: Baseline, post-intervention at 6 weeks, and 4-week follow-up.
Pressure pain threshold will be measured at local abdominal and lumbar sites, and at a remote site over the tibialis anterior muscle by using a handheld algometer. Three readings will be taken at each site and averaged. Higher values will indicate lower pain sensitivity.
Baseline, post-intervention at 6 weeks, and 4-week follow-up.
Menstrual pain intensity
Lasso di tempo: Baseline, 6 weeks post-intervention, and 4-week follow-up.
Menstrual pain intensity will be assessed using a Numeric Rating Scale during active menstruation. Participants will rate their pain on the days of menstrual pain, and the scores will be recorded for comparison over time. Higher scores will indicate greater pain intensity.
Baseline, 6 weeks post-intervention, and 4-week follow-up.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Menstrual symptom severity
Lasso di tempo: Baseline, 6 weeks post-intervention, and 4-week follow-up.
Menstrual symptom severity will be measured using the Moos Menstrual Distress Questionnaire. This questionnaire assesses the severity of physical and emotional symptoms related to menstruation. Higher scores indicate more severe menstrual symptoms.
Baseline, 6 weeks post-intervention, and 4-week follow-up.
Pain Catastrophizing
Lasso di tempo: Baseline, 6 weeks post-intervention, and 4-week follow-up.
Pain catastrophizing will be measured using the Pain Catastrophizing Scale. This scale assesses exaggerated negative thoughts and feelings about pain. Higher scores indicate greater catastrophizing.
Baseline, 6 weeks post-intervention, and 4-week follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dr. Mehak Naeem

Collaboratori

University of Health Sciences Lahore

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 aprile 2026

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

23 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UHS/DUGS-26/1959

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared owing to the confidentiality of study participants as well as the institutional restrictions. De-identified data may be available upon request to the corresponding author after getting institutional's approval.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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