Graded Motor Imagery for Primary Dysmenorrhea

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorDr. Mehak Naeem

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Graded Motor Imagery (GMI)

    Behavioral

    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.

  • Sham Graded Motor Imagery

    Behavioral

    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.

Treatment groups

81 Participants
are divided into 3 treatment groups
Group A: Graded Motor Imagery ProtocolExperimental treatment 1 intervention
Group B: Sham Graded Motor ImagerySham comparator 1 intervention
Group C: Wait-List ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pain Pressure Threshold

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.

Time frame
Baseline, post-intervention at 6 weeks, and 4-week follow-up.
2

Menstrual pain intensity

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.

Time frame
Baseline, 6 weeks post-intervention, and 4-week follow-up.

Secondary outcomes

1

Menstrual symptom severity

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.

Time frame
Baseline, 6 weeks post-intervention, and 4-week follow-up.
2

Pain Catastrophizing

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.

Time frame
Baseline, 6 weeks post-intervention, and 4-week follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Mehak Naeem

Lead sponsor

University of Health Sciences Lahore

Sponsor institution

University of Health Sciences Lahore

Collaborator