NCT07618832

Brief Summary

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. 1.Is there a decrease in pressure pain threshold (increased pain sensitivity) with graded motor imagery?
  2. 2.Is the intensity of menstrual pain reduced by graded motor imagery?
  3. 3.Is GMI helpful to reduce menstrual symptoms and pain catastrophizing (negative thinking about pain)?
  4. 4.Take part in a 6-week graded motor imagery program, sham program, or no intervention control.
  5. 5.Do laterality recognition, motor imagery, and mirror therapy exercises in the graded motor imagery group.
  6. 6.Complete pain and symptom assessments before and after the program, and again at follow-up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Apr 2026Aug 2026

Study Start

First participant enrolled

April 6, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 23, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

Graded Motor ImageryPrimary DysmenorrheaPrimary dysmenorrhea and pressure pain thresholdPrimary dysmenorrhea and altered pain sensitivityNon-pharmacological intervention for primary dysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (2)

  • Menstrual symptom severity

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

  • Pain Catastrophizing

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

Study Arms (3)

Graded Motor Imagery Protocol

EXPERIMENTAL

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.

Behavioral: Graded Motor Imagery (GMI)

Sham Graded Motor Imagery

SHAM COMPARATOR

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.

Behavioral: Sham Graded Motor Imagery

Wait-List Control

NO INTERVENTION

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.

Interventions

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.

Graded Motor Imagery Protocol

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.

Sham Graded Motor Imagery

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Saqib Rabbani

Lahore, Punjab Province, 54782, Pakistan

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 1, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations