Primary Dysmenorrhea (PD)NCT07618832
Graded Motor Imagery for Primary Dysmenorrhea
A study testing Graded Motor Imagery (GMI) in people with Primary Dysmenorrhea (PD), run by Dr. Mehak Naeem at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- Graded Motor Imagery (GMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dr. Saqib Rabbani
Lahore, Punjab Province, 54782
Dr. Saqib Rabbani, +923000425708, beh.sciences@uhs.edu.pk
drmehaknaeem@gmail.com
About this study
Official title: 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:
Read more
- Is there a decrease in pressure pain threshold (increased pain sensitivity) with graded motor imagery?
- Is the intensity of menstrual pain reduced by graded motor imagery?
- 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:
- Take part in a 6-week graded motor imagery program, sham program, or no intervention control.
- Do laterality recognition, motor imagery, and mirror therapy exercises in the graded motor imagery group.
- Complete pain and symptom assessments before and after the program, and again at follow-up.
Read the detailed description
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.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- Graded Motor Imagery (GMI), Sham Graded Motor Imagery
- Keywords
- Graded Motor Imagery, Primary Dysmenorrhea, Primary dysmenorrhea and pressure pain threshold, Primary dysmenorrhea and altered pain sensitivity, Non-pharmacological intervention for primary dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor Imagery (GMI)Behavioural
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 ImageryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 weeks post-intervention, and 4-week follow-up.
Secondary outcomes (2)
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.
Measured: Baseline, 6 weeks post-intervention, and 4-week follow-up.
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.
Measured: Baseline, 6 weeks post-intervention, and 4-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start6 Apr 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Mehak Naeem
- Sponsor type
- University, hospital or other
- Collaborators
- University of Health Sciences Lahore
- Responsible party
- Sponsor-investigator, Dr. Mehak Naeem, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618832
- Sponsor's protocol ID
- UHS/DUGS-26/1959
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Graded Motor Imagery on Pressure Pain Threshold and Pain Intensity in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07618832
- Acronym / sponsor ID
- UHS/DUGS-26/1959
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- Graded Motor Imagery, Primary Dysmenorrhea, Primary dysmenorrhea and pressure pain threshold, Primary dysmenorrhea and altered pain sensitivity, Non-pharmacological intervention for primary dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Dr. Mehak NaeemUniversity, hospital or other
- Collaborators
- University of Health Sciences Lahore
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a decrease in pressure pain threshold (increased pain sensitivity) with graded motor imagery?
- Is the intensity of menstrual pain reduced by graded motor imagery?
- 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:
- Take part in a 6-week graded motor imagery program, sham program, or no intervention control.
- Do laterality recognition, motor imagery, and mirror therapy exercises in the graded motor imagery group.
- Complete pain and symptom assessments before and after the program, and again at follow-up.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Graded Motor Imagery Protocol | Experimental | Behavioral: Graded Motor Imagery (GMI)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. |
| Sham Graded Motor Imagery | Sham comparator | Behavioral: Sham Graded Motor ImageryParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Graded Motor Imagery Protocol |
| Sham Graded Motor ImageryThe 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. | Behavioural | Sham Graded Motor Imagery |
Primary outcome
Pain Pressure Threshold
Time frame: 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.
Menstrual pain intensity
Time frame: 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.
2 secondary outcomes
Menstrual symptom severity
Time frame: Baseline, 6 weeks post-intervention, and 4-week follow-up.
Pain Catastrophizing
Time frame: Baseline, 6 weeks post-intervention, and 4-week follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery (GMI) in people with Primary Dysmenorrhea (PD), run by Dr. Mehak Naeem at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Pressure Threshold (time frame: Baseline, post-intervention at 6 weeks, and 4-week follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.