Graded Motor Imagery for Primary Dysmenorrhea
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:
- 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Punjab Province
-
Lahore, Punjab Province, 파키스탄, 54782
- 모병
- Dr. Saqib Rabbani
-
연락하다:
- Dr. Saqib Rabbani
- 전화번호: +923000425708
- 이메일: beh.sciences@uhs.edu.pk
-
연락하다:
-
수석 연구원:
- Mehak Naeem, DPT
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
|
가짜 비교기: 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. |
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.
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Pressure Threshold
기간: 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
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Menstrual symptom severity
기간: 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
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- UHS/DUGS-26/1959
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .