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The aim of this study is to determine the comparative effects of sacral release technique and lumbar mobilization in pain, symptoms severity and quality of life in primary dysmenorrhea.
This will be a randomized clinical trial, the study will be conducted at First Care Medical Complex, over 10 month duration, involving a 46 adolescent females aged 13-19 years diagnosed with primary dysmenorrhea selected through a non-probability convenience sampling technique. Participants will be randomly assigned to two intervention groups. Group A (n=23) will receive the Sacral Release Technique and Group B (n=23) will undergo Lumbar Mobilization. Interventions will provide for 6 weeks, 3 sessions per cycle for two consecutive menstrual cycles. Pain intensity will be measured by using the Numerical Pain Rating Scale (NPRS) and menstrual symptom severity will be evaluated using a structured symptom rating tool, and quality of life will be measured using EuroQOL. Data will be analyzed using SPSS version 25, and with p-value of <0.05 will be considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SACRAL RELEASE TECHNIQUE | Experimental | The sacral release technique is a gentle, non-invasive method used to relieve tension in the sacral area, improve pelvic alignment, and enhance overall comfort, particularly during pregnancy |
|
| LUMBAR MOBILIZATION | Active Comparator | Lumbar mobilization is a manual therapy technique used to relieve pain, restore joint motion, and improve mobility in the lower spine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SACRAL RELEASE TECHNIQUE | Other | The therapist will maintain gentle, sustained holds for 3 to 5 minutes per repetition, with 2 to 3 repetitions per session. Each session lasted 15 to 20 minutes. 3 times per week over a period of two consecutive menstrual cycles, for six-weeks period |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Rating Scale (NPRS) | The Numerical Pain Rating Scale (NPRS) is a unidimensional scale ranging from 0 (no pain) to 10 (worst possible pain). The NPRS demonstrates excellent test-retest reliability, with Intraclass Correlation Coefficients (ICC) typically above 0.90, indicating stability of responses over time. Its internal consistency has been shown to be high, with Cronbach's alpha values ranging from 0.86 to 0.95, reflecting a strong degree of reliability. The tool also has validity as it correlates significantly with other pain-related outcome measures domains of quality-of-life instruments | 6th week |
| Menstrual Symptom Questionnaire (MSQ) | It is a validated instrument designed to assess the frequency and intensity of common menstrual-related symptoms, including pain, mood changes, fatigue, bloating, and general discomfort. It provides a comprehensive overview of both physical and emotional aspects of menstruation, making it suitable for evaluating the effectiveness of interventions in conditions like primary dysmenorrhea. The scale demonstrates acceptable internal consistency, with a reported Cronbach's alpha of 0.78, indicating reliable measurement across diverse symptom domain | 6th week |
| EuroQol-5 Dimension Questionnaire (EQ-5D) | The EuroQol-5 Dimension Questionnaire (EQ-5D) is assessing health-related quality of life in women with primary dysmenorrhea. The internal consistency of the EQ-5D in related populations have reported a Cronbach's alpha ranging from 0.70 to 0.89, indicating acceptable to excellent reliability | 6th week |
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Inclusion Criteria:
Exclusion Criteria:
PRIMARY DYSMENORREA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| imran G amjad | Contact | 03324390125 | imran.amjad@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| sobia ghafoor, t-DPT | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ittefaq Hospital | Recruiting | Lahore | Punjab Province | 6400 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38532493 | Background | Gottschewsky N, Kraft D, Kaufmann T. Menarche, pubertal timing and the brain: female-specific patterns of brain maturation beyond age-related development. Biol Sex Differ. 2024 Mar 26;15(1):25. doi: 10.1186/s13293-024-00604-4. | |
| 37549686 | Background | Wu X, Zhen D, Liu X, Liao W, Dong X, Yang J, Zhao B, Wang C. Age at Menarche, Menopause Status and Metabolic Syndrome and its Components: Findings from the Henan Rural Cohort Study. Exp Clin Endocrinol Diabetes. 2023 Sep;131(9):463-471. doi: 10.1055/a-2095-2074. Epub 2023 Aug 7. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| LUMBAR MOBILIZATION | Other | Treatments will be administered three times per menstrual cycle over a six-weeks period |
|
| Background | Qureshi, M.A., et al., Coping Mechanisms of Menopausal Women and Its Impact on the Quality of Life at Mohan Pura, Rawalpindi. 2025. 15(3): p. 197-202 |
| Background | Rana, M.Y., et al., Factors influencing the age of menopause among Pakistani women. 2021. 11(3): p. 214-216. |
| Background | Keshwani, N., et al., Update in Adolescent Medicine, in Update in Pediatrics. 2024, Springer. p. 3-57. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |