Dysmenorrhea
Conditions
Keywords
dysmenorrhea, adolescent, girls, female, quality of life
Brief summary
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.
Detailed description
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.
Interventions
OTHERSACRAL RELEASE TECHNIQUE
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
OTHERLUMBAR MOBILIZATION
Treatments will be administered three times per menstrual cycle over a six-weeks period
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Unmarried female * Diagnosed with primary dysmenorrhea through WaLIDD Score * Regular menstrual cycles (21-35 days) * Pain score of \> 4 on the Numerical Pain Rating Scale (NPRS) during menstruation
Exclusion criteria
* Any pelvic inflammatory disease * Obesity * PCOS * Spinal deformity * Lumber radiculopathy * Heavy menstrual bleeding (menorrhagia) * Irregular menstrual cycles * Spine trauma and coccyx pain * History of pelvic or spinal surgery currently on hormonal therapy or other ongoing physiotherapy for dysmenorrhea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NPRS) | 6th week | 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 |
| Menstrual Symptom Questionnaire (MSQ) | 6th week | 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 |
| EuroQol-5 Dimension Questionnaire (EQ-5D) | 6th week | 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 |
Countries
Pakistan
Contacts
CONTACTimran G amjad
PRINCIPAL_INVESTIGATORsobia ghafoor, t-DPT
Riphah International University
Outcome results
None listed