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Recruiting NCT07576231

Effects of Sacral Release Technique and Lumbar Mobilization in Primary Dysmenorrhea.

No phase Interventional Dysmenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SACRAL RELEASE TECHNIQUE, LUMBAR MOBILIZATION.
Who it may be relevant to
Registry conditions: Dysmenorrhea. Basic parameters: 13 years — 19 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Effects of Sacral Release Technique and Lumbar Mobilization in Pain, Symptoms Severity and Quality of Life in Primary Dysmenorrhea.

Overview

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

  • Other SACRAL 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
  • Other LUMBAR MOBILIZATION
    Treatments will be administered three times per menstrual cycle over a six-weeks period

Primary outcome measures

  • Numerical Pain Rating Scale (NPRS) [Time frame: 6th week]
  • Menstrual Symptom Questionnaire (MSQ) [Time frame: 6th week]
  • EuroQol-5 Dimension Questionnaire (EQ-5D) [Time frame: 6th week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Ittefaq Hospital — Lahore

Publications

  • 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. PMID 38532493
  • 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. PMID 37549686
  • 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
  • Rana, M.Y., et al., Factors influencing the age of menopause among Pakistani women. 2021. 11(3): p. 214-216.
  • Keshwani, N., et al., Update in Adolescent Medicine, in Update in Pediatrics. 2024, Springer. p. 3-57.

Identifiers

NCT: NCT07576231 · REC/RCR & AHS/25/0505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗