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RecruitingNCT07576231Updated Sep 24, 2026

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

An interventional study of SACRAL RELEASE TECHNIQUE and LUMBAR MOBILIZATION in Dysmenorrhea, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to female participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
13 Years to 19 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Dysmenorrhea

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Keywords

  • dysmenorrhea
  • adolescent
  • girls
  • female
  • quality of life
03

Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    SACRAL RELEASE TECHNIQUE

    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

    Other: SACRAL RELEASE TECHNIQUE

  • Active comparator
    LUMBAR MOBILIZATION

    Lumbar mobilization is a manual therapy technique used to relieve pain, restore joint motion, and improve mobility in the lower spine.

    Other: LUMBAR MOBILIZATION

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6th week

  2. 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

    Time frame: 6th week

  3. 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

    Time frame: 6th week

06

Study locations

1 of 1 sites recruiting
  • Ittefaq Hospital
    Lahore, Punjab Province 6400, Pakistan
    • hina G gul, PhD* · Contact · hina.gul@riphah.edu.pk · 03214979172
    • Tanzila Nasrullah, MSPT(WH) · Principal investigator
    Recruiting
07

References and documents

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. PubMed 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. PubMed 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.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07576231
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 8, 2026
Start date
Oct 1, 2025
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Sep 24, 2026

Study contacts

imran G amjad
Contact
imran.amjad@riphah.edu.pk
03324390125
sobia ghafoor, t-DPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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