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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysmenorrhea
• Intervention / Treatment: Other: SACRAL RELEASE TECHNIQUE; Other: LUMBAR MOBILIZATION

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: imran G amjad; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 6400
      • Recruiting
      • Ittefaq Hospital
      • Contact: hina G gul, PhD*; Phone Number: 03214979172; Email: hina.gul@riphah.edu.pk
      • Principal Investigator: Tanzila Nasrullah, MSPT(WH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; Treatments will be administered three times per menstrual cycle over a six-weeks period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: sobia ghafoor, t-DPT, Riphah International University

Publications and helpful links

General Publications

• Gottschewsky, N., D. Kraft, and T.J.B.o.s.D. Kaufmann, Menarche, pubertal timing and the brain: female-specific patterns of brain maturation beyond age-related development. 2024. 15(1): p. 25.
• Wu, X., et al., Age at Menarche, Menopause Status and Metabolic Syndrome and its Components: Findings from the Henan Rural Cohort Study. 2023. 131(09): p. 463-471.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; adolescent; female; dysmenorrhea; girls
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dysmenorrhea
• Other Study ID Numbers: REC/RCR & AHS/25/0505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No