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

NCT07576231 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0505
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Keywords

dysmenorrhea; adolescent; girls; female; quality of life

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Other: SACRAL RELEASE TECHNIQUE

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.

Other: LUMBAR MOBILIZATION

Interventions

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

SACRAL RELEASE TECHNIQUE

LUMBAR MOBILIZATION OTHER

Treatments will be administered three times per menstrual cycle over a six-weeks period

LUMBAR MOBILIZATION

Eligibility Criteria

• Age: 13 Years - 19 Years
• Gender Eligibility Details: PRIMARY DYSMENORREA
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ittefaq Hospital

Lahore, Punjab Province, 6400, Pakistan

RECRUITING

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  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.

  BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• sobia ghafoor, t-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran G amjad

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)