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NCT Number: NCT07576231

Effects of Sacral Release Technique and Lumbar Mobilization 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.

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Key information

Conditions

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

Age range

13 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ittefaq Hospital

Lahore, Punjab Province, 6400, Pakistan

Location status: Recruiting

Location contact

Tanzila Nasrullah, MSPT(WH)

PRINCIPAL_INVESTIGATOR

hina G gul, PhD*

CONTACT

[email protected]

03214979172

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

LUMBAR MOBILIZATION

Other

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

Primary outcomes

  1. Numerical Pain Rating Scale (NPRS)

    Time frame: 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

  2. Menstrual Symptom Questionnaire (MSQ)

    Time frame: 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

  3. EuroQol-5 Dimension Questionnaire (EQ-5D)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

imran G amjad

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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