DysmenorrheaNCT07576231
Effects of Sacral Release Technique and Lumbar Mobilization in Primary Dysmenorrhea.
A study testing SACRAL RELEASE TECHNIQUE and LUMBAR MOBILIZATION in people with Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial 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 more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- SACRAL RELEASE TECHNIQUE and LUMBAR MOBILIZATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Any pelvic inflammatory disease
- Obesity
- PCOS
- Spinal deformity
- Lumber radiculopathy
- Heavy menstrual bleeding (menorrhagia)
Show all 9Show fewer
- Irregular menstrual cycles
- Spine trauma and coccyx pain
- History of pelvic or spinal surgery currently on hormonal therapy or other ongoing physiotherapy for dysmenorrhea
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Ittefaq Hospital
Lahore, Punjab Province, 6400
hina G gul, PhD*, 03214979172, hina.gul@riphah.edu.pk
Tanzila Nasrullah, MSPT(WH)
About this study
Official title: 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.
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.
- Conditions
- Dysmenorrhea
- Being tested
- SACRAL RELEASE TECHNIQUE, LUMBAR MOBILIZATION
- Keywords
- dysmenorrhea, adolescent, girls, female, quality of life
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SACRAL RELEASE TECHNIQUEOther
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 MOBILIZATIONOther
Treatments will be administered three times per menstrual cycle over a six-weeks period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: LUMBAR MOBILIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sobia ghafoor, t-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576231
- Sponsor's protocol ID
- REC/RCR & AHS/25/0505
- Status last verified
- Sep 2026
- First submitted
- 4 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38532493Wu 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 37549686Qureshi, 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 at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Sacral Release Technique and Lumbar Mobilization in Pain, Symptoms Severity and Quality of Life in Primary Dysmenorrhea.
- ClinicalTrials.gov ID
- NCT07576231
- Acronym / sponsor ID
- REC/RCR & AHS/25/0505
- Conditions
- Dysmenorrhea
- Keywords
- dysmenorrhea, adolescent, girls, female, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SACRAL RELEASE TECHNIQUE | Experimental | Other: SACRAL RELEASE TECHNIQUEThe 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 |
| LUMBAR MOBILIZATION | Active comparator | Other: LUMBAR MOBILIZATIONLumbar mobilization is a manual therapy technique used to relieve pain, restore joint motion, and improve mobility in the lower spine. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Any pelvic inflammatory disease
- Obesity
- PCOS
- Spinal deformity
- Lumber radiculopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SACRAL RELEASE TECHNIQUEThe 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 | SACRAL RELEASE TECHNIQUE |
| LUMBAR MOBILIZATIONTreatments will be administered three times per menstrual cycle over a six-weeks period | Other | LUMBAR MOBILIZATION |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 38532493Gottschewsky 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.
- Background: PubMed 37549686Wu 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.
- BackgroundQureshi, 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
- BackgroundRana, M.Y., et al., Factors influencing the age of menopause among Pakistani women. 2021. 11(3): p. 214-216.
- BackgroundKeshwani, N., et al., Update in Adolescent Medicine, in Update in Pediatrics. 2024, Springer. p. 3-57.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sobia ghafoor, t-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SACRAL RELEASE TECHNIQUE and LUMBAR MOBILIZATION in people with Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran G amjad (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS) (time frame: 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07576231, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.