NCT05357001

Brief Summary

The study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. Inclusion criteria will include nulliparous females in the age range of 18-25 years old. Exclusion criteria will be women with irregular menses (\<21 and \>35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. The participants will be allocated to two groups, group A and B. Group A will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. Group B will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

April 15, 2022

Last Update Submit

December 7, 2022

Conditions

Primary Dysmenorrhea

Keywords

Primary dysmenorrheaConnective tissue manipulationStretching

Outcome Measures

Primary Outcomes (1)

  • WaLIDD

    WaLIDD (Working ability, location, intensity, days of pain, dysmenorrhea) score and dysmenorrhea severity score. It was designed, which integrated features of dysmenorrhea such as: 1. number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region), 2. Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more), 3. number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and 4. frequency of disabling pain to perform their activities (never, almost never, almost always, always). Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points Score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea. Wong-Baker scale was reclassified to adjust a four-level scale.

    6 months

Study Arms (2)

Connective tissue manipulation

EXPERIMENTAL

technique to remove muscle spasticity

Other: Connective tissue manipulation

stretching exercise

EXPERIMENTAL

exercises to remove muscle spasticity

Other: stretching exercises

Interventions

Connective tissue manipulationOTHER

to remove muscle spasticity

Connective tissue manipulation
stretching exercisesOTHER

to remove muscle spasticity

stretching exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparous women • Age range of 18 to 25 years

You may not qualify if:

  • Women with irregular menses (\<21 days and \>35 days)
  • Systemic and gynecological diseases
  • Pregnant women
  • Women taking contraceptive pills
  • Traumatic injuries
  • Previous pelvic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinah Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • Osuga Y, Hayashi K, Kanda S. Long-term use of dienogest for the treatment of primary and secondary dysmenorrhea. J Obstet Gynaecol Res. 2020 Apr;46(4):606-617. doi: 10.1111/jog.14209. Epub 2020 Feb 12.

    PMID: 32050307BACKGROUND

  • Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.

    PMID: 24695505BACKGROUND

  • Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29.

    PMID: 26328887BACKGROUND

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr. Rabiya Noor, PhD

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

May 2, 2022

Study Start

June 15, 2022

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)