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CompletedNCT05357001Updated Dec 8, 2022

Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea

An interventional study of Connective tissue manipulation and stretching exercises in Primary Dysmenorrhea, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-08.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

All the participants will be informed about the manner of research and will be asked to sign the consent form after they are willing to participate in the study. WaLIDD score and dysmenorrhea severity scoring will be used to determine and assess the dysmenorrhea pain and severity. Treatment sessions will be conducted for 8 weeks, 3 times in a week and each session will be carried out for 20 minutes. At the end of two months, subjects will be assessed for their two menstrual cycles. SPSS 21 will be used for data analysis. After checking normality of data appropriate tests will be applied.

02

Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • Primary dysmenorrhea
  • Connective tissue manipulation
  • Stretching
03

In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's enrollment of 22 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Nulliparous women • Age range of 18 to 25 years

Exclusion criteria

Exclusion Criteria:

  • Women with irregular menses (\<21 days and >35 days)
  • Systemic and gynecological diseases
  • Pregnant women
  • Women taking contraceptive pills
  • Traumatic injuries
  • Previous pelvic surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Connective tissue manipulation

    technique to remove muscle spasticity

    Other: Connective tissue manipulation

  • Experimental
    stretching exercise

    exercises to remove muscle spasticity

    Other: stretching exercises

Interventions

  • OtherConnective tissue manipulation

    to remove muscle spasticity

  • Otherstretching exercises

    to remove muscle spasticity

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

1 site
  • Jinah Hospital
    Lahore, Punjab 54000, Pakistan
08

References and documents

Publications

  • 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. PubMed 32050307 ↗
  • Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6. PubMed 24695505 ↗
  • 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. PubMed 26328887 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05357001
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 2, 2022
Start date
Jun 15, 2022
Primary completion
Nov 15, 2022
Completion
Nov 15, 2022
Last update
Dec 8, 2022

Study contacts

Dr. Rabiya Noor, PhD
study chair · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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