Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effects of Connective Tissue Manipulation Versus Stretching Exercises on Pain and Symptoms Severity in Females With Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357001
• Other study ID #: REC/RCR&AHS/22/0501
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: December 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Nulliparous women • Age range of 18 to 25 years

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• Connective tissue manipulation
to remove muscle spasticity
• stretching exercises
to remove muscle spasticity

Locations

Country	Name	City	State
Pakistan	Jinah Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region),; Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more),; number of days of pain during menstruation (0, 1-2, 3-4, =5), and; 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