Effect of Cryotherapy on Primary Dysmenorrhoea

NCT06320145 | Completed DMC

• 1 other identifier: P.T.REC/012/004045
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women. Cryotherapy, therapeutic cooling, is one of the modalities widely used in sports medicine for a variety of treatment purposes. Physiological and neurological responses of musculoskeletal tissues to cooling have been extensively examined in the literature.

Conditions

Dysmenorrhea Primary

Keywords

Cryotherapy; Primary dysmenorrhoea

Outcome Measures

Primary Outcomes (1)

• Pain assessed by VAS

  Pain which is assessed by VAS scale ( which is from 0 to 10 the VAS as being 10 cm horizontal line with one end described as (no pain =0), and other end (the worst pain I ever felt = 10). Patients will be asked to mark a point on the line between the extremes that relates to their level of pain

  2 months

Study Arms (2)

Group A (Cryotherapy Group)

EXPERIMENTAL

About 15 Women suffering from primary dysmenorrhoea who will receive cryotherapy sessions (3 days per week for 20 minutes), in addition to core stability exercise.

Device: Cryotherapy; Other: core stability exercises

Group B (core stability Group)

EXPERIMENTAL

About 15 Women suffering from primary dysmenorrhoea who will receive core stability exercises only

Other: core stability exercises

Interventions

Cryotherapy DEVICE

This device used at the first, second and third day of period to decrease pain for 20 min at first, second and third day

Group A (Cryotherapy Group)

core stability exercises OTHER

core stability exercises

Group A (Cryotherapy Group); Group B (core stability Group)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All females with moderate to severe primary dysmenorrhea (as determined by V.A.S and WaLIDD Scale).
• All females will be virginal and non-smokers.
• Their BMI will be range from 20-30 kg/m2.
• They have regular menstrual cycle with menstrual cycle length of 28-30 days.

You may not qualify if:

• Any Pelvic pathology
• Malignancy.
• Uncontrolled type l Diabetes.
• Epilepsy
• pacemaker
• cancer
• skin disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy,Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• SOHAIR ELKOSAIRY, Professor

  Chairman of Physical Therapy,Faculty of Physical Therapy,Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Physical Therapy for Woman's Health Faculty of Physical Therapy

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 20, 2024
• Study Start: March 13, 2023
• Primary Completion: September 13, 2023
• Study Completion: October 1, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)