Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea

NCT ID: NCT06762106

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-10
• Study Completion Date: 2025-01-01

Brief Summary

Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour

Detailed Description

Dysmenorrhea is one of the most common gynecological conditions in women. Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour. It is accompanied by general symptoms, such as nausea and vomiting, malaise, weakness, lower backache, and diarrhea. In ovulatory cycles, women secrete high levels of or have increased sensitivity to prostaglandins. These prostaglandins may stimulate myometrial contractions and sensitize pain fibers, and thus induce pelvic pain.

Females of reproductive age often suffer from dysmenorrhea, a painful condition. Despite dysmenorrhea being generally considered a benign condition, a significant disability can result from it. Researchers suggest that dysmenorrhea has been linked to migraines, headaches, and fibromyalgia, among other painful disorders. The authors reported further evidence that dysmenorrhea can alter noxious sensory processing.

Primary dysmenorrhea usually begins six to 12 months after menarche and is characterized by spasmodic cramping pain in the lower abdomen that can radiate to the lower back and anterior or inner thighs. The pain usually has a clear temporal pattern: it begins a few hours before or at the start of menstruation, is most intense at onset, gradually waning over two to three days.

The purpose of this study was to investigate the effectiveness shockwave therapy on low back pain in primary dysmenorrhea.

Conditions

Dysmenorrhea; Back Pain Lower Back

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hot back group

30 subjects were treated by hot back in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles

Group Type: ACTIVE_COMPARATOR

hot back

Intervention Type: RADIATION

thermal hot back

shock wave and hot back group

30 subjects were treated by hot back and shockwave therapy in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles

Group Type: EXPERIMENTAL

shockwave therapy

Intervention Type: RADIATION

solid unite made with metal frame and case

Interventions

shockwave therapy

solid unite made with metal frame and case

Intervention Type: RADIATION

hot back

thermal hot back

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Their ages ranged from 18 to 30 years.
• Their BMI were not exceeding 29 Kg/m2.
• All patients were clinically diagnosed as low back pain during Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guideline

Exclusion Criteria

• Any known chronic disease (such as cardiovascular or renal diseases) or secondary dysmenorrhea.
• Being pregnant or planning to get pregnant any time during the trial.
• Having received other treatments for PD in the past half year.
• Irregular menstrual cycles.
• Mental or neurological disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Deraya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Minia

Minya, , Egypt

Countries

Egypt

Other Identifiers

physio 12 24

Identifier Type: -

Identifier Source: org_study_id