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CompletedNCT06762106Updated Jan 7, 2025

Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea

An interventional study of shockwave therapy and hot back in Dysmenorrhea and Back Pain Lower Back, sponsored by Deraya University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Deraya University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Sep 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Dysmenorrhea
  • Back Pain Lower Back

Keywords

  • dysmenorrhea
  • lower back pain
  • shock wave
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Deraya University is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

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

Study arms

  • Active comparator
    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

    Radiation: hot back

  • Experimental
    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

    Radiation: shockwave therapy

Interventions

  • Radiationshockwave therapy

    solid unite made with metal frame and case

  • Radiationhot back

    thermal hot back

06

What researchers measure

Primary outcomes

  1. Pain assessment

    VAS scoring method. 0 is the least while 10 is the highest

    Time frame: every month for three menstrual cycle

07

Study locations

1 site
  • Minia
    Minya, 05637, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06762106
Lead sponsor
Deraya University
Collaborators
Cairo University
Responsible party
Sponsor
First posted
Jan 7, 2025
Start date
Sep 10, 2023
Primary completion
Mar 2, 2024
Completion
Jan 1, 2025
Last update
Jan 7, 2025

Oversight

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

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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