NCT05015413

Brief Summary

Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 25, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

8 days

First QC Date

July 14, 2021

Last Update Submit

November 20, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sacroiliac joint pain

    •Pain intensity: it will by measure by VAS it's presented as 10 cm horizontal line on which the patient pain intensity is point between no pain at zero score to extreme pain at 10 score .

    About two months

  • Functional disability

    •Functional disability :it will be measure by oswestry disability index it is 10 point Patient reported outcome questionnaire which the higher score mean its the worst and the low score mean its the better outcome.

    About 2 month

  • Pain pressure threshold

    •Pain pressure threshold : it will be measure by a device Called pressure algometry

    About 2 month

Study Arms (2)

shock wave group

EXPERIMENTAL

Group A will receive shockwave therapy 2 session per week for 6 weeks

Device: Shockwave

low level laser group

EXPERIMENTAL

Group B will receive low level laser therapy 2 session per week for 6 weeks

Device: Shockwave

Interventions

ShockwaveDEVICE

Shock wave master 500 Germany

low level laser groupshock wave group

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostnatal women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • postnatal women suffering from sacroiliac joint pain for at least 3 months.
  • They should have moderate to severe pain .
  • They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests

You may not qualify if:

  • lumber or hip joint pathology
  • Acute pelvic bacterial or viral infection .
  • Receiving corticosteroid injections within the previous 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Manal Ahmed El shafei, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A will receive shock wave therapy Group B will receive low level laser therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical therapist in al Agoza police hospital

Study Record Dates

First Submitted

July 14, 2021

First Posted

August 20, 2021

Study Start

November 25, 2021

Primary Completion

December 3, 2021

Study Completion

December 29, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share