NCT05306236

Brief Summary

the purpose of the study will be to to examine the effect of low level laser therapy on pain and function disability in postnatal women with sacroiliac joint pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

March 23, 2022

Last Update Submit

July 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    The pain intensity will be assessed through visual analogue scale (VAS) for both groups before and after the end of treatment program. Each woman will be asked to mark a point on the line between the extremes that related to her pain intensity.

    up to 2 months

  • pain pressure threshold

    pressure algometer will be used to assess pain pressure threshold for both groups before and at the end of the study

    up to 2 months

Secondary Outcomes (1)

  • functional disability

    up to 2 months

Study Arms (2)

LLL therapy and postural correction ex (study group)

EXPERIMENTAL

study group will be treated by low level laser therapy and postural correction exercises

Other: LLL therapy , postural correction ex

postural correction ex (control group)

EXPERIMENTAL

control group will be treated by postural correction exercises only

Other: LLL therapy , postural correction ex

Interventions

study group: will receive low level laser therapy 2 sessions per week for 6 weeks in addition to posture correction exercises. control group: will be treated by posture correction ex only.

LLL therapy and postural correction ex (study group)postural correction ex (control group)

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Post natal women suffering from sacroiliac joint pain for at least 3 months.
  • They should have moderate to severe pain in the sacroiliac joint region (visual analogue scale ≥ 4).
  • They should have positive findings in at least three of five provocation sacroiliac joint tests (i.e., Patrick's sign, Gaenslen test, compression test, thigh thrust test and distraction test).
  • Their age will range from 25 to 40 years old.
  • Their Body mass index (BMI) will be ranged from 25 to 30 Kg /m2.
  • They should not have any musculoskeletal disorders.

You may not qualify if:

  • Lumber or hip joint pathology.
  • Acute pelvic bacterial or viral infections or tumour.
  • Taking nonsteroidal anti-inflammatory drugs, or hormonal treatments.
  • Having positive straight leg raising test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal Ahmed

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for women's health

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 1, 2022

Study Start

April 30, 2022

Primary Completion

June 30, 2022

Study Completion

July 28, 2022

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations