NCT04161443

Brief Summary

Sacroiliac joint as a potential source of low back pain is an overlooked problem. Yet, in the existing years there has been an increasing interest in sacroiliac joint as a pain originator and more attention is being paid into its assessment and treatment in the current literature. Muscle imbalance due to postural dysfunction involves mainly gluteus medius and hamstring; however the role of quadratus lumborum working on compensatory mechanism and its treatment effect in the management of sacroiliac joint dysfunction is yet not discovered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 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

Study Start

First participant enrolled

October 15, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

4.2 years

First QC Date

October 30, 2019

Last Update Submit

August 16, 2023

Conditions

Keywords

MET, Quadratus lumborum, Sacroilliac joint

Outcome Measures

Primary Outcomes (3)

  • visual analog scale to measure the change in level of Pain intensity

    A Visual Analogue ScalE is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end ranging from no pain to severe pain.

    Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.

  • Oswestry Disability Index to measure change in level of disability

    Change in level of disability as evaluated by means of Oswestry Disability Index 2.0 (ODI)

    Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.

  • SF-36 QUALITY OF LIFE to measure change in general health

    SF-36 measure 8 different health concepts including general health, physical functioning, role functioning, bodily pain, mental health, emotional functioning, vitality, and social functioning.

    Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline and 12th session at the end of 4th week.

Secondary Outcomes (1)

  • Hand Held Dynamometer to check gluteus medius muscle strength

    Total duration of treatment is 4 weeks and 12 sessions, 3 sessions per week on alternate days. Patients will be assessed at baseline, at 6th session at the end of 2nd week and 12th session at the end of 4th week.

Study Arms (2)

Experimental

EXPERIMENTAL

Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes. i. MET Quadratus lumborum ii. Ultrasound iii. Gluteus medius exercises iv. Hamstring stretch Posture advice and home exercise program

Other: physiotherapy

Comparator

ACTIVE COMPARATOR

Following physiotherapy treatment will be given to the participants in this group for 4 weeks and each session last for 30 minutes. i. Ultrasound ii.Gluteus medius exercises iii.Hamstring stretch

Other: physiotherapy

Interventions

* Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary. * The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention).

ComparatorExperimental

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with unilateral non-specific LBP
  • The Subjects having at least 3 pain provocative tests of SIJ positive out of 5.
  • Age 30-50 years. Both male and female.
  • Pain history greater than six weeks.
  • SIJ diagnostic scoring cut off point 4.
  • VAS cut off point mild to moderate.

You may not qualify if:

  • Radiating pain with sensory or motor deficits.
  • History of fracture or any spinal surgery
  • Trauma
  • Any dysfunction of hip or knee
  • Any systemic disease.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of physical medicine and rehabilitation, Dow University of health sciences

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Rabail Soomro

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Hussain Kari mi

    University of Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blinding will be used as the subjects and the assessor both will be blinded for the treatment used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Rabail Rani Soomro

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 13, 2019

Study Start

October 15, 2018

Primary Completion

December 10, 2022

Study Completion

December 10, 2022

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations