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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04161443
Other study ID # 019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date December 10, 2022

Study information

Verified date August 2023
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Going through current literature, it is evident that sacroiliac joint dysfunction as a postural dysfunction is highly prevalent among adult population. This dysfunction due to major muscle imbalances if not treated timely can result in serious consequences later in life where it becomes the permanent dysfunction involving the major changes in the joint itself. 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. All patients will be assessed and screened by consultants as indicated and will refer to physiotherapy with diagnosed non- specific chronic back pain.Patients will further be screened for SIJ dysfunction by physiotherapist.Only those patients who fulfill the criteria of Quadratus lumborum tightness & Gulteus medius weakness will randomly be selected and the sample of 70 will finally be selected for intervention.Written consent form will be taken from all study participants.Simple randomization technique will be used through "Randomization Main" software and randomization sheet will be generated. Patients will be further be assigned equally into two groups as per randomization sheet.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).


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 10, 2022
Est. primary completion date December 10, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - • 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. Exclusion Criteria: - Radiating pain with sensory or motor de?cits. - History of fracture or any spinal surgery - Trauma - Any dysfunction of hip or knee - Any systemic disease. - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
physiotherapy
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).

Locations

Country Name City State
Pakistan Institute of physical medicine and rehabilitation, Dow University of health sciences Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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 Hand Held Dynamometer to check gluteus medius muscle strength The strength of the gluteus medius muscle was assessed on the dominant side using the Microfet2 hand-held dynamometer (MicroFET 2, Hoogan Health Industries, West Jordan, UT, USA). 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.
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