NCT05809206

Brief Summary

This study will be conducted to compare between the effect of glutes maximus and glutes medius muscles strength on back muscle performance in patients with Sacroiliac joint dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 17, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 17, 2023

Last Update Submit

March 30, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Assessing the change in the peak torque of back muscles

    By using isokinetic dynamometer, and the unit of of measurement will be (Kg).

    at baseline and after 5 weeks of intervention

  • Assessing the change in pain threshold

    by using Traditional pressure algometers are ideal for measuring pressure pain threshold (PPTs) of superficial muscles and bony landmarks. Pressure pain threshold has been defined as the lowest stimulus intensity at which a subject perceives mechanical pain

    at baseline and after 5 weeks of intervention

  • Assessing the change in Functional ability level

    By using Modified Oswestry Disability Questionnaire (MODQ). The Oswestry Low Back Pain Disability Questionnaire Arabic version will be used to measure disability caused by low back pain in the general population. It consists of 10 questions each consisting of six alternatives. Every question is scored from 0-5 and a percentage are formulated as a result of the sum of the scores.

    at baseline and after 5 weeks of intervention

  • Assessing the change in pain intensity

    By using visual analogue scale (VAS). This scale will be used to measure the intensity of pain. It has been graded as a 10-cm line, which was used for measuring the intensity of perceived pain. In this scale, zero represents the absence of pain, 1-3 shows mild pain, 4-6 denotes moderate pain, and 7-10 indicates severe pain

    at baseline and after 5 weeks of intervention

Study Arms (3)

Glutes maximus Strengthening group

EXPERIMENTAL

Twenty patients received Strengthening exercises for Glutes maximus muscle and conventional physical therapy (corrective exercises and ultrasound).

Other: Glutes maximus strength protocolOther: Corrective ExercisesDevice: Ultrasound

Glutes Medius Strengthening group

EXPERIMENTAL

Twenty patients received Strengthening exercises for Glutes medius muscle and conventional physical therapy (corrective Exercises and therapeutic ultrasound (US).

Other: Gluteus medius strength programOther: Corrective ExercisesDevice: Ultrasound

Conventional treatment group

ACTIVE COMPARATOR

Twenty Patients received conventional therapy (corrective exercises and ultrasound).

Other: Corrective ExercisesDevice: Ultrasound

Interventions

The subjects attended physical therapy two times. Per week for a total of 10 visits. Each session lasted approximately 30 minutes. In the first five sessions, subjects performed the following exercises to strengthen the gluteus maximus: bilateral bridge, unilateral bridge, and non-weight-bearing hip extension in prone with the knee flexed at 90 degrees. In the next five sessions, abduction and external rotation in a quadruped ("fire hydrant" exercise) and weight-bearing hip extension (known as "deadlift" exercise) were added. Each exercise was performed for 10 repetitions. Elastic resistance was added to the fire hydrant, hip extension in prone and dead lift exercises to allow each subject to perform at a 10-repetition maximum. The resistance for each subject was adjusted weekly as needed. The exercise program was performed under direct supervision only during the physical therapy sessions.

Glutes maximus Strengthening group

Strengthening exercises for Gluteus Medius subdivisions: The anterior GMED exercise: side lying abduction exercise The middle GMED exercise: wall press Exercise The posterior GMED exercise: was the pelvic drop exercise

Glutes Medius Strengthening group

The following low back corrective exercises were given: To stretch the tight lower back muscles: Seated Forward Bend and Full Squat held for 5 sec and Repeated for 3 times, once a day. To strengthen the weak lower abdomen: Draw in and Reverse Crunch 3 seconds, repeated 5 times, once a day. To stretch the tight hip flexors: held for 10-15 seconds repeated 5 times on both legs, once a day. To stretch the tight quadriceps: held for 3 seconds, repeated 5 times on each side, once a day. To strengthen weak hamstrings: Kick Butts 2 sec, repeated 8 times, once a day.

Conventional treatment groupGlutes Medius Strengthening groupGlutes maximus Strengthening group

US was administered in continuous mode at PSIS with patient in prone lying position, with a frequency of 1 MHz and intensity of 0.8 W/cm2 for 5 minutes every alternating day

Conventional treatment groupGlutes Medius Strengthening groupGlutes maximus Strengthening group

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 25-40 years.
  • Patients with chronic lumbopelvic pain (more than 12 weeks) and clinical test positive for SIJD.
  • The pain distribution and tenderness on palpation under the posterior superior iliac spine (PSIS) are reliable signs that the SIJ is the source of pain.
  • Complaint of unilateral pain rather than bilateral pain is also considered more likely to be coming from an SIJ.
  • Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.

You may not qualify if:

  • Neurological disorder, psychosomatic disorder
  • Tumor.
  • Infection condition.
  • Recent surgeries.
  • Pregnancy.
  • Back pain referred from organic cause.
  • Osteoporosis and bone disease (induced or idiopathic).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic faculty of physica therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Reham Abd El-Moneim

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reham Abd El-Moneim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 12, 2023

Study Start

April 10, 2023

Primary Completion

June 15, 2023

Study Completion

August 15, 2023

Last Updated

April 12, 2023

Record last verified: 2023-03

Locations