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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05809206
Other study ID # Reham_Gomma_PhD
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 10, 2023
Est. completion date August 15, 2023

Study information

Verified date March 2023
Source Cairo University
Contact Reham Abd El-Moneim
Phone +201006722789
Email Rehamgomma.88@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The purposes of this study are: 1. To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back pain in patient with Sacroiliac joint dysfunction 2. To investigate the effect of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on back muscle performance in patients with Sacroiliac joint dysfunction 3. To investigate the effects of Gluteus maximus strengthening exercises and Gluteus medius strengthening exercises on function in patient with Sacroiliac joint Dysfunction


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Neurological disorder, psychosomatic disorder - Tumor. - Infection condition. - Recent surgeries. - Pregnancy. - Back pain referred from organic cause. - Osteoporosis and bone disease (induced or idiopathic).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Glutes maximus strength protocol
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.
Gluteus medius strength program
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
Corrective Exercises
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.
Device:
Ultrasound
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

Locations

Country Name City State
Egypt Outpatient clinic faculty of physica therapy cairo university Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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