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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05770986
Other study ID # 012/003955
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date May 2023

Study information

Verified date March 2023
Source Cairo University
Contact Alshaymaa AA Mohammed
Phone 01096617838
Email alshaymaa.mohammed2012@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low back pain (LBP) is highly prevalent that causes significant pain and disability. Core muscles are important for LBP. One of them is gluteus maximus, but effect of power's program for this muscle and its role in LBP is lacking in literature, so this study aims to study the effect of power's program of gluteus maximus on LBP.


Description:

Chronic mechanical low back pain (CMLBP) is a common musculoskeletal dysfunction affecting 53% of Egyptian population and 1.4 to 20.0% worldwide. which is a major social and economic burden. Patients with CMLBP experience time loss of work and recently became a workforce burden. Giving the fact that back pain is widely prevalent across Egyptian population and by addressing the functional deficits in those patients, Proper physical therapy intervention can help reducing such burden and improve over all work performance. The 'Powers Program' is a recent concept and it had been proven to be effective in improving lower extremity function and biomechanics. Up to the knowledge of the primary investigator, GMax strengthening using this program has not been conducted in patients with CMLBP. Studying this approach may benefit physical therapists by providing an evidence-based approach in treating patients with CMLBP through exercise therapy and improve functional performance of these patients therefore they can return to normal activities faster. Moreover, this study may benefit researchers interested in Gluteus maximus (GMax) muscle strength. We believe that this study may open up more rooms for future research to address such an important issue.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date May 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 45 Years
Eligibility Inclusion criteria - Both sex. - Age 21-45 years. - Chronic mechanical liw back pain for more than 3 years. - Body mass index 18.4-29.9 kg/m^2. Exclusion criteria - Back pain due to specific pathology. - postoperative - Trauma to lower quadrant with past 6 months. - Radicular pain. Lumbar instability.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Group A
the patient must attain the goal repetitions (and holds when required) at one level before progressing to the next level. The principal investigator will provide extensive education to the patient while progressing through the program. Three resistance bands will be used through the exercise progression; yellow band (low resistance), green band (moderate resistance) to blue band (high resistance). The patient will progress to more advanced level if he/she can sustain the position with high resistance band (blue) for one minute with three isometric holds of each exercise on each limb. three sets for 10 repetitions will be performed) Phases 1-3 of the program are focused on GMax activation. Phases 4- 5 are focused on GMax strength, and the final three phases emphasize functional applications of the GMax during ballistic tasks.
Group B
Flexibility exercises of the back muscles: knee to chest stretch, bridging, stretching exercises for hip flexors, piriformis, adductors and hamstring will be performed, with a hold of position for 30 s and with repetitions (3-5 times). Static stretches will be held for 30 seconds to induce changes in flexibility and will be repeated for three sets. Three sessions of stretching per week will be performed b. Prone resisted hip extension 10 repetitions for two sets. c. Hot pack: for 10 minutes. d. TENS: The electrodes will be placed over the area of most severe pain for 15 minutes.

Locations

Country Name City State
Egypt Central hospital of Alkhanka Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of low back Pain Using the Arabic version of visual analogue scale (VAS), the patient will mark on a 0-10 graphic rating scale in which the (0) value indicating no pain, 1 year
Secondary Severity of low back disability Arabic version of Oswestry Disability Index (ODI):
Participants will choose the best answer reflecting their condition in each domain of ODI.
1 year
Secondary Gluteus maximus strength GMax muscle strength assessment, the following procedure will be followed: Patient Position: prone with knee to be tested flexed to 90 degrees Clinician Position: mid-table on the side to be tested. Elbows in full extension and both hands fixed to stabilize the HHD. HHD Position: just proximal to the popliteal fossa of the limb to be tested Standard Command: "Go ahead, push-push push-push-push, and relax" Method of Testing: 2 trials of 5 second duration, isometric contraction. 1year
Secondary Single limb triple hop test for distnace: Description: The distance a patient will travel when 3 maximal forward hops will be performed in succession. One year
Secondary Single-Limb Crossover Hop Test for Distance Description: The distance a patient will travel in seconds when 3 maximal crossover forward hops are performed. Measurement method: The patient will stand on one limb, with the toes on the starting line. The patient will perform 3 consecutive maximal hops as far as possible forward and land on the same limb while alternately crossing over a 15-cm strip on the floor. The distance hopped will be measured (in centimeter) from the starting line to the point where the patient's heel landed after the third hop. One year
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