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Effect of Power's Program of Gluteus Maximus on LBP

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Disability, Gluteus maximus, Low back pain, Power's program

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Central hospital of AlkhankaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A ( power's group)

Group B ( control)

Arm Description

Patients will receive the eight phases of the power's program plus a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks).

Patients will receive a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks).

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

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.
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.
Single limb triple hop test for distnace:
Description: The distance a patient will travel when 3 maximal forward hops will be performed in succession.
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.

Full Information

First Posted
December 3, 2022
Last Updated
March 4, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05770986
Brief Title
Effect of Power's Program of Gluteus Maximus on LBP
Official Title
Gluteus Maximus Training Using Power's Program in Chronic Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Disability, Gluteus maximus, Low back pain, Power's program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients will be randomly allocated to an experimental and a control group as follow: Group A (n= 26) will receive the eight phases of the Powers program plus a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks). Group B (n= 26) will receive the same conventional treatment only.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A ( power's group)
Arm Type
Experimental
Arm Description
Patients will receive the eight phases of the power's program plus a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks).
Arm Title
Group B ( control)
Arm Type
Active Comparator
Arm Description
Patients will receive a conventional treatment of flexibility exercises, hot pack, transcutaneous electrical stimulation (TENS), prone resisted hip extension for 12 sessions (3 sessions per week for 4 weeks).
Intervention Type
Other
Intervention Name(s)
Group A
Other Intervention Name(s)
Power's Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group B
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of low back Pain
Description
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,
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Severity of low back disability
Description
Arabic version of Oswestry Disability Index (ODI): Participants will choose the best answer reflecting their condition in each domain of ODI.
Time Frame
1 year
Title
Gluteus maximus strength
Description
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.
Time Frame
1year
Title
Single limb triple hop test for distnace:
Description
Description: The distance a patient will travel when 3 maximal forward hops will be performed in succession.
Time Frame
One year
Title
Single-Limb Crossover Hop Test for Distance
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alshaymaa AA Mohammed
Phone
01096617838
Email
alshaymaa.mohammed2012@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas Fawzy
Organizational Affiliation
professor, department of physical Therapy for musculoskeletal disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central hospital of Alkhanka
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enas Fawzy

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Power's Program of Gluteus Maximus on LBP

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