NCT05770986

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.

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
52

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2022

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

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

December 3, 2022

Last Update Submit

March 4, 2023

Conditions

Keywords

DisabilityGluteus maximusLow back painPower's program

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Severity of low back disability

    1 year

  • Gluteus maximus strength

    1year

  • Single limb triple hop test for distnace:

    One year

  • Single-Limb Crossover Hop Test for Distance

    One year

Study Arms (2)

Group A ( power's group)

EXPERIMENTAL

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).

Other: Group A

Group B ( control)

ACTIVE COMPARATOR

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).

Other: Group B

Interventions

Group AOTHER

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.

Also known as: Power's Program
Group A ( power's group)
Group BOTHER

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.

Also known as: Control
Group B ( control)

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Back pain due to specific pathology.
  • postoperative
  • Trauma to lower quadrant with past 6 months.
  • Radicular pain. Lumbar instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central hospital of Alkhanka

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Enas Fawzy

    professor, department of physical Therapy for musculoskeletal disorders

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist at Central hospital of Alkhanka, Qalyubiya

Study Record Dates

First Submitted

December 3, 2022

First Posted

March 16, 2023

Study Start

May 1, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations