NCT05521165

Brief Summary

To study the effect of adding selected G Med muscle strengthening exercises to the APTA-guided program on pain, disability level, and G Med macromorphology in patients with NSCLBP.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 27, 2022

Last Update Submit

August 31, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • back Pain intensity level

    The Numerical Pain Rating Scale (NPRS) for pain is a one-dimensional measure of pain intensity.

    6 weeks

  • disability level of low back pain patients

    Back pain related disability is estimated using the cross-culturally adapted Arabic version of Oswestry disability index (ODI-AR).

    6 weeks

  • G Med macromorphology

    measuring gluteus medius thickness by ultrasonography

    6 weeks

Study Arms (2)

group A

EXPERIMENTAL

The patients in group (A) (n=29) will receive an American physical therapy association (APTA) guided program consisting of stretching exercises for global trunk, back muscles, and hamstring muscles, strengthening exercises for abdominal and back muscles, and stabilizing exercises for trunk and pelvic muscles.

Other: therapeutic exercises

group B

EXPERIMENTAL

The patients in group (B) (n=29) will receive treatment as in group (A) in addition to selected G Med strengthening exercises.

Other: therapeutic exercises

Interventions

strengthening exercises for gluteus medius and APTA guided program for NSCLBP

group Agroup B

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patients aged between 20-45yrs 2. Patients with NSCLBP (pain \> 3 months). 3. NSCLBP must have been present for at least the previous 12 weeks. 4. Patients with unilateral or bilateral symptoms that are worse on one side than the other, are referred by an orthopedist.

You may not qualify if:

  • \. 'Red Flag' symptoms include, a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower extremity neurological deficit.
  • \. History of previous back surgery. 3. History of the previous pelvis or hip surgeries. 4. Recent or old fractures in lower limbs. 5. Cognitive impairment and inability to understand the scale. 6. Systemic inflammatory diseases e.g., rheumatoid arthritis and ankylosing spondylitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Abe T, Loenneke JP, Thiebaud RS. Morphological and functional relationships with ultrasound measured muscle thickness of the lower extremity: a brief review. Ultrasound. 2015 Aug;23(3):166-73. doi: 10.1177/1742271X15587599. Epub 2015 May 29.

    PMID: 27433253BACKGROUND
  • Aboufazeli M, Akbari M, Jamshidi AA, Jafarpisheh MS. Comparison of Selective Local and Global Muscle Thicknesses in Females with and without Chronic Low Back Pain. Ortop Traumatol Rehabil. 2018 Jun 27;20(3):197-204. doi: 10.5604/01.3001.0012.1473.

    PMID: 30152768BACKGROUND
  • Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.

    PMID: 25262247BACKGROUND
  • Amabile AH, Bolte JH, Richter SD. Atrophy of gluteus maximus among women with a history of chronic low back pain. PLoS One. 2017 Jul 17;12(7):e0177008. doi: 10.1371/journal.pone.0177008. eCollection 2017.

    PMID: 28715424BACKGROUND
  • Ayotte NW, Stetts DM, Keenan G, Greenway EH. Electromyographical analysis of selected lower extremity muscles during 5 unilateral weight-bearing exercises. J Orthop Sports Phys Ther. 2007 Feb;37(2):48-55. doi: 10.2519/jospt.2007.2354.

    PMID: 17366959BACKGROUND
  • Bernet BA, Peskura ET, Meyer ST, Bauch PC, Donaldson MB. The effects of hip-targeted physical therapy interventions on low back pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2019 Feb;39:91-100. doi: 10.1016/j.msksp.2018.11.016. Epub 2018 Dec 1.

    PMID: 30553988BACKGROUND
  • Cooper NA, Scavo KM, Strickland KJ, Tipayamongkol N, Nicholson JD, Bewyer DC, Sluka KA. Prevalence of gluteus medius weakness in people with chronic low back pain compared to healthy controls. Eur Spine J. 2016 Apr;25(4):1258-65. doi: 10.1007/s00586-015-4027-6. Epub 2015 May 26.

    PMID: 26006705BACKGROUND
  • de Jesus FLA, Fukuda TY, Souza C, Guimaraes J, Aquino L, Carvalho G, Powers C, Gomes-Neto M. Addition of specific hip strengthening exercises to conventional rehabilitation therapy for low back pain: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1368-1377. doi: 10.1177/0269215520941914. Epub 2020 Jul 21.

    PMID: 32691625BACKGROUND

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Hadil Mo Mohamed salama

CONTACT

Mona Mo Ibrahim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

August 27, 2022

First Posted

August 30, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

January 1, 2024

Last Updated

September 2, 2022

Record last verified: 2022-08