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Gluteus Medius Strengthening n Non Specific Chronic Low Back Pain

Primary Purpose

Gluteus Medius, Ultrasonography, NSCLBP

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
therapeutic exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gluteus Medius, Ultrasonography, NSCLBP

Eligibility Criteria

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

Inclusion Criteria:

  • 1. 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.

Exclusion Criteria:

  • 1. 'Red Flag' symptoms include, a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower extremity neurological deficit.

    2. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    group A

    group B

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    back Pain intensity level
    The Numerical Pain Rating Scale (NPRS) for pain is a one-dimensional measure of pain intensity.
    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).
    G Med macromorphology
    measuring gluteus medius thickness by ultrasonography

    Secondary Outcome Measures

    Full Information

    First Posted
    August 27, 2022
    Last Updated
    August 31, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05521165
    Brief Title
    Gluteus Medius Strengthening n Non Specific Chronic Low Back Pain
    Official Title
    Effect of Gluteus Medius Strengthening on Pain, Function, and Muscle Macromorphology in Nonspecific Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (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

    5. Study Description

    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.
    Detailed Description
    Low back pain (LBP) is a significant global health problem. It occurs in all age groups from children to the elderly. Costs associated with health care and work disability attributed to LBP vary between countries and are influenced by social and health care approaches. In almost all people with LBP, it is not possible to identify a specific cause. Only a small proportion of people have a well-understood pathological reason e.g., a vertebral fracture, malignancy, or infection. On the other hand, non-specific chronic low back pain (NSCLBP) accounts for about 85% of LBP patients treated in primary care, and the vast majority of patients with LBP seen by physical therapists are classified under this designation. A recently published systematic review examined the impairment of lower extremity muscle strength in LBP disorders. The researchers reported a significant reduction in hip abductor, extensor, and knee extensor strength in patients with LBP compared to their healthy controls. Researchers examined the strength of gluteus medius (G Med) muscle function in patients with LBP compared to non-LBP controls. The study reported that G Med muscle strength was decreased and several trigger points were developed but there were unclear results on fatigability, activity level, and macromorphology compared to healthy individuals. It was evident, however, that the slight increase in muscle thickness of certain local and global muscles during contraction in the NSCLBP group compared to a healthy group when examined by ultrasonography could be an indicator that the strengthening of the multifidus, the transversus abdominis, and the G Med prevents the occurrence of LBP. Exercise therapy is one of the inexpensive tools addressing pain relief and disability management in patients with subacute, chronic low back pain (CLBP) compared to usual care, according to the recently published systematic review. Various types of exercise interventions should be used by physical therapists in the management of CLBP, as recommended by the American Physical Therapy Association (APTA) guidelines for clinical practice. In a study by Mendis & Hides (2016), they demonstrated lumbar-pelvic muscle imbalance in LBP and improvement in sartorius and G Med muscle size when motor training interventions were applied in non-weight-bearing and weight-bearing positions during treatment of LBP. A recent study evaluated the effectiveness of adding specific hip strengthening exercises to a conventional rehabilitation program in the management of LBP patients. The results of the systematic review revealed that hip strengthening exercises could reduce pain and disability in these patients. At the same time, there is still a knowledge gap regarding the effect of G Med strengthening exercise specifically on pain and disability levels in patients with NSCLBP and muscle macromorphology (thickness), as recommended in several recent systematic reviews.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gluteus Medius, Ultrasonography, NSCLBP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    58 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    group B
    Arm Type
    Experimental
    Arm Description
    The patients in group (B) (n=29) will receive treatment as in group (A) in addition to selected G Med strengthening exercises.
    Intervention Type
    Other
    Intervention Name(s)
    therapeutic exercises
    Intervention Description
    strengthening exercises for gluteus medius and APTA guided program for NSCLBP
    Primary Outcome Measure Information:
    Title
    back Pain intensity level
    Description
    The Numerical Pain Rating Scale (NPRS) for pain is a one-dimensional measure of pain intensity.
    Time Frame
    6 weeks
    Title
    disability level of low back pain patients
    Description
    Back pain related disability is estimated using the cross-culturally adapted Arabic version of Oswestry disability index (ODI-AR).
    Time Frame
    6 weeks
    Title
    G Med macromorphology
    Description
    measuring gluteus medius thickness by ultrasonography
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. 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. Exclusion Criteria: 1. 'Red Flag' symptoms include, a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower extremity neurological deficit. 2. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hadil Mo Mohamed salama
    Phone
    01092755255
    Email
    hadilmohamed71@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona Mo Ibrahim
    Phone
    01004046183

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27433253
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30152768
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25262247
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28715424
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17366959
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30553988
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26006705
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32691625
    Citation
    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.
    Results Reference
    background

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