Clinical trial NCT05521165: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gluteus Medius, Ultrasonography, NSCLBP
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: back Pain intensity level
timeFrame: 6 weeks
measure: disability level of low back pain patients
timeFrame: 6 weeks
measure: G Med macromorphology
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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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.
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.
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.
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.