Clinical trial NCT06922981: Periodized Resistance and Aerobic Training in Non-Specific Chronic Low Back Pain
Official title: Comparison Between Periodized Resistance and Aerobic Training Programs on Nonspecific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness of two forms of periodized exercise training programs (resistance and aerobic ) using the best recommended parameters (volume, intensity, rest period, and frequency) on the best available outcome measures (pain, disability, fear of movement, back and abdominal muscular endurance, upper body strength (latissimus dorsi muscle),and lower body strength ( gluteus maximus )

Detailed description: Low back pain (LBP) is a significant health problem and the leading cause of disability throughout the world, representing one of the most common reasons for primary care physician visits, with a lifetime prevalence reported as high as about 80%. It causes a significant economic and social burden that will become even more daunting in the coming decades. People with LBP are 2.5 times more likely to experience psychological distress and pain compared to normal people, which can adversely affect quality of life. Low back pain is commonly classified as nonspecific or specific due to the reported cause and as acute (\<6weeks), subacute (6-12 weeks), or chronic (\>12weeks) according to the duration of symptoms. A periodized training model is considered more effective at improving the physiological function than non-periodized (basic progressive overload), as it allows progressive adjustment of volume and intensity of training program.periodization is defined as the planned manipulation of training variables (load, sets, and repetitions) in order to maximize training adaptations and to prevent the onset of overtraining syndrome. Various periodization models exist: undulating periodization comprises a frequent variation in stimuli between low, moderate, and high intensity typically on a weekly basis, whereas traditional linear periodization typically contains low load and high volume in the initial phase of training with a gradual shift towards high load and low volume as the training progresses. Periodization may also be beneficial due to adding variation to workouts by manipulating sets, repetitions, exercise order, number of exercises, resistance, rest periods, type of contractions, or training frequency. Another added benefit is the avoidance of training plateaus or boredom. Thus it seems reasonable to consider a periodized training model in the management of those with NSCLBP.

Eligibility criteria: Inclusion Criteria:

* Male or female participants with nonspecific (nonspecific pathology) chronic (\> 12 weeks) low back pain (localized below the costal margin and above the gluteal fold) (Owen et al., 2020).

  * Participants aged between 18 to 45 years (Wewege et al., 2018).
  * Participants with Body Mass Index (BMI) 18.5-29.9 Kg/m2.
  * VAS score 3-8 cm (Pieler-Bruha, 2009).
  * ODI score 10-60 (Pieler-Bruha, 2009).

Exclusion Criteria:

* Participants will be excluded if they did not meet the inclusion criteria mentioned above such as pain due to or associated with:

  * Pregnancy
  * Infection
  * Fracture
  * Tumor
  * Structural deformity (e.g. scoliosis)
  * Radicular syndrome or cauda equine syndrome
  * Inflammatory disorders (Owen et al., 2020)

Primary outcomes:
measure: Pain Intensity Measured by Visual Analogue Scale (VAS)
timeFrame: baseline (week 0) and at the end of intervention (week 8)
measure: Disability Level Measured by the Oswestry Disability Index (ODI)
timeFrame: baseline (week 0) and at the end of intervention (week 8)
measure: Fear of movement measured by Tampa Scale of Kinesiophobia (TSK)
timeFrame: baseline (week 0) and at the end of intervention (week 8)
measure: Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test
timeFrame: baseline (week 0) and at the end of intervention (week 8)
measure: Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test Back Isometric Muscular Endurance Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test (BSBE)
timeFrame: baseline (week 0) and at the end of intervention (week 8)
measure: Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer
timeFrame: baseline (week 0) and at the end of intervention (week 8)
measure: Gluteus Maximus Muscle Strength Measured by Hand-Held Dynamometer
timeFrame: baseline (week 0) and at the end of intervention (week 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Cairo Universi
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo Universi
Study officials:
References:
citation: Cashin AG, Booth J, McAuley JH, Jones MD, Hubscher M, Traeger AC, Fried K, Moseley GL. Making exercise count: Considerations for the role of exercise in back pain treatment. Musculoskeletal Care. 2022 Jun;20(2):259-270. doi: 10.1002/msc.1597. Epub 2021 Oct 21.
citation: Calatayud J, Guzman-Gonzalez B, Andersen LL, Cruz-Montecinos C, Morell MT, Roldan R, Ezzatvar Y, Casana J. Effectiveness of a Group-Based Progressive Strength Training in Primary Care to Improve the Recurrence of Low Back Pain Exacerbations and Function: A Randomised Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8326. doi: 10.3390/ijerph17228326.
citation: Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
citation: Wewege MA, Booth J, Parmenter BJ. Aerobic vs. resistance exercise for chronic non-specific low back pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2018;31(5):889-899. doi: 10.3233/BMR-170920.
citation: Lorenz D, Morrison S. CURRENT CONCEPTS IN PERIODIZATION OF STRENGTH AND CONDITIONING FOR THE SPORTS PHYSICAL THERAPIST. Int J Sports Phys Ther. 2015 Nov;10(6):734-47.
citation: Tjosvoll SO, Mork PJ, Iversen VM, Rise MB, Fimland MS. Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study. BMC Sports Sci Med Rehabil. 2020 May 8;12:30. doi: 10.1186/s13102-020-00181-0. eCollection 2020.