Periodized Resistance and Aerobic Training in Non-Specific Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain

• Registration Number: NCT06922981
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-12-22
• Study Start: 2023-12-25
• Primary Completion: 2024-05-25
• Study Completion: 2024-06-25
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measured by Visual Analogue Scale (VAS)	baseline (week 0) and at the end of intervention (week 8)	Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal scale where 0 cm represents "no pain" and 10 cm represents "worst imaginable pain." Participants will rate their pain at rest and during movement.
Disability Level Measured by the Oswestry Disability Index (ODI)	baseline (week 0) and at the end of intervention (week 8)	Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a validated 10-item questionnaire measuring limitations in daily activities due to pain. Each item is scored from 0 to 5, with total scores ranging from 0% (no disability) to 100% (severe disability). Higher scores indicate greater disability.
Fear of movement measured by Tampa Scale of Kinesiophobia (TSK)	baseline (week 0) and at the end of intervention (week 8)	Fear of movement related to pain will be assessed using the Tampa Scale of Kinesiophobia (TSK), a validated 17-item questionnaire designed to measure fear of movement and injury-related avoidance behavior. Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), with total scores ranging from 17 (low fear) to 68 (high fear).
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	baseline (week 0) and at the end of intervention (week 8)	Abdominal endurance will be assessed using the Abdominal Muscular Endurance Test, which requires participants to perform a curl-up to the rhythm of a metronome for as long as possible.
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)	baseline (week 0) and at the end of intervention (week 8)	Back endurance will be assessed using the Biering-Sørensen Back Endurance Test (BSBE), which evaluates the endurance of the lumbar extensor muscles. The test involves the participant holding a prone position on a plinth with the upper body suspended and supported only by the pelvis and legs, maintaining this position for as long as possible.
Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer	baseline (week 0) and at the end of intervention (week 8)	Latissimus dorsi muscle strength will be assessed using a hand-held dynamometer. Participants will be instructed to perform a manual muscle contraction while the dynamometer is placed on the posterior surface of distal humerus. resistance was applied in the direction of shoulder flexion. The maximal force generated during the contraction will be recorded in newtons (N).
Gluteus Maximus Muscle Strength Measured by Hand-Held Dynamometer	baseline (week 0) and at the end of intervention (week 8)	Gluteus maximus muscle strength will be assessed using a hand-held dynamometer. Participants will be asked to perform a hip extension against the dynamometer placed 5 c m proximal to the knee joint. The maximal force exerted during the movement will be recorded in newtons (N) to assess muscle strength.

Trial Locations

Locations (1)

Faculty of Physical Therapy, Cairo Universi; 🇪🇬 Giza, Egypt