Effects of Lumbar Stabilization and Graded Activity Exercises on Selected Biochemical Mediators and Clinical Outcomes in Patients with Non-Specific Chronic Low Back Pain

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR201904487417085

Enrollment

Registered

2019-04-09

Start date

2019-01-21

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases

Interventions

Lumbar Stabilization Exercise

Graded Activity Exercise

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years but not more than 60 years 2. Pain duration of at least three months for patient participants 3. Non-Specific Chronic low back pain with or without radiating symptoms 4. No red flags indicating any serious pathology or peripheral neuropathy 5. History of no LBP for the apparently healthy participants within the last 6 months

Exclusion criteria

Exclusion criteria: Participants having: 1. A diagnosis of spinal inflammatory disease like Ankylosing Spondylolistis 2. Spinal fracture or dislocation; 3. Motor or sensory deficit; 4. Spinal surgery; 5. Pregnancy; 6. Any cardiopulmonary diseases or systemic disease like diabetes; 7. Use of pain medications (Non-steroidal anti-inflammatories drugs, steroids and analgesics) whether orally or topical application within the last two days before presentation 8. Psychotropic medications like benzodiazepine. 9. Medical conditions such as haematological disorder, acute or chronic liver diseases, autoimmune disease. 10. History of smoking and drinking alcohol within the last 6 months

Design outcomes

Primary

Measure	Time frame
Serum levels of interleukin 1A (IL1A), interleukin 18 receptor 1 (IL18R1), interleukin 6 (IL-6), interleukin 18 receptor accessory protein (IL18RAP), cyclooxygenase 2 (COX2), catechol-O-methyltransferase (COMT) will be determined before and after intervention. Interleukin-I is reported to cause intervertebral disc degeneration by regulating the destruction of disc matrix and by activating degradative enzymes and inhibiting the re-synthesis of proteoglycans (Le Maitre et al, 2005; Omair et al, 2013). It also modulates pain by inducing prostaglandin E2 (PGE2) synthesis which in turn enhances the activity of phospholipase A2 and COX2 (Le Maitre et al, 2005; Omair et al, 2013). Interleukin-I and IL6 both secreted by the intervertebral disc help sensitize the nociceptors that innervate the disc (Omair et al, 2013). Interleukin-18 is responsible for the production of IL-ß, chemokines, nitric oxide and prostaglandins (Omair et al, 2013). The function of up regulation of PGE2 in disc degeneration and peripheral modulation of pain is said to be sub-served by COX2 genes (Miyamoto et al, 2002; Omair et al, 2013). Catechol O-methyltransferase have been associated with numerous endo-phenotypes believed to underlie chronic pain disorders, including autonomic dysregulation, alterations in pain processing and modulation, sleep dysfunction, and anxiety (Tegeder and Lotsch, 2009; Omair et al, 2013).	—

Measure

Time frame

Serum levels of interleukin 1A (IL1A), interleukin 18 receptor 1 (IL18R1), interleukin 6 (IL-6), interleukin 18 receptor accessory protein (IL18RAP), cyclooxygenase 2 (COX2), catechol-O-methyltransferase (COMT) will be determined before and after intervention. Interleukin-I is reported to cause intervertebral disc degeneration by regulating the destruction of disc matrix and by activating degradative enzymes and inhibiting the re-synthesis of proteoglycans (Le Maitre et al, 2005; Omair et al, 2013). It also modulates pain by inducing prostaglandin E2 (PGE2) synthesis which in turn enhances the activity of phospholipase A2 and COX2 (Le Maitre et al, 2005; Omair et al, 2013). Interleukin-I and IL6 both secreted by the intervertebral disc help sensitize the nociceptors that innervate the disc (Omair et al, 2013). Interleukin-18 is responsible for the production of IL-ß, chemokines, nitric oxide and prostaglandins (Omair et al, 2013). The function of up regulation of PGE2 in disc degeneration and peripheral modulation of pain is said to be sub-served by COX2 genes (Miyamoto et al, 2002; Omair et al, 2013). Catechol O-methyltransferase have been associated with numerous endo-phenotypes believed to underlie chronic pain disorders, including autonomic dysregulation, alterations in pain processing and modulation, sleep dysfunction, and anxiety (Tegeder and Lotsch, 2009; Omair et al, 2013).

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Secondary

Measure	Time frame
Visual Analogue Scale. To assess participants pain intensity before and after intervention. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (Gould et al, 2001). The patient marks on the line the point that they feel represents their perception of their current state of pain (Gould et al, 2001). The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (Gould et al, 2001).;The Roland-Morris Disability Questionnaire 24 (RMDQ24): To assess participants disability before and after intervention. The Roland-Morris Disability Questionnaire 24 (RMDQ24) is designed to be completed by patients in order to assess their physical disability due to low back pain (Roland and Fairbank, 2000). The RMDQ is short, simple to complete, and readily understood by patients. It has twenty-four items related specifically to physical functions that were likely to be affected by low back pain (Roland and Fairbank, 2000) (Appendix B). The RMDQ score was calculated by adding up the number of items checked. Items are not weighted (Roland and Fairbank, 2000). The scores therefore range from 0 (no disability) to 24 (maximum disability).	—

Measure

Time frame

Visual Analogue Scale. To assess participants pain intensity before and after intervention. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (Gould et al, 2001). The patient marks on the line the point that they feel represents their perception of their current state of pain (Gould et al, 2001). The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (Gould et al, 2001).;The Roland-Morris Disability Questionnaire 24 (RMDQ24): To assess participants disability before and after intervention. The Roland-Morris Disability Questionnaire 24 (RMDQ24) is designed to be completed by patients in order to assess their physical disability due to low back pain (Roland and Fairbank, 2000). The RMDQ is short, simple to complete, and readily understood by patients. It has twenty-four items related specifically to physical functions that were likely to be affected by low back pain (Roland and Fairbank, 2000) (Appendix B). The RMDQ score was calculated by adding up the number of items checked. Items are not weighted (Roland and Fairbank, 2000). The scores therefore range from 0 (no disability) to 24 (maximum disability).

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Countries

Nigeria

Contacts

Public ContactSaturday Oghumu

PhD Candidate at the School of Postgraduate Studies Department of Physiotherapy University of Lagos

nickyyivieosa@gmail.com+2348034215928

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026