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A clinical study to evaluate the effect of exercise interventions in persons with chronic low back pain

Effect of exercise interventions in improving clinical outcomes in a sub-group of population with chronic low back pain positive for central sensitization

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041143
Enrollment
120
Registered
2022-03-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: M999- Biomechanical lesion, unspecified

Interventions

Intervention1: Exercises: All participants with CLBP and central sensitization will receive 12-week individualized, twice-weekly exercise sessions lasting 30-60 minutes. The Aerobic Group will be sub

Sponsors

Integral University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Persons between 18-59 years of age 2. CLBP of more than 3 months duration 3. Pain intensity of more than 4 4. Positive for Central Sensitization-related sign and symptoms [Smart et al., 2011] 5. Cognitively intact [Mini-Mental State Examination score >24] 6. Basic working knowledge of English language 7. Should not be suffering from any other chronic pain condition, high blood pressure, Raynaud’s disease, frostbite, any open cut, sore, or bone fracture, other major illness such as cancer, visual and/or hearing impairment, and psychiatric disorders. 8. Further, all participants will be screened for contraindications to exercise using the Physical Activity Readiness Questionnaire and any participant who provides positive response to items 1, 2, 3, 4, 6 or 7 will be referred to a physician for medical clearance [ACSM, 1995].

Exclusion criteria

Exclusion criteria: 1. Participants who are contra-indicated to participate in physical activity [Medicine, 2010] 2. Participants who have undertaken any surgical procedures to spine or suffering from symptomatic spine diseases. 3. Participants, who report acute pain within 48 hours prior to the appointment 4. Participants, who have taken any analgesic, hypnotic or antidepressant medication in the past 72 hours.

Design outcomes

Primary

MeasureTime frame
Conditioned Pain Modulation as measured by Cold Pressor TestTimepoint: Baseline, 3-months and 6-months. Difference of 5.3% in pressure pain threshold values from baseline greater than the inherent error of measurement in the treatment arms will be considered a significant effect on CPM as measured by the Cold Pressor Test

Secondary

MeasureTime frame
Isometric Muscle Strength [spine extensors, gluteus maximus, gluteus medius, and hip lateral rotators], Quality of Life Timepoint: Baseline, 3 months after intervention and 3 months of no therapy.

Countries

India

Contacts

Public ContactG Shankar Ganesh

Integral University

abdurraheem@iul.ac.in9616739965

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 9, 2026