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

Not Applicable

Conditions: Health Condition 1: M999- Biomechanical lesion, unspecified

Registration Number: CTRI/2022/03/041143

Lead Sponsor: Integral University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 215

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conditioned Pain Modulation as measured by Cold Pressor TestTimepoint: Baseline, 3-months and 6-months. <br/ ><br> <br/ ><br>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 Outcome Measures

Name	Time	Method
Isometric Muscle Strength [spine extensors, gluteus maximus, gluteus medius, and hip lateral rotators], Quality of Life <br/ ><br>Timepoint: Baseline, 3 months after intervention and 3 months of no therapy.