Health Condition 1: M95-M95- Other disorders of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Group A: Conventional physiotherapy combined with Agriculture Support Exoskeleton for 6 weeks
Control Intervention1: Group B: Conventional physiotherapy alone without Agriculture Suppor
Sponsors
Datta Meghe Institute of Higher Education and Research
Visvesvaraya National Institute of Technology VNIT
Eligibility
Inclusion criteria
Inclusion criteria: Clinical diagnosis of CLBP persisting for more than three months and present on at least half of the days in the past six months, consistent with WHO criteria. According to the NIH Research Task Force, CLBP is pain that is only felt between the twelfth thoracic vertebra (T12) and the gluteal fold. Eligible participants must report moderate pain intensity, defined as a Visual Analogue Scale (VAS) score of 3-7 at baseline. Participants must be actively engaged in agricultural work for more than or equal to hours per day on less than or equal to 5 days per week, with a minimum of 5 years of farming experience, and must be employed as farm laborers during the harvesting period (February-March). All participants must demonstrate clinical features consistent with mechanical or movement-related LBP. Sacroiliac joint dysfunction will be considered present when at least three out of five standard provocative manoeuvres yield positive findings, with either the thigh thrust test or compression test being mandatory among the positive findings. Participants must additionally exhibit one or more of the following characteristics: low back pain that worsens with sustained end-range movements or postures; evidence of lumbar hypermobility on segmental motion assessment; mobility deficits of the thoracic spine or lumbo-pelvic/hip regions; reduced trunk or pelvic-region muscle strength or endurance; or movement coordination impairments during performance of community, work-related, recreational, or occupational activities. All participants must be willing to participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they have a history of lumbar spine surgery within the preceding 12 months or are scheduled for major surgery within the next 12 months. Additional exclusion criteria include the presence of radiating LBP; positive straight leg raise or slump tests indicating neural tension; fractures; neurological disorders, participation in structured spine-specific exercise training within the three months preceding study enrollment, uncontrolled mental health conditions that may impede participation, and contraindications to physical activity. Further exclusions include inflammatory arthritis, active malignancy, pregnancy, or childbirth within the past six months, severe musculoskeletal deformities, or any condition contraindicating the safe use of an exoskeleton device. Agricultural workers employed primarily as office staff, truck drivers, recent migrants, or landlords not actively involved in field work, or individuals not engaged in agricultural work during the preceding year will not be eligible. Participants using medications likely to influence neuromuscular or physiological responses, including anticoagulants or systemic corticosteroids, will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity (Quadruple VAS) Physical Function [Roland Morris disability questionnaire (RMDQ)]Timepoint: At four time points: baseline (week 0, pre-intervention), post-intervention (week 6), follow-up 1 (3 months), and follow-up 2 (6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional disability [Revised Oswestry Disability Index (RODI)] Work Productivity Questionnaire Short Form-12 (SF-12)Timepoint: At four time points: baseline (week 0, pre-intervention), post-intervention (week 6), follow-up 1 (3 months), and follow-up 2 (6 months). | — |
Countries
India
Contacts
Public ContactGurjeet Kaur
Datta Meghe Institute of Higher Education and Research
Outcome results
None listed