Effects of an innovative lumbar support comprising hot pack and core muscle feedback activation feedback in individuals with low back pai

Phase 2

Recruiting

• Conditions: Chronic non- specific low back pain; Low back pain, lumbar support, assistive device, treatment outcome, clinical effectiveness

• Registration Number: TCTR20190905002
• Lead Sponsor: Thailand Research Fund (TRF) †Research and Researchers for Industries (RRi)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-05
• Study Completion: 2020-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Presence of mild to moderate low back pain (VAS = 3/10 †7/10) in the area between 12th rib to gluteal fold for more than 3 months
2. Body mass index (BMI) more than 18.5 kg/m2 but less than 30 kg/m2
3. Communicating in Thai fluently
4. Willing to participate

Exclusion Criteria

1. Referred pain or numbness at lower limbs
2. Impaired sensation at body and lower limbs
3. History of past surgery of spine or lower extremities
4. History of injury from accident in the previous 3 months
5. Structural deformities of the spine
6. Pregnancy
7. Specific spinal disorders or nerve root compression
8. Inflammation or infection at spine and back
9. Severe medical conditions such as cardiovascular disease, renal failure, hypertension, diabetes
10. Received physical therapy or any pain-relieving medications in the previous 3 months

Note: Withdrawal criteria will be considered as following:
1.Getting accident or injury during the study period
2.Not wearing an innovative lumbar support continually or taking pain-relieving medication more than 15% of study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a 100-mm visual analog scale,Pressure pain threshold 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a Pressure algometer,Thermal pain threshold 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a Thermal Sensory Analyzer,Tissue blood flow 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a Laser doppler blood flow meter,Thickness of transversus abdominis muscle 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a Ultrasound imaging

Secondary Outcome Measures

Name	Time	Method
umbopelvic stability test 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a Pressure biofeedback,Active straight leg raising test 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a 6-point likert scales,Cross-sectional area of lumbar multifidus muscles 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a Ultrasound imaging,Disability 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a Oswestry disability questionnaire,Quality of life 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a SF-36 Questionnaire,Quality of life 5 months: Baseline, Immediately after wearing LS, 1 month, 2 month (end of intervention), 3 month (a SF-36 Questionnaire