High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study
| Autor: | Krishn Khanna, Christopher R. Abrecht, Kasra Amirdelfan, Michael Yang, Surekha Reddy, Prasad Shirvalkar, Bobby Tay, Amitabh Gulati, Vinay Reddy, Mindy Hong |
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| Rok vydání: | 2021 |
| Předmět: |
HFIT
Comparative Effectiveness Research medicine.medical_specialty noninvasive treatment Clinical Trials and Supportive Activities Clinical Sciences law.invention Quality of life Randomized controlled trial Clinical Research law Rating scale Back pain medicine pain Journal of Pain Research business.industry Pain Research Chronic pain Evaluation of treatments and therapeutic interventions Repeated measures design Pharmacology and Pharmaceutical Sciences medicine.disease Oswestry Disability Index Anesthesiology and Pain Medicine Clinical Trial Report 6.1 Pharmaceuticals Musculoskeletal neuromodulation Orthopedic surgery Physical therapy Chronic Pain medicine.symptom chronic pain business human activities |
| Zdroj: | Journal of Pain Research |
| ISSN: | 1178-7090 |
| Popis: | Kasra Amirdelfan,1 Mindy Hong,2 Bobby Tay,3 Surekha Reddy,4 Vinay Reddy,4 Michael Yang,5 Krishn Khanna,3 Prasad Shirvalkar,6 Christopher Abrecht,7 Amitabh Gulati8 1IPM Medical Group, Walnut Creek, CA, USA; 2Hinge Health, San Francisco, CA, USA; 3Department of Orthopaedic Surgery, University of California San Francisco, San Francisco, CA, USA; 4Spine and Nerve Diagnostic Center, Roseville, CA, USA; 5Summit Pain Alliance, Santa Rosa, CA, USA; 6UCSF Weill Institute of Neurosciences University of California San Francisco, San Francisco, CA, USA; 7Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA, USA; 8Memorial Sloan Kettering Cancer Center, New York, NY, USACorrespondence: Amitabh GulatiMemorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USATel +1 212 639-2000Email amitabhgulati@gmail.comPurpose: This study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP).Methods: A pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. MannâWhitney U-test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time.Results: The average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohenâs d (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05).Conclusion: A larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients.Keywords: HFIT, pain, chronic pain, neuromodulation, noninvasive treatment |
| Databáze: | OpenAIRE |
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