Unique ID issued by UMIN | UMIN000030881 |
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Receipt number | R000035197 |
Scientific Title | Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial |
Date of disclosure of the study information | 2018/01/18 |
Last modified on | 2023/04/25 15:15:35 |
Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial
Dietary supplementation in patients following lumbar spine surgery
Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial
Dietary supplementation in patients following lumbar spine surgery
Japan |
lumbar spinal stenosis
Orthopedics | Rehabilitation medicine |
Others
NO
To evaluate the efficacy of amino acid supplementation in patients treated with surgery for lumbar spinal stenosis.
Efficacy
Zurich Claudication Questionnaire at 3 months after lumbar surgery
body composition, gait speed, handgrip and knee strength, albumin, Controlling Nutritional Status, Numerical Rating Scale, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire, 36 item Short Form Survey
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
Intervention group
Twice-daily ingestion of amino acids supplementation for 3 weeks after spinal surgery (100kcal, protein 10g)
Postoperative rehabilitation for 3 weeks
Control group
Twice-daily ingestion of placebo (non amino acids) supplementation for 3 weeks after spinal surgery (100kcal, protein 0g )
Postoperative rehabilitation for 3 weeks
50 | years-old | <= |
90 | years-old | > |
Male and Female
Patients treated with lumbar decompression
surgery or spinal fusion surgery for lumbar spinal stenosis
More than 3 levels spinal fusion, chronic kidney disease, diabetes mellitus patients treated with insulin therapy, milk or soy allergy, BMI > 30kg/m2, cognitive impairment, a history of psychiatric illness, previous spine surgery, peripheral artery disorders
80
1st name | Mamoru |
Middle name | |
Last name | Kawakami |
Wakayama Medical University Kihoku Hospital
Spine Care Center
649-7113
Katsuragi-cho, Ito-gun, Wakayama, Japan
0736-22-0066
kawakami@wakayama-med.ac.jp
1st name | Masakazu |
Middle name | |
Last name | Minetama |
Spine Care Center, Wakayama Medical University Kihoku Hospital.
Spine Care Center
649-7113
Katsuragi-cho, Ito-gun, Wakayama, Japan
0736-22-0066
masakazumasakazu910@hotmail.co.jp
Wakayama Medical University
not applicable
Self funding
Institutional Review Board at Wakayama Medical University
811-1, Kimiidera, Wakayama city, Japan
073-447-2300
wa-rinri@wakayama-med.ac.jp
NO
2018 | Year | 01 | Month | 18 | Day |
Published
80
No significant differences were observed in the mean changes on the ZCQ between the two groups at 12 weeks and 52 weeks. At 2 weeks postoperatively, the non-amino acid group showed significant deterioration compared with the amino acids group for strengths of knee extensor and knee flexor. At 12 weeks, the amino acids group showed significant improvements in knee extensor strength and knee flexor strength compared with the non-amino acid group.
2023 | Year | 04 | Month | 25 | Day |
2023 | Year | 03 | Month | 20 | Day |
Main results already published
2018 | Year | 01 | Month | 18 | Day |
2018 | Year | 01 | Month | 12 | Day |
2018 | Year | 01 | Month | 18 | Day |
2022 | Year | 07 | Month | 15 | Day |
2018 | Year | 01 | Month | 18 | Day |
2023 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035197
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