UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030881
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

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Basic information

Public title

Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial

Acronym

Dietary supplementation in patients following lumbar spine surgery

Scientific Title

Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial

Scientific Title:Acronym

Dietary supplementation in patients following lumbar spine surgery

Region

Japan


Condition

Condition

lumbar spinal stenosis

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of amino acid supplementation in patients treated with surgery for lumbar spinal stenosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Zurich Claudication Questionnaire at 3 months after lumbar surgery

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intervention group
Twice-daily ingestion of amino acids supplementation for 3 weeks after spinal surgery (100kcal, protein 10g)
Postoperative rehabilitation for 3 weeks

Interventions/Control_2

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

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients treated with lumbar decompression
surgery or spinal fusion surgery for lumbar spinal stenosis

Key exclusion criteria

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

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Mamoru
Middle name
Last name Kawakami

Organization

Wakayama Medical University Kihoku Hospital

Division name

Spine Care Center

Zip code

649-7113

Address

Katsuragi-cho, Ito-gun, Wakayama, Japan

TEL

0736-22-0066

Email

kawakami@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Masakazu
Middle name
Last name Minetama

Organization

Spine Care Center, Wakayama Medical University Kihoku Hospital.

Division name

Spine Care Center

Zip code

649-7113

Address

Katsuragi-cho, Ito-gun, Wakayama, Japan

TEL

0736-22-0066

Homepage URL


Email

masakazumasakazu910@hotmail.co.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

not applicable

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board at Wakayama Medical University

Address

811-1, Kimiidera, Wakayama city, Japan

Tel

073-447-2300

Email

wa-rinri@wakayama-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

80

Results

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.

Results date posted

2023 Year 04 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 03 Month 20 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 01 Month 18 Day

Date of IRB

2018 Year 01 Month 12 Day

Anticipated trial start date

2018 Year 01 Month 18 Day

Last follow-up date

2022 Year 07 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 18 Day

Last modified on

2023 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035197


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name