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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016786
Receipt No. R000019480
Scientific Title Impact of Ligaplex I on the subjective recovery rate of chiropractic patients with neck or low back pain.
Date of disclosure of the study information 2015/03/13
Last modified on 2015/03/12

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Basic information
Public title Impact of Ligaplex I on the subjective recovery rate of chiropractic patients with neck or low back pain.
Acronym Nutrition impact on neck and low back pain
Scientific Title Impact of Ligaplex I on the subjective recovery rate of chiropractic patients with neck or low back pain.
Scientific Title:Acronym Nutrition impact on neck and low back pain
Region
North America

Condition
Condition Patients with neck and low back pain were prescribed Ligaplex
Classification by specialty
Medicine in general Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measure Neck Disability Index, Roland-Morris, SF-36, and VAS for pain. Determine if taking Ligaplex improved patient outcomes with neck and low back pain over 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survey values on the VAS, NDI, RM, and SF-36.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ligaplex at 2 capsules per day.
Interventions/Control_2
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
17 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Neck or low back pain, and provided informed consent.
Key exclusion criteria Unstable fractures, severe osteoporosis, multiple myeloma, osteomyelitis, primary bone tumor, Paget's disease, cauda equina, rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, abdominal aortic aneurysm, and spondylolisthesis.
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name John Ward, DC, MA, MS
Organization Texas Chiropractic College
Division name Research
Zip code
Address 5912 Spencer Highway, Pasadena, TX 77505
TEL 2819985704
Email jward@txchiro.edu

Public contact
Name of contact person
1st name
Middle name
Last name John Ward
Organization Texas Chiropractic College
Division name Research
Zip code
Address 5912 Spencer Highway, Pasadena, TX 77505
TEL 2819985704
Homepage URL
Email jward@txchiro.edu

Sponsor
Institute Standard Process
Institute
Department

Funding Source
Organization Standard Process
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results: All four groups reported less pain and disability over the course of the study. Between group comparisons of improvement over 4-weeks of care for VAS score (p=0.975), NDI score (p=0.522), SF-36 (p=0.285), and Roland-Morris Low Back Pain score (p=0.296) did not demonstrate a statistically significant difference between groups. 
Conclusions: No differences in outcome were seen between the subjects who received the supplement and those who did not over a 4-week period.  
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
2014 Year 10 Month 30 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 12 Day
Last modified on
2015 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019480

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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