UMIN-CTR Clinical Trial

Basic information
Public title	Carpal Tunnel Syndrome: A Pilot Prospective Case Series of Typical Chiropractic Multimodal Treatment
Acronym	CTS-MT
Scientific Title	Carpal Tunnel Syndrome: A Pilot Prospective Case Series of Typical Chiropractic Multimodal Treatment
Scientific Title:Acronym	CTS:A Pilot Prospective Case Series of Typical Chiropractic Multimodal Treatment
Region	North America

Condition
Condition	Carpal Tunnel Syndrome
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main objective is to describe the common interventions in a chiropractic setting and observe the value of cervical treatment concurrent with wrist treatment for both conditions as a pilot for future study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decreased symptoms, functional measure and nerve conduction velocity improvement.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	25 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients had one of the following had to be positive: 1.Positive Nerve Conduction Velocity (NCV) Sensory Study 2.Positive Tinel 3.Positive Phalen 4.Positive Sucher Stretch15,16
Key exclusion criteria	Exclusion criteria included patients who had concurrent metabolic complications such as diabetes, other confounding peripheral neuropathic factors, previous steroidal injections, previous surgical care, current pharmacological care, or lack of follow through with the re-exams, final neurodiagnostic testing or dropout prior to completion of care.
Target sample size	8

Research contact person
Last name of lead principal investigator	1st name David Middle name Neil Last name Taylor
Organization	Multimed Center, Inc.
Division name	none
Zip code	77586
Address	Seabrook
TEL	14132222658
Email	dntaylordc3@gmail.com

Public contact
1st name of contact person	1st name David Middle name Neil Last name Taylor
Organization	Multimed Center, Inc
Division name	none
Zip code	77586
Address	3419 Bay Breeze Dr
TEL	14132222658
Homepage URL
Email	dntaylordc3@gmail.com

Sponsor
Institute	Multimed Center, Inc 3419 Bay Breeze Dr Seabrook, Texas 77586
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Multimed Center, Inc

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

IRB Contact (For public release)
Organization	Multimed Center, Inc
Address	3419 Bay Breeze Dr
Tel	4132222658
Email	dntaylordc3@gmail.com

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	2019 Year 05 Month 15 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	8
Results
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	No longer recruiting
Date of protocol fixation	2005 Year 12 Month 15 Day
Date of IRB	2005 Year 01 Month 31 Day
Anticipated trial start date	2006 Year 01 Month 01 Day
Last follow-up date	2019 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a prospective observation of outcomes from a small cohort of patients treated for carpal tunnel syndrome, detailing diagnostic and treatment methods commonly employed in a chiropractic office. The incidence of simple carpal tunnel syndrome vs neurological double crush syndrome is observed.

Management information
Registered date	2019 Year 04 Month 28 Day
Last modified on	2019 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041720