UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036619
Receipt number R000041720
Scientific Title Carpal Tunnel Syndrome: A Pilot Prospective Case Series of Typical Chiropractic Multimodal Treatment
Date of disclosure of the study information 2019/05/15
Last modified on 2019/04/28 01:54:47

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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

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

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 or person

Institute

Multimed Center, Inc
3419 Bay Breeze Dr
Seabrook, Texas 77586

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041720