UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006957
Receipt number R000007816
Scientific Title LSS (Lumbar Spinal Stenosis) with Acupuncture and Physical Therapy study
Date of disclosure of the study information 2011/12/27
Last modified on 2011/12/27 14:20:46

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Basic information

Public title

LSS (Lumbar Spinal Stenosis) with Acupuncture and Physical Therapy study

Acronym

LAP study

Scientific Title

LSS (Lumbar Spinal Stenosis) with Acupuncture and Physical Therapy study

Scientific Title:Acronym

LAP study

Region

Japan


Condition

Condition

Lumbar Spinal Stenosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of conservative treatments on the quality of life and functional status of patients with Lumbar Spinal Stenosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Zurich claudication questionnaire[ Time Frame: Baseline, 1 month ]

Key secondary outcomes

1. Oswestry Disability Index [ Time Frame: Baseline, 1 month ]
2. Visual Analogue Scale[ Time Frame: Baseline, 1 month ]
3. Developed Original LSS Score[ Time Frame: Baseline, 1 month ]


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Pharmacotherapy

Interventions/Control_2

Exercise

Interventions/Control_3

Acupuncture

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1. The patient must have neurogenic intermittent claudication
2. Lumbar spinal stenosis identified by MRI

Key exclusion criteria

1. Clinically significant neurological or skeletal dysfunction
2. SLR positive
3. Uncontrolled DM
4. Patients receiving anticoagulant treatment (e.g., ticlopidine hydrochloride, warfarin)
5. Patients receiving antidepressant or antipsychotic treatment
6. Current or history of critical limb ischemia
7. Diagnosis of RA
8. Patients receiving dialysis treatment
9. Unlikely to be compliant with protocol

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Takano

Organization

Iwai Medical Foundation

Division name

Orthopedics

Zip code


Address

8-17-2 Minamikoiwa, Edogawa-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Takano

Organization

Iwai Medical Foundation

Division name

Orthopedics

Zip code


Address

8-17-2 Minamikoiwa, Edogawa-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Iwai Medical Foundation

Institute

Department

Personal name



Funding Source

Organization

Japanese Society for Musculoskeletal Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

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

2011 Year 12 Month 27 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 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

Preinitiation

Date of protocol fixation

2011 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 12 Month 27 Day

Last modified on

2011 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007816


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name