UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046340
Receipt number R000052876
Scientific Title Comparing the effect of stabilization exercises with and without dry needling on pain and performance of patients with chronic low back pain
Date of disclosure of the study information 2022/01/10
Last modified on 2021/12/10 03:59:56

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Basic information

Public title

Comparing the effect of stabilization exercises with and without dry needling on pain and performance of patients with chronic low back pain

Acronym

Comparing the effect of stabilization exercises with and without dry needling on pain and performance of patients with chronic low back pain

Scientific Title

Comparing the effect of stabilization exercises with and without dry needling on pain and performance of patients with chronic low back pain

Scientific Title:Acronym

Comparing the effect of stabilization exercises with and without dry needling on pain and performance of patients with chronic low back pain

Region

Asia(except Japan)


Condition

Condition

pretest-posttest

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparing the effect of stabilization exercises with and without dry needling on pain and performance of patients with chronic low back pain

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain

Key secondary outcomes

disability


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Interventions/Control_1

stabilization exercises with dry needles

Interventions/Control_2

stabilization exercises without dry needles

Interventions/Control_3

control

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

30 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

pain above 3 in VAS

Key exclusion criteria

neurological discomfort

Target sample size

66


Research contact person

Name of lead principal investigator

1st name amir
Middle name
Last name letafatkar

Organization

kharazmi university

Division name

Sport medicine

Zip code

6664743

Address

tehran

TEL

00989195394692

Email

letafatkaramir@yahoo.com


Public contact

Name of contact person

1st name amir
Middle name
Last name letafatkar

Organization

Kharazmi University

Division name

sport medicine

Zip code

6664743

Address

tehran

TEL

00989357465993

Homepage URL


Email

letafatkaramir@yahoo.com


Sponsor or person

Institute

kharazmi university

Institute

Department

Personal name



Funding Source

Organization

self funding

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

Sport science research center

Address

tehran

Tel

982122258085

Email

letafatkaramir@yahoo.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

2022 Year 01 Month 10 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

66

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

Completed

Date of protocol fixation

2021 Year 05 Month 04 Day

Date of IRB

2021 Year 08 Month 10 Day

Anticipated trial start date

2021 Year 05 Month 10 Day

Last follow-up date

2021 Year 09 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 12 Month 10 Day

Last modified on

2021 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052876


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name