Effects of Dry Needling, Static Stretching and IASTM in P... | NCT04118231

Studies
Effects of Dry Needling, Static Stretching and IASTM in People With Hamstring Muscle Shortness

NCT04118231

Sponsor

Gazi University

Status

Completed

Last Update Posted

Jan 25, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hamstring Muscle Shortness and Elastographic Examination

Interventions

Dry needling

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Oct 1, 2020Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Oct 3, 2019

First Submission Date that Met QC Criteria

Oct 4, 2019

First Posted Date

Oct 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2022

Last Update Posted Date

Jan 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to investigate the effects of dry needling, static stretching and instrument assisted soft tissue mobilization on joint range of motion, performance and muscle structure in individuals with Hamstring muscle shortness and to examine the changes in soft tissue before and after application with the help of ultrasound elastography.

Detailed Description

The study was randomly divided into 3 groups. Group 1: Hamstring muscle group of patients for 5 minutes Instrument Assisted Soft Tissue Mobilization made of stainless steel instruments used by soft tissue mobilization by the therapist. In order to reduce friction and increase lubricity before application; If there is an unexpected erythema, edema or other unexpected side effects, the application will be stopped immediately.

2.Group: In the Hamstring muscle group of the patients, the acupuncture needles, which are made of stainless steel, sterile and disposable, will be applied under the supervision of an expert doctor for 30-45 seconds. In case of unexpected side effects, the application will be terminated.

Group 3: Patients' Hamstring muscle group under the supervision of the physiotherapist for a total of 5 minutes; A total of 10 repetitions of static tension will be applied for 30 seconds.

Before starting the study, anthropometric measurements, vertical and horizontal jump amounts of all participants will be measured before the application. Digital inclinometer will be used to determine the range of motion of the joint. Measurements will be made before and after the first application and the last measurement will be made 3 days after the end of 12 sessions. In addition, soft tissue changes in the hamstring muscle of the participants will be evaluated by US elastography before and at the end of the 12th session.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dry needling	Experimental		Other: Dry needling
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dry needling	Other	Group 1: Dry needling Group 2: static stretching Group 3: IASTM	Dry needling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Range of motion	The amount of hip flexion will be measured using a digital inclinometer.	4 weeks
Muscle Strength	Muscle strength will be assessed in newton using a digital hand dinanometer.	4 weeks
Vertical jump	The amount of vertical jump will be calculated from the value of cm by the tape measure fixed to the wall.	4 weeks
Muscle stiffness	Muscle stiffness will be evaluated by an expert radiologist using ultrasound elastography.	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-35 age range
Volunteer to participate in the study
Not having a diagnosed condition

Exclusion Criteria:

Having any diagnosed discomfort
Being pregnant
Previously undergo surgery on the lower extremity
Physical therapy and rehabilitation of lower extremity in the last 6 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gazi University		Ankara		06500	Turkey (Türkiye)
Gökhan maraş

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000079245	Dry Needling
D052580	Muscle Stretching Exercises

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D005081	Exercise Therapy

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