NCT05702697

Brief Summary

To study efficacy of focus extracorporeal shock wave therapy on the flexibility of hamstring muscles in healthy subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 6, 2023

Last Update Submit

January 18, 2023

Conditions

Hamstring Tightness

Outcome Measures

Primary Outcomes (1)

  • Passive knee extension test

    The clinician extends the knee until reaching the maximal tolerable stretch of the hamstring muscle as indicated by the patient with the ipsilateral hip remaining in 90 of flexion. The knee angle is then measured with a goniometer

    Immediately after every F-ESWT treatment, for 3sessions

Secondary Outcomes (3)

  • Back-saver sit-and-reach test (BSSR)

    Immediately after every F-ESWT treatment, for 3sessions

  • Sit and reach test (SRT)

    Immediately after every F-ESWT treatment, for 3sessions

  • Toe touch test (TT)

    Immediately after every F-ESWT treatment, for 3sessions

Study Arms (2)

F-ESWT

EXPERIMENTAL

F-EWST with 0.15 mJ/mm2 intensity and 6 Hz frequency for 3 weeks. The shocking head was placed at the muscle positions of the long head of the bicep femoris, semitendinosus, and semimembranosus for 1,000, 500, and 500 shocks, respectively, accounting for 2,000 shocks in total/ session/week.

Device: focus extracorporeal shock wave therapyBehavioral: Home stretching program

Sham-ESWT

SHAM COMPARATOR

sham ESWT by using the focused shockwave device and placing the shocking head in the same muscle positions as performed in the intervention group with 0.01 mJ/mm2 intensity and 6 Hz frequency in 2,000 shocks/session/week for 3 weeks.

Behavioral: Home stretching program

Interventions

focus extracorporeal shock wave therapyDEVICE

F-EWST with 0.15 mJ/mm2 intensity and 6 Hz frequency for 3 weeks. The shocking head was placed at the muscle positions of the long head of the bicep femoris, semitendinosus, and semimembranosus for 1,000, 500, and 500 shocks, respectively, accounting for 2,000 shocks in total/ session/week.

F-ESWT
Home stretching programBEHAVIORAL

The leaflet on hamstring stretching exercises (in a sitting posture)

F-ESWTSham-ESWT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Limited hamstring flexibility; passive knee extension degree \>20
  • No underlying disease

You may not qualify if:

  • Patients with history of physical therapy in past 3 month
  • Patient with analgesic drug such as muscle relaxant or NSAID.
  • Patient with limited hamstring flexibility due to neurological or musculoskeletal diseases.
  • Patient with cardiac pacemaker, pregnancy, hypercoagulable conditions, severe osteoporosis, malignancy or active infection around intervention site.
  • Patient with history of chronic knee or back pain
  • Patient cannot follow home stretching exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical medicine and rehabilitation

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Kim YW, Chang WH, Kim NY, Kwon JB, Lee SC. Effect of Extracorporeal Shock Wave Therapy on Hamstring Tightness in Healthy Subjects: A Pilot Study. Yonsei Med J. 2017 May;58(3):644-649. doi: 10.3349/ymj.2017.58.3.644.

    PMID: 28332373BACKGROUND

Study Officials

  • Songsuda Roongsaiwatana, M.D.

    Ramathibodi Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 27, 2023

Study Start

September 1, 2020

Primary Completion

January 31, 2021

Study Completion

August 1, 2021

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)