The Efficacy of Focus Extracorporeal Shock Wave Therapy on Hamstring Tightness

The Efficacy of Focus Extracorporeal Shock Wave Therapy on Hamstring Tightness in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Hamstring Tightness
• Intervention / Treatment: Device: focus extracorporeal shock wave therapy; Behavioral: Home stretching program

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F-ESWT; 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 therapy; 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.; Behavioral: Home stretching program; The leaflet on hamstring stretching exercises (in a sitting posture)
Sham Comparator: Sham-ESWT; 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; The leaflet on hamstring stretching exercises (in a sitting posture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Study Director: Songsuda Roongsaiwatana, M.D., Mahidol University, Ramathibodi Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: COA. MURA2020/1084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No