Hamstring TightnessNCT05702697
The Efficacy of Focus Extracorporeal Shock Wave Therapy on Hamstring Tightness
A study testing focus extracorporeal shock wave therapy and Home stretching program in people with Hamstring Tightness, run by Mahidol University at 1 site in Thailand.
Trial summary
To study efficacy of focus extracorporeal shock wave therapy on the flexibility of hamstring muscles in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Tightness
- What is being tested?
- focus extracorporeal shock wave therapy and Home stretching program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Limited hamstring flexibility; passive knee extension degree >20
- No underlying disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Hamstring Tightness
- Being tested
- focus extracorporeal shock wave therapy, Home stretching program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Home stretching programBehavioural
The leaflet on hamstring stretching exercises (in a sitting posture)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: focus extracorporeal shock wave therapy; Behavioral: 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. Receives: Behavioral: Home stretching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after every F-ESWT treatment, for 3sessions
Secondary outcomes (3)
Back-saver sit-and-reach test (BSSR)
Measured: Immediately after every F-ESWT treatment, for 3sessions
Sit and reach test (SRT)
Measured: Immediately after every F-ESWT treatment, for 3sessions
Toe touch test (TT)
Measured: Immediately after every F-ESWT treatment, for 3sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Sep 2020
- Primary completion31 Jan 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hamstring TightnessStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songsuda Roongsaiwatana, Mahidol University
- Investigators
- Songsuda Roongsaiwatana, M.D., Study director, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702697
- Sponsor's protocol ID
- COA. MURA2020/1084
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28332373
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Focus Extracorporeal Shock Wave Therapy on Hamstring Tightness in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05702697
- Acronym / sponsor ID
- COA. MURA2020/1084
- Conditions
- Hamstring Tightness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study efficacy of focus extracorporeal shock wave therapy on the flexibility of hamstring muscles in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-ESWT | Experimental | Device: focus extracorporeal shock wave therapy, Behavioral: Home stretching programF-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. |
| Sham-ESWT | Sham comparator | Behavioral: Home stretching programsham 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Limited hamstring flexibility; passive knee extension degree >20
- No underlying disease
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focus extracorporeal shock wave therapyF-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 | F-ESWT |
| Home stretching programThe leaflet on hamstring stretching exercises (in a sitting posture) | Behavioural | F-ESWT, Sham-ESWT |
Primary outcome
Passive knee extension test
Time frame: Immediately after every F-ESWT treatment, for 3sessions
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
3 secondary outcomes
Back-saver sit-and-reach test (BSSR)
Time frame: Immediately after every F-ESWT treatment, for 3sessions
Sit and reach test (SRT)
Time frame: Immediately after every F-ESWT treatment, for 3sessions
Toe touch test (TT)
Time frame: Immediately after every F-ESWT treatment, for 3sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 28332373Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songsuda Roongsaiwatana, M.D. study director
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focus extracorporeal shock wave therapy and Home stretching program in people with Hamstring Tightness, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive knee extension test (time frame: Immediately after every F-ESWT treatment, for 3sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.