Traumatic Transfemoral AmputationNCT07440550
Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees
A study testing Extracorporeal shockwave therapy (ESWT) and Therapeutic exercise in people with Traumatic Transfemoral Amputation and Painful Bone Spur, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Painful bone spur is one of the causes of residual limb pain in individuals with traumatic lower extremity amputation and can be a significant problem in rehabilitation clinics. This study aimed to investigate the effectiveness of extracorporeal shockwave therapy (ESWT) on pain and size of bone spur in traumatic… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Traumatic Transfemoral Amputation, Painful Bone Spur
- What is being tested?
- Extracorporeal shockwave therapy (ESWT) and Therapeutic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2024to 15 Sep 2025
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral transfemoral amputation due to trauma for at least 6 months
- male aged between 18 and 65
- pain in the stump region of 3 or more on the visual analog scale (VAS) for at least 1 month
- bone spur in the stump diagnosed by radiography
- failure to provide sufficient benefit from previous conservative treatment (lack of at least 50% pain reduction with analgesics and nonsteroidal anti-inflammatory drugs)
- failure to provide adequate response to socket revision
Who cannot join
- infection, cellulite, neuroma, fracture, skin problems that may cause pain in the stump other than bone spur
- corticosteroid injection or surgery to the stump in the last 6 months
- conditions in which the use of ESWT is contraindicated, such as bone tumors, metabolic bone problems, nerve conduction and blood circulation disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
Ankara, Turkey
About this study
Official title: Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees: A Randomized Controlled Trial
Painful bone spur is one of the causes of residual limb pain in individuals with traumatic lower extremity amputation and can be a significant problem in rehabilitation clinics. This study aimed to investigate the effectiveness of extracorporeal shockwave therapy (ESWT) on pain and size of bone spur in traumatic transfemoral amputees with painful bone spur. Twenty nine traumatic transfemoral amputees who had painful spur were randomized into two groups: Group 1 (ESWT + therapeutic exercise) and Group 2 (sham ESWT + therapeutic exercise). The visual analog scale for pain felt in the stump at rest and during walking with the prosthesis, the lower extremity functional scale, Houghton scale, Locomotor capacity index, and radiologically determined bone spur size were used as outcome measures. All participants were evaluated before, 4 weeks after, and 12 weeks after ESWT/sham ESWT application.
- Being tested
- Extracorporeal shockwave therapy (ESWT), Therapeutic exercise, sham ESWT
- Keywords
- Amputation, Bone spur, Extracorporeal Shockwave Therapy, Pain
- Medical subject headings
- Osteophyte, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapy (ESWT)Device
Participants in Group 1 received a total of four sessions of ESWT, once a week for four consecutive weeks, with an intensity of 0.3 mj/mm2, a frequency of 4 Hz, and 1500 pulses/session
Therapeutic exerciseOther
Balance-coordination and endurance-enhancing exercises, range of motion exercises, isometric and isotonic strengthening exercises were applied to patients in both groups five days a week for four weeks
sham ESWTDevice
Participants in Group 2 received a total of four sessions of sham ESWT, once a week for four consecutive weeks, with an intensity of 0 mj/mm2, a frequency of 4 Hz, and 1500 pulses/session
| Study group | Role | What they receive |
|---|---|---|
| ESWT + therapeutic exercise | Active comparator | Not described Receives: Device: Extracorporeal shockwave therapy (ESWT); Other: Therapeutic exercise |
| sham ESWT + therapeutic exercise | Sham comparator | Not described Receives: Other: Therapeutic exercise; Device: sham ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale at rest and during walking with the prosthesis. It is a 10 cm scale, that 0 demostrates no pain and 10 indicates the most unbearable pain
Measured: At baseline, 4 weeks post-application, and 12 weeks post-application
Secondary outcomes (4)
Lower Extremity Functional Scale
The scale can be scored from 0 to 80 points. Higher scores indicate better functionality.
Measured: At baseline, 4 weeks post-application, and 12 weeks post-application
Houghton Scale
The total score ranges from a minimum of 0 to a maximum of 12; higher scores indicate better performance and comfort.
Measured: At baseline, 4 weeks post-application, and 12 weeks post-application
Locomotor Capacity Index
The maximum score is 42, and locomotor ability increases as the total score increases.
Measured: At baseline, 4 weeks post-application, and 12 weeks post-application
Radiologically determined size of bone spur
Anterior-posterior/lateral X-ray images of the remaining femur are taken, and the size of the bony prominence is measured in millimeters.
Measured: At baseline, 4 weeks post-application, and 12 weeks post-application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start16 Mar 2024
- Primary completion15 Mar 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Transfemoral AmputationStudies of the same condition, open and under way.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdan Korkmaz, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440550
- Sponsor's protocol ID
- E-68869993-000-1309046
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There should be a commitment that patient data will only be shared with the ethics committee upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07440550
- Acronym / sponsor ID
- E-68869993-000-1309046
- Keywords
- Amputation, Bone spur, Extracorporeal Shockwave Therapy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 27 Feb 2026 (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.
Painful bone spur is one of the causes of residual limb pain in individuals with traumatic lower extremity amputation and can be a significant problem in rehabilitation clinics. This study aimed to investigate the effectiveness of extracorporeal shockwave therapy (ESWT) on pain and size of bone spur in traumatic transfemoral amputees with painful bone spur. Twenty nine traumatic transfemoral amputees who had painful spur were randomized into two groups: Group 1 (ESWT + therapeutic exercise) and Group 2 (sham ESWT + therapeutic exercise). The visual analog scale for pain felt in the stump at rest and during walking with the prosthesis, the lower extremity functional scale, Houghton scale, Locomotor capacity index, and radiologically determined bone spur size were used as outcome measures. All participants were evaluated before, 4 weeks after, and 12 weeks after ESWT/sham ESWT application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT + therapeutic exercise | Active comparator | Device: Extracorporeal shockwave therapy (ESWT), Other: Therapeutic exercise |
| sham ESWT + therapeutic exercise | Sham comparator | Other: Therapeutic exercise, Device: sham ESWT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- unilateral transfemoral amputation due to trauma for at least 6 months
- male aged between 18 and 65
- pain in the stump region of 3 or more on the visual analog scale (VAS) for at least 1 month
- bone spur in the stump diagnosed by radiography
- failure to provide sufficient benefit from previous conservative treatment (lack of at least 50% pain reduction with analgesics and nonsteroidal anti-inflammatory drugs)
Key exclusion criteria (3 listed)
- infection, cellulite, neuroma, fracture, skin problems that may cause pain in the stump other than bone spur
- corticosteroid injection or surgery to the stump in the last 6 months
- conditions in which the use of ESWT is contraindicated, such as bone tumors, metabolic bone problems, nerve conduction and blood circulation disorders
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 |
|---|---|---|
| Extracorporeal shockwave therapy (ESWT)Participants in Group 1 received a total of four sessions of ESWT, once a week for four consecutive weeks, with an intensity of 0.3 mj/mm2, a frequency of 4 Hz, and 1500 pulses/session | Device | ESWT + therapeutic exercise |
| Therapeutic exerciseBalance-coordination and endurance-enhancing exercises, range of motion exercises, isometric and isotonic strengthening exercises were applied to patients in both groups five days a week for four weeks | Other | ESWT + therapeutic exercise, sham ESWT + therapeutic exercise |
| sham ESWTParticipants in Group 2 received a total of four sessions of sham ESWT, once a week for four consecutive weeks, with an intensity of 0 mj/mm2, a frequency of 4 Hz, and 1500 pulses/session | Device | sham ESWT + therapeutic exercise |
Primary outcome
Visual Analog Scale
Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application
Visual Analog Scale at rest and during walking with the prosthesis. It is a 10 cm scale, that 0 demostrates no pain and 10 indicates the most unbearable pain
4 secondary outcomes
Lower Extremity Functional Scale
Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application
Houghton Scale
Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application
Locomotor Capacity Index
Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application
Radiologically determined size of bone spur
Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application
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 Feb 2026.
- Individual participant dataSharing planned: No. There should be a commitment that patient data will only be shared with the ethics committee upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave therapy (ESWT) and Therapeutic exercise in people with Traumatic Transfemoral Amputation and Painful Bone Spur, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 Feb 2026. 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 Turkey (Türkiye). 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?
Visual Analog Scale (time frame: At baseline, 4 weeks post-application, and 12 weeks post-application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2026.