Skip to main content
OpenTrials
Completed

NCT Number: NCT07440550

Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Transfemoral Amputation Bone Diseases Exostoses Hyperostosis Musculoskeletal Diseases Neurologic Manifestations Osteophyte Pain Painful Bone Spur Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Turkey, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for the current study :

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 exercise

Other

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 ESWT

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Lower Extremity Functional Scale

    Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application

    The scale can be scored from 0 to 80 points. Higher scores indicate better functionality.

  2. Houghton Scale

    Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application

    The total score ranges from a minimum of 0 to a maximum of 12; higher scores indicate better performance and comfort.

  3. Locomotor Capacity Index

    Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application

    The maximum score is 42, and locomotor ability increases as the total score increases.

  4. Radiologically determined size of bone spur

    Time frame: At baseline, 4 weeks post-application, and 12 weeks post-application

    Anterior-posterior/lateral X-ray images of the remaining femur are taken, and the size of the bony prominence is measured in millimeters.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Efficacy of Extracorporeal Shockwave Therapy on Painful Bone Spur in Traumatic Transfemoral Amputees: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.