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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Transfemoral Amputation; Painful Bone Spur
• Intervention / Treatment: Device: Extracorporeal shockwave therapy (ESWT); Other: Therapeutic exercise; Device: sham ESWT

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Ankara, Turkey, Turkey (Türkiye)
      • Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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
Active Comparator: ESWT + therapeutic exercise	Device: 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; Other: Therapeutic exercise; 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 Comparator: sham ESWT + therapeutic exercise	Other: Therapeutic exercise; 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; Device: sham ESWT; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline, 4 weeks post-application, and 12 weeks post-application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Extremity Functional Scale	The scale can be scored from 0 to 80 points. Higher scores indicate better functionality.	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.	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.	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.	At baseline, 4 weeks post-application, and 12 weeks post-application

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Amputation; Extracorporeal Shockwave Therapy; Bone spur
• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Exostoses; Hyperostosis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Osteophyte; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy; Exercise Therapy
• Other Study ID Numbers: E-68869993-000-1309046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There should be a commitment that patient data will only be shared with the ethics committee upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No