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

NCT07440550 | Completed

• 1 other identifier: E-68869993-000-1309046
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Traumatic Transfemoral Amputation; Painful Bone Spur

Keywords

Amputation; Bone spur; Extracorporeal Shockwave Therapy; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lower Extremity Functional Scale

  At baseline, 4 weeks post-application, and 12 weeks post-application

• Houghton Scale

  At baseline, 4 weeks post-application, and 12 weeks post-application

• Locomotor Capacity Index

  At baseline, 4 weeks post-application, and 12 weeks post-application

• Radiologically determined size of bone spur

  At baseline, 4 weeks post-application, and 12 weeks post-application

Study Arms (2)

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

Interventions

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

ESWT + therapeutic exercise

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

ESWT + therapeutic exercise; sham ESWT + therapeutic exercise

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

sham ESWT + therapeutic exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Erkek
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteophyte; Pain

Interventions

Extracorporeal Shockwave Therapy; Exercise Therapy

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: March 16, 2024
• Primary Completion: March 15, 2025
• Study Completion: September 15, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)