Clinical Trials Directory

Trials / Completed

CompletedNCT07440550

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Academic / Other
Sex
Male
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEExtracorporeal 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
OTHERTherapeutic 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
DEVICEsham 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

Timeline

Start date
2024-03-16
Primary completion
2025-03-15
Completion
2025-09-15
First posted
2026-02-27
Last updated
2026-02-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07440550. Inclusion in this directory is not an endorsement.