Traumatic Transfemoral Amputation, Painful Bone Spur
Conditions
Keywords
Amputation, Bone spur, Extracorporeal Shockwave Therapy, Pain
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.
Interventions
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 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
DEVICEsham 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
Sponsors
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Functional Scale | 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. |
| Houghton Scale | 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. |
| Locomotor Capacity Index | 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. |
| Radiologically determined size of bone spur | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed