Clinical trial NCT04484584: Complex Decongestive Therapy on Distal Radius Fracture
Official title: The Effect of Complex Decongestive Treatment on Edema and Hand Functions in Patients With Distal Radius Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fracture
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2020-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with distal radius fracture

Brief summary: Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged exudation period create a physiological problem. It causes the recovery time of tissues to be completed late and the functional gains to be delayed.

The aim of the study is to investigate the effect of Complex decongestive therapy on traumatic edema, pain and functionality.

Detailed description: Patients are composed of patients who are referred to the physical medicine and rehabilitation clinic. All patients eligible for the study were informed about treatment and possible risks, and a consent form was signed. Determined evaluations were made to the patients. After 3 weeks of treatment, patients will be invited to the controls and the long-term effects of the treatments will be investigated.

Patients with a diameter difference of more than 50 ml between two extremities and patients without Sudeck Atrophy will be included in the treatment.

The study was planned as a single blind with randomized control. The physiotherapist who performed the treatment received manual lymph drainage therapy training.

The patients were distributed to groups with a computer-based data distribution system. While the patients are sent for treatment, they are directed according to the first assessment. The person who performed the assessment and those who received treatment were planned differently.

The primary purpose of the study was to investigate the long-term effectiveness of complex decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions. Other objectives are to investigate the long-term effects on range of motion, muscle strength, grip strength, pain, and daily living activities.

Eligibility criteria: Inclusion Criteria:

* Over 45 years
* Unilateral distal radius fracture treated with plaster cast
* Begin treatment after (7-10) days after removing the plaster
* At least 50 mL of the volume difference between the upper extremities
* Having signed the consent form

Exclusion Criteria:

* Associated ulna fracture
* Pathological fracture
* polytrauma
* Bilateral fractures
* With chronic kidney disease
* The presence of infection

Primary outcomes:
measure: Volumetric test measurement
timeFrame: at baseline
measure: Volumetric test measurement
timeFrame: 4. week
measure: Michigan Hand Outcomes Questionnarie
timeFrame: at baseline
measure: Michigan Hand Outcomes Questionnarie
timeFrame: 4. week
measure: Patient Rated Wrist Evaluation
timeFrame: at baseline
measure: Patient Rated Wrist Evaluation
timeFrame: 4. week
measure: Quick DASH
timeFrame: at baseline
measure: Quick DASH
timeFrame: 4. week
Secondary outcomes:
measure: Myometer test
timeFrame: at baseline
measure: Myometer test
timeFrame: 4.week
measure: Dynamometer test
timeFrame: at baseline
measure: Dynamometer test
timeFrame: 4.week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi konuk training and research hospital
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: meltem vural
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: banu aydeniz
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: tuba Altun
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahçeşehir University
name: Hasan Kerem Alptekin
role: STUDY_DIRECTOR
References:
citation: Priganc V, Walter JR, Sublett SH. Edema assessment and management practice patterns among hand therapists: Survey research. J Hand Ther. 2020 Jul-Sep;33(3):378-385. doi: 10.1016/j.jht.2019.04.005. Epub 2019 Oct 14.
citation: Rohner-Spengler M, Frotzler A, Honigmann P, Babst R. Effective Treatment of Posttraumatic and Postoperative Edema in Patients with Ankle and Hindfoot Fractures: A Randomized Controlled Trial Comparing Multilayer Compression Therapy and Intermittent Impulse Compression with the Standard Treatment with Ice. J Bone Joint Surg Am. 2014 Aug 6;96(15):1263-1271. doi: 10.2106/JBJS.K.00939.
citation: Miller LK, Jerosch-Herold C, Shepstone L. Effectiveness of edema management techniques for subacute hand edema: A systematic review. J Hand Ther. 2017 Oct-Dec;30(4):432-446. doi: 10.1016/j.jht.2017.05.011. Epub 2017 Aug 12.