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Complex Decongestive Therapy on Distal Radius Fracture

The Effect of Complex Decongestive Treatment on Edema and Hand Functions in Patients With Distal Radius Fracture

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04484584
Enrollment
100
Registered
2020-07-23
Start date
2020-03-17
Completion date
2021-07-17
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

Manual lymphatic drainage Manuel lymphatic drainage therapeutic technique is used for reducing edema and symptoms related with edema by accelerating lymphatic drainage. The aim of massage along the extremity is to provide fluid drainage.Manuel lymphatic drainage stimulates the internal contraction of lymphatic channels. If interstitial space concentration of protein is reduced, it provides drainage of obstructed lymph fluid from local lymph nodes.

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Volumetric test measurementat baselineVolumetric test measurement is more than 50 mL, edema is considered to be present.
Michigan Hand Outcomes Questionnarieat baselineThe raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
Patient Rated Wrist Evaluationat baselineThe PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Quick DASHat baselineQuick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: (\[n total score / n\] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.

Secondary

MeasureTime frameDescription
Myometer testat baselineMyometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
Dynamometer testat baselineA grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 \< 34.7 34.7-54.5 \> 54.5 50-54 \< 32.9 32.9-50.7 \> 50.7 55-59 \< 30.7 30.7-48.5 \> 48.5 60-64 \< 30.2 30.2-48.0 \> 48.0 65-69 \< 28.2 28.2-44.0 \> 44.0 70-99 \< 21.3 21.3-35.1 \> 35.1 for females(in kg): 45-49 \< 18.6 18.6-32.4 \> 32.4 50-54 \< 18.1 18.1-31.9 \> 31.9 55-59 \< 17.7 17.7-31.5 \> 31.5 60-64 \< 17.2 17.2-31.0 \> 31.0 65-69 \< 15.4 15.4-27.2 \> 27.2 70-99 \< 14.7 14.7-24.5 \> 24.5

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026