Complex Decongestive Therapy on Distal Radius Fracture

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484584
• Other study ID #: Traumatic Edema
• Status: Completed
• Start date: March 17, 2020
• Est. completion date: July 17, 2021

Study information

• Verified date: August 2022
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 17, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• complex decongestive therapy
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.

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi konuk training and research hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric test measurement	Volumetric test measurement is more than 50 mL, edema is considered to be present.	at baseline
Primary	Volumetric test measurement	Volumetric test measurement is more than 50 mL, edema is considered to be present.	4. week
Primary	Michigan Hand Outcomes Questionnarie	The 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.	at baseline
Primary	Michigan Hand Outcomes Questionnarie	The 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.	4. week
Primary	Patient Rated Wrist Evaluation	The 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.	at baseline
Primary	Patient Rated Wrist Evaluation	The 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.	4. week
Primary	Quick DASH	Quick 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.	at baseline
Primary	Quick DASH	Quick 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.	4. week
Secondary	Myometer test	Myometer 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.	at baseline
Secondary	Myometer test	Myometer 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.	4.week
Secondary	Dynamometer test	A 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	at baseline
Secondary	Dynamometer test	A 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	4.week