Complex Decongestive Therapy on Distal Radius Fracture

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

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: complex decongestive therapy

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34158
    • Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with distal radius fracture

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Complex Decongestive Therapy Group (CDT); Complex Decongestive Therapy Group: The treatment was applied by a specialist therapist who received CDT training. The study group rehabilitation and CDT application is 1 hour. CDT Treatment Protocol: Deep abdominal technique application Neck region CDT application (supraclavicular fossa circular motion-Eflöraj) Circular movements on ipsilateral Axillar lymph nodes Circular movements on bottle neck cubital fossa Front arm bucket pumping pump push MLD application of dorsal and palmar face of the hand to ulnar and radial bundles Bandage Treatment (Fingers and hand and forearm bandage): Patients can stay for 6-8 hours or until the next day. Patients can do exercises in bandages. The patient is given home education. The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic rehabilitation is the same as the control group.	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.
Orthopedic Rehabilitation Group (OR); Orthopedic Rehabilitation Group: The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic Rehabilitation Treatment Protocol: Exercises to be done at 4 to 6 weeks: Wrist NEH (at the pain limit),active exercise,Grasp exercise Exercises to be done at 6 to 8 weeks: Wrist NEH (at the pain limit),Active assistive / active exercise, Grasp exercise,Supination-pronation exercise. (Opposite baths and classical massage are recommended from orthopedics) Exercises to be done at 8 to 10 weeks: Stretching exercises,Finger strengthening spring with Digiflex spring, Power web combo hand finger arm amplifier, Msd theraflex hand exercise dough, Theraband flevbar exercise bar. Exercises to be done at 10 to 12 weeks Wrist strengthening exercises, Resistant exercises to all muscles.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric test measurement	Volumetric test measurement is more than 50 mL, edema is considered to be present.	at baseline
Volumetric test measurement	Volumetric test measurement is more than 50 mL, edema is considered to be present.	4. week
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Principal Investigator: meltem vural, Bakırköy Dr. Sadi Konuk Training and Research Hospital; Principal Investigator: banu aydeniz, Bakırköy Dr. Sadi Konuk Training and Research Hospital; Principal Investigator: tuba Altun, Bakırköy Dr. Sadi Konuk Training and Research Hospital; Study Director: Hasan Kerem Alptekin, Bahçeşehir University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Actual): July 17, 2021
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: Traumatic Edema

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No