Complex Decongestive Therapy on Distal Radius Fracture

NCT04484584 | Completed

• 1 other identifier: Traumatic Edema
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Myometer test

  at baseline

• Myometer test

  4.week

• Dynamometer test

  at baseline

• Dynamometer test

  4.week

Study Arms (2)

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

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

Interventions

complex decongestive therapy OTHER

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.

Complex Decongestive Therapy Group (CDT); Orthopedic Rehabilitation Group (OR)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with distal radius fracture

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi konuk training and research hospital

Istanbul, 34158, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31623957 BACKGROUND

• 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.

  PMID: 25100773 BACKGROUND

• 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.

  PMID: 28807598 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• meltem vural

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• banu aydeniz

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• tuba Altun

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Hasan Kerem Alptekin

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc,Physotherapist

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 23, 2020
• Study Start: March 17, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

TU (1)