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Effect of Wrist Stabilization Exercise Combined with Taping on Wrist Pain and Function in Postpartum Women with Wrist Pain

Status Approved

  • First Submitted Date

    2021/03/11

  • Registered Date

    2021/03/17

  • Last Updated Date

    2021/03/10

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006011
    Unique Protocol ID 1044396-202010-HR-184-01
    Public/Brief Title Effect of Wrist Stabilization Exercise Combined with Taping on Wrist Pain and Function in Postpartum Women with Wrist Pain
    Scientific Title Effect of Wrist Stabilization Exercise Combined with Taping on Wrist Pain and Function in Postpartum Women with Wrist Pain
    Acronym Wrist Stabilization Exercise with Taping on pain and function in Postpartum Women
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1044396-202010-HR-184-01
    Approval Date 2020-11-09
    Institutional Review Board Name Gachon University Institutional Review Board
    Institutional Review Board Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-750-8566
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hwi-young Cho
    Title Associate Professor
    Telephone +82-32-820-4560
    Affiliation Gachon University
    Address Bogeongwahaggan 611, Gachon university Medical campus, 191, Hambangmoe-ro, Yeonsu-gu, Incheon, Republic of Korea
    Contact Person for Public Queries
    Name Tae-sung In
    Title Assistant Professor
    Telephone +82-54-420-4068
    Affiliation Gimcheon University
    Address 214 Daehak-ro, Gimcheon, Gyeongsangbuk-do Province, Republic of Korea
    Contact Person for Updating Information
    Name Hwi-young Cho
    Title Associate Professor
    Telephone +82-32-820-4560
    Affiliation Gachon University
    Address Bogeongwahaggan 611, Gachon university Medical campus, 191, Hambangmoe-ro, Yeonsu-gu, Incheon, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-11-12 Actual
    Target Number of Participant 45
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Gimcheon University
    Recruitment Status Completed
    Date of First Enrollment 2020-11-12 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Gachon University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Gachon University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Introduction
    Physical problems in women after childbirth are considered a risk factor for health and emotional well-being, and various musculoskeletal pains such as back, neck, and shoulders are common.
    Wrist pain that occurs after childbirth is called “DeQuervain Disease” or “baby wrist” and is common in clinical practice. This pain is due to several causes including strain and joint relaxation.
    In a study in which taping was applied to patients with injured wrist and lower back joints, it was reported that there was an effect of improving pain and muscle strength. Park Jin-Hyun and Kim Gyeong reported that the grip strength and muscle activity were improved as a result of taping in patients with lateral gastric arthritis. It is said that taping can improve the motor function of the muscle by increasing blood and lymph circulation between the muscle and the skin, and prevent secondary damage by improving the function of the damaged muscle and joint.
    Several studies report that taping significantly improved pain and dysfunction, but studies on wrist pain in women after childbirth are insufficient. In addition, it has not been confirmed that there is a more significant therapeutic effect when combined with stabilization exercise in a relaxed state of the joint after childbirth.
    
    Aim
    The purpose of this study is to evaluate the effects of wrist stabilization exercise combined with taping on wrist pain, disability, and quality of life in postpartum women with wrist pain. 
    
    Subjects
    Forty-five patients with wrist pain will be recruited and randomly divided into three groups: the Wrist stabilization exercise + Taping therapy (WSE+TT) group (n=15), the Wrist stabilization exercise (WSE) group (n=15), and the control group (n=15). 
    
    Intervention
    The WSE+TT and WSE groups will perform wrist stabilization exercises for 40 minutes (once a day, five times a week for eight weeks), and the control group will perform P-ROM exercise for the same amount of time. Additionally, the WSE+TT group attach taping to the wrist and forearm during the training period. 
    
    Outcome measurements
    The VAS will be used to assess pain level of the wrist. The DASH and SF-36 will be used to evaluate the degree of wrist disability and quality of life, respectively.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator, Outcome Accessor
    Allocation RCT
    Intervention Type Behavioral, Others (Taping)
    Intervention Description
    The intervention method was designed through an expert meeting of 3 professional therapists with more than 5 years of experience in musculoskeletal physical therapy and 2 professors in the department of physical therapy. The WSE+TT and WSE groups performed wrist stabilization exercises for 40 minutes a day for 8 weeks, using elastic bands and dumbbells. After fixing the elastic band to the ring, an isometric contraction exercise was performed for the wrist flexor and extensor, radial, and ulnar deviation muscles in a sitting or standing position so that the elastic band was at the front, back, left, and right sides of the body. In each direction, three sets of 10 repetitions were performed as a method of maintaining for 10 seconds against resistance, and a 1-minute break between sets was provided. In addition, the dumbbell was held in the hand in a sitting position, and the arm was raised to the front, back, and sideways (shoulder flexion, extension, abduction) to the height possible while maintaining the wrist in a neutral position for 10 seconds. Each was performed 10 times. Thera-Band (TheraBand, Akron, USA) offers a different amount of resistance depending on the band color. Therefore, the Thera-Band band of appropriate strength was selected for each patient by the therapist. Dumbbells were gradually increased from 0.5 kg to 2 kg according to the patient's condition every week. The control group performed passive ROM exercise for wrist flexion, extension radial & ulnar deviation instead of stabilization exercise for the same time as other groups for the same time period.
    For taping, an elastic tape of about 60-80 cm in length was used depending on the length of the forearm, and with the muscle stretched as much as possible, the wrist extensor and flexor muscles were attached from the origin to insertion site of the muscle. An elastic tape of approximately 15 cm in length was wound around the wrist one round starting from the radial side of the wrist.
    Number of Arms 3
    Arm 1

    Arm Label

    WSE+TT group

    Target Number of Participant

    15

    Arm Type

    Active comparator

    Arm Description

    WSE+TT group performs wrist stabilization exercises for 40 minutes a day for 8 weeks, using elastic bands and dumbbells. After fixing the elastic band to the ring, an isometric contraction exercise is performed for the wrist flexor and extensor, radial, and ulnar deviation muscles in a sitting or standing position so that the elastic band is at the front, back, left, and right sides of the body.
    In each direction, three sets of 10 repetitions are performed as a method of maintaining for 10 seconds against resistance, and a 1-minute break between sets is provided.
    In addition, the dumbbell is held in the hand in a sitting position, and the arm is raised to the front, back, and sideways (shoulder flexion, extension, abduction) to the height possible while maintaining the wrist in a neutral position for 10 seconds. Each was performed 10 times.
    Thera-Band (TheraBand, Akron, USA) offers a different amount of resistance depending on the band color. Therefore, the Thera-Band band of appropriate strength is selected for each patient by the therapist. Dumbbells are gradually increased from 0.5 kg to 2 kg according to the patient's condition every week.
    For taping, an elastic tape of about 60-80 cm in length is used depending on the length of the forearm, and with the muscle stretched as much as possible, the wrist extensor and flexor muscles were attached from the origin to insertion site of the muscle. An elastic tape of approximately 15 cm in length is wound around the wrist one round starting from the radial side of the wrist.
    Arm 2

    Arm Label

    WSE group

    Target Number of Participant

    15

    Arm Type

    Sham comparator

    Arm Description

    WSE group performs wrist stabilization exercises for 40 minutes a day for 8 weeks, using elastic bands and dumbbells. After fixing the elastic band to the ring, an isometric contraction exercise is performed for the wrist flexor and extensor, radial, and ulnar deviation muscles in a sitting or standing position so that the elastic band is at the front, back, left, and right sides of the body.
    In each direction, three sets of 10 repetitions are performed as a method of maintaining for 10 seconds against resistance, and a 1-minute break between sets is provided.
    In addition, the dumbbell is held in the hand in a sitting position, and the arm is raised to the front, back, and sideways (shoulder flexion, extension, abduction) to the height possible while maintaining the wrist in a neutral position for 10 seconds. Each was performed 10 times.
    Thera-Band (TheraBand, Akron, USA) offers a different amount of resistance depending on the band color. Therefore, the Thera-Band band of appropriate strength is selected for each patient by the therapist. Dumbbells are gradually increased from 0.5 kg to 2 kg according to the patient's condition every week.
    Arm 3

    Arm Label

    Control group

    Target Number of Participant

    15

    Arm Type

    Sham comparator

    Arm Description

    The control group performs passive ROM exercise for wrist flexion, extension radial & ulnar deviation instead of stabilization exercise for the same time as other groups for the same time period.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (O00-O99)Pregnancy, childbirth and the puerperium 
       (O99.8)Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium 

    Postpartum women with wrist pain
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~40Year

    Description

    Postpartum women with wrist pain has a visual analogue scale (VAS) of 30 mm or higher, and has never experienced wrist pain before pregnancy and had been given birth for less than 1 year.
    Exclusion Criteria
    Subjects taking pain-related medications or receiving other treatments are excluded.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Pain intensity using 100-mm VAS
    Timepoint
    Pre and post intervention
    Secondary Outcome(s) 1
    Outcome
    Wrist dysfunction using the DASH questionnaire
    Timepoint
    Pre and post intervention
    Secondary Outcome(s) 2
    Outcome
    Quality of life using the Short Form 36 (SF-36) questionnaire
    Timepoint
    Pre and post intervention
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2022. 10
    Way of Sharing Available on Request
    (hwiyoung@gachon.ac.kr)
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