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
CRIS Registration Number |
KCT0006011 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Gachon University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Gachon University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2022. 10 |
Way of Sharing | Available on Request
(hwiyoung@gachon.ac.kr) |
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