Effect of Immobilization of the Metacarpophalangeal Joint in Thumb Osteoarthritis on Pain and Function Three Months Follow up: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change of Pain intensity
研究概览
简要总结
The aim of this study is to compare the effect of Whale and Colditz static orthosis on pain and functional abilities of hand in thumb carpometacarpal osteoarthritis as a unique treatment.
Patients with thumb CMC OA will be recruited at Tecan Hand Center Clinic. Participants will be assigned using a randomized allocation in two groups. For group A a "Whale orthotic" will be constructed and for group B a Colditz orthotic. Both static splint will endorse for 3 months. Inclusion criteria for this study were adult over 18 diagnosed with carpometacarpal joint osteoarthritis with a pain intensity during Activities of Daily Living (ADL's) up to 4 / 10 on the Visual Analog Scale (VAS).
Patients were excluded from participation if they had: a neurological disorder affecting the upper limb; had received previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers or thumb; had fractures or a significant hand injury or previous surgery to the wrist or hand; had hand or finger tenosynovitis and/ or Dupuytren's disease. Were also excluded patients who did not complete Dash Spanish version questionnaire or if they did not sign the informed consent.
The outcome measure will be pain intensity and functional abilities as measured with the Visual Analogue Scale (VAS) and Disabilities of the Arm, Shoulder and Hand (DASH), respectively. All measures will be collected at baseline and end of the intervention.
详细描述
A hand therapy blinded to the subjects' intervention took baseline measurements (Spanish- Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and pain intensity) prior to randomization.
Participants were introduced in an Excel database in order of arrival and were randomized into 2 equal groups by an automatic program (Group A : Whale orthotic. Group B Colditz Orthotic). The same low temperature thermoplastic material was used for both orthoses (Orfit Colors NS 2.0 mm, micro perforated/ Orfit Industries, Wijnegem, Belgium). The orthoses were custom -fabricated for each patient by a hand therapy clinician experienced in orthopedic cases.
Both groups of patients received identical orthotic wearing instructions. Patients were asked to use the orthosis during the nighttime and also during daytime ADL's for three to four hours per day. Each patient was also provided with a data collection sheet in order to control treatment adherence. All patients were asked to report any discomfort when using the orthosis. The orthosis was the only treatment intervention received by the participants. No therapeutic exercises, modalities or other complementary treatments were offered to the patients in order not to interfere with the individual effectiveness of the orthosis. Patients were contacted by telephone a week after and were ask about pain intensity. Three months after first evaluation, participants were cited in hand therapy clinic in order to collect again outcomes measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old
- •Having diagnosed with carpometacarpal joint osteoarthritis
- •Had given their consent
排除标准
- •Had neurological disorder affecting the upper limb
- •Had received previous treatment for their hand problem in the last 6 months
- •Had hand or finger tenosynovitis
- •Suffering Dupuytren's disease.
研究组 & 干预措施
Experimental group
It is a thumb orthotic that does not include wrist joint but includes the metacarpophalangeal joint.
干预措施: Whale orthosis (Device)
Control group
It is a thumb orthotic that does not include wrist joint neither metacarpophalangeal joint.
干预措施: Colditz orthosis (Device)
结局指标
主要结局
Change of Pain intensity
时间窗: Change from Baseline and at 3-month post-interventions
Visual analogue scale
次要结局
- Change of DASH questionnaire(Change from Baseline and at 3-month post-interventions)
研究者
Raquel Cantero-Téllez
Profesor
University of Malaga
