Clinical Trials Directory

Trials / Completed

CompletedNCT04738201

Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis

Investigation of Clinical Effects of a Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis: A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
University of Malaga · Academic / Other
Sex
Female
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. The aim of the proposed study is to assess the effect of proprioceptive training on pain, function and sense perception in patients with carpometacarpal osteoarthritis (CMC OA).

Detailed description

A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of CMC joint OA grade 1-2 (aged 18 years and above). Both assessor and statistician will remained blinded. The research diagnostic criteria for carpometacarpal joint osteoarthritis will be used to assess all individuals who agree to participate. Based on the clinical and radiological findings, the participants will be classified by a rheumatology. Those with CMC OA grade 2-3 will be included in the study. Standard conservative thumb CMC joint OA treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions). The severity of pain with activity will be measured according to the visual analog scale (VAS). QuickDASH questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) testing. All outcome measures will be collected at baseline, immediately following the intervention at 4 weeks and at 12 weeks following the end of the intervention. Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria. All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.

Conditions

Interventions

TypeNameDescription
OTHERProprioceptive thumb exercises.Exercises for recognition of thumb position and thumb force sense.

Timeline

Start date
2021-03-20
Primary completion
2021-04-26
Completion
2021-06-10
First posted
2021-02-04
Last updated
2022-03-10

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04738201. Inclusion in this directory is not an endorsement.