Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis

NCT ID: NCT04819139

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-06-01

Brief Summary

In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the patient during activity daily life (ADL).

The goal of the study is compared joint position error (JPE) with joint force sense error (JFSE) in subjects with carpometacarpal (CMC) joint osteoarthritis and investigated a possible correlation between thumb pain intensity and thumb proprioception in patients with CMC joint OA.

Detailed Description

Forty-five subjects over 18 with thumb CMC joint OA in the dominant hand grade 1-3 according o the Eaton Classification Stage will be evaluated for thumb active joint position sense (JPS) test and Force sense test to measure proprioception function. For measurement of JPS, the subjects will blindfolded and repositioned their thumb to a target position, which will be determined by the examiner previously. For force sense, participants will should reproduce pinch force measure with dynamometer. The severity of pain with activity will be measured according to the visual analog scale (VAS).

Conditions

Thumb Osteoarthritis; Proprioceptive Disorders; Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Thumb exercises +orthosis

Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises consisted of active - resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes.

In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain.

Group Type: ACTIVE_COMPARATOR

Active Excersises

Intervention Type: OTHER

Active thumb exercises

Reeducation ADL

Intervention Type: OTHER

Reeducation in the activities daily life

Joint protection

Intervention Type: OTHER

Used of a thumb orthosis

Thumb exercises +orthosis+ proprioceptive program exercises

Participants will be instructed to perform daily exercises grouped in 3 sets of 10 repetitions in the absence of pain for 4 weeks. If the patient experienced pain, the number of repetitions dropped sequentially until the exercise was performed pain free. Exercises consisted of active - resistive exercises for the first dorsal interosseous (FDI) muscle, manual distraction of the CMC joint and relaxation of the adductor thumb muscle. Each participant will also engaged in a one month re-education/joint protection program for thumb use during ADL's and completed a weekly record sheet for monitoring purposes.

In addiction, they will received a "thumb whale" orthosis to wear at night and during ADL's as needed for pain. In addiction, patients will received a proprioceptive program exercises using also a online program with a laptop.

Group Type: EXPERIMENTAL

Active Excersises

Intervention Type: OTHER

Active thumb exercises

Reeducation ADL

Intervention Type: OTHER

Reeducation in the activities daily life

Joint protection

Intervention Type: OTHER

Used of a thumb orthosis

Proprioception exercises

Intervention Type: OTHER

Specific proprioception exercises

Interventions

Active Excersises

Active thumb exercises

Intervention Type: OTHER

Reeducation ADL

Reeducation in the activities daily life

Intervention Type: OTHER

Joint protection

Used of a thumb orthosis

Intervention Type: OTHER

Proprioception exercises

Specific proprioception exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises

Exclusion Criteria

• Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Raquel Cantero-Téllez

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Raquel Cantero-Téllez

Málaga, Málaga, Spain

Countries

Spain

Other Identifiers

2021-THUMB-1

Identifier Type: -

Identifier Source: org_study_id