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

NCT04819139 | Completed

• 1 other identifier: 2021-THUMB-1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Thumb Osteoarthritis; Proprioceptive Disorders; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be measured according to the visual analog scale (VAS). The VAS scale is a unidimensional measure of pain intensity and is widely used in adult populations, including those with rheumatic diseases. Sensitivity and reliability of the instrument are well defined including sensitivity to change in pain for patients with chronic inflammatory or degenerative joint pain

  baseline - 2 days

Secondary Outcomes (2)

• JPS

  baseline - 2 days

• FS

  baseline- 2 days

Study Arms (2)

Thumb exercises +orthosis

ACTIVE COMPARATOR

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.

Other: Active Excersises; Other: Reeducation ADL; Other: Joint protection

Thumb exercises +orthosis+ proprioceptive program exercises

EXPERIMENTAL

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.

Other: Active Excersises; Other: Reeducation ADL; Other: Joint protection; Other: Proprioception exercises

Interventions

Active Excersises OTHER

Active thumb exercises

Thumb exercises +orthosis; Thumb exercises +orthosis+ proprioceptive program exercises

Reeducation ADL OTHER

Reeducation in the activities daily life

Thumb exercises +orthosis; Thumb exercises +orthosis+ proprioceptive program exercises

Joint protection OTHER

Used of a thumb orthosis

Thumb exercises +orthosis; Thumb exercises +orthosis+ proprioceptive program exercises

Proprioception exercises OTHER

Specific proprioception exercises

Thumb exercises +orthosis+ proprioceptive program exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Raquel Cantero-Téllez

Málaga, Málaga, 29012, Spain

Location

MeSH Terms

Conditions

Somatosensory Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: April 1, 2021
• Primary Completion: April 20, 2021
• Study Completion: June 1, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)