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

• ClinicalTrials.gov Identifier: NCT04819139
• Recruitment Status: Completed
• First Posted: March 26, 2021
• Last Update Posted: June 18, 2021
• Sponsor: University of Malaga
• Information provided by (Responsible Party): Raquel Cantero-Téllez, University of Malaga

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Thumb Osteoarthritis; Proprioceptive Disorders; Pain, Chronic	Other: Active Excersises; Other: Reeducation ADL; Other: Joint protection; Other: Proprioception exercises	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Interaction Between Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis. A Cross-sectional Study.
• Actual Study Start Date: April 1, 2021
• Actual Primary Completion Date: April 20, 2021
• Actual Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Other: Active Excersises; Active thumb exercises; Other: Reeducation ADL; Reeducation in the activities daily life; Other: Joint protection; Used of a thumb orthosis
Experimental: 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.	Other: Active Excersises; Active thumb exercises; Other: Reeducation ADL; Reeducation in the activities daily life; Other: Joint protection; Used of a thumb orthosis; Other: Proprioception exercises; Specific proprioception exercises

Outcome Measures

Primary Outcome Measures :

1. Pain intensity [ Time Frame: baseline - 2 days ]
   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

Secondary Outcome Measures :

1. JPS [ Time Frame: baseline - 2 days ]
   For measurement of JPS, the subjects were blindfolded and repositioned their thumb to a target position, which was determined by the examiner previously
2. FS [ Time Frame: baseline- 2 days ]
   For force sense, participants should reproduce pinch force measure with dynamometer.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

Raquel Cantero-Téllez

Malaga, Málaga, Spain, 29012

Sponsors and Collaborators

University of Malaga

More Information

• Responsible Party: Raquel Cantero-Téllez, Principal investigator, University of Malaga
• ClinicalTrials.gov Identifier: NCT04819139
• Other Study ID Numbers: 2021-THUMB-1
• First Posted: March 26, 2021
• Last Update Posted: June 18, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Somatosensory Disorders; Chronic Pain; Pain; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Sensation Disorders; Nervous System Diseases