Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis (thumb)

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

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).

Study Overview

• Status: Completed
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Other: Proprioceptive thumb exercises.

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga
    • Malaga, Málaga, Spain, 29012
      • Raquel Cantero-Téllez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage
• Pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the therapy initial evaluation.
• The ability to read and understand the patient information sheets and exercises

Exclusion Criteria:

• Neurological disorder affecting the upper limb.
• Had received specific treatment for hand or thumb pain in the same limb in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb; - Fractures or a significant hand injury or previous surgery to the wrist or hand;
• Tenosynovitis and/or Dupuytren disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group; Thumb orthosis at night. Daily exercises program during 4 weeks grouped in 3 sets of 10 repetitions in absence of pain. Exercises will 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.	Other: Proprioceptive thumb exercises.; Exercises for recognition of thumb position and thumb force sense.
EXPERIMENTAL: Experimental group; The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase.	Other: Proprioceptive thumb exercises.; Exercises for recognition of thumb position and thumb force sense.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint position Sense (JPS)	Proprioception using active joint position sense (JPS) has been utilized in studies to establish a correlation between therapy intervention and proprioception. The target position of 30º CMC abduction will be selected. Joint angle will be measured using a standard clear plastic goniometer.	baseline-4 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level.	baseline-4 and 12 weeks
Quick dash	The QuickDASH questionnaire will be used to measure upper extremity function. This tool consists of 11 items providing a total score ranging from 0 to 100 where 0 indicates no limitation and 100 suggests full disability. Eight items include questions about the ability of the patient to perform certain daily activities.	baseline-4 and 12 weeks
Canadian Occupational Performance Measure	Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM). The COPM enables subjects to identify goals for hand therapy and engage in a subject-specific therapeutic process. It has been established that the COPM has good convergent validity and responsiveness for evaluating the relationship between patient self-perception and satisfaction for patients with CMC thumb OA .	baseline-4 and 12 weeks

Collaborators and Investigators

• Sponsor: University of Malaga

Publications and helpful links

General Publications

• Cantero-Tellez R, Perez-Cruzado D, Villafane JH, Garcia-Orza S, Naughton N, Valdes K. The Effect of Proprioception Training on Pain Intensity in Thumb Basal Joint Osteoarthritis: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Mar 17;19(6):3592. doi: 10.3390/ijerph19063592.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2021
• Primary Completion (ACTUAL): April 26, 2021
• Study Completion (ACTUAL): June 10, 2021

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: January 30, 2021
• First Posted (ACTUAL): February 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Osteoarthritis; Thumb pain; Thumb proprioception
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No