NCT04738201

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

November 2, 2020

Last Update Submit

March 8, 2022

Conditions

Thumb Osteoarthritis

Keywords

Thumb painThumb proprioceptionOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Visual Analogue Scale (VAS)

    baseline-4 and 12 weeks

  • Quick dash

    baseline-4 and 12 weeks

  • Canadian Occupational Performance Measure

    baseline-4 and 12 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Experimental group

EXPERIMENTAL

The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase.

Other: Proprioceptive thumb exercises.

Interventions

Proprioceptive thumb exercises.OTHER

Exercises for recognition of thumb position and thumb force sense.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen over 60 diagnosis with CMC joint OA
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raquel Cantero-Téllez

Málaga, Málaga, 29012, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35329279DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2020

First Posted

February 4, 2021

Study Start

March 20, 2021

Primary Completion

April 26, 2021

Study Completion

June 10, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)