NCT03815734

Brief Summary

The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery and during the period of immobilization immediately after it, applying motor imagery, improvements are achieved on pain, strength, edema and / or inflammation, function and the joint range, accelerating the recovery process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

5.1 years

First QC Date

January 16, 2019

Last Update Submit

June 30, 2024

Conditions

Keywords

Mental practicemotor imagerytrapeziometacarpal osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change from Preoperative pain to postoperative pain

    Visual Analogue Scale (VAS). "0" (better) to "10" (worse)

    2 weeks before the surgery/5, 7 and 11 weeks after surgery

Secondary Outcomes (6)

  • Mobility of hand

    2 weeks before the surgery/5, 7 and 11 weeks after surgery

  • Joint mobility

    2 weeks before the surgery/5, 7 and 11 weeks after surgery

  • Strength

    2 weeks before the surgery/5, 7 and 11 weeks after surgery

  • Edema/inflammation

    2 weeks before the surgery/5, 7 and 11 weeks after surgery

  • Quality of life and function

    2 weeks before the surgery/5, 7 and 11 weeks after surgery

  • +1 more secondary outcomes

Study Arms (2)

control group

NO INTERVENTION

Non intervention group

intervention group

EXPERIMENTAL

motor imagery group

Procedure: motor imagery

Interventions

motor imageryPROCEDURE

motor imagery during the postoperative immobilization period

intervention group

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participants on the surgical waiting list of the Hospital of León

You may not qualify if:

  • Other hand pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva

León, 24196, Spain

Location

Related Publications (2)

  • Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.

    PMID: 19345768BACKGROUND
  • Prado-Robles E, Delgado-Gil JA, Navarro-Prada SR, Rodriguez-Martin B, Gomez-Martinez M, Seco-Calvo J. The effects of motor imagery on trapeziometacarpal osteoarthritis in women during the post-surgical immobilisation period: A protocol for a randomised clinical trial. Br J Occup Ther. 2023 Aug;86(8):531-539. doi: 10.1177/03080226221137771. Epub 2022 Dec 29.

Study Officials

  • Jesús Seco Calvo

    Universidad de León

    STUDY DIRECTOR

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
SPONSOR INVESTIGATOR
PI Title
Principal investigator. Occupational Therapy

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 24, 2019

Study Start

January 1, 2019

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations