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Completed

NCT Number: NCT04777526

Effectiveness of Proprioceptive Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis

Objective: To establish the effectiveness of a proprioceptive training program as a complementary therapy for a traditional protocol in position control, pain intensity, upper limb function and occupation performance for patients with thumb CMC joint OA.

Methods: Standard conservative thumb CMC joint OA treatments were received for both the control (n=26) and experimental groups (n=26) for a period of 12 weeks. The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions). The severity of pain with activity was measured according to the visual analog scale (VAS). QuickDASH questionnaire was used to measure upper extremity function. Patient's occupational performance was measured with the Canadian Occupational Performance Measure (COPM) and proprioception was assessed using Joint position sense (JPS) testing.

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Key information

Conditions

Thumb Osteoarthritis

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Raquel Cantero-Téllez

Málaga, 29014, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients were included if they satisfied the following inclusion criteria; over 18 years of age with a diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage (14), a minimum 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,and the ability to read and understand the patient information sheets and exercises.

Exclusion criteria

Patients were excluded from participation if they had a 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, had fractures or a significant hand injury or previous surgery to the wrist or hand, or had hand or finger tenosynovitis and/or Dupuytren disease. We also excluded patients with cognitive impairments who were not able to understand the informed consent and/or exercise program.

Treatment and study plan

Proprioception exercises

Other

Exercises for recognition of thumb position and thumb force sense.

Joint protection program

Other

Reeducation in the activities daily life

Thumb orthosis

Other

Thumb night orthosis

Manual distraction

Other

Manual distraction of CMC joint

Primary outcomes

  1. Joint position Sense (JPS)

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: baseline- 3- 12 weeks

    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.

  2. Canadian Occupational Performance Measure

    Time frame: baseline- 3- 12 weeks

    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 .

  3. Quick-dash

    Time frame: baseline- 3- 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

Clinical Effects of a Proprioceptive Thumb Exercise for Individuals With Carpometacarpal Joint Osteoarthritis: A Prospective Quasi-experimental Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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