Clinical trial NCT04738201: Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis
Official title: Investigation of Clinical Effects of a Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Keywords: Thumb pain
Thumb proprioception
Osteoarthritis
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Joint position Sense (JPS)
timeFrame: baseline-4 and 12 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: baseline-4 and 12 weeks
measure: Quick dash
timeFrame: baseline-4 and 12 weeks
measure: Canadian Occupational Performance Measure
timeFrame: baseline-4 and 12 weeks
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Raquel Cantero-Téllez
state: Málaga
Study officials:
References:
citation: 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.