Investigation of Clinical Effects of a Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Malaga
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Joint position Sense (JPS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Proprioceptive thumb exercises. (Other)
Experimental group
The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase.
Intervention: Proprioceptive thumb exercises. (Other)
Outcomes
Primary Outcomes
Joint position Sense (JPS)
Time Frame: baseline-4 and 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
- Canadian Occupational Performance Measure(baseline-4 and 12 weeks)
- Visual Analogue Scale (VAS)(baseline-4 and 12 weeks)
- Quick dash(baseline-4 and 12 weeks)
Investigators
Raquel Cantero-Téllez
Principal Investigator
University of Malaga