Manual Therapy for Hand Osteoarthritis

Study Overview
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Brief Summary
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Osteoarthritis (OA) of the hand is a major cause of pain and functional limitation, central sensitization of pain can be one of the causes: this hypothesis opens avenues for research in the modulation of pain pathways. The peripherally directed therapies may modulate pain perception bilaterally. This hypothesis opens avenues for future research in the modulation of pain pathways, perhaps offering targets to optimize peripheral manual and physical therapies for pain management in hand OA. Several studies have reported the outcomes of multimodal approach to central sensitization evaluated by generalized pressure pain hypersensitivity in patients with carpometacarpal (CMC) OA. Neurodynamic techniques are a form of manual therapy directed to the neural structures through positioning and movement of multiple joints. Recent technologies have facilitated the use of robots as tools to assist patients in the rehabilitation process thus maximizing patient outcomes. These robotic tools assist the patient with carrying out exercise protocols, optimal for the activity of the control group.

Official Title
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Neural Manual vs. Robotic Assisted Mobilization to Improve Hand Range of Motion and Reduce Pain Hypersensitivity in Hand Osteoarthritis: a Randomized Controlled Trial

Conditions
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Hand Osteoarthritis

Intervention / Treatment
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* Device: Neural mobilization
* Device: Gloreha device
* Device: Standardized exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the dominant hand. To be included in the study, the subjects need to have a history of repetitive use of their dominant hand (eg, ex-factory worker) and a diagnosis of hand OA in the dominant hand, according on radiographic findings. Exclusion Criteria: If they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI). Patients with a medical history of carpal tunnel syndrome, surgical interventions to the hand, DeQuervain's tenosynovitis, or with degenerative or non-degenerative neurological conditions in which pain perception is altered will be excluded. None of the individuals in this study will have received prior interventions for hand OA.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Neural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week). | Device: Neural mobilization<br>* The first 6 exercises consist of active range of motion movements of the hand designed to improve joint flexibility. The remaining 3 exercises are designed to strengthen grip and pinch by using a non-latex polymer ball: the Thera-Band Hand Exerciser (The Hygenic Corporation, Akron, OH) Subjects began with 10 repetitions the first 4 sessions, progressed to 12 repetitions the next 2 sessions, then 15 (2 sessions), and finally 20, if able, during the last sessions.<br>Device: Standardized exercise<br>* 9 exercises: active range of motion, strengthen grip and pinch<br>|
| Active Comparator: Control group<br>Gloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week). | Device: Gloreha device<br>* Robotic assisted passive mobilization.<br>Device: Standardized exercise<br>* 9 exercises: active range of motion, strengthen grip and pinch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Pain intensity at 3 months | visual analogue scale | baseline, immediately post-intervention, and at 1- and 3-month post-interventions, Baseline up to 5 minutes. | 
| Change from QuickDASH questionnaire at 3 months | will be used to measure upper extremity function | baseline, immediately post-intervention, and at 1- and 3-month post-interventions Baseline, up to 5 minutes. | 
| Change from Pressure Pain Thresholds (PPT) at 3 months | is a quantitative sensory test of tissue sensitivity and it is defined as the minimal amount of pressure that produces pain, measured via a pressure algometer. PPT will be assessed bilaterally over the hand (first CMC at the center of the anatomical snuffbox, and unciform apophysis of the hamate bone), the C5-C6 zygapophyseal joint, the median, ulnar and radial nerves, and tibialis anterior muscle by an assessor blinded to the subjects condition. | Baseline and immediately post-interventionand, at 1- and 3-month post-interventions. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor conduction velocity |  | Baseline up to 5 minutes | 
| Range of Motion |  | Baseline up to 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Hand, Rehabilitation