Manual Therapy for Hand Osteoarthritis
Primary Purpose
Hand Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Neural mobilization
Gloreha device
Standardized exercise
Sponsored by
About this trial
This is an interventional treatment trial for Hand Osteoarthritis focused on measuring Osteoarthritis, Hand, Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Jorge Hugo Villafañe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Neural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week).
Gloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week).
Outcomes
Primary Outcome Measures
Change from Pain intensity at 3 months
visual analogue scale
Change from QuickDASH questionnaire at 3 months
will be used to measure upper extremity function
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.
Secondary Outcome Measures
Motor conduction velocity
Range of Motion
Full Information
NCT ID
NCT02701335
First Posted
February 27, 2016
Last Updated
August 25, 2016
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT02701335
Brief Title
Manual Therapy for Hand Osteoarthritis
Official Title
Neural Manual vs. Robotic Assisted Mobilization to Improve Hand Range of Motion and Reduce Pain Hypersensitivity in Hand Osteoarthritis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Osteoarthritis
Keywords
Osteoarthritis, Hand, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Neural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Gloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week).
Intervention Type
Device
Intervention Name(s)
Neural mobilization
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Gloreha device
Intervention Description
Robotic assisted passive mobilization.
Intervention Type
Device
Intervention Name(s)
Standardized exercise
Intervention Description
9 exercises: active range of motion, strengthen grip and pinch
Primary Outcome Measure Information:
Title
Change from Pain intensity at 3 months
Description
visual analogue scale
Time Frame
baseline, immediately post-intervention, and at 1- and 3-month post-interventions, Baseline up to 5 minutes.
Title
Change from QuickDASH questionnaire at 3 months
Description
will be used to measure upper extremity function
Time Frame
baseline, immediately post-intervention, and at 1- and 3-month post-interventions Baseline, up to 5 minutes.
Title
Change from Pressure Pain Thresholds (PPT) at 3 months
Description
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.
Time Frame
Baseline and immediately post-interventionand, at 1- and 3-month post-interventions.
Secondary Outcome Measure Information:
Title
Motor conduction velocity
Time Frame
Baseline up to 5 minutes
Title
Range of Motion
Time Frame
Baseline up to 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Jorge Hugo Villafañe
City
Piossasco
State/Province
Turin
ZIP/Postal Code
10045
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31675184
Citation
Pedersini P, Valdes K, Cantero-Tellez R, Cleland JA, Bishop MD, Villafane JH. Effects of Neurodynamic Mobilizations on Pain Hypersensitivity in Patients With Hand Osteoarthritis Compared to Robotic Assisted Mobilization: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Feb;73(2):232-239. doi: 10.1002/acr.24103. Epub 2021 Jan 3.
Results Reference
derived
Learn more about this trial
Manual Therapy for Hand Osteoarthritis
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