Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Manual Therapy for Hand Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701335
Recruitment Status : Unknown
Verified August 2016 by Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi Onlus.
Recruitment status was:  Enrolling by invitation
First Posted : March 8, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi Onlus

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.


Condition or disease Intervention/treatment Phase
Hand Osteoarthritis Device: Neural mobilization Device: Gloreha device Device: Standardized exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Experimental group
Neural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week).
Device: Neural mobilization
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.

Device: Standardized exercise
9 exercises: active range of motion, strengthen grip and pinch

Active Comparator: Control group
Gloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week).
Device: Gloreha device
Robotic assisted passive mobilization.

Device: Standardized exercise
9 exercises: active range of motion, strengthen grip and pinch




Primary Outcome Measures :
  1. Change from Pain intensity at 3 months [ Time Frame: baseline, immediately post-intervention, and at 1- and 3-month post-interventions, Baseline up to 5 minutes. ]
    visual analogue scale

  2. Change from QuickDASH questionnaire at 3 months [ Time Frame: baseline, immediately post-intervention, and at 1- and 3-month post-interventions Baseline, up to 5 minutes. ]
    will be used to measure upper extremity function

  3. Change from Pressure Pain Thresholds (PPT) at 3 months [ Time Frame: Baseline and immediately post-interventionand, at 1- and 3-month post-interventions. ]
    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 :
  1. Motor conduction velocity [ Time Frame: Baseline up to 5 minutes ]
  2. Range of Motion [ Time Frame: Baseline up to 5 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701335


Locations
Layout table for location information
Italy
Jorge Hugo Villafañe
Piossasco, Turin, Italy, 10045
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Layout table for additonal information
Responsible Party: Jorge Hugo Villafañe, PhD, Researcher, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02701335    
Other Study ID Numbers: Project Code:GR-2013-02358472
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi Onlus:
Osteoarthritis
Hand
Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases