Manual Therapy for Hand Osteoarthritis

Hand Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02701335
• Other study ID #: Project Code:GR-2013-02358472
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 27, 2016
• Last updated: August 25, 2016
• Start date: July 2016
• Est. completion date: April 2018

Study information

• Verified date: August 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

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.
• Gloreha device
Robotic assisted passive mobilization.
• Standardized exercise
9 exercises: active range of motion, strengthen grip and pinch

Locations

Country	Name	City	State
Italy	Jorge Hugo Villafañe	Piossasco	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	Yes
Primary	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.	Yes
Secondary	Motor conduction velocity		Baseline up to 5 minutes	Yes
Secondary	Range of Motion		Baseline up to 5 minutes	Yes