Manual Therapy for Hand Osteoarthritis

NCT02701335 | Unknown

• 1 other identifier: Project Code:GR-2013-02358472
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Osteoarthritis

Keywords

Osteoarthritis; Hand; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Motor conduction velocity

  Baseline up to 5 minutes

• Range of Motion

  Baseline up to 5 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

Neural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week).

Device: Neural mobilization; Device: Standardized exercise

Control group

ACTIVE COMPARATOR

Gloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week).

Device: Gloreha device; Device: Standardized exercise

Interventions

Neural mobilization DEVICE

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.

Experimental group

Gloreha device DEVICE

Robotic assisted passive mobilization.

Control group

Standardized exercise DEVICE

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

Control group; Experimental group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Jorge Hugo Villafañe

Piossasco, Turin, 10045, Italy

Location

Related Publications (1)

• 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.

  PMID: 31675184 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 27, 2016
• First Posted: March 8, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: August 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)