Hand OsteoarthritisNCT02701335
Manual Therapy for Hand Osteoarthritis
A study testing Neural mobilization, Gloreha device and Standardized exercise in people with Hand Osteoarthritis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Neural mobilization, Gloreha device and Standardized exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Neural mobilization, Gloreha device, Standardized exercise
- Keywords
- Osteoarthritis, Hand, Rehabilitation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilizationDevice
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 deviceDevice
Robotic assisted passive mobilization.
Standardized exerciseDevice
9 exercises: active range of motion, strengthen grip and pinch
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Neural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week). Receives: Device: Neural mobilization; Device: Standardized exercise |
| Control group | Active comparator | Gloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week). Receives: Device: Gloreha device; Device: Standardized exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Pain intensity at 3 months
visual analogue scale
Measured: 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
Measured: 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.
Measured: Baseline and immediately post-interventionand, at 1- and 3-month post-interventions.
Secondary outcomes (2)
Motor conduction velocity
Measured: Baseline up to 5 minutes
Range of Motion
Measured: Baseline up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701335
- Sponsor's protocol ID
- Project Code:GR-2013-02358472
- Status last verified
- Aug 2016
- First submitted
- 27 Feb 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31675184
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02701335
- Acronym / sponsor ID
- Project Code:GR-2013-02358472
- Conditions
- Hand Osteoarthritis
- Keywords
- Osteoarthritis, Hand, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Neural mobilization, Device: Standardized exerciseNeural mobilization and standardized exercise . 12 sessions over 4 weeks (3 sessions per week). |
| Control group | Active comparator | Device: Gloreha device, Device: Standardized exerciseGloreha device and standardized exercise. 12 sessions over 4 weeks (3 sessions per week). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural mobilizationThe 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 | Experimental group |
| Gloreha deviceRobotic assisted passive mobilization. | Device | Control group |
| Standardized exercise9 exercises: active range of motion, strengthen grip and pinch | Device | Control group, Experimental group |
Primary outcome
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
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
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.
2 secondary outcomes
Motor conduction velocity
Time frame: Baseline up to 5 minutes
Range of Motion
Time frame: Baseline up to 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Derived from this study: PubMed 31675184Pedersini 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.
- Individual participant dataSharing planned: No
Related trials for Hand Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
Recruiting
Acupuncture vs Sham Acupuncture for Hand Osteoarthritis
Hand Osteoarthritis
Not yet recruitingPhase 2
Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis
Hand Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization, Gloreha device and Standardized exercise in people with Hand Osteoarthritis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.