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Standard of Care for Arthritis of the Hand

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Arthritis of the Hand+2 MoreStandard of care - Other
Eligibility
21 - 80
All Sexes
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Study Summary

The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with chronic hand joint pain due to arthritis.

Eligible Conditions
  • Arthritis of the Hand
  • Chronic Pain
  • Opioid Use Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Standard of care
1
Ruxolitinib
1
Standard of care

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Change from baseline to day 30

Day 30
Milligrams of Morphine Equivalent (MME)
Non-opioid pain medicine usage
Pain Disability Index (PDI)
Pain intensity, Emotional function, and General physical function (PEG) scale
Patient Health Questionnaire (PHQ-9)
The Pain, Enjoyment of Life and General Activity scale (PEG)

Trial Safety

Safety Progress

1 of 3

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1
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1
Ruxolitinib
2
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Side Effects for

Cinacalcet
32%Nausea
24%Vomiting
13%Diarrhoea
7%Nasopharyngitis
5%Muscle spasms
1%Pneumonia
1%Coronary artery disease
1%Arrhythmia
1%Angina pectoris
1%Cardiac failure congestive
1%Myocardial infarction
1%Gastrointestinal haemorrhage
1%Catheter related complication
1%Arthritis bacterial
1%Bronchopneumonia
1%Gastroenteritis
1%Gastrointestinal infection
1%Septic shock
1%Arteriovenous fistula site complication
1%Fall
1%Joint dislocation
1%Shunt stenosis
1%Shunt occlusion
1%Dehydration
1%Fluid retention
1%Hypoglycaemia
1%Transient ischaemic attack
1%Dyspnoea
1%Pulmonary oedema
1%Shock
1%Respiratory tract infection
This histogram enumerates side effects from a completed 2007 Phase 4 trial (NCT00110890) in the Cinacalcet ARM group. Side effects include: Nausea with 32%, Vomiting with 24%, Diarrhoea with 13%, Nasopharyngitis with 7%, Muscle spasms with 5%.

Trial Design

2 Treatment Groups

AR digital treatment
1 of 2
Standard of Care
1 of 2

Active Control

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: Standard of Care · No Placebo Group · N/A

Standard of Care
Other
Experimental Group · 1 Intervention: Standard of care · Intervention Types: Other
AR digital treatment
Device
ActiveComparator Group · 1 Intervention: Nottingham AR smartphone app with active intervention · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to day 30

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,248 Previous Clinical Trials
2,029,051 Total Patients Enrolled
San Diego Veterans Healthcare SystemFED
32 Previous Clinical Trials
3,879 Total Patients Enrolled
VRx Medical IncLead Sponsor
Thomas Rutledge, PhDPrincipal InvestigatorSan Diego Veterans Healthcare System
2 Previous Clinical Trials
650 Total Patients Enrolled

Eligibility Criteria

Age 21 - 80 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female adult.
You have chronic hand pain at a severity of 4 and above (on a 0 to 10 scale) daily.
References

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