Parkinson's DiseaseNCT05410392
Telemedicine Intervention in Patients With Chronic Pain in PD
A study testing Physical exercise intervention, Cognitive exercise intervention and Health education in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Pain is a very common and disabling symptom in Parkinson's disease, yet it is often untreated. This study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Physical exercise intervention, Cognitive exercise intervention and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of idiopathic PD
- At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
- Response to dopaminergic medication
Who cannot join
- Angina pectoris
- History of myocardial infarction (MI) within 6 months
- History of ventricular dysrhythmia requiring current therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Pain is a very common and disabling symptom in Parkinson's disease, yet it is often untreated. This study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. This approach would offer an easily implemented and affordable way to encourage and maintain use of these interventions by patients virtually indefinitely through remote access technology. The study findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and chronic pain.
Read the detailed description
Project Background/Rationale: Pain is one of the most disabling and common nonmotor symptoms in Parkinson's disease (PD), with a prevalence of 40-85%. Research indicates that undertreatment of pain is particularly high in the PD population. Only about one-half of patients with PD who report pain receive regular pain medications. There is increasing interest in nonpharmacological treatments for chronic pain in PD to supplement pharmacological approaches. While there is evidence to support the utility of physical exercise to improve chronic pain management, relatively less is known about the role of cognitive exercise.
Project Objective: The investigators propose to conduct a pilot randomized, controlled trial in patients with chronic pain in PD to assess the impact of physical and cognitive exercise interventions on pain outcomes.
Project Methods: A total of 166 community-dwelling Veterans, 40 years of age or older, with chronic pain in mild-to-moderate PD will be randomly assigned in a 2 x 2 factorial design to one of four groups (1 - combined cognitive and physical intervention, 2 - physical intervention only, 3 - cognitive intervention only, 4 - health education). The investigators will test the effects of the interventions at 3 months for the outcome of pain severity.
- Conditions
- Parkinson's Disease
- Being tested
- Physical exercise intervention, Cognitive exercise intervention, Health education
- Keywords
- Parkinson's disease, Pain
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise interventionBehavioural
Home-based physical exercise with the use of a stationary recumbent style bike.
Cognitive exercise interventionBehavioural
Home-based cognitive exercise with the use of smartphone to complete cognitive activities.
Health educationBehavioural
Provision of general information about a variety of topics
| Study group | Role | What they receive |
|---|---|---|
| Combined physical and cognitive exercise intervention | Experimental | Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months. Receives: Behavioral: Physical exercise intervention; Behavioral: Cognitive exercise intervention |
| Physical exercise intervention | Experimental | Participants will receive the physical exercise intervention for 3 months. Receives: Behavioral: Physical exercise intervention |
| Cognitive exercise intervention | Experimental | Participants will receive the cognitive exercise intervention for 3 months. Receives: Behavioral: Cognitive exercise intervention |
| Control group | Active comparator | Participants will receive health education for 3 months. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Change in pain severity score from baseline to 3-month follow-up is the outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jan 2023
- Primary completion31 Mar 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David William Sparrow, DSc, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410392
- Sponsor's protocol ID
- N3769-R
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Intervention in Patients With Chronic Pain in PD
- ClinicalTrials.gov ID
- NCT05410392
- Acronym / sponsor ID
- N3769-R
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Jun 2022 (actual)
- 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.
Pain is a very common and disabling symptom in Parkinson's disease, yet it is often untreated. This study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. This approach would offer an easily implemented and affordable way to encourage and maintain use of these interventions by patients virtually indefinitely through remote access technology. The study findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and chronic pain.
Detailed description
Project Background/Rationale: Pain is one of the most disabling and common nonmotor symptoms in Parkinson's disease (PD), with a prevalence of 40-85%. Research indicates that undertreatment of pain is particularly high in the PD population. Only about one-half of patients with PD who report pain receive regular pain medications. There is increasing interest in nonpharmacological treatments for chronic pain in PD to supplement pharmacological approaches. While there is evidence to support the utility of physical exercise to improve chronic pain management, relatively less is known about the role of cognitive exercise.
Project Objective: The investigators propose to conduct a pilot randomized, controlled trial in patients with chronic pain in PD to assess the impact of physical and cognitive exercise interventions on pain outcomes.
Project Methods: A total of 166 community-dwelling Veterans, 40 years of age or older, with chronic pain in mild-to-moderate PD will be randomly assigned in a 2 x 2 factorial design to one of four groups (1 - combined cognitive and physical intervention, 2 - physical intervention only, 3 - cognitive intervention only, 4 - health education). The investigators will test the effects of the interventions at 3 months for the outcome of pain severity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined physical and cognitive exercise intervention | Experimental | Behavioral: Physical exercise intervention, Behavioral: Cognitive exercise interventionParticipants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months. |
| Physical exercise intervention | Experimental | Behavioral: Physical exercise interventionParticipants will receive the physical exercise intervention for 3 months. |
| Cognitive exercise intervention | Experimental | Behavioral: Cognitive exercise interventionParticipants will receive the cognitive exercise intervention for 3 months. |
| Control group | Active comparator | Behavioral: Health educationParticipants will receive health education for 3 months. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physician diagnosis of idiopathic PD
- At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
- Response to dopaminergic medication
Key exclusion criteria (3 listed)
- Angina pectoris
- History of myocardial infarction (MI) within 6 months
- History of ventricular dysrhythmia requiring current therapy
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 |
|---|---|---|
| Physical exercise interventionHome-based physical exercise with the use of a stationary recumbent style bike. | Behavioural | Combined physical and cognitive exercise intervention, Physical exercise intervention |
| Cognitive exercise interventionHome-based cognitive exercise with the use of smartphone to complete cognitive activities. | Behavioural | Cognitive exercise intervention, Combined physical and cognitive exercise intervention |
| Health educationProvision of general information about a variety of topics | Behavioural | Control group |
Primary outcome
Pain Severity
Time frame: 3 months
Change in pain severity score from baseline to 3-month follow-up is the outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
David William Sparrow, DSc principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise intervention, Cognitive exercise intervention and Health education in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain Severity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.