Chronic PainNCT06903962
Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)
A study testing Mind-Body Intervention in people with Chronic Pain and Chronic Pain Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow). 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain, Chronic Pain Syndrome, Repetitive Stress Injury
- What is being tested?
- Mind-Body Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2025to 1 Jun 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult (≥ 18 years of age)
- A disability score ≥ 40 as per the QuickDASH survey
- Presence of pain and perceived disability for a minimum of 3 months
- Willing to engage in a Mind-Body intervention
- Positive visualization test (onset of pain when patients visualize themselves performing tasks that generally bring on pain)
Who cannot join
- Clear organic diagnosis of pain (e.g., cancer, infection, etc…) not inclusive of non-specific findings on imaging studies (e.g., mild arthritis)
- Age greater than 60 years (due to an increased risk of there being an organic/physical cause for their pain and confounding results)
- Diagnosis of cognitive impairment or dementia
- Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
- Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered in this category
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Ashley Scafetta, 617-754-2882, ascafett@bidmc.harvard.edu
About this study
The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow).
- To determine if a mind-body intervention improves upper extremity functional capacity (ie., Disability of Arm Shoulder Hand - DASH) among people with chronic wrist, elbow, and shoulder pain
- To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants.
- To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.
- Being tested
- Mind-Body Intervention
- Medical subject headings
- Chronic Pain, Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body InterventionBehavioural
The mind-body intervention will include regular approximate 2 hour educational sessions and didactics learning mind body techniques. The sessions will be twice per week for the first 4 weeks and then subsequently once per week for a total of 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Mind-body Intervention | Experimental | Mind body techniques for the intervention will be taught in lectures and group discussion sessions Receives: Behavioral: Mind-Body Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
The DASH is a commonly used and validated 38 question survey self-report survey assessing the effects of upper extremity disabling conditions on functional activity, pain, sleep, and other parameters
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary outcomes (4)
Upper Extremity Function Scale
The Upper Extremity Function Scale is an alternative instrument to the DASH which contains both common and unique evaluation questions.
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Brief Pain Inventory Questionnaire (Short Form)
The Brief Pain Inventory questionnaire will be utilized to gauge pain intensity during the duration of the study.
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Pain Anxiety Symptom Scale (short form 20)
The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain.
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Somatic Symptom Score (SSS-8)
The 8 question SSS-8 is an abbreviated version of the 15 question Patient Health Questionnaire (PHQ)-15. SSS-8 survey questions pertain to pain, the gastrointestinal system, fatigue, and cardiovascular complaints.
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start28 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a cohort study in which all participants will receive the mind-body intervention. We will not modify participant medication regimens and no pain or other medication prescriptions will be issued by the research team at any time
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Donnino, Beth Israel Deaconess Medical Center
- Investigators
- Michael Donnino, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903962
- Sponsor's protocol ID
- 2023P000579
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2025
- Last updated
- 18 Feb 2026
- Results posted
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)
- ClinicalTrials.gov ID
- NCT06903962
- Acronym / sponsor ID
- 2023P000579
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Apr 2025 (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.
The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow).
- To determine if a mind-body intervention improves upper extremity functional capacity (ie., Disability of Arm Shoulder Hand - DASH) among people with chronic wrist, elbow, and shoulder pain
- To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants.
- To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a cohort study in which all participants will receive the mind-body intervention. We will not modify participant medication regimens and no pain or other medication prescriptions will be issued by the research team at any time
| Arm | Type | Receives |
|---|---|---|
| Experimental: Mind-body Intervention | Experimental | Behavioral: Mind-Body InterventionMind body techniques for the intervention will be taught in lectures and group discussion sessions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult (≥ 18 years of age)
- A disability score ≥ 40 as per the QuickDASH survey
- Presence of pain and perceived disability for a minimum of 3 months
- Willing to engage in a Mind-Body intervention
- Positive visualization test (onset of pain when patients visualize themselves performing tasks that generally bring on pain)
Key exclusion criteria (5 listed)
- Clear organic diagnosis of pain (e.g., cancer, infection, etc…) not inclusive of non-specific findings on imaging studies (e.g., mild arthritis)
- Age greater than 60 years (due to an increased risk of there being an organic/physical cause for their pain and confounding results)
- Diagnosis of cognitive impairment or dementia
- Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
- Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered in this category
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 |
|---|---|---|
| Mind-Body InterventionThe mind-body intervention will include regular approximate 2 hour educational sessions and didactics learning mind body techniques. The sessions will be twice per week for the first 4 weeks and then subsequently once per week for a total of 13 weeks. | Behavioural | Experimental: Mind-body Intervention |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
The DASH is a commonly used and validated 38 question survey self-report survey assessing the effects of upper extremity disabling conditions on functional activity, pain, sleep, and other parameters
4 secondary outcomes
Upper Extremity Function Scale
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Brief Pain Inventory Questionnaire (Short Form)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Pain Anxiety Symptom Scale (short form 20)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Somatic Symptom Score (SSS-8)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
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 18 Feb 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.
Michael Donnino, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Intervention in people with Chronic Pain and Chronic Pain Syndrome, run by Beth Israel Deaconess Medical Center 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Feb 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?
Contact Ashley Scafetta (617-754-2882, ascafett@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) (time frame: Baseline, 4 weeks, 8 weeks, 13 weeks). 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 18 Feb 2026.