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NCT Number: NCT06903962

Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)

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. 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 2. To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants. 3. To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.

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Key information

Conditions

Chronic Pain Chronic Pain Syndrome Cumulative Trauma Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Repetitive Stress Injury Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Ashley Scafetta

CONTACT

[email protected]

617-754-2882

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Mind-Body Intervention

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Upper Extremity Function Scale

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks

    The Upper Extremity Function Scale is an alternative instrument to the DASH which contains both common and unique evaluation questions.

  2. Brief Pain Inventory Questionnaire (Short Form)

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks

    The Brief Pain Inventory questionnaire will be utilized to gauge pain intensity during the duration of the study.

  3. Pain Anxiety Symptom Scale (short form 20)

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks

    The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain.

  4. Somatic Symptom Score (SSS-8)

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Scafetta

CONTACT

[email protected]

617-754-2882

Michael Donnino, MD

CONTACT

[email protected]

617-754-2882

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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