NCT05498077

Brief Summary

For patients with chronic pain, how does a 10 minute guided body scan meditation affect pressure pain threshold and extent of pain on a body diagram?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

August 8, 2022

Last Update Submit

August 10, 2022

Conditions

Keywords

Central SensitizationMeditation

Outcome Measures

Primary Outcomes (6)

  • Global Rating of Change

    This is a form the subject fills out rating their overall pain experience after an intervention. The scale is from -7 (Significantly worse to +7 Significantly better) and measures the amount of change the person feels they have experienced.

    Immediately After intervention

  • Pain pressure Threshold

    This is a pressure algometer the measures the sensitivity of an area on the body to direct pressure. It measures the amount of pressure that is applied to the subject's body. The clinician will apply pressure to the subject's skin at the tibialis anterior, lumbar paraspinals and upper trapezius muscles on the dominant hand side. The clinician will ask the subject "I want you to tell me the moment the sensation changes from pressure to discomfort and say "STOP". That is the reading/measurement the clinician will take. The outcome is assessing a change in pressure discomfort before the meditation and immediately after the meditation.

    Immediately Before and immediately after intervention

  • Neck Disability Index

    This is a questionnaire to measure the amount of disability the subject perceives due to their neck pain.

    Immediately Before the intervention

  • Oswestry Disability Index

    This is a questionnaire to measure the amount of disability the subject perceives due to their back pain

    Immediately Before the intervention

  • Pain Body Diagram

    This is an body image drawing. The subject colors in the area on the image of where they are experiencing pain. This outcome is assessing the location and extent of the area of pain in the body and how it changes with the intervention. The way this is assessed is by dividing the body image drawing into a grid. The body pain diagram consists of an outline of the entire body from anterior and posterior views. An overlay is created dividing the body pain diagram into 45 anatomical regions The overlay is placed over the body pain diagram, and the examiner recorded a score of 1 if pain is indicated and 0 if no pain is indicated in each of the 45 regions. Pain is considered present if any portion of the region was shaded, no matter how small.

    Immediately Before the intervention and immediately after intervention

  • Numeric Pain Rating Scale

    This is a scale assessing the subjects pain. It is a scale from 0 (no pain) to 10 (being the most severe pain). The subject will be assessed if their pain rating changed from before the intervention to after the intervention.

    Immediately Before the intervention and immediately after intervention

Study Arms (1)

10 minute body scan meditation

EXPERIMENTAL

Participants will be taken through a 10 minute body scan meditation by a physical therapist

Procedure: Body scan meditation

Interventions

Subject is placed through a brief body scan meditation to determine whether this intervention affects a person's pain experience

10 minute body scan meditation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects are from a convenience sample of patients seeking physical therapy care from a physician referral or direct-access to a privately owned physical therapy clinic English speaking
  • Central Sensitization Inventory \> 40
  • Subject complains of disproportionate non mechanical unpredictable pattern of pain provocation in response to multiple non-specific aggravating/easing factors
  • Pain disproportionate to the nature and extent of injury or pathology
  • Strong association with maladaptive beliefs and pain behaviors
  • Diffuse, nonanatomic areas of pain and tenderness on palpation

You may not qualify if:

  • Does not meet the criteria above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whole Body Health Physical Therapy

Portland, Oregon, 97212, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case series
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 11, 2022

Study Start

May 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations