Chronic PainNCT05498077
Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
A study testing Body scan meditation in people with Chronic Pain, run by Therapeutic Neuroscience Research Group at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Body scan meditation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not meet the criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
Whole Body Health Physical Therapy
Portland, Oregon, 97212
About this study
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?
Read the detailed description
Patients who present with central sensitization in physical therapy will go through a 10 minute body scan meditation. If patient meets criteria then they will fill out pre-intervention measures including hand dominance, gender identity, duration of pain, work status, pain body diagram, current pain level, previous medication and a neck disability index or an oswestry disability index.
Subject will then be asked what position they feel most comfortable to be led through this body scan meditation.
After the meditation, the participant will fill out another pain body diagram, current pain level, global rating of change and pain pressure threshold.
At this point the study is over and the subject will return to their physical therapy treatment.
- Conditions
- Chronic Pain
- Being tested
- Body scan meditation
- Keywords
- Central Sensitization, Meditation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body scan meditationProcedure or surgery
Subject is placed through a brief body scan meditation to determine whether this intervention affects a person's pain experience
| Study group | Role | What they receive |
|---|---|---|
| 10 minute body scan meditation | Experimental | Participants will be taken through a 10 minute body scan meditation by a physical therapist Receives: Procedure: Body scan meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediately Before the intervention and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 May 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (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.
- 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
- Case series
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therapeutic Neuroscience Research Group
- Sponsor type
- Research network
- Collaborators
- Rockhurst University, Evidence In Motion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498077
- Sponsor's protocol ID
- PSFMcConahay
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 11 Aug 2022
- 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 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
- ClinicalTrials.gov ID
- NCT05498077
- Acronym / sponsor ID
- PSFMcConahay
- Conditions
- Chronic Pain
- Keywords
- Central Sensitization, Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Therapeutic Neuroscience Research GroupResearch network
- Collaborators
- Rockhurst University, Evidence In Motion
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Aug 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.
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?
Detailed description
Patients who present with central sensitization in physical therapy will go through a 10 minute body scan meditation. If patient meets criteria then they will fill out pre-intervention measures including hand dominance, gender identity, duration of pain, work status, pain body diagram, current pain level, previous medication and a neck disability index or an oswestry disability index.
Subject will then be asked what position they feel most comfortable to be led through this body scan meditation.
After the meditation, the participant will fill out another pain body diagram, current pain level, global rating of change and pain pressure threshold.
At this point the study is over and the subject will return to their physical therapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series
| Arm | Type | Receives |
|---|---|---|
| 10 minute body scan meditation | Experimental | Procedure: Body scan meditationParticipants will be taken through a 10 minute body scan meditation by a physical therapist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet the criteria above
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 |
|---|---|---|
| Body scan meditationSubject is placed through a brief body scan meditation to determine whether this intervention affects a person's pain experience | Procedure or surgery | 10 minute body scan meditation |
Primary outcome
Global Rating of Change
Time frame: Immediately After intervention
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.
Pain pressure Threshold
Time frame: Immediately Before and immediately after intervention
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.
Neck Disability Index
Time frame: Immediately Before the intervention
This is a questionnaire to measure the amount of disability the subject perceives due to their neck pain.
Oswestry Disability Index
Time frame: Immediately Before the intervention
This is a questionnaire to measure the amount of disability the subject perceives due to their back pain
Pain Body Diagram
Time frame: Immediately Before the intervention and immediately after intervention
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.
Numeric Pain Rating Scale
Time frame: Immediately Before the intervention and immediately after intervention
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body scan meditation in people with Chronic Pain, run by Therapeutic Neuroscience Research Group 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Aug 2022. 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?
Results are not available in the source record.
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?
Global Rating of Change (time frame: Immediately After intervention). The study lists 6 primary outcomes in all. 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 11 Aug 2022.