PainNCT03642938

Exercise Dosing for Pain in Healthy Participants

A study testing Walking Exercise in people with Pain, run by Duquesne University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Walking Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2015to 6 Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Between age 18-40
Normal BMI (18.5-25.0)
Heart Rate (HR) 60-100 bmp
BP less than or equal to 140/90

Who cannot join

Age <18 or >40 years
Cardiac, respiratory, neurological or musculoskeletal disease
Acute pain
Chronic pain condition
Diabetes
BMI ≥ 25.1 or ≤ 18.4

Show all 11Show fewer

Regular participation in high intensity athletic/sporting activities
Sedentary
Anxiety or depression disorders
Tape allergy
Currently pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Duquesne University
Pittsburgh, Pennsylvania, 15282

Other trials in United States

About this study

Official title: The Dosing of Aerobic Exercise Therapy on Experimentally-induced Pain in Healthy Female Participants.

In this study investigators will examine the effect of dose related to exercise therapy for pain in healthy adult humans. An acute pain model will be employed to study the effect of exercise dose on pain. Acute pain models are currently used to study pain (both acute and chronic) in human samples as there is currently no chronic pain model.

Read the detailed description

This study is designed as a randomized controlled trial with repeated measures. The effect of exercise dose on pain: subjects will be randomly assigned to one of four exercise groups: 1.) no exercise (control); 2.) low dose exercise (3x/week); 3.) moderate dose exercise (5x/week). 4.) high dose exercise (10x/week).

Conditions: Pain
Being tested: Walking Exercise, Control
Keywords: Exercise, Dose, Analgesia
Medical subject headings: Pain, Motor Activity, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Walking ExerciseBehavioural
Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
ControlBehavioural
The Control group will perform 30 minutes of quiet rest.

Study groups in NCT03642938
Study group	Role	What they receive
Low Dose Exercise	Experimental	The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week. Receives: Behavioral: Walking Exercise
Moderate Dose Exercise	Experimental	The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week. Receives: Behavioral: Walking Exercise
High Dose Exercise	Experimental	The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week. Receives: Behavioral: Walking Exercise
Control	Sham comparator	The Control group will perform quiet rest, three times per week for one week. Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Intervention Effects on Mechanical Sensitivity Threshold
Subjects' cutaneous mechanical sensitivity threshold will be examined using standard monofilaments that apply a force of 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g and 1.0g to the forearm and calf. Percent Baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). A filament of different weight is applied to the skin to look at the threshold of response.
Measured: baseline and 24 hrs-post final intervention session
Intervention Effects on Constant Heat Pain Intensity
Subjects' constant heat pain intensity rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Measured: baseline and 24 hrs-post final intervention session
Intervention Effects on Constant Heat Pain Unpleasantness
Subjects' constant heat pain unpleasantness rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Measured: baseline and 24 hrs-post final intervention session
Intervention Effects on Radiant Heat Sensitivity
Subjects' radiant heat sensitivity will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 60 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "sensitivity threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Measured: baseline and 24 hrs-post final intervention session
Intervention Effects on Radiant Heat Pain
Subjects' radiant heat pain threshold will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 20 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "pain threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Measured: baseline and 24 hrs-post final intervention session
Intervention Effects on Pressure Pain Threshold
Subjects' pressure pain threshold will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied at constant ramping pressure until participant defined cutoff in kg at "pain threshold"). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Measured: baseline and 24 hrs-post final intervention session
Intervention Effects on Constant Pressure Pain Intensity
Subjects' constant pressure pain intensity rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Measured: baseline and 24 hrs-post final intervention session
Intervention Effects on Constant Pressure Pain Unpleasantness
Subjects' constant pressure pain unpleasantness rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score).This will be assessed on the forearm and calf. Percent change from baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Measured: baseline and 24 hrs-post final intervention session

Secondary outcomes (2)

Heart Rate
Heart rate will be measured before and after each exercise session. Percent pre-exercise session in heart rate (bpm) from start to end of exercise session will be calculated (100*Value at end trial/Value at start of trial).
Measured: days 1, 3, & 5 at start and end of each exercise session
Borg Rate of Perceived Exertion (RPE)
Subjects will indicate rate of perceived exertion before and after each exercise session. Percent of pre-exercise RPE from start to end of exercise session will be calculated (100* end of trial / start of trial).
Measured: days 1, 3, & 5 at start and end of each exercise session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 20156 Jun 2017

First posted22 Aug 2018
Study start11 Feb 2015
Primary completion6 Jun 2017
Study completion6 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Randomised
Intervention model: Parallel groups
Model description: Pseudo-randomized controlled trial
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03642938
Sponsor's protocol ID: 2014-04-22
Other IDs: UL1TR001857
Status last verified: Jul 2023
First submitted: 15 Aug 2018
Last updated: 2 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to share. Raw data is available through the peer review publication.

Publications

Polaski AM, Phelps AL, Szucs KA, Ramsey AM, Kostek MC, Kolber BJ. The dosing of aerobic exercise therapy on experimentally-induced pain in healthy female participants. Sci Rep. 2019 Oct 16;9(1):14842. doi: 10.1038/s41598-019-51247-0.
PubMed 31619738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Dosing of Aerobic Exercise Therapy on Experimentally-induced Pain in Healthy Female Participants.
ClinicalTrials.gov ID: NCT03642938
Acronym / sponsor ID: 2014-04-22
Conditions: Pain
Keywords: Exercise, Dose, Analgesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Duquesne UniversityUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 11 Feb 2015 (actual)
Primary completion: 6 Jun 2017 (actual)
Study completion: 6 Jun 2017 (actual)
First posted: 22 Aug 2018 (actual)
Results: Posted 2 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Pseudo-randomized controlled trial

Arm	Type	Receives
Low Dose Exercise	Experimental	Behavioral: Walking ExerciseThe Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Moderate Dose Exercise	Experimental	Behavioral: Walking ExerciseThe Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
High Dose Exercise	Experimental	Behavioral: Walking ExerciseThe High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Control	Sham comparator	Behavioral: ControlThe Control group will perform quiet rest, three times per week for one week.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Between age 18-40
Normal BMI (18.5-25.0)
Heart Rate (HR) 60-100 bmp
BP less than or equal to 140/90

Key exclusion criteria (11 listed)

Age <18 or >40 years
Cardiac, respiratory, neurological or musculoskeletal disease
Acute pain
Chronic pain condition
Diabetes

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
Walking ExerciseExercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.	Behavioural	High Dose Exercise, Low Dose Exercise, Moderate Dose Exercise
ControlThe Control group will perform 30 minutes of quiet rest.	Behavioural	Control

Primary outcome

Intervention Effects on Mechanical Sensitivity Threshold
Time frame: baseline and 24 hrs-post final intervention session
Subjects' cutaneous mechanical sensitivity threshold will be examined using standard monofilaments that apply a force of 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g and 1.0g to the forearm and calf. Percent Baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline). A filament of different weight is applied to the skin to look at the threshold of response.
Intervention Effects on Constant Heat Pain Intensity
Time frame: baseline and 24 hrs-post final intervention session
Subjects' constant heat pain intensity rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Intervention Effects on Constant Heat Pain Unpleasantness
Time frame: baseline and 24 hrs-post final intervention session
Subjects' constant heat pain unpleasantness rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Intervention Effects on Radiant Heat Sensitivity
Time frame: baseline and 24 hrs-post final intervention session
Subjects' radiant heat sensitivity will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 60 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "sensitivity threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Intervention Effects on Radiant Heat Pain
Time frame: baseline and 24 hrs-post final intervention session
Subjects' radiant heat pain threshold will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 20 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "pain threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Intervention Effects on Pressure Pain Threshold
Time frame: baseline and 24 hrs-post final intervention session
Subjects' pressure pain threshold will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied at constant ramping pressure until participant defined cutoff in kg at "pain threshold"). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Intervention Effects on Constant Pressure Pain Intensity
Time frame: baseline and 24 hrs-post final intervention session
Subjects' constant pressure pain intensity rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).
Intervention Effects on Constant Pressure Pain Unpleasantness
Time frame: baseline and 24 hrs-post final intervention session
Subjects' constant pressure pain unpleasantness rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score).This will be assessed on the forearm and calf. Percent change from baseline to 24 hrs post-intervention will then be calculated (100*Value at 24 hours/Value at Baseline).

2 secondary outcomes

Heart Rate
Time frame: days 1, 3, & 5 at start and end of each exercise session
Borg Rate of Perceived Exertion (RPE)
Time frame: days 1, 3, & 5 at start and end of each exercise session

Results and safety

Results posted to the registry on 2 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose Exercise	10	10
Moderate Dose Exercise	10	10
High Dose Exercise	10	10
Control	11	10

Primary outcome: Intervention Effects on Mechanical Sensitivity Threshold

Time frame: baseline and 24 hrs-post final intervention session. Mean (Standard Error). Unit: 100*Value at 24 hours/Value at Baseline

Measure	Low Dose Exercise n = 10	Moderate Dose Exercise n = 10	High Dose Exercise n = 10	Control n = 10
Forearm Data	125.6 (38)	93.56 (36.03)	63.04 (15.08)	70.27 (23.15)
Calf Data	299 (138.9)	396.7 (138.1)	202.4 (65.09)	287 (138.9)

Primary outcome: Intervention Effects on Constant Heat Pain Intensity

Time frame: baseline and 24 hrs-post final intervention session. Mean (Standard Error). Unit: 100*Value at 24 hours/Value at Baseline

Measure	Low Dose Exercise n = 10	Moderate Dose Exercise n = 10	High Dose Exercise n = 10	Control n = 10
Forearm	88.79 (4.819)	80.03 (21.37)	80.16 (14.24)	110.4 (55.20)
Calf	59.46 (9.12)	114.3 (34.57)	79.4 (22.68)	136.3 (31.55)

Primary outcome: Intervention Effects on Constant Heat Pain Unpleasantness

Time frame: baseline and 24 hrs-post final intervention session. Mean (Standard Error). Unit: 100*Value at 24 hours/Value at Baseline

Measure	Low Dose Exercise n = 10	Moderate Dose Exercise n = 10	High Dose Exercise n = 10	Control n = 10
forearm	110.1 (20.33)	130.7 (48.24)	110.6 (35.89)	79.63 (39.68)
calf	65.94 (9.63)	137.5 (33.49)	83.20 (24.27)	118.1 (39.50)

Primary outcome: Intervention Effects on Radiant Heat Sensitivity

Time frame: baseline and 24 hrs-post final intervention session. Mean (Standard Error). Unit: 100*Value at 24 hours/Value at Baseline

Measure	Low Dose Exercise n = 10	Moderate Dose Exercise n = 10	High Dose Exercise n = 10	Control n = 10
forearm	99.08 (1.4)	101.2 (2.4)	99.8 (1.46)	100.8 (1.4)
calf	100.1 (2.68)	101.5 (1.51)	102.8 (3.10)	102 (1.50)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during trial period only (1 week). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose Exercise	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Moderate Dose Exercise	0 of 10 (0%)	0 of 10 (0%)	0 of 10
High Dose Exercise	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Control	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31619738Polaski AM, Phelps AL, Szucs KA, Ramsey AM, Kostek MC, Kolber BJ. The dosing of aerobic exercise therapy on experimentally-induced pain in healthy female participants. Sci Rep. 2019 Oct 16;9(1):14842. doi: 10.1038/s41598-019-51247-0.
Individual participant dataSharing planned: No. There is no plan to share. Raw data is available through the peer review publication.

Related trials for Pain

Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus

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.

Kimberly A Szucs, PhD principal investigator

Duquesne University

Amy L Phelps, PhD principal investigator

Duquesne University

Matthew C Kostek, PhD principal investigator

Duquesne University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Walking Exercise in people with Pain, run by Duquesne University 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 2 Aug 2023. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 2 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intervention Effects on Mechanical Sensitivity Threshold (time frame: baseline and 24 hrs-post final intervention session). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642938, which also lists 1 linked publication.

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 2 Aug 2023.