PainNCT02608463
Neuropathic Pain in Pregnancy
A study testing painDETECT Questionnaire, Pain Catastrophizing Scale and Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale in people with Pain and Pregnancy, run by University of Arkansas at 1 site in United States.
Trial summary
This will be the first study to investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study will enroll 60 pregnant subjects, age 18-45. All participants will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a treatment option. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- painDETECT Questionnaire, Pain Catastrophizing Scale and Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 19 Apr 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 18-45 years old,
- ability to give informed consent,
- viable pregnancy, and
- enrollment prior or equal to 24 weeks gestation
- Subjects enrolled in Part A and willing to consent to Part B of this protocol
- Pregnant with current chronic neuropathic pain
Show all 13Show fewer
- Subjects failed treatment with amitriptyline or nortriptyline as defined by one of the following:
- no clinical improvement following a 4-week trial of amitriptyline or nortriptyline (i.e., CGI-I score ≥4)
- an inability to tolerate the medication (i.e., side effects)
- Subjects must pass the TMS Safety Checklist Adult Safety Screen (TASS).
- Subjects should be off medication, which can lower seizure thresholds (e.g., amitriptyline and nortriptyline) for at least two weeks prior to study entry.
- Subjects with neuropathic pain including those with diagnosis of spinal cord injury, fibromyalgia, compression neuropathies (including diabetic peripheral neuropathy), post stroke pain, and multiple sclerosis
- Subjects with a baseline VAS score greater than 30
Who cannot join
- Active or history of substance use disorder within the past year
- Non-English speaking
- Part B
- Current or past history of a seizure disorder (e.g., epilepsy)
- Current history of preeclampsia
- Current or history of brain lesions (e.g., aneurysm)
Show all 21Show fewer
- History of major head trauma (e.g., stroke; previous cranial neurosurgery)
- Ferromagnetic metal in the head, neck, or chest (e.g., plates or pins, bullets, shrapnel)
- Microprocessor implants in the head (e.g., cochlear implants) or life-sustaining microprocessor implants anywhere in the body (e.g., prosthetic cardiac valves)
- Cardiac pacemaker
- Active or inactive implants (e.g., deep brain stimulators, vagus nerve stimulators)
- Active treatment with medications that lower seizure threshold (e.g., bupropion, amitriptyline, nortriptyline, or other TCA)
- Increased intracranial pressure (which lowers seizure threshold)
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease defined as heart disease that causes moderate to severe symptoms and/or is characterized by moderate to severe pathology, including a recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV.
- Bipolar disorder (to reduce the risk of mania)
- History of suicide attempt(s)
- Family history of epilepsy
- Heavy alcohol consumption within the past 48 hours
- Permanent makeup or tattoos with metallic dyes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205
About this study
This will be the first study to investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study will enroll 60 pregnant subjects, age 18-45. All participants will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a treatment option.
Read the detailed description
Neuropathic pain is a common pain disorder that is caused by problems in the nervous system. It affects more women than men and commonly occurs in pregnancy. Physicians have little information to guide their treatment of neuropathic pain in pregnancy. The overall goal of this study is to define the course, management, and pregnancy outcomes of neuropathic pain in pregnancy and the acute postpartum period. It is difficult to manage neuropathic pain in pregnancy as treatment options must minimize their risk to the unborn child as they have a direct effect on infant outcomes through their exposure in utero. Thus, other treatments are needed. Repetitive transcranial magnetic stimulation (rTMS) may be an acceptable alternative to medications. Transcranial magnetic stimulation uses a magnetic force to change the way nerves work in the brain. This non-invasive and localized mechanism of action makes it attractive for use in special populations, such as pregnancy. Study visits will occur approximately every 4-6 weeks during pregnancy until approximately 3 months postpartum for a maximum of 12 visits.
- Being tested
- painDETECT Questionnaire, Pain Catastrophizing Scale, Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale, Beck Depression Inventory, Visual Analogue Scale
- Keywords
- neuropathic pain, pregnancy
- Medical subject headings
- Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painDETECT QuestionnaireBehavioural
Also called PDQ
This self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes. The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain. There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body.
Pain Catastrophizing ScaleBehavioural
Also called PCS
The PCS is a 13-item self-report scale. It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness.
Pain Intensity Scale, Pain Interference Scale, Pain Behavior ScaleBehavioural
Also called Pain Measures
The 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity "right now." The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, \& recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days.
The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), \& verbal reports of pain. It assesses pain interference over the past 7 days.
All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific.
Beck Depression InventoryBehavioural
Also called BDI
The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms. It is a 21 item questionnaire with 4-5 responses for each question. Responses are coded 0-3 for the 4 point scales. The 5 point scales include an additional 2a and 2b response code. The symptom categories reflect overt behavioral manifestations of depression. The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock \& Erbaugh, 1961).
Visual Analogue ScaleBehavioural
Also called VAS
100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state.
Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement ScaleBehavioural
Also called PGIC & CGI-I
The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale.
The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD.
Transcranial Magnetic StimulationDevice
Also called NeuroStar® TMS
Subjects will undergo daily repetitive transcranial magnetic stimulation (rTMS), defined as Monday through Friday, for a total of 10 consecutive sessions. rTMS will be applied using the NeuroStar TMS Therapy System through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. The coil is applied to the primary motor cortex, M1, contralateral to the painful side. The optimal stimulus site, motor hot spot, will be determined according to visual detection of muscle twitches, and a resting motor threshold is defined as the minimal intensity necessary to induce at least one visible muscle twitch. An rTMS session consists of 10 trains at 90% intensity of resting motor threshold (one train, 100 pulses at 10 Hz; intertrain interval, 50s).
| Study group | Role | What they receive |
|---|---|---|
| Part A - Neuropathic Pain | Other | Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group. Receives: Behavioral: painDETECT Questionnaire; Behavioral: Pain Catastrophizing Scale; Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale; Behavioral: Beck Depression Inventory; Behavioral: Visual Analogue Scale; Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale |
| Part A - Non-Neuropathic Pain | Other | Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group. Receives: Behavioral: painDETECT Questionnaire; Behavioral: Pain Catastrophizing Scale; Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale; Behavioral: Beck Depression Inventory; Behavioral: Visual Analogue Scale; Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale |
| Part A - Control | Other | Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group. Receives: Behavioral: painDETECT Questionnaire; Behavioral: Pain Catastrophizing Scale; Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale; Behavioral: Beck Depression Inventory; Behavioral: Visual Analogue Scale; Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale |
| Part B - rTMS | Experimental | Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS). Receives: Behavioral: Beck Depression Inventory; Behavioral: Visual Analogue Scale; Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale; Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Visual Analogue Scale for Pain
100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. The total score ranges from 0-100 with higher numbers indicating worse outcomes. The VAS will be administered at every subject visit.
Measured: Baseline and end of study participation, an average of 194 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
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.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All subjects will participate in Part A, receive standard of care and complete the painDETECT Questionnaire (PDQ) to be assigned to 1 of 3 groups based on the PDQ score. Subjects in Part A will complete the following at study entry and each study visit: the Beck Depression Inventory (BDI), Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), and measures of pain intensity, interference, behavior. At each visit after study entry, subjects will complete the Patients' Global Impression of Change scale (PGIC); clinicians will complete the Clinical Global Impression-Global Improvement scale (CGI-I). Subjects in Part B will receive rTMS and be followed daily until day 29 after last rTMS session. For each session, subjects will complete a VAS prior, immediately after, and 60 minutes post, day 22 \& day 29; a BDI on Days 1, 5, 12, 22, \& 29; on days 5, 12, 22, \& 29 subjects will complete the PGIC; clinicians will complete the CGI-I.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shona L Ray-Grififth, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608463
- Sponsor's protocol ID
- 204737
- Status last verified
- May 2021
- First submitted
- 13 Nov 2015
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain in Pregnancy
- ClinicalTrials.gov ID
- NCT02608463
- Acronym / sponsor ID
- 204737
- Keywords
- neuropathic pain, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be the first study to investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study will enroll 60 pregnant subjects, age 18-45. All participants will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a treatment option.
Detailed description
Neuropathic pain is a common pain disorder that is caused by problems in the nervous system. It affects more women than men and commonly occurs in pregnancy. Physicians have little information to guide their treatment of neuropathic pain in pregnancy. The overall goal of this study is to define the course, management, and pregnancy outcomes of neuropathic pain in pregnancy and the acute postpartum period. It is difficult to manage neuropathic pain in pregnancy as treatment options must minimize their risk to the unborn child as they have a direct effect on infant outcomes through their exposure in utero. Thus, other treatments are needed. Repetitive transcranial magnetic stimulation (rTMS) may be an acceptable alternative to medications. Transcranial magnetic stimulation uses a magnetic force to change the way nerves work in the brain. This non-invasive and localized mechanism of action makes it attractive for use in special populations, such as pregnancy. Study visits will occur approximately every 4-6 weeks during pregnancy until approximately 3 months postpartum for a maximum of 12 visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All subjects will participate in Part A, receive standard of care and complete the painDETECT Questionnaire (PDQ) to be assigned to 1 of 3 groups based on the PDQ score. Subjects in Part A will complete the following at study entry and each study visit: the Beck Depression Inventory (BDI), Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), and measures of pain intensity, interference, behavior. At each visit after study entry, subjects will complete the Patients' Global Impression of Change scale (PGIC); clinicians will complete the Clinical Global Impression-Global Improvement scale (CGI-I). Subjects in Part B will receive rTMS and be followed daily until day 29 after last rTMS session. For each session, subjects will complete a VAS prior, immediately after, and 60 minutes post, day 22 \& day 29; a BDI on Days 1, 5, 12, 22, \& 29; on days 5, 12, 22, \& 29 subjects will complete the PGIC; clinicians will complete the CGI-I.
| Arm | Type | Receives |
|---|---|---|
| Part A - Neuropathic Pain | Other | Behavioral: painDETECT Questionnaire, Behavioral: Pain Catastrophizing Scale, Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale, Behavioral: Beck Depression Inventory, Behavioral: Visual Analogue Scale, Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement ScaleSubjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group. |
| Part A - Non-Neuropathic Pain | Other | Behavioral: painDETECT Questionnaire, Behavioral: Pain Catastrophizing Scale, Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale, Behavioral: Beck Depression Inventory, Behavioral: Visual Analogue Scale, Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement ScaleSubjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group. |
| Part A - Control | Other | Behavioral: painDETECT Questionnaire, Behavioral: Pain Catastrophizing Scale, Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale, Behavioral: Beck Depression Inventory, Behavioral: Visual Analogue Scale, Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement ScaleSubjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group. |
| Part B - rTMS | Experimental | Behavioral: Beck Depression Inventory, Behavioral: Visual Analogue Scale, Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale, Device: Transcranial Magnetic StimulationSubjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- age 18-45 years old,
- ability to give informed consent,
- viable pregnancy, and
- enrollment prior or equal to 24 weeks gestation
- Subjects enrolled in Part A and willing to consent to Part B of this protocol
Key exclusion criteria (21 listed)
- Active or history of substance use disorder within the past year
- Non-English speaking
- Part B
- Current or past history of a seizure disorder (e.g., epilepsy)
- Current history of preeclampsia
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 |
|---|---|---|
| painDETECT QuestionnaireAlso: PDQThis self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes. The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain. There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body. | Behavioural | Part A - Control, Part A - Neuropathic Pain, Part A - Non-Neuropathic Pain |
| Pain Catastrophizing ScaleAlso: PCSThe PCS is a 13-item self-report scale. It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness. | Behavioural | Part A - Control, Part A - Neuropathic Pain, Part A - Non-Neuropathic Pain |
| Pain Intensity Scale, Pain Interference Scale, Pain Behavior ScaleAlso: Pain MeasuresThe 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity "right now." The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, \& recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days. The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), \& verbal reports of pain. It assesses pain interference over the past 7 days. All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific. | Behavioural | Part A - Control, Part A - Neuropathic Pain, Part A - Non-Neuropathic Pain |
| Beck Depression InventoryAlso: BDIThe BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms. It is a 21 item questionnaire with 4-5 responses for each question. Responses are coded 0-3 for the 4 point scales. The 5 point scales include an additional 2a and 2b response code. The symptom categories reflect overt behavioral manifestations of depression. The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock \& Erbaugh, 1961). | Behavioural | Part A - Control, Part A - Neuropathic Pain, Part A - Non-Neuropathic Pain, Part B - rTMS |
| Visual Analogue ScaleAlso: VAS100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. | Behavioural | Part A - Control, Part A - Neuropathic Pain, Part A - Non-Neuropathic Pain, Part B - rTMS |
| Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement ScaleAlso: PGIC & CGI-IThe PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale. The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD. | Behavioural | Part A - Control, Part A - Neuropathic Pain, Part A - Non-Neuropathic Pain, Part B - rTMS |
| Transcranial Magnetic StimulationAlso: NeuroStar® TMSSubjects will undergo daily repetitive transcranial magnetic stimulation (rTMS), defined as Monday through Friday, for a total of 10 consecutive sessions. rTMS will be applied using the NeuroStar TMS Therapy System through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. The coil is applied to the primary motor cortex, M1, contralateral to the painful side. The optimal stimulus site, motor hot spot, will be determined according to visual detection of muscle twitches, and a resting motor threshold is defined as the minimal intensity necessary to induce at least one visible muscle twitch. An rTMS session consists of 10 trains at 90% intensity of resting motor threshold (one train, 100 pulses at 10 Hz; intertrain interval, 50s). | Device | Part B - rTMS |
Primary outcome
Change From Baseline Visual Analogue Scale for Pain
Time frame: Baseline and end of study participation, an average of 194 days
100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state. The total score ranges from 0-100 with higher numbers indicating worse outcomes. The VAS will be administered at every subject visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shona L Ray-Grififth, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing painDETECT Questionnaire, Pain Catastrophizing Scale and Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale in people with Pain and Pregnancy, run by University of Arkansas 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 13 inclusion and 21 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 23 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2020). 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?
Change From Baseline Visual Analogue Scale for Pain (time frame: Baseline and end of study participation, an average of 194 days). 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 23 Jun 2021; AzTrials last refreshed its copy on 4 Nov 2026.