HIVNCT01419314
Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy
A study testing Splinting application to the lower extremities and Splint liner application in people with HIV and AIDS, run by Texas Woman's University at 1 site in United States.
Trial summary
WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of splints at night works to bring the pain down and help you sleep better (in people living with HIV/AIDS related neuropathy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, AIDS, Peripheral Neuropathy
- What is being tested?
- Splinting application to the lower extremities and Splint liner application
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult PLWA 18 and older, with a clinical diagnosis of symptomatic bilateral LE PN will be invited to participate.
- The participants will be on a stable pain and HIV/AIDS management regimen without foreseeable alterations or changes to said pharmacological regimen, which may include pain and or sleep medications.
- The participants will be community dwelling individuals, able to walk at or above a modified independence level with or without the need of an assistive device to ambulate, such as a cane or walker.
- Eligible participants will report at least one of the following clinical symptoms: paresthesia, dysesthesia, and report night cramps in the LE
Who cannot join
- Participants will be excluded if they have a clinical diagnosis of any of the following: significant cardiovascular or pulmonary disease (specifically, myocardial infarction within the past six months, angina, or dyspnea at rest), paraplegia, hemiplegia, other major neurological dysfunction, diabetes, absent pedal pulse during examination, sleep apnea, or are pregnant.
- Additionally, patients unable to read English, patients with changes to their pharmacological management during the study and or using any mechanical devices to assist in normalizing sleep will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Street Health Center-HCHD
Houston, Texas, 77009
About this study
WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of splints at night works to bring the pain down and help you sleep better (in people living with HIV/AIDS related neuropathy).
HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the Harris County Hospital District (HCHD).
Read more
WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two treatment groups. In one group, you will be asked to wear leg splints at night and the other you will wear the liners of the splints only.
You will be asked to answer questions about how well you sleep, how long you sleep, and about your discomfort at the legs. The researcher will be there to help, but the investigators want you to answer the questions on your own if you can. You will be asked to reach forwards standing next to a wall and to walk for 6 minutes after that. The tests will de done in random order. The sessions will be done at the beginning, at week three and week six. You should finish all of the testing and questionnaires in an hour or less, for a total of three hours over six weeks in the investigators clinic.
You will receive instructions on how to use the splints with liners or the liners alone at home. You will be asked to wear them at night only for the next 6 weeks. Finally, the principal investigator will contact you weekly by phone, to discuss issues of comfort and your ability to adhere to the instructions provided.
Read the detailed description
The medical management of people living with the Human Immunodeficiency Virus that ultimately leads to the development of Acquired Immunodeficiency Syndrome has progressed dramatically since the beginning of the pandemic in the early 1980's. Despite advances in management and prevention, it is estimated that 33 million people worldwide are infected with this virus. Of those, 1.1 million people living with HIV/AIDS reside in the United States, while 56,000 new cases are added to this total every year. Medical providers are challenged to achieve a delicate balance between offering effective anti-retroviral therapeutic interventions while monitoring undesired side effects in an aging population of "People Living with HIV/AIDS" (PLWA). Indeed, the life expectancy of PLWA has continued to increase in the industrialized world, approaching parity with non-infected individuals.
Pain and sleep disturbances are commonly associated with chronic systemic diseases such as fibromyalgia, arthritis, chronic liver disease and HIV/AIDS. Data collected from a cohort of 317 PLWA, indicate that 55% of them experienced and ranked increases in pain and sleep disturbances among the top four symptoms associated with living with HIV/AIDS. Pain and sleep disturbances were only preceded in reported prevalence by self-reported fatigue and drowsiness. A review of systemic diseases' impact on sleep, suggests that alterations in rapid eye movement (REM), non-REM sleep stages, as well as an increase in sleep disturbances are associated with HIV disease progression into AIDS; moreover, 26% of the variance in sleep disturbances experienced by PLWA in that study was attributed to pain and other psychosocial factors.
Peripheral neuropathy (PN) is among the most common complications associated with long-term survival with HIV/AIDS. It is estimated that 30-60% of all PLWA will develop PN at some point during the course of the disease, with an increased prevalence seen in this patient population as the disease progresses from HIV into AIDS. Functional impairments have also been reported in the presence of neuropathies. Different authors have reported significant differences in gait quality, walking speed and total distance walked in individuals with damage to the peripheral nervous system. Despite advances in medical management of HIV infection, the direct impact of commonly experienced symptoms associated with living with HIV/AIDS, such as pain and sleep disturbances in the current era of anti-retroviral therapy has not been extensively reported in the literature.
In a recent pilot study, conducted by this author and colleagues, the use of night time lower extremity (LE) splinting showed promising results in the management of pain and sleep disturbances. This pilot study design was a crossover study that included 22 PLWA with PN and evaluated the effects of a three-week bilateral lower splints application on pain and sleep. A 20% improvement in both pain and sleep scores was reported in this pilot study. Additionally, a moderate effect size for pain and sleep scores was found. The results suggested that the analgesic effect of the splint application persisted for a period of several weeks following discontinuation of the lower splint application. These results were obtained using a relatively small sample of patients and without a long-term follow-up post-splinting application. Finally, that study could not determine whether the source of the pain inhibition was due to the application of a full contact protective sheath on the lower leg or the short-term immobilization at the ankle joints provided by the splints.
Purpose and Hypotheses
Therefore, the purpose and primary aim of this study is to evaluate the management of pain and sleep disturbances in people living with HIV/AIDS-related PN with the use of bilateral LE splints versus a control/placebo intervention of bilateral LE splint liner application. The null hypotheses for the primary aim are:
- There is no difference in pain and sleep scores between the bilateral LE splints and those obtained using the splint liners only following a three and six-week application.
- There is no difference in pain and sleep scores between baseline and following a six-week LE splint application.
The secondary aim is to identify factors influencing function, as measured by the functional reach test and the six-minute walk test; and their relationship with pain and sleep disturbances in the presence of HIV/AIDS related neuropathy.
- Conditions
- HIV, AIDS, Peripheral Neuropathy, Pain, Sleep
- Being tested
- Splinting application to the lower extremities, Splint liner application
- Keywords
- Physical Therapy, Splint, Sleep, Pain, 6 min walk, forward reach, Function
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Peripheral Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splinting application to the lower extremitiesDevice
Also called Walkabout splint
Walkabout™ splints (Don Joy Orthopedics, Vista, CA, USA) will used in the splinting treatment. The Walkabout splint is a one-piece injection molded walking boot fitted with a rocker bottom allowing for ambulation. The participants will be fitted and instructed to wear the bilateral LE splints to sleep for the duration of the study (6 weeks).
Splint liner applicationDevice
Also called Walkabout liner
The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study (6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Splinting application | Experimental | Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only. Receives: Device: Splinting application to the lower extremities |
| Splint liner application | Placebo comparator | The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study. Receives: Device: Splint liner application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores at Week 3
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Measured: Week 3
Pain Scores
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Measured: Week 6
Sleep Quality/Quantity Scores (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.
Measured: week 3
Sleep Quality/Quantity Scores (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.
Measured: week 6
Secondary outcomes (4)
Function-Reach
Forward reach test
For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.
Measured: week 3
Function-Reach
Forward reach test
For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.
Measured: week 6
Function-Walking Distance
Six minute walk test
For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.
Measured: week 3
Function-Walking Distance
Six minute walk test
For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
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 HIVStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Harris County Hospital District, DJO Incorporated
- Responsible party
- Principal investigator, Robert Sandoval, Texas Woman's University
- Investigators
- Robert Sandoval, MS, PT, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419314
- Sponsor's protocol ID
- 16196
- Status last verified
- Dec 2012
- First submitted
- 10 Aug 2011
- Last updated
- 3 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sandoval R, Runft B, Roddey T. Pilot study: does lower extremity night splinting assist in the management of painful peripheral neuropathy in the HIV/AIDS population? J Int Assoc Physicians AIDS Care (Chic). 2010 Nov-Dec;9(6):368-81. doi: 10.1177/1545109710373828. Epub 2010 Nov 12.
PubMed 21075912
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01419314
- Acronym / sponsor ID
- 16196
- Conditions
- HIV, AIDS, Peripheral Neuropathy, Pain, Sleep
- Keywords
- Physical Therapy, Splint, Sleep, Pain, 6 min walk, forward reach, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Harris County Hospital District, DJO Incorporated
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 3 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of splints at night works to bring the pain down and help you sleep better (in people living with HIV/AIDS related neuropathy).
HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the Harris County Hospital District (HCHD).
WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two treatment groups. In one group, you will be asked to wear leg splints at night and the other you will wear the liners of the splints only.
You will be asked to answer questions about how well you sleep, how long you sleep, and about your discomfort at the legs. The researcher will be there to help, but the investigators want you to answer the questions on your own if you can. You will be asked to reach forwards standing next to a wall and to walk for 6 minutes after that. The tests will de done in random order. The sessions will be done at the beginning, at week three and week six. You should finish all of the testing and questionnaires in an hour or less, for a total of three hours over six weeks in the investigators clinic.
You will receive instructions on how to use the splints with liners or the liners alone at home. You will be asked to wear them at night only for the next 6 weeks. Finally, the principal investigator will contact you weekly by phone, to discuss issues of comfort and your ability to adhere to the instructions provided.
Detailed description
The medical management of people living with the Human Immunodeficiency Virus that ultimately leads to the development of Acquired Immunodeficiency Syndrome has progressed dramatically since the beginning of the pandemic in the early 1980's. Despite advances in management and prevention, it is estimated that 33 million people worldwide are infected with this virus. Of those, 1.1 million people living with HIV/AIDS reside in the United States, while 56,000 new cases are added to this total every year. Medical providers are challenged to achieve a delicate balance between offering effective anti-retroviral therapeutic interventions while monitoring undesired side effects in an aging population of "People Living with HIV/AIDS" (PLWA). Indeed, the life expectancy of PLWA has continued to increase in the industrialized world, approaching parity with non-infected individuals.
Pain and sleep disturbances are commonly associated with chronic systemic diseases such as fibromyalgia, arthritis, chronic liver disease and HIV/AIDS. Data collected from a cohort of 317 PLWA, indicate that 55% of them experienced and ranked increases in pain and sleep disturbances among the top four symptoms associated with living with HIV/AIDS. Pain and sleep disturbances were only preceded in reported prevalence by self-reported fatigue and drowsiness. A review of systemic diseases' impact on sleep, suggests that alterations in rapid eye movement (REM), non-REM sleep stages, as well as an increase in sleep disturbances are associated with HIV disease progression into AIDS; moreover, 26% of the variance in sleep disturbances experienced by PLWA in that study was attributed to pain and other psychosocial factors.
Peripheral neuropathy (PN) is among the most common complications associated with long-term survival with HIV/AIDS. It is estimated that 30-60% of all PLWA will develop PN at some point during the course of the disease, with an increased prevalence seen in this patient population as the disease progresses from HIV into AIDS. Functional impairments have also been reported in the presence of neuropathies. Different authors have reported significant differences in gait quality, walking speed and total distance walked in individuals with damage to the peripheral nervous system. Despite advances in medical management of HIV infection, the direct impact of commonly experienced symptoms associated with living with HIV/AIDS, such as pain and sleep disturbances in the current era of anti-retroviral therapy has not been extensively reported in the literature.
In a recent pilot study, conducted by this author and colleagues, the use of night time lower extremity (LE) splinting showed promising results in the management of pain and sleep disturbances. This pilot study design was a crossover study that included 22 PLWA with PN and evaluated the effects of a three-week bilateral lower splints application on pain and sleep. A 20% improvement in both pain and sleep scores was reported in this pilot study. Additionally, a moderate effect size for pain and sleep scores was found. The results suggested that the analgesic effect of the splint application persisted for a period of several weeks following discontinuation of the lower splint application. These results were obtained using a relatively small sample of patients and without a long-term follow-up post-splinting application. Finally, that study could not determine whether the source of the pain inhibition was due to the application of a full contact protective sheath on the lower leg or the short-term immobilization at the ankle joints provided by the splints.
Purpose and Hypotheses
Therefore, the purpose and primary aim of this study is to evaluate the management of pain and sleep disturbances in people living with HIV/AIDS-related PN with the use of bilateral LE splints versus a control/placebo intervention of bilateral LE splint liner application. The null hypotheses for the primary aim are:
- There is no difference in pain and sleep scores between the bilateral LE splints and those obtained using the splint liners only following a three and six-week application.
- There is no difference in pain and sleep scores between baseline and following a six-week LE splint application.
The secondary aim is to identify factors influencing function, as measured by the functional reach test and the six-minute walk test; and their relationship with pain and sleep disturbances in the presence of HIV/AIDS related neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splinting application | Experimental | Device: Splinting application to the lower extremitiesParticipants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only. |
| Splint liner application | Placebo comparator | Device: Splint liner applicationThe liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult PLWA 18 and older, with a clinical diagnosis of symptomatic bilateral LE PN will be invited to participate.
- The participants will be on a stable pain and HIV/AIDS management regimen without foreseeable alterations or changes to said pharmacological regimen, which may include pain and or sleep medications.
- The participants will be community dwelling individuals, able to walk at or above a modified independence level with or without the need of an assistive device to ambulate, such as a cane or walker.
- Eligible participants will report at least one of the following clinical symptoms: paresthesia, dysesthesia, and report night cramps in the LE
Key exclusion criteria (2 listed)
- Participants will be excluded if they have a clinical diagnosis of any of the following: significant cardiovascular or pulmonary disease (specifically, myocardial infarction within the past six months, angina, or dyspnea at rest), paraplegia, hemiplegia, other major neurological dysfunction, diabetes, absent pedal pulse during examination, sleep apnea, or are pregnant.
- Additionally, patients unable to read English, patients with changes to their pharmacological management during the study and or using any mechanical devices to assist in normalizing sleep will be excluded from this study.
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 |
|---|---|---|
| Splinting application to the lower extremitiesAlso: Walkabout splintWalkabout™ splints (Don Joy Orthopedics, Vista, CA, USA) will used in the splinting treatment. The Walkabout splint is a one-piece injection molded walking boot fitted with a rocker bottom allowing for ambulation. The participants will be fitted and instructed to wear the bilateral LE splints to sleep for the duration of the study (6 weeks). | Device | Splinting application |
| Splint liner applicationAlso: Walkabout linerThe liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study (6 weeks). | Device | Splint liner application |
Primary outcome
Pain Scores at Week 3
Time frame: Week 3
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Pain Scores
Time frame: Week 6
A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Sleep Quality/Quantity Scores (PSQI)
Time frame: week 3
The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.
Sleep Quality/Quantity Scores (PSQI)
Time frame: week 6
The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.
4 secondary outcomes
Function-Reach
Time frame: week 3
Function-Reach
Time frame: week 6
Function-Walking Distance
Time frame: week 3
Function-Walking Distance
Time frame: week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21075912Sandoval R, Runft B, Roddey T. Pilot study: does lower extremity night splinting assist in the management of painful peripheral neuropathy in the HIV/AIDS population? J Int Assoc Physicians AIDS Care (Chic). 2010 Nov-Dec;9(6):368-81. doi: 10.1177/1545109710373828. Epub 2010 Nov 12.
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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.
Robert Sandoval, MS, PT principal investigator
Texas Woman's 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 Splinting application to the lower extremities and Splint liner application in people with HIV and AIDS, run by Texas Woman's 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 2 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 3 Jan 2013. 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 3 Jan 2013). 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?
Pain Scores at Week 3 (time frame: Week 3). The study lists 4 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 NCT01419314, 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 3 Jan 2013.