Shoulder PainNCT01094301
Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain
A study testing The SPR System in people with Shoulder Pain, run by SPR Therapeutics, Inc. at 4 sites in United States.
Trial summary
Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- The SPR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2010to 25 Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Trial Stage Inclusion Criteria:
- At least 21 years of age
- Post-stroke shoulder pain
Trial Stage Exclusion Criteria:
- Use of habit-forming (narcotic) medications
- History of recurrent skin infections
- Bleeding disorder
- Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or complex regional pain syndrome
- Heart arrhythmia or artificial heart valves
- Uncontrolled seizures
- Implanted Electronic Device
Implant Stage Inclusion Criteria
- Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Carolinas Healthcare System/Carolinas Rehabilitation
Charlotte, North Carolina, 28203
MetroHealth Medical Center
Cleveland, Ohio, 44109
Moss Rehab/ Albert Einstein Healthcare Network
Elkins Park, Pennsylvania, 19027
Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain
Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.
Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.
- Conditions
- Shoulder Pain
- Being tested
- The SPR System
- Keywords
- electrical stimulation, neurostimulation, neuromodulation, shoulder pain, post-stroke shoulder pain, hemiplegic shoulder pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SPR SystemDevice
The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.
| Study group | Role | What they receive |
|---|---|---|
| The SPR System | Experimental | The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started. Receives: Device: The SPR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Trial Stage)
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Measured: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Pain Intensity (Implant Stage)
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON.
Measured: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)
Device-Related Adverse Events
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Measured: Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)
Number of Subjects Who Were a Trial Stage Success
The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.
Measured: End of Treatment (EOT)
Number of Subjects Who Were an Implant Stage Success
Number of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.
Measured: 12-weeks post IPG-Stim ON
Secondary outcomes (14)
Pain Interference (Trial Stage)
Subjects were asked to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Measured: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Pain-Free Passive Range of Motion (Trial Stage)
Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Measured: Baseline, 3-week (Trial Stage), 6-week (Trial Stage);
Quality of Life (Trial Stage)
Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for Baseline, 3-week (End of Placebo), and 6-week (End of Treatment) were reported.
Measured: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Number of Participants Completing the Economic Impact Survey
Subjects were asked to document pain medication, doctor visits, supplies, related treatments, need for caregivers, time spent in skilled nursing facilities, and lost work due to their shoulder pain. This data was collected from subjects at Baseline and asked to recall this data for the 6-months prior to study enrollment. National average costs were not available for these data points, and therefore the overall economic impact of shoulder pain could not be reported.
Measured: Baseline
Emotional Functioning (Trial Stage)
Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Measured: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
User Satisfaction (Trial Stage)
Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the Smartpatch Stimulation System as a method for managing post-stroke shoulder pain.
Measured: 6-week (Trial Stage)
Global Impact of Stimulation Therapy (Trial Stage)
The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.
Measured: 3-week (Trial Stage), 6-week (Trial Stage)
Quality of Life (Implant Stage)
Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months, post IPG-Stim ON were reported.
Measured: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Pain Interference (Implant Stage)
Subjects were asked to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim On.
Measured: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Pain-Free Passive Range of Motion (Implant Stage)
Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.
Measured: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Emotional Functioning (Implant Stage)
Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.
Measured: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Global Impact of Stimulation Therapy (Implant Stage)
The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.
Measured: 3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage)
User Satisfaction (Implant Stage)
Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the IPG System as a method for managing post-stroke shoulder pain.
Measured: 12-weeks,12-months post IPG-Stim ON (Implant Stage)
Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)
Subjects were asked to assess their arm impairment using the Stroke Upper Limb Capacity Scale (SULCS) test. The SULCS is a validated upper limb capacity scale which includes tasks directly related to activities of daily living individuals experience in their home environment. The SULCS consists of 10 items, with each item having a possible score of 0 or 1: 3 items for arm capacity without active hand capacity; 4 items for arm capacity and basic hand capacity; and, 3 items for complex hand capacity. These scores were summed with a higher score indicating better capacity, with 10 being the max score. The average score across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Trial Stage).
Measured: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startApr 2010
- Primary completion25 Jul 2017
- Study completion25 Jul 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 Shoulder 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPR Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NDI Medical, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094301
- Sponsor's protocol ID
- NDI-0122-CSP-001
- Status last verified
- Sep 2018
- First submitted
- 25 Mar 2010
- Last updated
- 12 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Nguyen VQ, Bock WC, Groves CC, Whitney M, Bennett ME, Lechman TE, Strother R, Grill JH, Stager KW, Chae J. Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Am J Phys Med Rehabil. 2015 Feb;94(2):146-53. doi: 10.1097/PHM.0000000000000173.
PubMed 25251248
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain
- ClinicalTrials.gov ID
- NCT01094301
- Acronym / sponsor ID
- NDI-0122-CSP-001
- Conditions
- Shoulder Pain
- Keywords
- electrical stimulation, neurostimulation, neuromodulation, shoulder pain, post-stroke shoulder pain, hemiplegic shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SPR Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NDI Medical, LLC
- Study start
- Apr 2010
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Posted 12 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.
Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The SPR System | Experimental | Device: The SPR SystemThe SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| The SPR SystemThe SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started. | Device | The SPR System |
Primary outcome
Pain Intensity (Trial Stage)
Time frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Pain Intensity (Implant Stage)
Time frame: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON.
Device-Related Adverse Events
Time frame: Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Number of Subjects Who Were a Trial Stage Success
Time frame: End of Treatment (EOT)
The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.
Number of Subjects Who Were an Implant Stage Success
Time frame: 12-weeks post IPG-Stim ON
Number of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.
14 secondary outcomes
Pain Interference (Trial Stage)
Time frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Pain-Free Passive Range of Motion (Trial Stage)
Time frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage);
Quality of Life (Trial Stage)
Time frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Number of Participants Completing the Economic Impact Survey
Time frame: Baseline
Emotional Functioning (Trial Stage)
Time frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
User Satisfaction (Trial Stage)
Time frame: 6-week (Trial Stage)
Global Impact of Stimulation Therapy (Trial Stage)
Time frame: 3-week (Trial Stage), 6-week (Trial Stage)
Quality of Life (Implant Stage)
Time frame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Pain Interference (Implant Stage)
Time frame: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Pain-Free Passive Range of Motion (Implant Stage)
Time frame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Emotional Functioning (Implant Stage)
Time frame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)
Global Impact of Stimulation Therapy (Implant Stage)
Time frame: 3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage)
User Satisfaction (Implant Stage)
Time frame: 12-weeks,12-months post IPG-Stim ON (Implant Stage)
Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)
Time frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25251248Nguyen VQ, Bock WC, Groves CC, Whitney M, Bennett ME, Lechman TE, Strother R, Grill JH, Stager KW, Chae J. Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Am J Phys Med Rehabil. 2015 Feb;94(2):146-53. doi: 10.1097/PHM.0000000000000173.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The SPR System in people with Shoulder Pain, run by SPR Therapeutics, Inc. at 4 sites 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?
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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 12 Sep 2018). 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 Intensity (Trial Stage) (time frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)). The study lists 5 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 NCT01094301, 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 12 Sep 2018.