Plantar FasciitisNCT02895698
Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain
A study testing Dry cupping and Stretching exercises in people with Plantar Fasciitis and Heel Spur Syndrome, run by Imam Abdulrahman Bin Faisal University.
Trial summary
The main aim of this study is to investigate the effects of dry cupping on calf muscle trigger points in patients with plantar heel pain. A secondary aim is to examine the correlation between several outcome measures in those patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fasciitis, Heel Spur Syndrome, Chronic Plantar Fasciitis
- What is being tested?
- Dry cupping and Stretching exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral plantar heel pain.
- Trigger point(s) in the gastrocnemius/soleus muscle(s).
- Central or centro-medial tenderness in the plantar aspect of the heel.
Who cannot join
- Red flags: tumor, fracture, rheumatoid arthritis, osteoporosis, or any severe vascular condition in the lower limbs.
- Neurological symptoms: sciatica, tarsal tunnel syndrome.
- Previous surgery in the affected leg below the hip.
- Fibromyalgia.
- Previous manual therapy treatment for the same condition within the past 6 months.
- History of more than three corticosteroid injections within the past year.
About this study
The main aim of this study is to investigate the effects of dry cupping on calf muscle trigger points in patients with plantar heel pain. A secondary aim is to examine the correlation between several outcome measures in those patients.
Read the detailed description
Plantar heel pain is a condition often seen by healthcare providers. It is presented as pain and tenderness under the heel with weight bearing activities. Approximately 15% of athletic and non-athletic adults who have foot complaints seek professional care for plantar heel pain. There are different names and definitions for this condition in the literature such as plantar heel pain, plantar fasciitis, plantar fasciosis, plantar fasciopathy, heel spur syndrome, and jogger's heel. The reason for inconsistency in defining the condition is due to disagreement on the underlying pathology. A number of conditions may result in plantar heel pain, namely plantar fasciitis (most common), calcaneus fracture, heel fat pad atrophy, and peripheral nerve dysfunction. Recently, several studies have shown that myofascial trigger points (MTrPs) or tender points in the calf muscles may be associated with plantar heel pain. Many studies have determined risk factors in the development of plantar heel pain, classifying them as either intrinsic or extrinsic. Intrinsic risk factors comprise the anatomical (ROM of the ankle and subtalar joints position) or demographic characteristics of the individual (age, gender, weight and height). Extrinsic risk factors are related mainly to the subject's activity environment, such as running on a hard surface, time spent weight bearing, and previous injury. All these factors lead to an increase in the mechanical load on the foot, specifically the plantar fascia. Treatment of plantar heel pain usually targets the plantar fascia or other structures in the plantar heel area using several interventions such as cortisone injection, therapeutic ultrasound, laser, ice, heel pads, and night splints. Evidence varies regarding the effectiveness of these interventions.
The main aim of this study is to investigate the immediate and carry-over effects of dry cupping on calf muscle trigger points on pain and function in patients with plantar heel pain.
- Being tested
- Dry cupping, Stretching exercises
- Keywords
- Cupping, Dry cupping, Myofascial trigger points
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry cuppingDevice
Dry cupping. First, the therapist identified the trigger point on calf muscle.After identification of the trigger point, the participant was in prone with the ankle outside the edge of the bed. Ultrasound gel was then placed over the trigger point as a lubricant to increase the suctioning of the plastic vacuum cup, after which the cup was placed. Air was withdrawn from the cup to create a suction force. The cup was maintained for 10 minutes, and the participant was asked to do active ankle dorsiflexion exercise after 5 minutes of placing the cup. The therapist held the cup in place while the participant performed exercise.
Stretching exercisesOther
- The participant was in prone with the ankle outside the edge of the bed. The participant was asked to do active ankle dorsiflexion exercise after 5 minutes of lying on bed.
- Standing self-stretching of the calf muscles.
- Plantar fascia-specific self-stretching.The participant was instructed to start gently at first and then to work more aggressively as long as the pain is tolerable.
- All stretches were done six times and the duration of each stretch is 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Dry cupping + active dorsiflexion exercise + stretching exercise Receives: Device: Dry cupping |
| Control group | Other | stretching exercise + active dorsiflexion without cupping Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
- A self-reporting scale.
- The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Measured: Change from Baseline in VAS at 5 minutes post intervention
Visual analogue scale (VAS)
- A self-reporting scale.
- The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Measured: Change from Baseline in VAS at 2 days post intervention
Morning first steps visual analogue scale
- A self-reporting scale.
- The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Measured: Change from Baseline in morning visual Analog Scale at 2 days post intervention
Pressure pain threshold (PPT)
- The PPT was measured with an electronic algometer.
- Pressure was applied at a rate of 40 kilopascal (kPa/s), and participants pressed a switch when the sensation changed from pressure only to pressure and pain.
Measured: Change from Baseline in PPT at 5 minutes post intervention
Pressure pain threshold (PPT)
- The PPT was measured with an electronic algometer.
- Pressure was applied at a rate of 40 kPa/s, and participants pressed a switch when the sensation changed from pressure only to pressure and pain.
Measured: Change from Baseline in PPT at 2 days post intervention
The patient-specific functional scale (PSFS)
- A clinical outcome measure that allows participant to state their own functional status.
- The examiner asked the participant about three important activities that they were unable to do or had difficulty doing. The participants rated their level of function on a scale starting from 0, which is the lowest functional level, and 10, which is the highest level of function.
Measured: Change from Baseline in PSFS at 2 days post intervention
Ankle dorsiflexion range of motion (ROM)
- An inclinometer was used to measure the ROM of ankle dorsiflexion.
- The participant stands in a calf-stretch position, with knee extended or knee flexed (modified lunge position) then to move forward until the heel starts to rise or to maximum stretch. Then the examiner measured the range of motion.
Measured: Change from Baseline in ankle dorsiflexion ROM at 5 minutes post intervention
Ankle dorsiflexion range of motion (ROM)
- An inclinometer was used to measure the ROM of ankle dorsiflexion.
- The participant stands in a calf-stretch position, with knee extended or knee flexed (modified lunge position) then to move forward until the heel starts to rise or to maximum stretch. Then the examiner measured the range of motion.
Measured: Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention
Ankle plantar flexion strength
Ankle plantar flexion strength was assessed by asking the participant to perform as many single-leg heel rises as possible in standing at a rate of one every 2 seconds, and the examiner counted the repetitions.
Measured: Change from Baseline in ankle plantar flexion strength at 5 minutes post intervention
Ankle plantar flexion strength
Ankle plantar flexion strength was assessed by asking the participant to perform as many single-leg heel rises as possible in standing at a rate of one every 2 seconds, and the examiner counted the repetitions.
Measured: Change from Baseline in ankle plantar flexion strength at 2 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies 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
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali M Al Shami, Ph.D, Study director, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895698
- Sponsor's protocol ID
- IRB-2014-04-322
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
PubMed 12917892Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of calf muscle stretching for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2007 Apr 19;8:36. doi: 10.1186/1471-2474-8-36.
PubMed 17442119Ieong E, Afolayan J, Carne A, Solan M. Ultrasound scanning for recalcitrant plantar fasciopathy. Basis of a new classification. Skeletal Radiol. 2013 Mar;42(3):393-8. doi: 10.1007/s00256-012-1470-x. Epub 2012 Jul 22.
PubMed 22820618Irving DB, Cook JL, Menz HB. Factors associated with chronic plantar heel pain: a systematic review. J Sci Med Sport. 2006 May;9(1-2):11-22; discussion 23-4. doi: 10.1016/j.jsams.2006.02.004. Epub 2006 Apr 3.
PubMed 16584917Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.
PubMed 17400020Messier SP, Pittala KA. Etiologic factors associated with selected running injuries. Med Sci Sports Exerc. 1988 Oct;20(5):501-5.
PubMed 3193867Renan-Ordine R, Alburquerque-Sendin F, de Souza DP, Cleland JA, Fernandez-de-Las-Penas C. Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2011 Feb;41(2):43-50. doi: 10.2519/jospt.2011.3504. Epub 2011 Jan 31.
PubMed 21285525Riddle DL, Pulisic M, Pidcoe P, Johnson RE. Risk factors for Plantar fasciitis: a matched case-control study. J Bone Joint Surg Am. 2003 May;85(5):872-7. doi: 10.2106/00004623-200305000-00015.
PubMed 12728038Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.
PubMed 25361863
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Trigger Point Dry Cupping on Plantar Heel Pain
- ClinicalTrials.gov ID
- NCT02895698
- Acronym / sponsor ID
- IRB-2014-04-322
- Keywords
- Cupping, Dry cupping, Myofascial trigger points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to investigate the effects of dry cupping on calf muscle trigger points in patients with plantar heel pain. A secondary aim is to examine the correlation between several outcome measures in those patients.
Detailed description
Plantar heel pain is a condition often seen by healthcare providers. It is presented as pain and tenderness under the heel with weight bearing activities. Approximately 15% of athletic and non-athletic adults who have foot complaints seek professional care for plantar heel pain. There are different names and definitions for this condition in the literature such as plantar heel pain, plantar fasciitis, plantar fasciosis, plantar fasciopathy, heel spur syndrome, and jogger's heel. The reason for inconsistency in defining the condition is due to disagreement on the underlying pathology. A number of conditions may result in plantar heel pain, namely plantar fasciitis (most common), calcaneus fracture, heel fat pad atrophy, and peripheral nerve dysfunction. Recently, several studies have shown that myofascial trigger points (MTrPs) or tender points in the calf muscles may be associated with plantar heel pain. Many studies have determined risk factors in the development of plantar heel pain, classifying them as either intrinsic or extrinsic. Intrinsic risk factors comprise the anatomical (ROM of the ankle and subtalar joints position) or demographic characteristics of the individual (age, gender, weight and height). Extrinsic risk factors are related mainly to the subject's activity environment, such as running on a hard surface, time spent weight bearing, and previous injury. All these factors lead to an increase in the mechanical load on the foot, specifically the plantar fascia. Treatment of plantar heel pain usually targets the plantar fascia or other structures in the plantar heel area using several interventions such as cortisone injection, therapeutic ultrasound, laser, ice, heel pads, and night splints. Evidence varies regarding the effectiveness of these interventions.
The main aim of this study is to investigate the immediate and carry-over effects of dry cupping on calf muscle trigger points on pain and function in patients with plantar heel pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: Dry cuppingDry cupping + active dorsiflexion exercise + stretching exercise |
| Control group | Other | Other: Stretching exercisesstretching exercise + active dorsiflexion without cupping |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unilateral plantar heel pain.
- Trigger point(s) in the gastrocnemius/soleus muscle(s).
- Central or centro-medial tenderness in the plantar aspect of the heel.
Key exclusion criteria (6 listed)
- Red flags: tumor, fracture, rheumatoid arthritis, osteoporosis, or any severe vascular condition in the lower limbs.
- Neurological symptoms: sciatica, tarsal tunnel syndrome.
- Previous surgery in the affected leg below the hip.
- Fibromyalgia.
- Previous manual therapy treatment for the same condition within the past 6 months.
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 |
|---|---|---|
| Dry cuppingDry cupping. First, the therapist identified the trigger point on calf muscle.After identification of the trigger point, the participant was in prone with the ankle outside the edge of the bed. Ultrasound gel was then placed over the trigger point as a lubricant to increase the suctioning of the plastic vacuum cup, after which the cup was placed. Air was withdrawn from the cup to create a suction force. The cup was maintained for 10 minutes, and the participant was asked to do active ankle dorsiflexion exercise after 5 minutes of placing the cup. The therapist held the cup in place while the participant performed exercise. | Device | Treatment group |
| Stretching exercises* The participant was in prone with the ankle outside the edge of the bed. The participant was asked to do active ankle dorsiflexion exercise after 5 minutes of lying on bed. * Standing self-stretching of the calf muscles. * Plantar fascia-specific self-stretching.The participant was instructed to start gently at first and then to work more aggressively as long as the pain is tolerable. * All stretches were done six times and the duration of each stretch is 30 seconds. | Other | Control group |
Primary outcome
Visual analogue scale (VAS)
Time frame: Change from Baseline in VAS at 5 minutes post intervention
* A self-reporting scale. * The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Visual analogue scale (VAS)
Time frame: Change from Baseline in VAS at 2 days post intervention
* A self-reporting scale. * The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Morning first steps visual analogue scale
Time frame: Change from Baseline in morning visual Analog Scale at 2 days post intervention
* A self-reporting scale. * The scale is presented as a 10-cm horizontal line on which the participant pain intensity is represented by a point between the two ends: one end is labelled no pain, and the other end is labelled worst pain imaginable.
Pressure pain threshold (PPT)
Time frame: Change from Baseline in PPT at 5 minutes post intervention
* The PPT was measured with an electronic algometer. * Pressure was applied at a rate of 40 kilopascal (kPa/s), and participants pressed a switch when the sensation changed from pressure only to pressure and pain.
Pressure pain threshold (PPT)
Time frame: Change from Baseline in PPT at 2 days post intervention
* The PPT was measured with an electronic algometer. * Pressure was applied at a rate of 40 kPa/s, and participants pressed a switch when the sensation changed from pressure only to pressure and pain.
The patient-specific functional scale (PSFS)
Time frame: Change from Baseline in PSFS at 2 days post intervention
* A clinical outcome measure that allows participant to state their own functional status. * The examiner asked the participant about three important activities that they were unable to do or had difficulty doing. The participants rated their level of function on a scale starting from 0, which is the lowest functional level, and 10, which is the highest level of function.
Ankle dorsiflexion range of motion (ROM)
Time frame: Change from Baseline in ankle dorsiflexion ROM at 5 minutes post intervention
* An inclinometer was used to measure the ROM of ankle dorsiflexion. * The participant stands in a calf-stretch position, with knee extended or knee flexed (modified lunge position) then to move forward until the heel starts to rise or to maximum stretch. Then the examiner measured the range of motion.
Ankle dorsiflexion range of motion (ROM)
Time frame: Change from Baseline in ankle dorsiflexion ROM at 2 days post intervention
* An inclinometer was used to measure the ROM of ankle dorsiflexion. * The participant stands in a calf-stretch position, with knee extended or knee flexed (modified lunge position) then to move forward until the heel starts to rise or to maximum stretch. Then the examiner measured the range of motion.
Ankle plantar flexion strength
Time frame: Change from Baseline in ankle plantar flexion strength at 5 minutes post intervention
Ankle plantar flexion strength was assessed by asking the participant to perform as many single-leg heel rises as possible in standing at a rate of one every 2 seconds, and the examiner counted the repetitions.
Ankle plantar flexion strength
Time frame: Change from Baseline in ankle plantar flexion strength at 2 days post intervention
Ankle plantar flexion strength was assessed by asking the participant to perform as many single-leg heel rises as possible in standing at a rate of one every 2 seconds, and the examiner counted the repetitions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Background: PubMed 12917892Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
- Background: PubMed 17442119Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of calf muscle stretching for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2007 Apr 19;8:36. doi: 10.1186/1471-2474-8-36.
- Background: PubMed 22820618Ieong E, Afolayan J, Carne A, Solan M. Ultrasound scanning for recalcitrant plantar fasciopathy. Basis of a new classification. Skeletal Radiol. 2013 Mar;42(3):393-8. doi: 10.1007/s00256-012-1470-x. Epub 2012 Jul 22.
- Background: PubMed 16584917Irving DB, Cook JL, Menz HB. Factors associated with chronic plantar heel pain: a systematic review. J Sci Med Sport. 2006 May;9(1-2):11-22; discussion 23-4. doi: 10.1016/j.jsams.2006.02.004. Epub 2006 Apr 3.
- Background: PubMed 17400020Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.
- Background: PubMed 3193867Messier SP, Pittala KA. Etiologic factors associated with selected running injuries. Med Sci Sports Exerc. 1988 Oct;20(5):501-5.
- Background: PubMed 21285525Renan-Ordine R, Alburquerque-Sendin F, de Souza DP, Cleland JA, Fernandez-de-Las-Penas C. Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2011 Feb;41(2):43-50. doi: 10.2519/jospt.2011.3504. Epub 2011 Jan 31.
- Background: PubMed 12728038Riddle DL, Pulisic M, Pidcoe P, Johnson RE. Risk factors for Plantar fasciitis: a matched case-control study. J Bone Joint Surg Am. 2003 May;85(5):872-7. doi: 10.2106/00004623-200305000-00015.
- Background: PubMed 25361863Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.
- 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.
Ali M Al Shami, Ph.D study director
Imam Abdulrahman Bin Faisal University
Questions about this trial
What is this clinical trial studying?
A study testing Dry cupping and Stretching exercises in people with Plantar Fasciitis and Heel Spur Syndrome, run by Imam Abdulrahman Bin Faisal University.
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 3 inclusion and 6 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 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analogue scale (VAS) (time frame: Change from Baseline in VAS at 5 minutes post intervention). The study lists 10 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 NCT02895698, which also lists 9 linked publications.
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 2016.