Post-exercise Muscle RecoveryNCT02622971
Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery
A study testing PBMT and Cryotherapy in people with Post-exercise Muscle Recovery, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any procedure. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post-exercise Muscle Recovery
- What is being tested?
- PBMT and Cryotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Jan 2016
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects were included in the study if they performed less than 2 exercise session per week
Who cannot join
- Subjects were excluded if occurred any musculoskeletal injury to hips or knees within the previous two months,
- if they were currently using pharmacological agents or nutritional supplements regularly,
- if a musculoskeletal injury during the study occurred or if they reported use of either alcohol or tobacco.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)
São Paulo, São Paulo, 01504-001
About this study
Official title: Isolated and Combined Effects of Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery
Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric test in isokinetic dynamometer to measure muscle function). After, volunteers performed the exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS measure and MVC test were repeated. The treatments according to randomisation were performed three minutes after exercise protocol and it were performed again in 24, 48, 72h after eccentric exercise.
The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute, 1 hour, 24, 48, 72 and 96 hours after exercise protocol).
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial was performed at the Laboratory of Phototherapy in Sport and Exercise at Nove de Julho University in the city of São Paulo, Brazil.
Fifty healthy untrained male subjects were recruited from university staff and students to participate in the study. All participants voluntarily must agree to participate and they signed the informed consent statement. The intention-to-treat analysis was followed.
The volunteers were randomly allocated to five experimental groups (n=10 per group) according to the applied comparator. Randomisation was carried out by a simple drawing of lots (A, B, C, D or E). Blood samples (10 ml) was taken by a qualified nurse to analyse CK activity posteriorly. This blood collection was repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after eccentric protocol.
A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher. DOMS assessments were performed at baseline, immediately after eccentric exercise protocol (1 minute), and it was repeated at 1, 24, 48, 72 and 96 hours after the exercise protocol. Before exercise protocol, volunteers will perform a stretching and warm-up of the non-dominant lower limb and then they will perform Maximum voluntary contraction (MVC) to evaluate muscle function. MVC measurements were repeated at the same time intervals as the CK measures.
The exercise protocol consists in 75 eccentric isokinetic contractions of the knee extensor musculature in the non-dominant leg (5 sets of 15 repetitions, 30-second rest interval between sets) at a velocity of 60°.seg-1 in both the eccentric and concentric movements with a 60° range of motion (between 90° and 30° of knee flexion).
Regarding to treatment, all volunteers received the treatment according to randomisation three minutes after eccentric exercise protocol. Comparators were repeated at 24, 48, and 72 hours following the collection of additional blood samples for CK analyses and MVC and DOMS assessments.
The five groups was divided in: PBMT (photobiomodulation therapy)+cryotherapy; cryotherapy+PBMT; active PBMT; placebo PBMT and only cryotherapy.
PBMT was applied employing a cordless, portable GameDay™ Super Pulsed Laser (manufactured by Multi Radiance Medical, USA) to 6 sites of quadriceps femoris in direct contact with the skin (2 centrally - rectus femoral and vastus intermedius; 2 laterally - vastus lateralis; and 2 medially - vastus medialis) and cryotherapy was done with two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) that will cover the entire quadriceps for 20 minutes.
- Conditions
- Post-exercise Muscle Recovery
- Being tested
- PBMT, Cryotherapy
- Keywords
- phototherapy, cryotherapy, exercise, fatigue, recovery
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMTOther
Also called photobiomodulation therapy
Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
CryotherapyOther
Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.
| Study group | Role | What they receive |
|---|---|---|
| PBMT and Cryotherapy | Active comparator | Volunteers allocated in this group received phototherapy (PBMT - applied in six points of quadriceps) and cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. Receives: Other: PBMT; Other: Cryotherapy |
| Cryotherapy and PBMT | Active comparator | Volunteers allocated in this group received cryotherapy (20 minutes in PRICE protocol) and phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. Receives: Other: PBMT; Other: Cryotherapy |
| PBMT (active phototherapy) | Active comparator | Volunteers allocated in this group received active phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. Receives: Other: PBMT |
| PBMT (placebo phototherapy) | Placebo comparator | Volunteers allocated in this group received placebo phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. The placebo PBMT device was identical to the active devices and displayed the same settings and emitted the same sound regardless of the comparator. Receives: Other: PBMT |
| Cryotherapy | Active comparator | Volunteers allocated in this group cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. Two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) were used in order to cover the entire quadriceps. Rubber belts were used to apply compression and to affix the packs tightly to the volunteers' quadriceps. Receives: Other: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum voluntary contraction (MVC)
The MVC test consisted of three five-second isometric contractions of the knee extensors of the non-dominant leg. The highest torque value of the three contractions (peak torque) was used for statistical analysis.
Measured: one week
Secondary outcomes (2)
Evaluation of Delayed Onset Muscle Soreness (DOMS)
A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher.
Measured: one week
CK (Creatine Kinase) activity
Blood samples (10 ml) was taken by a qualified nurse blinded to the allocation of the volunteers to the five experimental groups from the antecubital vein. Spectrophotometry and specific reagent kits (Labtest®, São Paulo - SP, Brazil) were used to analyze CK (Creatine Kinase) activity as an indirect marker of muscle damage.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-exercise Muscle RecoveryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Multi Radiance Medical
- Responsible party
- Principal investigator, Adriane Aver Vanin, University of Nove de Julho
- Investigators
- Ernesto Cesar P Leal-Junior, PhD, PT, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622971
- Sponsor's protocol ID
- CEP 470.174
- Status last verified
- Feb 2016
- First submitted
- 24 Nov 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: all data is stored and saved in electronic devices to clarify any possible doubt regarding to methodological procedures and results.
Publications
Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
PubMed 24942380Grandinetti Vdos S, Miranda EF, Johnson DS, de Paiva PR, Tomazoni SS, Vanin AA, Albuquerque-Pontes GM, Frigo L, Marcos RL, de Carvalho Pde T, Leal-Junior EC. The thermal impact of phototherapy with concurrent super-pulsed lasers and red and infrared LEDs on human skin. Lasers Med Sci. 2015 Jul;30(5):1575-81. doi: 10.1007/s10103-015-1755-0. Epub 2015 May 19.
PubMed 25987340Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.
PubMed 20602109Graham CA, Stevenson J. Frozen chips: an unusual cause of severe frostbite injury. Br J Sports Med. 2000 Oct;34(5):382-3. doi: 10.1136/bjsm.34.5.382.
PubMed 11049150Moeller JL, Monroe J, McKeag DB. Cryotherapy-induced common peroneal nerve palsy. Clin J Sport Med. 1997 Jul;7(3):212-6. doi: 10.1097/00042752-199707000-00011.
PubMed 9262890Bassett FH 3rd, Kirkpatrick JS, Engelhardt DL, Malone TR. Cryotherapy-induced nerve injury. Am J Sports Med. 1992 Sep-Oct;20(5):516-8. doi: 10.1177/036354659202000505.
PubMed 1443317
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated and Combined Effects of Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery
- ClinicalTrials.gov ID
- NCT02622971
- Acronym / sponsor ID
- CEP 470.174
- Conditions
- Post-exercise Muscle Recovery
- Keywords
- phototherapy, cryotherapy, exercise, fatigue, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Multi Radiance Medical
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Dec 2015 (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.
Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric test in isokinetic dynamometer to measure muscle function). After, volunteers performed the exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS measure and MVC test were repeated. The treatments according to randomisation were performed three minutes after exercise protocol and it were performed again in 24, 48, 72h after eccentric exercise.
The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute, 1 hour, 24, 48, 72 and 96 hours after exercise protocol).
Detailed description
A randomized, double-blind, placebo-controlled clinical trial was performed at the Laboratory of Phototherapy in Sport and Exercise at Nove de Julho University in the city of São Paulo, Brazil.
Fifty healthy untrained male subjects were recruited from university staff and students to participate in the study. All participants voluntarily must agree to participate and they signed the informed consent statement. The intention-to-treat analysis was followed.
The volunteers were randomly allocated to five experimental groups (n=10 per group) according to the applied comparator. Randomisation was carried out by a simple drawing of lots (A, B, C, D or E). Blood samples (10 ml) was taken by a qualified nurse to analyse CK activity posteriorly. This blood collection was repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after eccentric protocol.
A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher. DOMS assessments were performed at baseline, immediately after eccentric exercise protocol (1 minute), and it was repeated at 1, 24, 48, 72 and 96 hours after the exercise protocol. Before exercise protocol, volunteers will perform a stretching and warm-up of the non-dominant lower limb and then they will perform Maximum voluntary contraction (MVC) to evaluate muscle function. MVC measurements were repeated at the same time intervals as the CK measures.
The exercise protocol consists in 75 eccentric isokinetic contractions of the knee extensor musculature in the non-dominant leg (5 sets of 15 repetitions, 30-second rest interval between sets) at a velocity of 60°.seg-1 in both the eccentric and concentric movements with a 60° range of motion (between 90° and 30° of knee flexion).
Regarding to treatment, all volunteers received the treatment according to randomisation three minutes after eccentric exercise protocol. Comparators were repeated at 24, 48, and 72 hours following the collection of additional blood samples for CK analyses and MVC and DOMS assessments.
The five groups was divided in: PBMT (photobiomodulation therapy)+cryotherapy; cryotherapy+PBMT; active PBMT; placebo PBMT and only cryotherapy.
PBMT was applied employing a cordless, portable GameDay™ Super Pulsed Laser (manufactured by Multi Radiance Medical, USA) to 6 sites of quadriceps femoris in direct contact with the skin (2 centrally - rectus femoral and vastus intermedius; 2 laterally - vastus lateralis; and 2 medially - vastus medialis) and cryotherapy was done with two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) that will cover the entire quadriceps for 20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PBMT and Cryotherapy | Active comparator | Other: PBMT, Other: CryotherapyVolunteers allocated in this group received phototherapy (PBMT - applied in six points of quadriceps) and cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. |
| Cryotherapy and PBMT | Active comparator | Other: PBMT, Other: CryotherapyVolunteers allocated in this group received cryotherapy (20 minutes in PRICE protocol) and phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. |
| PBMT (active phototherapy) | Active comparator | Other: PBMTVolunteers allocated in this group received active phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. |
| PBMT (placebo phototherapy) | Placebo comparator | Other: PBMTVolunteers allocated in this group received placebo phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. The placebo PBMT device was identical to the active devices and displayed the same settings and emitted the same sound regardless of the comparator. |
| Cryotherapy | Active comparator | Other: CryotherapyVolunteers allocated in this group cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. Two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) were used in order to cover the entire quadriceps. Rubber belts were used to apply compression and to affix the packs tightly to the volunteers' quadriceps. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects were included in the study if they performed less than 2 exercise session per week
Key exclusion criteria (3 listed)
- Subjects were excluded if occurred any musculoskeletal injury to hips or knees within the previous two months,
- if they were currently using pharmacological agents or nutritional supplements regularly,
- if a musculoskeletal injury during the study occurred or if they reported use of either alcohol or tobacco.
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 |
|---|---|---|
| PBMTAlso: photobiomodulation therapyEffects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery. | Other | Cryotherapy and PBMT, PBMT (active phototherapy), PBMT (placebo phototherapy), PBMT and Cryotherapy |
| CryotherapyEffects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery. | Other | Cryotherapy, Cryotherapy and PBMT, PBMT and Cryotherapy |
Primary outcome
Maximum voluntary contraction (MVC)
Time frame: one week
The MVC test consisted of three five-second isometric contractions of the knee extensors of the non-dominant leg. The highest torque value of the three contractions (peak torque) was used for statistical analysis.
2 secondary outcomes
Evaluation of Delayed Onset Muscle Soreness (DOMS)
Time frame: one week
CK (Creatine Kinase) activity
Time frame: one week
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 3 Feb 2016.
- Results publication: PubMed 24942380Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
- Results publication: PubMed 25987340Grandinetti Vdos S, Miranda EF, Johnson DS, de Paiva PR, Tomazoni SS, Vanin AA, Albuquerque-Pontes GM, Frigo L, Marcos RL, de Carvalho Pde T, Leal-Junior EC. The thermal impact of phototherapy with concurrent super-pulsed lasers and red and infrared LEDs on human skin. Lasers Med Sci. 2015 Jul;30(5):1575-81. doi: 10.1007/s10103-015-1755-0. Epub 2015 May 19.
- Results publication: PubMed 20602109Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.
- Results publication: PubMed 11049150Graham CA, Stevenson J. Frozen chips: an unusual cause of severe frostbite injury. Br J Sports Med. 2000 Oct;34(5):382-3. doi: 10.1136/bjsm.34.5.382.
- Results publication: PubMed 9262890Moeller JL, Monroe J, McKeag DB. Cryotherapy-induced common peroneal nerve palsy. Clin J Sport Med. 1997 Jul;7(3):212-6. doi: 10.1097/00042752-199707000-00011.
- Results publication: PubMed 1443317Bassett FH 3rd, Kirkpatrick JS, Engelhardt DL, Malone TR. Cryotherapy-induced nerve injury. Am J Sports Med. 1992 Sep-Oct;20(5):516-8. doi: 10.1177/036354659202000505.
- Individual participant dataSharing planned: Yes. all data is stored and saved in electronic devices to clarify any possible doubt regarding to methodological procedures and results.
Related trials for Post-exercise Muscle Recovery
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Shower Gel and Participant-Reported Post-Exercise Soreness in Regular Exercisers
Post-Exercise Recovery, Muscle Soreness
Recruiting
Microcurrent Therapy and the Post-Exercise Physiological Response (MENS_PE)
Muscle Fatigue
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
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.
Ernesto Cesar P Leal-Junior, PhD, PT principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBMT and Cryotherapy in people with Post-exercise Muscle Recovery, run by University of Nove de Julho at 1 site in Brazil.
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 1 inclusion and 3 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 Feb 2016. 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 Brazil. 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?
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?
Maximum voluntary contraction (MVC) (time frame: one week). 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 NCT02622971, which also lists 6 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 3 Feb 2016.