Wrist InjuriesNCT04842669
Effects of Low Level Laser Therapy On Exercise Induced Muscle Damage in Wrist Flexors Of Untrained Young Adults
A study testing low level laser therapy and Conservative treatment in people with Wrist Injuries, run by Riphah International University at 1 site in Pakistan.
Trial summary
The main aim of the current study is to investigate the effects of Low-level Laser Therapy on exercise-induced muscle damage of wrist flexors in untrained young adults. A randomized controlled trial will be conducted at Sargodha Medical College, University of Sargodha. The sample size calculated is 16. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrist Injuries
- What is being tested?
- low level laser therapy and Conservative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2020to 17 Aug 2021
- 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Un-trained young Adults
Who cannot join
- Any Trauma
- Any psychological condition
- Participation in any scheduled Physical training
- Athlete population
- Use of any nutritional supplement
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sargodha Medical College (University of Sargodha)
Sargodha, Punjab Province, 46000
About this study
Official title: Effects of Low Level Laser Therapy On Exercise Induced Muscle Damage in Wrist Flexors Of Untrained Young Adults.
The main aim of the current study is to investigate the effects of Low-level Laser Therapy on exercise-induced muscle damage of wrist flexors in untrained young adults. A randomized controlled trial will be conducted at Sargodha Medical College, University of Sargodha. The sample size calculated is 16. The participants will be divided into two equal group; 1) Interventional group (Low level laser therapy), 2) Control group (conventional) each having 8 participants. The study duration will be six months after approval from Research board. Blocked randomization sampling technique will be used. The subjects will be randomly assigned to any of the interventional or control group. Interventional group will further be allocated to prophylactic or therapeutic group. Only Un-trained young Adults, Aged 19-25 (under-graduate/college and university students) without gender discrimination will be included in the study. Tools used in the study will be TALAG Scale (Soreness assessment), Goniometer (ROM), Algometer (Pressure¬-pain Threshold), Electronic digital hand Dynamometer (Grip Strength) and PRS (Perceived Recovery Status Scale). Data will be collected at baseline, 1hr, 24hr, 72hr, 96hr, 120hr, 148hr, 168hr and 192 hrs after the induction protocol.
Read the detailed description
Wrist flexors play a crucial role in hand function. This group of small muscles is of high importance in our day to day tasks like carrying heavy objects and for activities in which forceful and/or rapid wrist flexions are required. Apart from this, the wrist flexors have a distinctive neural control as compared to the other surrounding musculature.
Muscle exhaustion that is induced after eccentric exercise, can either be of acute onset or delayed onset. Exercise induced muscle soreness that persists for about 4 to 6 hours before it returns to pre-exercise level is termed as acute soreness. On the other hand, muscle soreness beginning at 8 to 24 hours after eccentric exercise, with peak level at 24 to 48 hours is known as delayed soreness. Delayed-Onset Muscle Soreness (DOMS) is a common neuromuscular condition characterized by increased sensitivity to pain that is apparent with unaccustomed or vigorous exercise, a day after performance. DOMS becomes evident about 6-8 hours after an intense exercise bout and peaks at approximately 24-72 hours post-exercise. During first few hours of intensive exercise metabolism get disturbed that leads to inefficient physical activity and performance. Prolonged metabolic disturbances and physical activity and performance impairment progressing to days ultimately induce tissue damage that we call as delayed-onset muscle soreness. Event that produces muscle soreness is suggested as a mechanical disruption of sarcomeres leading to swelling of injured muscle fibers thus initiating an inflammatory response leading to the excitement of nociceptors.
Exercise-induced muscle injury is similar in pathological change and pathogenic mechanism in humans and animals. Human beings and animals have shown parallel reactions to changes caused by muscle damage induced by eccentric exercises. The beginning of initial exercise-induced muscle damage may be draining but is pain free. Later on, after 8-24 hours of muscle damage initiation, the subsequent inflammation results in delayed onset of muscle soreness.
It has been assumed that whenever an un-habitual physical exercise is carried out by a person then muscle injury occurs. A high level of muscle injury is associated with eccentric activities. Muscle injury is more likely to occur in untrained individuals who start practicing exercise. Furthermore, incidence of muscle injury is more common with exercises involving eccentric activities. Loss of strength, muscle inflammation, high level of muscle proteins in blood and delayed onset of muscle soreness DOMS are considered to be the expected outcomes of muscle injury. Different electro-physical modalities are being used by Physical therapists. In many conditions, improved healing and functioning are achieved by the use of these electro-physical modalities. Some animal studies have also reported the positive role of Low-Level Laser Therapy, when used in optimal parameters of irradiations, in enhancing the muscle healing and decreasing inflammation. Increased amount and activity of mitochondria and increased cross-sectional area of muscle fiber is associated with training. Increased muscle mass and improved mitochondrial function result in shift in muscle fiber type composition, from type two B to type Two A, and an increase in local glycogen storage capability. These combined adaptations make specialized athletes chiefly different from untrained people.
Several studies performed on human and animals evidenced the action of Low-level Laser Therapy in achieving therapeutic and physiological effects involving improvement of muscle functioning through interaction with biological tissues. Decrease in muscle fatigue has been reported by several researchers with the application of Laser Therapy before exercises that induces fatigue while considerable functional enhancement has also been evidenced by some investigators with Laser application after performing fatigue inducing exercises. Therapeutic effect of LLLT may be explained by mechanisms involving improved microcirculation of tissue, anti-inflammatory effect, decreased oxidative stress and decrease in tissue ischemia.
In 2016, a study was conducted to evaluate the effects of low level laser therapy on post exercise recovery of skeletal muscle and improvement in muscle performance and function. The conclusion of this study was that pre-exercise treatment with low level laser therapy increases muscle performance along with improvement in biochemical markers associated with inflammation and muscle injury.
In August 2011, Wouber Hérickson de Brito and fellows carried out a comparative study to investigate whether muscle performance could be increased with endurance training associated with LLLT when compared to the same training without LLLT. Results suggested a great decrease in fatigue when training was combined with LLLT, thus improving the muscle performance.
In August 2010, a study was carried out to find out the effectiveness of low-level laser therapy (LLLT) on muscle performance, fatigue development, and biochemical markers of post-exercise recovery on bicep muscle. Results clearly suggested that endurance for repetitive elbow flexion has been increased with the application of LLLT before exercise while levels of reactive protein, creatine kinase and blood lactate has been decreased after performance of exercise.
In July 2010, to investigate the effects of Low-level laser therapy before eccentric exercise on muscle damage markers in humans. It was concluded that LLLT therapy when given before performance of eccentric exercise, accelerated the increase of muscle proteins in the blood serum and the decrease in muscle force.
In July 2011, a study was carried out to compare the effects of Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans. The study showed that both red and infrared LLLT are effective in delaying the development skeletal muscle fatigue and in improvement of skeletal functioning.
In August 2009, to investigate the Effects of Low-Level Laser Irradiation on Skeletal Muscle Injury after Eccentric Exercise. It was the first study performed on animal model to investigate these effects. It was concluded that Low-level He-Ne laser therapy exerts therapeutic effects by improving anti-oxidative capacity of muscle as well as decreasing the inflammatory reaction.
- Conditions
- Wrist Injuries
- Being tested
- low level laser therapy, Conservative treatment
- Keywords
- exercise induced muscle damage, wrist flexor, low level laser therapy
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyOther
Endo-laser 422 with interchangeable laser probes will be used for the purpose. It is a 2-channel unit and is software operated. For treatment of small surfaces with mono laser there are diodes of 25, 100 and 500 milliWatt.Frequency will be adjusted to 500 Hz, dose 0.1/cm2 with time duration of 1-5 minutes.
Conservative treatmentOther
(Topical ibuprofen gel) for muscle soreness will be provided
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | Low level laser therapy Receives: Other: low level laser therapy |
| Conservative treatment | Active comparator | Conservative treatment Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS):
The Numeric Rating Scale is an 11 point scale where the end points are the extremes of no pain and pain as bad as it could be, or worst pain. Numerical Rating Scale has good sensitivity and generates data that can be statistically analyzed for audit purposes.
Measurements were done at 24, 48, 72, 96,120, 144 and 168, and 192 hours at the same time of the day.
Measured: 8th day (192 hours)
TALAG Scale (Soreness assessment):
TALAG scale will be used to assess the perceived soreness. It consists of points 1-7 on scale. The minimum level 1 with no pain and a maximum point 7 with unbearably painful.Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Measured: 8th day (192 hours)
Goniometer
Physical therapists widely use goniometer for measurement of different joint ranges to evaluate any ROM limitation. The universal full circle goniometer is the preferred instrument for measuring ROM.Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Measured: 8th day (192 hours)
Pressure-pain Threshold by Algometer
Algometer is a reliable tool for measuring pressure pain threshold(22).The Pressure Pain Threshold will be evaluated using an analogue algometer (Baseline, 60 pounds capacity) by applying vertical pressure. To stimulate the participant's pain, the pressure will be increased at a rate of 1kg/cm2.Measurements will be taken pre and post treatment for 2 times during study. Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Measured: 8th day (192 hours)
Electronic digital hand Dynamometer
Grip strength will be evaluated with an electronic digital hand dynamometer as per recommendations. Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Measured: 8th day (192 hours)
Secondary outcomes (1)
Perceived Recovery (Perceived Recovery Status Scale):
PRS scale is a convenient, noninvasive marker of recovery relative to subsequent training.
This scale consist of 10 points from 0 -10 with the minimum value 0 for very poorly recovered and maximum 10 value for very well recovered.Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Measured: 8th day (192 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start20 Oct 2020
- Primary completion20 Apr 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuriesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842669
- Sponsor's protocol ID
- REC/00864 Kirran Sikandar
- Status last verified
- Sep 2021
- First submitted
- 10 Apr 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Level Laser Therapy On Exercise Induced Muscle Damage in Wrist Flexors Of Untrained Young Adults.
- ClinicalTrials.gov ID
- NCT04842669
- Acronym / sponsor ID
- REC/00864 Kirran Sikandar
- Conditions
- Wrist Injuries
- Keywords
- exercise induced muscle damage, wrist flexor, low level laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- 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 the current study is to investigate the effects of Low-level Laser Therapy on exercise-induced muscle damage of wrist flexors in untrained young adults. A randomized controlled trial will be conducted at Sargodha Medical College, University of Sargodha. The sample size calculated is 16. The participants will be divided into two equal group; 1) Interventional group (Low level laser therapy), 2) Control group (conventional) each having 8 participants. The study duration will be six months after approval from Research board. Blocked randomization sampling technique will be used. The subjects will be randomly assigned to any of the interventional or control group. Interventional group will further be allocated to prophylactic or therapeutic group. Only Un-trained young Adults, Aged 19-25 (under-graduate/college and university students) without gender discrimination will be included in the study. Tools used in the study will be TALAG Scale (Soreness assessment), Goniometer (ROM), Algometer (Pressure¬-pain Threshold), Electronic digital hand Dynamometer (Grip Strength) and PRS (Perceived Recovery Status Scale). Data will be collected at baseline, 1hr, 24hr, 72hr, 96hr, 120hr, 148hr, 168hr and 192 hrs after the induction protocol.
Detailed description
Wrist flexors play a crucial role in hand function. This group of small muscles is of high importance in our day to day tasks like carrying heavy objects and for activities in which forceful and/or rapid wrist flexions are required. Apart from this, the wrist flexors have a distinctive neural control as compared to the other surrounding musculature.
Muscle exhaustion that is induced after eccentric exercise, can either be of acute onset or delayed onset. Exercise induced muscle soreness that persists for about 4 to 6 hours before it returns to pre-exercise level is termed as acute soreness. On the other hand, muscle soreness beginning at 8 to 24 hours after eccentric exercise, with peak level at 24 to 48 hours is known as delayed soreness. Delayed-Onset Muscle Soreness (DOMS) is a common neuromuscular condition characterized by increased sensitivity to pain that is apparent with unaccustomed or vigorous exercise, a day after performance. DOMS becomes evident about 6-8 hours after an intense exercise bout and peaks at approximately 24-72 hours post-exercise. During first few hours of intensive exercise metabolism get disturbed that leads to inefficient physical activity and performance. Prolonged metabolic disturbances and physical activity and performance impairment progressing to days ultimately induce tissue damage that we call as delayed-onset muscle soreness. Event that produces muscle soreness is suggested as a mechanical disruption of sarcomeres leading to swelling of injured muscle fibers thus initiating an inflammatory response leading to the excitement of nociceptors.
Exercise-induced muscle injury is similar in pathological change and pathogenic mechanism in humans and animals. Human beings and animals have shown parallel reactions to changes caused by muscle damage induced by eccentric exercises. The beginning of initial exercise-induced muscle damage may be draining but is pain free. Later on, after 8-24 hours of muscle damage initiation, the subsequent inflammation results in delayed onset of muscle soreness.
It has been assumed that whenever an un-habitual physical exercise is carried out by a person then muscle injury occurs. A high level of muscle injury is associated with eccentric activities. Muscle injury is more likely to occur in untrained individuals who start practicing exercise. Furthermore, incidence of muscle injury is more common with exercises involving eccentric activities. Loss of strength, muscle inflammation, high level of muscle proteins in blood and delayed onset of muscle soreness DOMS are considered to be the expected outcomes of muscle injury. Different electro-physical modalities are being used by Physical therapists. In many conditions, improved healing and functioning are achieved by the use of these electro-physical modalities. Some animal studies have also reported the positive role of Low-Level Laser Therapy, when used in optimal parameters of irradiations, in enhancing the muscle healing and decreasing inflammation. Increased amount and activity of mitochondria and increased cross-sectional area of muscle fiber is associated with training. Increased muscle mass and improved mitochondrial function result in shift in muscle fiber type composition, from type two B to type Two A, and an increase in local glycogen storage capability. These combined adaptations make specialized athletes chiefly different from untrained people.
Several studies performed on human and animals evidenced the action of Low-level Laser Therapy in achieving therapeutic and physiological effects involving improvement of muscle functioning through interaction with biological tissues. Decrease in muscle fatigue has been reported by several researchers with the application of Laser Therapy before exercises that induces fatigue while considerable functional enhancement has also been evidenced by some investigators with Laser application after performing fatigue inducing exercises. Therapeutic effect of LLLT may be explained by mechanisms involving improved microcirculation of tissue, anti-inflammatory effect, decreased oxidative stress and decrease in tissue ischemia.
In 2016, a study was conducted to evaluate the effects of low level laser therapy on post exercise recovery of skeletal muscle and improvement in muscle performance and function. The conclusion of this study was that pre-exercise treatment with low level laser therapy increases muscle performance along with improvement in biochemical markers associated with inflammation and muscle injury.
In August 2011, Wouber Hérickson de Brito and fellows carried out a comparative study to investigate whether muscle performance could be increased with endurance training associated with LLLT when compared to the same training without LLLT. Results suggested a great decrease in fatigue when training was combined with LLLT, thus improving the muscle performance.
In August 2010, a study was carried out to find out the effectiveness of low-level laser therapy (LLLT) on muscle performance, fatigue development, and biochemical markers of post-exercise recovery on bicep muscle. Results clearly suggested that endurance for repetitive elbow flexion has been increased with the application of LLLT before exercise while levels of reactive protein, creatine kinase and blood lactate has been decreased after performance of exercise.
In July 2010, to investigate the effects of Low-level laser therapy before eccentric exercise on muscle damage markers in humans. It was concluded that LLLT therapy when given before performance of eccentric exercise, accelerated the increase of muscle proteins in the blood serum and the decrease in muscle force.
In July 2011, a study was carried out to compare the effects of Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans. The study showed that both red and infrared LLLT are effective in delaying the development skeletal muscle fatigue and in improvement of skeletal functioning.
In August 2009, to investigate the Effects of Low-Level Laser Irradiation on Skeletal Muscle Injury after Eccentric Exercise. It was the first study performed on animal model to investigate these effects. It was concluded that Low-level He-Ne laser therapy exerts therapeutic effects by improving anti-oxidative capacity of muscle as well as decreasing the inflammatory reaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Other: low level laser therapyLow level laser therapy |
| Conservative treatment | Active comparator | Other: Conservative treatmentConservative treatment |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Un-trained young Adults
Key exclusion criteria (5 listed)
- Any Trauma
- Any psychological condition
- Participation in any scheduled Physical training
- Athlete population
- Use of any nutritional supplement
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 |
|---|---|---|
| low level laser therapyEndo-laser 422 with interchangeable laser probes will be used for the purpose. It is a 2-channel unit and is software operated. For treatment of small surfaces with mono laser there are diodes of 25, 100 and 500 milliWatt.Frequency will be adjusted to 500 Hz, dose 0.1/cm2 with time duration of 1-5 minutes. | Other | Low level laser therapy |
| Conservative treatment(Topical ibuprofen gel) for muscle soreness will be provided | Other | Conservative treatment |
Primary outcome
Numeric pain rating scale (NPRS):
Time frame: 8th day (192 hours)
The Numeric Rating Scale is an 11 point scale where the end points are the extremes of no pain and pain as bad as it could be, or worst pain. Numerical Rating Scale has good sensitivity and generates data that can be statistically analyzed for audit purposes. Measurements were done at 24, 48, 72, 96,120, 144 and 168, and 192 hours at the same time of the day.
TALAG Scale (Soreness assessment):
Time frame: 8th day (192 hours)
TALAG scale will be used to assess the perceived soreness. It consists of points 1-7 on scale. The minimum level 1 with no pain and a maximum point 7 with unbearably painful.Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Goniometer
Time frame: 8th day (192 hours)
Physical therapists widely use goniometer for measurement of different joint ranges to evaluate any ROM limitation. The universal full circle goniometer is the preferred instrument for measuring ROM.Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Pressure-pain Threshold by Algometer
Time frame: 8th day (192 hours)
Algometer is a reliable tool for measuring pressure pain threshold(22).The Pressure Pain Threshold will be evaluated using an analogue algometer (Baseline, 60 pounds capacity) by applying vertical pressure. To stimulate the participant's pain, the pressure will be increased at a rate of 1kg/cm2.Measurements will be taken pre and post treatment for 2 times during study. Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
Electronic digital hand Dynamometer
Time frame: 8th day (192 hours)
Grip strength will be evaluated with an electronic digital hand dynamometer as per recommendations. Measurement of all dependent variables at 24, 48, 72, 96,120, 144 and 168, and 192 hours after eccentric exercise were taken at the same time of the day.
1 secondary outcome
Perceived Recovery (Perceived Recovery Status Scale):
Time frame: 8th day (192 hours)
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 30 Sep 2021.
- 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.
Maria Khalid, MSOMPT principal investigator
Riphah International 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 low level laser therapy and Conservative treatment in people with Wrist Injuries, run by Riphah International University at 1 site in Pakistan.
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 5 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 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
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?
Numeric pain rating scale (NPRS): (time frame: 8th day (192 hours)). 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?
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 30 Sep 2021.