Trigger Point Pain, MyofascialNCT04348097
Comparison of Dry Needling and Activator Trigger Point Therapy on Upper Trapezius Trigger Points.
A study testing Activator instrument and dry needle in people with Trigger Point Pain, Myofascial, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study was to compare the effects of Dry needling and Activator trigger point therapy on upper trapezius trigger points.Randomized controlled trial was conducted on Sixty-eight patients with active upper trapezius trigger points meeting the inclusion criteria i.e Age limit 20-45 both genders, presence… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Activator instrument and dry needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2019to 20 Feb 2020
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age limit 20-45
- male and female .
- Presence of unilateral or bilateral upper trapezius Trigger Points.
- Patients identified with presence of trigger points.
Who cannot join
- Specific neck pain,
- Evidence of spinal cord compression
- Recent neck surgery or trauma.
- Long-term use of corticosteroids. Anticoagulant use, e.g. Warfarin. Presence of a blood coagulation disorder. Contraindication for needling such as local infection, pregnancy with threatened abortion
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Medical Rehabilitation
Islamabad, Punjab Province, 46000
About this study
The aim of this study was to compare the effects of Dry needling and Activator trigger point therapy on upper trapezius trigger points.Randomized controlled trial was conducted on Sixty-eight patients with active upper trapezius trigger points meeting the inclusion criteria i.e Age limit 20-45 both genders, presence of unilateral or bilateral upper trapezius Trigger Points. For bilateral presence of trigger points, the more painful side was selected. If more than one trigger points were present on the side to be treated, most painful trigger point was treated. Patients fulfilling essential criteria to identify the trigger points. According to Simon's criteria, which included a palpable taut band that was detected with palpation, the presence of a sensitive nodule in the taut band which was determined with algometry and referral pain. Exclusion criteria was specific neck pain, e.g. radiculopathy, systemic or inflammatory pain., evidence of spinal cord compression, recent neck surgery or trauma, long-term use of corticosteroids, anticoagulant use, e.g. Warfarin, presence of a blood coagulation disorder, contraindication for needling such as local infection, pregnancy with threatened abortion. Participants were selected by purposive sampling, group randomization using lottery method technique. All the participants were assessed using Numeric pain rating scale to measure pain, algometer to measure pain pressure threshold and inclinometer to measure cervical lateral flexion range of motion. A demographic form was used to collect data from patients. Patients were randomly assigned in dry needling and activator therapy group. Treatment was given at a frequency of 2 sessions per week and total 6 sessions were given to both group during a course of 3 weeks. The data was analyzed using SPSS 21.
Read the detailed description
A myofascial trigger point (TrP) has been described as a hyperirritable spot located in a taut band of muscle; or a small pea or rope-like nodular or crepitant (crackling, grating) area within the muscle, which is painful to palpation or compression and refers pain, tenderness, or an autonomic response to a remote area. Some investigators stated that when pressure is applied to a TrP, a -jump sign‖ or -jump response‖ is elicited whereby the patient reacts with facial grimacing or by jumping away from the examiner.Patients with myofascial trigger points are generally characterized by the presence of one or more of the following symptoms: local pain, referred pain according to a typical pattern, pain when exerting compression or stretch on the muscle, local twitch response (LTR) provoked by the snapping palpation of the taut band, reduced force, and decreased range of motion (ROM). A combination of these symptoms can result in less functionality and quality-of-life. As a consequence, pain, ROM, and functionality are frequently used to measure the effect of treatment in patients with myofascial pain syndrome . Myofascial trigger points can be further differentiated as active or latent . Active and latent myofascial trigger points elicit local and referred pain, however active myofascial trigger points also reproduce patient symptoms, whereas latent myofascial trigger points do not .
Dry needling is a minimally invasive procedure in which an acupuncture needle is inserted directly into an myofascial trigger points.The advantages of dry needling are being increasingly documented and include an immediate reduction in local, referred, and widespread pain , and restoration of range of motion and muscle activation patterns.Dry needling is typically used to treat muscles, ligaments, tendons, subcutaneous fascia, scar tissue, peripheral nerves, and neurovascular bundles for the management of a variety of neuromusculoskeletal pain syndromes Chiropractic activator tool is an instrument for assisting with manipulation having cushioned head devices which require the applicator to pre - load or arm the device by pulling a handle against the action of a strong spring force.
A study was conducted in 2015 which concluded that Dry needling can be recommended to relieve myofacial trigger point pain of neck and shoulders in short and medium terms.
A study conducted in 2015 and found that There is moderate evidence that ischemic compression results in pain reduction, whereas there is strong evidence that dry needling has a positive effect on pain reduction. This decrease is greater compared with active range of motion exercises as well as no or placebo intervention A study conducted in 2014 and reported that dry needling is beneficial for decreasing pain immediately after treatment and at a 4-wk follow-up in patients with neck pain.
A research in 2019 showed that both extracorporeal shock wave therapy and dry needling can be employed to treat myofacial trigger point of the upper trapezius muscle in patients with non specific neck pain .
A research conducted in 2018 observed the changes in the ROM and neck disability index with Superficial dry needling and Deep dry needling techniques, but these changes were more significant in patients treated with Deep dry needling, especially in the follow-up periods A research in 2008 suggested that both ischaemic compression and activator trigger point therapy have an equal immediate clinically important effect on upper trapezius trigger point pain A study in 2008 suggested that activator trigger point therapy appeared to be more effective than myofascial band therapy or sham ultrasound in treating patients with non-specific neck pain and upper trapezius trigger points
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Activator instrument, dry needle
- Keywords
- Activator therapy, Dry needling,, Myofascial pain, Upper trapezius.
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activator instrumentDevice
activator instrument was placed perpendicular over the identified trigger point and 10 thrusts were delivered, with a rate of one thrust per second
dry needleDevice
By wrist flexion and extension movements, the trigger point was needled in different directions and tried to elicit at least one local twitch response during the procedure and patient's familiar referral pain was tried to obtain . Each dry needling procedure lasted 1-2 minutes
| Study group | Role | What they receive |
|---|---|---|
| activator trigger point therapy | Experimental | The Activator adjusting instrument used had force settings ranging from 1 to 6
. For this study a force setting of 3 was used. Receives: Device: Activator instrument; Device: dry needle |
| Trigger point dry needling | Active comparator | First, a tight band was held between the index finger and the thumb of the non-dominant hand and the needle (0.25-40 mm - Shen Long) was perpendicularly inserted into the muscle with the dominant hand. Receives: Device: Activator instrument; Device: dry needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
The NPRS was used to measure the pain intensity of myofasial trigger points of the upper trapezius muscle . NPRS is a valid and reliable tool to assess pain. It consists of 10cm long line scale on which patient reports his/her pain from 0 (no pain) to (10 (worst possible pain)
Measured: for three weeks
Inclinometer
PAOMPT Bubble inclinometer was used in our study. Patient was educated abot the procedure. Inclinometer was placed on patients head. Cervical lateral flexion was recorded by stabilizing the shoulder of the patient and asking him/her to bring his/her ear towards the shoulder. Reading was recorded by the tilt of fluid inside the inclinometer.
Measured: for three weeks
Algometer
The pain pressre threshold was taken by applying vertical pressure over selected trigger point by a sixty pound baseline algometer. Pressure was increased at the rate of 1kg/cm until the patient reported the pain by saying 'yes'. 3 readings were taken at the interval of ten seconds and mean was considered as the selected measurement
Measured: for three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Jul 2019
- Primary completion1 Nov 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Trigger Point Pain, MyofascialStudies 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
- Outcomes assessor
- Enrolment
- 68 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
- NCT04348097
- Sponsor's protocol ID
- REC/00464 Salman Sabir
- Status last verified
- Apr 2020
- First submitted
- 6 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
PubMed 24725800Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
PubMed 25768071Ramsey FE, Tomlanovich MC, Nowak RM. Cricothyrotomy instrumentation. JACEP. 1978 Sep;7(9):345-6. doi: 10.1016/s0361-1124(78)80362-1. No abstract available.
PubMed 45708Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
PubMed 25724849Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
PubMed 26304789Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.
PubMed 25143704Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
PubMed 25576642Jensen EV, Block GE, Ferguson DJ, DeSombre ER. Estrogen receptors in breast cancer. World J Surg. 1977 May;1(3):341-2. doi: 10.1007/BF01556853. No abstract available.
PubMed 883334
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dry Needling and Activator Trigger Point Therapy on Upper Trapezius Trigger Points.
- ClinicalTrials.gov ID
- NCT04348097
- Acronym / sponsor ID
- REC/00464 Salman Sabir
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- Activator therapy, Dry needling,, Myofascial pain, Upper trapezius.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 15 Apr 2020 (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 aim of this study was to compare the effects of Dry needling and Activator trigger point therapy on upper trapezius trigger points.Randomized controlled trial was conducted on Sixty-eight patients with active upper trapezius trigger points meeting the inclusion criteria i.e Age limit 20-45 both genders, presence of unilateral or bilateral upper trapezius Trigger Points. For bilateral presence of trigger points, the more painful side was selected. If more than one trigger points were present on the side to be treated, most painful trigger point was treated. Patients fulfilling essential criteria to identify the trigger points. According to Simon's criteria, which included a palpable taut band that was detected with palpation, the presence of a sensitive nodule in the taut band which was determined with algometry and referral pain. Exclusion criteria was specific neck pain, e.g. radiculopathy, systemic or inflammatory pain., evidence of spinal cord compression, recent neck surgery or trauma, long-term use of corticosteroids, anticoagulant use, e.g. Warfarin, presence of a blood coagulation disorder, contraindication for needling such as local infection, pregnancy with threatened abortion. Participants were selected by purposive sampling, group randomization using lottery method technique. All the participants were assessed using Numeric pain rating scale to measure pain, algometer to measure pain pressure threshold and inclinometer to measure cervical lateral flexion range of motion. A demographic form was used to collect data from patients. Patients were randomly assigned in dry needling and activator therapy group. Treatment was given at a frequency of 2 sessions per week and total 6 sessions were given to both group during a course of 3 weeks. The data was analyzed using SPSS 21.
Detailed description
A myofascial trigger point (TrP) has been described as a hyperirritable spot located in a taut band of muscle; or a small pea or rope-like nodular or crepitant (crackling, grating) area within the muscle, which is painful to palpation or compression and refers pain, tenderness, or an autonomic response to a remote area. Some investigators stated that when pressure is applied to a TrP, a -jump sign‖ or -jump response‖ is elicited whereby the patient reacts with facial grimacing or by jumping away from the examiner.Patients with myofascial trigger points are generally characterized by the presence of one or more of the following symptoms: local pain, referred pain according to a typical pattern, pain when exerting compression or stretch on the muscle, local twitch response (LTR) provoked by the snapping palpation of the taut band, reduced force, and decreased range of motion (ROM). A combination of these symptoms can result in less functionality and quality-of-life. As a consequence, pain, ROM, and functionality are frequently used to measure the effect of treatment in patients with myofascial pain syndrome . Myofascial trigger points can be further differentiated as active or latent . Active and latent myofascial trigger points elicit local and referred pain, however active myofascial trigger points also reproduce patient symptoms, whereas latent myofascial trigger points do not .
Dry needling is a minimally invasive procedure in which an acupuncture needle is inserted directly into an myofascial trigger points.The advantages of dry needling are being increasingly documented and include an immediate reduction in local, referred, and widespread pain , and restoration of range of motion and muscle activation patterns.Dry needling is typically used to treat muscles, ligaments, tendons, subcutaneous fascia, scar tissue, peripheral nerves, and neurovascular bundles for the management of a variety of neuromusculoskeletal pain syndromes Chiropractic activator tool is an instrument for assisting with manipulation having cushioned head devices which require the applicator to pre - load or arm the device by pulling a handle against the action of a strong spring force.
A study was conducted in 2015 which concluded that Dry needling can be recommended to relieve myofacial trigger point pain of neck and shoulders in short and medium terms.
A study conducted in 2015 and found that There is moderate evidence that ischemic compression results in pain reduction, whereas there is strong evidence that dry needling has a positive effect on pain reduction. This decrease is greater compared with active range of motion exercises as well as no or placebo intervention A study conducted in 2014 and reported that dry needling is beneficial for decreasing pain immediately after treatment and at a 4-wk follow-up in patients with neck pain.
A research in 2019 showed that both extracorporeal shock wave therapy and dry needling can be employed to treat myofacial trigger point of the upper trapezius muscle in patients with non specific neck pain .
A research conducted in 2018 observed the changes in the ROM and neck disability index with Superficial dry needling and Deep dry needling techniques, but these changes were more significant in patients treated with Deep dry needling, especially in the follow-up periods A research in 2008 suggested that both ischaemic compression and activator trigger point therapy have an equal immediate clinically important effect on upper trapezius trigger point pain A study in 2008 suggested that activator trigger point therapy appeared to be more effective than myofascial band therapy or sham ultrasound in treating patients with non-specific neck pain and upper trapezius trigger points
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| activator trigger point therapy | Experimental | Device: Activator instrument, Device: dry needleThe Activator adjusting instrument used had force settings ranging from 1 to 6 . For this study a force setting of 3 was used. |
| Trigger point dry needling | Active comparator | Device: Activator instrument, Device: dry needleFirst, a tight band was held between the index finger and the thumb of the non-dominant hand and the needle (0.25-40 mm - Shen Long) was perpendicularly inserted into the muscle with the dominant hand. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age limit 20-45
- male and female .
- Presence of unilateral or bilateral upper trapezius Trigger Points.
- Patients identified with presence of trigger points.
Key exclusion criteria (4 listed)
- Specific neck pain,
- Evidence of spinal cord compression
- Recent neck surgery or trauma.
- Long-term use of corticosteroids. Anticoagulant use, e.g. Warfarin. Presence of a blood coagulation disorder. Contraindication for needling such as local infection, pregnancy with threatened abortion
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 |
|---|---|---|
| Activator instrumentactivator instrument was placed perpendicular over the identified trigger point and 10 thrusts were delivered, with a rate of one thrust per second | Device | Trigger point dry needling, activator trigger point therapy |
| dry needleBy wrist flexion and extension movements, the trigger point was needled in different directions and tried to elicit at least one local twitch response during the procedure and patient's familiar referral pain was tried to obtain . Each dry needling procedure lasted 1-2 minutes | Device | Trigger point dry needling, activator trigger point therapy |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: for three weeks
The NPRS was used to measure the pain intensity of myofasial trigger points of the upper trapezius muscle . NPRS is a valid and reliable tool to assess pain. It consists of 10cm long line scale on which patient reports his/her pain from 0 (no pain) to (10 (worst possible pain)
Inclinometer
Time frame: for three weeks
PAOMPT Bubble inclinometer was used in our study. Patient was educated abot the procedure. Inclinometer was placed on patients head. Cervical lateral flexion was recorded by stabilizing the shoulder of the patient and asking him/her to bring his/her ear towards the shoulder. Reading was recorded by the tilt of fluid inside the inclinometer.
Algometer
Time frame: for three weeks
The pain pressre threshold was taken by applying vertical pressure over selected trigger point by a sixty pound baseline algometer. Pressure was increased at the rate of 1kg/cm until the patient reported the pain by saying 'yes'. 3 readings were taken at the interval of ten seconds and mean was considered as the selected measurement
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 15 Apr 2020.
- Background: PubMed 24725800Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
- Background: PubMed 25768071Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
- Background: PubMed 45708Ramsey FE, Tomlanovich MC, Nowak RM. Cricothyrotomy instrumentation. JACEP. 1978 Sep;7(9):345-6. doi: 10.1016/s0361-1124(78)80362-1. No abstract available.
- Background: PubMed 25724849Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
- Background: PubMed 26304789Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
- Background: PubMed 25143704Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.
- Background: PubMed 25576642Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
- Background: PubMed 883334Jensen EV, Block GE, Ferguson DJ, DeSombre ER. Estrogen receptors in breast cancer. World J Surg. 1977 May;1(3):341-2. doi: 10.1007/BF01556853. No abstract available.
- 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 Activator instrument and dry needle in people with Trigger Point Pain, Myofascial, 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 4 inclusion and 4 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 15 Apr 2020. 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: for three weeks). The study lists 3 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 NCT04348097, which also lists 8 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 15 Apr 2020.