Chronic PainACUPATHWAYNCT04490798
Effectiveness of Acupuncture Clinical Pathway
An observational study of Chronic Pain and Lumbar Back Pain, run by Hospital Son Llatzer at 1 site in Spain.
Trial summary
The study will be described the development and implementation of the Clinical pathway (CPW) for acupuncture treatment in the management of patients with some chronic pain conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Lumbar Back Pain, Osteoarthritis, Knee
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 3,245 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2020to 15 Jan 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>18 years), who received acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), applying Acupuncture Treatment Clinical Pathway.
Who may be able to join
- Adult patients (>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Applying Acupuncture treatment Clinical Pathway and completed at least 50% of the medical appointments.
- Adult patients (>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Without applying Acupuncture treatment Clinical Pathway or not completed at least 50% of the medical appointments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Longitudinal Cohort Study to Determine the Effectiveness of Integrated a Clinical Pathway Approach for Chronic Pain Treatment With Acupuncture in a Pain Clinic
The study will be described the development and implementation of the Clinical pathway (CPW) for acupuncture treatment in the management of patients with some chronic pain conditions. The effectiveness of this CPW will be explored in this study through retrospective analysis of clinical outcomes after administration of acupuncture treatment summarised in the guidelines.
Read the detailed description
This longitudinal, observational, retrospective study included adults (>18 years) with common chronic pain condition treated at the Son Llàtzer University Hospital Pain Clinic, in Palma de Mallorca, Spain, from January 2015 to December 2018. All patients received treatment according to the Acupuncture Clinical Pathway developed. The primary outcome measures will be a change in pain intensity measured by VAS for pain at the completion of treatment. Number of responder patients, reduction of pain medication intake, improve of quality of live scale, sleep quality index and scale of anxiety and depression after treatment are also to be included in the study.
The purpose of this study is to assess the effectiveness of integrated a clinical pathway approach for chronic pain treatment with acupuncture in a Pain Clinic.
- Conditions
- Chronic Pain, Lumbar Back Pain, Osteoarthritis, Knee, Headache, Shoulder Pain, Cervicalgia
- Being tested
- Electroacupuncture
- Keywords
- acupuncture treatment, clinical pathway
- Medical subject headings
- Chronic Pain, Low Back Pain, Osteoarthritis, Knee, Headache, Shoulder Pain, Neck Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat the different painful syndromes. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar back pain | Patients with lumbar back pain treated following the Acupuncture Treatment Clinic Pathway. Receives: Procedure: Electroacupuncture | |
| Musculoskeletal pain | Patients with musculoskeletal pain treated following the Acupuncture Treatment Clinic Pathway. Receives: Procedure: Electroacupuncture | |
| Cervicalgia | Patients with cervicalgia treated following the Acupuncture Treatment Clinic Pathway. Receives: Procedure: Electroacupuncture | |
| Knee osteoarthritis | Patients with knee osteoarthritis treated following the Acupuncture Treatment Clinic Pathway. Receives: Procedure: Electroacupuncture | |
| Headache | Patients with headache treated following the Acupuncture Treatment Clinic Pathway. Receives: Procedure: Electroacupuncture | |
| Shoulder pain | Patients with shoulder pain treated following the Acupuncture Treatment Clinic Pathway. Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by VAS for pain at the completion of treatment
Overall average pain intensity over the last month will be assessed by a continuous scale comprised of a horizontal line, anchored by 'no pain' (score of 0) and 'worst imaginable pain' (score of 100 (100 mm scale)
Measured: Baseline and after the completion of treatment at 4 months
Secondary outcomes (5)
Number of responder patients to the acupuncture treatment.
Responders will be defined as patients with a reduction of pain scores of more than 30%, decreasing medication intake or improving quality of live scale (≥ 20%), sleep quality index (≥ 30%) following our Clinical Pathway.
Measured: Baseline, 1 month and after the completion of treatment at 4 months
Reduction of pain medication intake after treatment
Analgesic medicine use will be obtained with a questionnaire elaborated according to the European Health Interview Survey (EUROHIS) recommendations. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ('Have you taken any pain medicine prescribed by your general practitioner?') as well as any medication not prescribed by their general practitioner ('Have you taken any pain medicine not prescribed by your general practitioner') and (2) whether their prescribed and non-prescribed pain medication use has increased or decreased.
Measured: Baseline, 1 month and after the completion of treatment at 4 months
Improve of quality of live scale after treatment
Patient-related quality of live by SF-12 measured. The Spanish version validated by Schmidt S et al is used
Measured: Baseline, 1 month and after the completion of treatment at 4 months
Improve sleep quality index after treatment
Measured with the Pittsburgh Sleep Quality Index (PSQ). The Spanish version validated by Hita-Contreras F et al is used
Measured: Baseline, 1 month and after the completion of treatment at 4 months
Improve of scale of anxiety and depression after treatment
Levels of depression and anxiety will be measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al is used.
Measured: Baseline, 1 month and after the completion of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start12 Jun 2020
- Primary completion31 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Mata, Hospital Son Llatzer
- Investigators
- Javier Mata, MD, Principal investigator, Anaesthesia Department, Son Llàtzer University Hospital. Palma, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490798
- Sponsor's protocol ID
- ACUPATHWAY.R.1
- Acronym
- ACUPATHWAY
- Status last verified
- Feb 2021
- First submitted
- 26 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
PubMed 9820257Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
PubMed 22965186Lee MS, Ernst E. Acupuncture for pain: an overview of Cochrane reviews. Chin J Integr Med. 2011 Mar;17(3):187-9. doi: 10.1007/s11655-011-0665-7. Epub 2011 Feb 27.
PubMed 21359919Vickers AJ, Linde K. Acupuncture for chronic pain. JAMA. 2014 Mar 5;311(9):955-6. doi: 10.1001/jama.2013.285478.
PubMed 24595780Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
PubMed 26977696Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
PubMed 28192789Camm AJ, Fox KAA. Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants. Open Heart. 2018 Apr 21;5(1):e000788. doi: 10.1136/openhrt-2018-000788. eCollection 2018.
PubMed 29713485Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
PubMed 25046131Nosikov A , Gudex C . eds. EUROHIS:, "Developing common instruments for health surveys. Amsterdam: IOS Press, 2003.".
Monton C, Perez Echeverria MJ, Campos R, Garcia Campayo J, Lobo A. [Anxiety scales and Goldberg's depression: an efficient interview guide for the detection of psychologic distress]. Aten Primaria. 1993 Oct 15;12(6):345-9. Spanish.
PubMed 8218816Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras R, Brugulat P, Mompart A, Medina A, Ferrer M, Alonso J. [Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population]. Med Clin (Barc). 2012 Dec 8;139(14):613-25. doi: 10.1016/j.medcli.2011.10.024. Epub 2012 Jan 11. Spanish.
PubMed 22244683Hita-Contreras F, Martinez-Lopez E, Latorre-Roman PA, Garrido F, Santos MA, Martinez-Amat A. Reliability and validity of the Spanish version of the Pittsburgh Sleep Quality Index (PSQI) in patients with fibromyalgia. Rheumatol Int. 2014 Jul;34(7):929-36. doi: 10.1007/s00296-014-2960-z. Epub 2014 Feb 8.
PubMed 24509897Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019.
PubMed 19836888Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
PubMed 29198932
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Longitudinal Cohort Study to Determine the Effectiveness of Integrated a Clinical Pathway Approach for Chronic Pain Treatment With Acupuncture in a Pain Clinic
- ClinicalTrials.gov ID
- NCT04490798
- Acronym / sponsor ID
- ACUPATHWAY / ACUPATHWAY.R.1
- Conditions
- Chronic Pain, Lumbar Back Pain, Osteoarthritis, Knee, Headache, Shoulder Pain, Cervicalgia
- Keywords
- acupuncture treatment, clinical pathway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,245 participants (actual)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 29 Jul 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 study will be described the development and implementation of the Clinical pathway (CPW) for acupuncture treatment in the management of patients with some chronic pain conditions. The effectiveness of this CPW will be explored in this study through retrospective analysis of clinical outcomes after administration of acupuncture treatment summarised in the guidelines.
Detailed description
This longitudinal, observational, retrospective study included adults (>18 years) with common chronic pain condition treated at the Son Llàtzer University Hospital Pain Clinic, in Palma de Mallorca, Spain, from January 2015 to December 2018. All patients received treatment according to the Acupuncture Clinical Pathway developed. The primary outcome measures will be a change in pain intensity measured by VAS for pain at the completion of treatment. Number of responder patients, reduction of pain medication intake, improve of quality of live scale, sleep quality index and scale of anxiety and depression after treatment are also to be included in the study.
The purpose of this study is to assess the effectiveness of integrated a clinical pathway approach for chronic pain treatment with acupuncture in a Pain Clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lumbar back pain | – | Procedure: ElectroacupuncturePatients with lumbar back pain treated following the Acupuncture Treatment Clinic Pathway. |
| Musculoskeletal pain | – | Procedure: ElectroacupuncturePatients with musculoskeletal pain treated following the Acupuncture Treatment Clinic Pathway. |
| Cervicalgia | – | Procedure: ElectroacupuncturePatients with cervicalgia treated following the Acupuncture Treatment Clinic Pathway. |
| Knee osteoarthritis | – | Procedure: ElectroacupuncturePatients with knee osteoarthritis treated following the Acupuncture Treatment Clinic Pathway. |
| Headache | – | Procedure: ElectroacupuncturePatients with headache treated following the Acupuncture Treatment Clinic Pathway. |
| Shoulder pain | – | Procedure: ElectroacupuncturePatients with shoulder pain treated following the Acupuncture Treatment Clinic Pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years), who received acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), applying Acupuncture Treatment Clinical Pathway.
Key inclusion criteria (2 listed)
- Adult patients (>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Applying Acupuncture treatment Clinical Pathway and completed at least 50% of the medical appointments.
- Adult patients (>18 years) Acupuncture treatment for chronic pain (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Without applying Acupuncture treatment Clinical Pathway or not completed at least 50% of the medical appointments.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ElectroacupunctureThe electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat the different painful syndromes. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation. | Procedure or surgery | Cervicalgia, Headache, Knee osteoarthritis, Lumbar back pain, Musculoskeletal pain, Shoulder pain |
Primary outcome
Change in pain intensity measured by VAS for pain at the completion of treatment
Time frame: Baseline and after the completion of treatment at 4 months
Overall average pain intensity over the last month will be assessed by a continuous scale comprised of a horizontal line, anchored by 'no pain' (score of 0) and 'worst imaginable pain' (score of 100 (100 mm scale)
5 secondary outcomes
Number of responder patients to the acupuncture treatment.
Time frame: Baseline, 1 month and after the completion of treatment at 4 months
Reduction of pain medication intake after treatment
Time frame: Baseline, 1 month and after the completion of treatment at 4 months
Improve of quality of live scale after treatment
Time frame: Baseline, 1 month and after the completion of treatment at 4 months
Improve sleep quality index after treatment
Time frame: Baseline, 1 month and after the completion of treatment at 4 months
Improve of scale of anxiety and depression after treatment
Time frame: Baseline, 1 month and after the completion of treatment at 4 months
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 10 Feb 2021.
- Background: PubMed 9820257Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
- Background: PubMed 22965186Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
- Background: PubMed 21359919Lee MS, Ernst E. Acupuncture for pain: an overview of Cochrane reviews. Chin J Integr Med. 2011 Mar;17(3):187-9. doi: 10.1007/s11655-011-0665-7. Epub 2011 Feb 27.
- Background: PubMed 24595780Vickers AJ, Linde K. Acupuncture for chronic pain. JAMA. 2014 Mar 5;311(9):955-6. doi: 10.1001/jama.2013.285478.
- Background: PubMed 26977696Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
- Background: PubMed 28192789Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Background: PubMed 29713485Camm AJ, Fox KAA. Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants. Open Heart. 2018 Apr 21;5(1):e000788. doi: 10.1136/openhrt-2018-000788. eCollection 2018.
- Background: PubMed 11690728Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Background: PubMed 25046131von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
- BackgroundNosikov A , Gudex C . eds. EUROHIS:, "Developing common instruments for health surveys. Amsterdam: IOS Press, 2003.".
- Background: PubMed 8218816Monton C, Perez Echeverria MJ, Campos R, Garcia Campayo J, Lobo A. [Anxiety scales and Goldberg's depression: an efficient interview guide for the detection of psychologic distress]. Aten Primaria. 1993 Oct 15;12(6):345-9. Spanish.
- Background: PubMed 22244683Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras R, Brugulat P, Mompart A, Medina A, Ferrer M, Alonso J. [Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population]. Med Clin (Barc). 2012 Dec 8;139(14):613-25. doi: 10.1016/j.medcli.2011.10.024. Epub 2012 Jan 11. Spanish.
- 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.
Javier Mata, MD principal investigator
Anaesthesia Department, Son Llàtzer University Hospital. Palma, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Lumbar Back Pain, run by Hospital Son Llatzer at 1 site in Spain.
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 2 inclusion and 0 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 10 Feb 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 Spain. 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?
Change in pain intensity measured by VAS for pain at the completion of treatment (time frame: Baseline and after the completion of treatment at 4 months). 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 NCT04490798, which also lists 22 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 10 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.