Diabetic Neuropathy, PainfulNCT05670600
The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
A study testing foot and ankle exercise in people with Diabetic Neuropathy, Painful, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- foot and ankle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2021to 29 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and over,
- Having been diagnosed with Type 2 diabetes for at least one year,
- Diagnosed with diabetic peripheral neuropathy for at least 6 months by EMG by a neurologist,
- Individuals with diabetes mellitus with neuropathic pain who score 12 or higher on the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) pain scale,
- Visual Analogue Scale (VAS) value to be at least 1,
- Receiving medical treatment for diabetic neuropathy,
Show all 10Show fewer
- Did not receive physical therapy and non-pharmacological treatment during the research period,
- Having no physical and mental problems that will prevent communication,
- Having blood glucose meters at home,
- Individuals with smart device use,
Who cannot join
- Peripheral vascular complications due to diabetes or another etiology,
- Having a history of surgery on the knee, ankle and hip and indication for surgery during the intervention period,
- Those who cannot communicate on the phone (with hearing problems),
- Having nephropathy, retinopathy and diabetic foot,
- Neurological diseases (stroke, cerebrovascular diseases, epilepsy) and serious musculoskeletal problems (rheumatoid arthritis, osteoarthritis)
- Neurocognitive disorder (Alzheimer's disease, dementia),
- Not taking any physical therapy during the intervention period,
- Patients with deep vein thrombosis, femur fractures, surgical conditions, open wounds
Trial locations and contacts
1 site in 1 country.
About this study
The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.
Read the detailed description
In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- foot and ankle exercise
- Keywords
- Diabetic neuropathic pain, exercise, foot and ankle, pain, quality of life
- Medical subject headings
- Diabetic Neuropathies, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot and ankle exerciseOther
Foot and Ankle Exercise Phase
- Pulling the foot upwards from the ankle
- Bending the foot down from the ankle
- Spreading the feet like a fan, moving the toes in and out to the right and left
- Circle drawing exercise with ankle
- Towel folding exercise
- Bottle rolling exercise under the feet (The water in the bottle will be warm tap water)
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp. Receives: Other: foot and ankle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level at 4th and 8th weeks compared to baseline.
Pain scores of the patients were checked after foot and ankle exercise training. The scale, developed by Price, McGrath, Rafii, and Buckingham, is a measurement tool that evaluates pain severity. The scale is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The marked numerical value indicates the severity of the patient's perception of pain. A VAS value of 1 to 4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. As scores increase, the level of pain worsens and general health deteriorates.
Measured: Two months
Secondary outcomes (1)
Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state
After the interventions, the patient's scores on the effect of neuropathic pain on quality of life are checked. Poole, Murphy, and Nurmka (2009) developed a questionnaire on the impact of neuropathic pain on quality of life. The scale consisting of 42 items; symptoms were divided into 6 subscales under the headings of relationships, psychological, social activity, physical activity, and personal/self care. The results of the questionnaire on the effect of neuropathic pain on the quality of life were calculated by summing the 42-item scores. The total score range is between 42 and 210. The score range for each item is between 1 and 5.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start4 Jul 2021
- Primary completion31 Dec 2021
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental research method was used. There is an intervention and control group. While the intervention group was given foot and ankle exercise training, no intervention was given to the control group. The Visual Analog Scale (VAS) of Neuropathic Pain was calculated by another researcher, who applied foot and ankle exercises to both groups before starting the exercise (1st measurement), fourth (2nd measurement) and at the end of the eighth week (3rd measurement). The Impact on Quality of Life Questionnaire (NePIQoL) was administered.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Görgülü Polat, Gazi University
- Investigators
- Ülkü Polat, Prof., Principal investigator, Gazi UniversitySelin Çiftçi, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670600
- Sponsor's protocol ID
- Gaziüniversite
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all IPD underlying results in a publication
Publications
Feldman EL, Callaghan BC, Pop-Busui R, Zochodne DW, Wright DE, Bennett DL, Bril V, Russell JW, Viswanathan V. Diabetic neuropathy. Nat Rev Dis Primers. 2019 Jun 13;5(1):41. doi: 10.1038/s41572-019-0092-1.
PubMed 31197153Hazari A, Maiya AG, Shivashankara KN, Agouris I, Monteiro A, Jadhav R, Kumar S, Shashi Kumar CG, Mayya SS. Kinetics and kinematics of diabetic foot in type 2 diabetes mellitus with and without peripheral neuropathy: a systematic review and meta-analysis. Springerplus. 2016 Oct 19;5(1):1819. doi: 10.1186/s40064-016-3405-9. eCollection 2016.
PubMed 27812455van Laake-Geelen CCM, Smeets RJEM, Quadflieg SPAB, Kleijnen J, Verbunt JA. The effect of exercise therapy combined with psychological therapy on physical activity and quality of life in patients with painful diabetic neuropathy: a systematic review. Scand J Pain. 2019 Jul 26;19(3):433-439. doi: 10.1515/sjpain-2019-0001.
PubMed 31112511Degu H, Wondimagegnehu A, Yifru YM, Belachew A. Is health related quality of life influenced by diabetic neuropathic pain among type II diabetes mellitus patients in Ethiopia? PLoS One. 2019 Feb 4;14(2):e0211449. doi: 10.1371/journal.pone.0211449. eCollection 2019.
PubMed 30716109Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012 Dec;35(12):2451-8. doi: 10.2337/dc12-0656. Epub 2012 Sep 18.
PubMed 22991449Dermanovic Dobrota V, Hrabac P, Skegro D, Smiljanic R, Dobrota S, Prkacin I, Brkljacic N, Peros K, Tomic M, Lukinovic-Skudar V, Basic Kes V. The impact of neuropathic pain and other comorbidities on the quality of life in patients with diabetes. Health Qual Life Outcomes. 2014 Dec 3;12:171. doi: 10.1186/s12955-014-0171-7.
PubMed 25468384Francia P, Anichini R, De Bellis A, Seghieri G, Lazzeri R, Paternostro F, Gulisano M. Diabetic foot prevention: the role of exercise therapy in the treatment of limited joint mobility, muscle weakness and reduced gait speed. Ital J Anat Embryol. 2015;120(1):21-32.
PubMed 26738255Mueller MJ, Tuttle LJ, Lemaster JW, Strube MJ, McGill JB, Hastings MK, Sinacore DR. Weight-bearing versus nonweight-bearing exercise for persons with diabetes and peripheral neuropathy: a randomized controlled trial. Arch Phys Med Rehabil. 2013 May;94(5):829-38. doi: 10.1016/j.apmr.2012.12.015. Epub 2012 Dec 28.
PubMed 23276801Cerrahoglu L, Kosan U, Sirin TC, Ulusoy A. Range of Motion and Plantar Pressure Evaluation for the Effects of Self-Care Foot Exercises on Diabetic Patients with and Without Neuropathy. J Am Podiatr Med Assoc. 2016 May;106(3):189-200. doi: 10.7547/14-095.
PubMed 27269974Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 Sep-Oct;26(5):424-9. doi: 10.1016/j.jdiacomp.2012.05.007. Epub 2012 Jun 18.
PubMed 22717465Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Mar 19;13:36. doi: 10.1186/1471-2474-13-36.
PubMed 22429765Ahn S, Song R. Effects of Tai Chi Exercise on glucose control, neuropathy scores, balance, and quality of life in patients with type 2 diabetes and neuropathy. J Altern Complement Med. 2012 Dec;18(12):1172-8. doi: 10.1089/acm.2011.0690. Epub 2012 Sep 17.
PubMed 22985218Monteiro RL, Sartor CD, Ferreira JSSP, Dantas MGB, Bus SA, Sacco ICN. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2018 Nov 14;19(1):400. doi: 10.1186/s12891-018-2323-0.
PubMed 30428863Monteiro RL, Ferreira JSSP, Silva EQ, Donini A, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial. Sensors (Basel). 2020 Sep 9;20(18):5129. doi: 10.3390/s20185129.
PubMed 32916792Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 27;15:137. doi: 10.1186/1471-2474-15-137.
PubMed 24767584
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05670600
- Acronym / sponsor ID
- Gaziüniversite
- Conditions
- Diabetic Neuropathy, Painful
- Keywords
- Diabetic neuropathic pain, exercise, foot and ankle, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 4 Jan 2023 (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 carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.
Detailed description
In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental research method was used. There is an intervention and control group. While the intervention group was given foot and ankle exercise training, no intervention was given to the control group. The Visual Analog Scale (VAS) of Neuropathic Pain was calculated by another researcher, who applied foot and ankle exercises to both groups before starting the exercise (1st measurement), fourth (2nd measurement) and at the end of the eighth week (3rd measurement). The Impact on Quality of Life Questionnaire (NePIQoL) was administered.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: foot and ankle exerciseThe intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years and over,
- Having been diagnosed with Type 2 diabetes for at least one year,
- Diagnosed with diabetic peripheral neuropathy for at least 6 months by EMG by a neurologist,
- Individuals with diabetes mellitus with neuropathic pain who score 12 or higher on the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) pain scale,
- Visual Analogue Scale (VAS) value to be at least 1,
Key exclusion criteria (8 listed)
- Peripheral vascular complications due to diabetes or another etiology,
- Having a history of surgery on the knee, ankle and hip and indication for surgery during the intervention period,
- Those who cannot communicate on the phone (with hearing problems),
- Having nephropathy, retinopathy and diabetic foot,
- Neurological diseases (stroke, cerebrovascular diseases, epilepsy) and serious musculoskeletal problems (rheumatoid arthritis, osteoarthritis)
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 |
|---|---|---|
| foot and ankle exerciseFoot and Ankle Exercise Phase 1. Pulling the foot upwards from the ankle 2. Bending the foot down from the ankle 3. Spreading the feet like a fan, moving the toes in and out to the right and left 4. Circle drawing exercise with ankle 5. Towel folding exercise 6. Bottle rolling exercise under the feet (The water in the bottle will be warm tap water) | Other | intervention group |
Primary outcome
Change in pain level at 4th and 8th weeks compared to baseline.
Time frame: Two months
Pain scores of the patients were checked after foot and ankle exercise training. The scale, developed by Price, McGrath, Rafii, and Buckingham, is a measurement tool that evaluates pain severity. The scale is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The marked numerical value indicates the severity of the patient's perception of pain. A VAS value of 1 to 4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. As scores increase, the level of pain worsens and general health deteriorates.
1 secondary outcome
Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state
Time frame: Two 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 4 Mar 2026.
- Background: PubMed 31197153Feldman EL, Callaghan BC, Pop-Busui R, Zochodne DW, Wright DE, Bennett DL, Bril V, Russell JW, Viswanathan V. Diabetic neuropathy. Nat Rev Dis Primers. 2019 Jun 13;5(1):41. doi: 10.1038/s41572-019-0092-1.
- Background: PubMed 27812455Hazari A, Maiya AG, Shivashankara KN, Agouris I, Monteiro A, Jadhav R, Kumar S, Shashi Kumar CG, Mayya SS. Kinetics and kinematics of diabetic foot in type 2 diabetes mellitus with and without peripheral neuropathy: a systematic review and meta-analysis. Springerplus. 2016 Oct 19;5(1):1819. doi: 10.1186/s40064-016-3405-9. eCollection 2016.
- Background: PubMed 31112511van Laake-Geelen CCM, Smeets RJEM, Quadflieg SPAB, Kleijnen J, Verbunt JA. The effect of exercise therapy combined with psychological therapy on physical activity and quality of life in patients with painful diabetic neuropathy: a systematic review. Scand J Pain. 2019 Jul 26;19(3):433-439. doi: 10.1515/sjpain-2019-0001.
- Background: PubMed 30716109Degu H, Wondimagegnehu A, Yifru YM, Belachew A. Is health related quality of life influenced by diabetic neuropathic pain among type II diabetes mellitus patients in Ethiopia? PLoS One. 2019 Feb 4;14(2):e0211449. doi: 10.1371/journal.pone.0211449. eCollection 2019.
- Background: PubMed 22991449Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012 Dec;35(12):2451-8. doi: 10.2337/dc12-0656. Epub 2012 Sep 18.
- Background: PubMed 25468384Dermanovic Dobrota V, Hrabac P, Skegro D, Smiljanic R, Dobrota S, Prkacin I, Brkljacic N, Peros K, Tomic M, Lukinovic-Skudar V, Basic Kes V. The impact of neuropathic pain and other comorbidities on the quality of life in patients with diabetes. Health Qual Life Outcomes. 2014 Dec 3;12:171. doi: 10.1186/s12955-014-0171-7.
- Background: PubMed 26738255Francia P, Anichini R, De Bellis A, Seghieri G, Lazzeri R, Paternostro F, Gulisano M. Diabetic foot prevention: the role of exercise therapy in the treatment of limited joint mobility, muscle weakness and reduced gait speed. Ital J Anat Embryol. 2015;120(1):21-32.
- Background: PubMed 23276801Mueller MJ, Tuttle LJ, Lemaster JW, Strube MJ, McGill JB, Hastings MK, Sinacore DR. Weight-bearing versus nonweight-bearing exercise for persons with diabetes and peripheral neuropathy: a randomized controlled trial. Arch Phys Med Rehabil. 2013 May;94(5):829-38. doi: 10.1016/j.apmr.2012.12.015. Epub 2012 Dec 28.
- Background: PubMed 27269974Cerrahoglu L, Kosan U, Sirin TC, Ulusoy A. Range of Motion and Plantar Pressure Evaluation for the Effects of Self-Care Foot Exercises on Diabetic Patients with and Without Neuropathy. J Am Podiatr Med Assoc. 2016 May;106(3):189-200. doi: 10.7547/14-095.
- Results publication: PubMed 22717465Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 Sep-Oct;26(5):424-9. doi: 10.1016/j.jdiacomp.2012.05.007. Epub 2012 Jun 18.
- Results publication: PubMed 22429765Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Mar 19;13:36. doi: 10.1186/1471-2474-13-36.
- Results publication: PubMed 22985218Ahn S, Song R. Effects of Tai Chi Exercise on glucose control, neuropathy scores, balance, and quality of life in patients with type 2 diabetes and neuropathy. J Altern Complement Med. 2012 Dec;18(12):1172-8. doi: 10.1089/acm.2011.0690. Epub 2012 Sep 17.
- Individual participant dataSharing planned: No. all IPD underlying results in a publication
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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.
Ülkü Polat, Prof. principal investigator
Gazi University
Selin Çiftçi principal investigator
Gazi 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 foot and ankle exercise in people with Diabetic Neuropathy, Painful, run by Gazi University at 1 site in Turkey (Türkiye).
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 10 inclusion and 8 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 4 Mar 2026. 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 Turkey (Türkiye). 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 level at 4th and 8th weeks compared to baseline. (time frame: Two 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 NCT05670600, which also lists 20 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 4 Mar 2026.