Diabetic Peripheral Neuropathic PainNCT06737861
Buerger Exercises With Whole Body Vibration in Diabetic Peripheral Neuropathy
A study testing Group A and Group B in people with Diabetic Peripheral Neuropathic Pain and Balance Changes, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine if a combined intervention of Buerger exercises and whole-body vibration therapy can improve pain, circulation, and balance in adults with diabetic peripheral neuropathy. Participants will: Perform Buerger exercises three times daily in both groups. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain, Balance Changes, Ankle Brachial Index
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2024to 30 Jul 2025
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with both genders male and female will be included in the study.
- The Age limit for the participants will be 50-70 years.
- Patients diagnosed with diabetes from last 5 Years.
- The participants with Hb1Ac higher than 6.7mmol/L.
- Patients diagnosed with diabetic peripheral neuropathy with scores ≥ 4 on Michigan Neuropathy Screening Instrument (MNSI).
- Patients with Ankle Brachial Index < 1-1.2mmHg.
- Those patients who were able to participate in exercise interventions.
Who cannot join
- The patients with Numeric Pain Rating Scale values greater than 4.
- Patients with severe cardiovascular or musculoskeletal conditions contraindicating exercise.
- Patients with serious mental problems or inability to communicate.
- Patients with Deep venous thrombosis.
- Patients with Diabetic foot ulcers or foot gangrene.
- Patients having serious complications of diabetes, such as amputation and patients who are unable to complete the entire program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Buerger Exercises With Whole Body Vibration on Pain, Balance and Lower Limb Perfusion in Patients With Diabetic Peripheral Neuropathy
The goal of this clinical trial is to determine if a combined intervention of Buerger exercises and whole-body vibration therapy can improve pain, circulation, and balance in adults with diabetic peripheral neuropathy.
Participants will:
Perform Buerger exercises three times daily in both groups. Receive whole-body vibration therapy three times per week (intervention group only).
Complete assessments at baseline, the 4th, 8th, 12th weeks, and a follow-up at the 16th week.
Outcome measures include pain rating, ankle-brachial index, balance scale, and timed mobility test. Statistical analyses will assess within-group and between-group effects based on data distribution.
Read the detailed description
This study, titled "Effects of Buerger Exercises with Whole Body Vibration on Pain, Balance, and Lower Limb Perfusion in Patients with Diabetic Peripheral Neuropathy," aims to assess the combined effectiveness of Buerger exercises and Whole-Body Vibration (WBV) therapy in addressing diabetic peripheral neuropathy (DPN). DPN is a common complication of diabetes mellitus, affecting roughly 50% of diabetic individuals globally and leading to sensory impairments, pain, mobility issues, and an elevated risk for severe foot complications. In Pakistan, where a large population suffers from diabetes, there is an urgent need for effective interventions for DPN. Existing research has shown that Buerger exercises alone are beneficial in improving lower limb circulation, the ankle-brachial index, and capillary refill time, while also reducing neuropathy risk by promoting blood circulation to the lower limbs. Separately, WBV therapy has demonstrated improvements in sensory perception, neuropathy scores, balance, and quality of life, as well as enhanced muscle strength and reflex responses through motor unit activation. Despite this evidence, the combined effect of these two interventions has not been studied extensively, creating a research gap regarding their potential synergistic benefits. This study seeks to fill that gap by evaluating outcomes in pain, balance, and circulation among DPN patients receiving both interventions, with the hypothesis that the combination may be more effective than Buerger exercises alone.
This randomized controlled trial (RCT) will be conducted at Civil Hospital Sialkot and Social Security Hospital Sialkot and is expected to last ten months. Participants, aged 50-70 and diagnosed with DPN, will be randomly assigned to two groups: an intervention group that receives both Buerger exercises and WBV therapy, and a control group performing only Buerger exercises. WBV therapy sessions will occur three times weekly at a frequency of 25 Hz, each lasting 12 minutes with a protocol of four 3-minute bouts. The Buerger exercises will be performed daily by both groups, with three cycles per session and three sessions per day. Outcomes will be measured using the Numeric Pain Rating Scale (NPRS) for pain assessment, the Ankle-Brachial Index (ABI) for lower limb perfusion, the Berg Balance Scale (BBS) for balance, and the Timed Up and Go Test (TUGT) for functional mobility. Data collection will take place at baseline, the 4th, 8th, and 12th weeks, and there will be a follow-up at the 16th week to determine if the benefits are sustained.
The study will recruit participants who meet specific inclusion criteria, such as having an HbA1c level higher than 6.7 mmol/L and MNSI scores indicating DPN, while excluding those with severe pain, cardiovascular conditions, deep vein thrombosis, or advanced diabetes complications like diabetic foot. A single-blinded approach will be used to ensure that outcome assessors are not aware of the participant's group allocation. Data will be analyzed using SPSS-27, with normality checks via Kolmogorov-Smirnov and Shapiro-Wilk tests. If data is normally distributed, within-group comparisons will use Repeated Measures ANOVA and between-group comparisons will use one-way ANOVA; if data is not normally distributed, the Mann-Whitney U test will be used for between-group comparisons and the Friedman test for within-group comparisons.
This study is significant in that it will address a clinical gap by evaluating the combined impact of Buerger exercises and WBV therapy on pain, balance, and circulation in individuals with DPN. If successful, it could offer a more effective treatment option to improve quality of life and functionality in this patient population. The study timeline includes major milestones such as title approval, synopsis defense, data collection, analysis, and a final report, all aimed at completing the study within ten months after approval. Ethical considerations have been meticulously planned, with informed consent processes in both English and Urdu to ensure participants' understanding and voluntary involvement. This research has the potential to provide meaningful insights into a novel intervention strategy for DPN management, which could be beneficial in both clinical practice and future research applications.
- Being tested
- Group A, Group B
- Keywords
- Buerger Exercises, Whole Body Vibration Therapy, Diabetic peripheral neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Also called Buerger exercises with Whole Body Vibration
Participants will perform Buerger exercises three times daily, with each session including three cycles. Additionally, they will receive Whole Body Vibration therapy at a frequency of 25 Hz, three times per week. Each WBV session will last 12 minutes, divided into four 3-minute bouts, aiming to improve pain, balance, and lower limb circulation in diabetic peripheral neuropathy patients.
Group BOther
Also called Buerger exercises
Participants will perform Buerger exercises three times daily, with each session consisting of three cycles. This exercise regimen is aimed at assessing its effectiveness on pain, balance, and circulation in diabetic peripheral neuropathy patients, serving as a comparison to the combined intervention with WBV therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Buerger exercises and Whole Body Vibration (WBV) exercise group Receives: Other: Group A |
| Group B | Active comparator | Buerger exercises group Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Brachial Index (ABI)
The ABI is a non-invasive measure of lower limb perfusion, calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure. An improvement in ABI suggests better blood circulation, which is a key outcome for assessing the intervention's effect on lower limb vascular health.
Measured: Assessment at baseline after, 4th, 8th, 12th and 16th week
Secondary outcomes (2)
Numeric Pain rating Scale (NPRS)
NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), used to measure the intensity of pain experienced by participants. This self-reported scale helps quantify pain levels and gauge the effectiveness of the intervention on pain reduction.
Measured: Assessment at baseline after, 4th, 8th, 12th and 16th week
Mini-Balance Evaluation Systems Test (Mini-BESTest)
MiniBESTest is 14 items, each scored on a 3-point scale (0 = severe impairment, 2 = normal), with a maximum score of 28.
Covers four balance domains:
Anticipatory postural adjustments (e.g., sit-to-stand, rise on toes) Reactive postural control (compensatory stepping responses) Sensory orientation (balance under altered sensory conditions) Dynamic gait (dual-task walking, pivot turns, speed changes) Lower scores indicate poorer balance and higher fall risk. A cut-off score of ≤19/28 is often used to identify individuals at risk of falls.
Measured: Assessment at baseline after, 4th, 8th, 12th and 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start20 Dec 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic PainStudies 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
- Model description
- interventional study model for this study is a parallel-group randomized controlled trial (RCT). This model involves two distinct groups: Intervention Group: Participants receive both Buerger exercises and Whole Body Vibration (WBV) therapy. Control Group: Participants receive only Buerger exercises without WBV therapy. Each participant is assigned randomly to one of these groups, ensuring that comparisons between the combined therapy and single therapy are unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the distinct and combined effects of the two therapies on pain, balance, and lower limb perfusion in patients with diabetic peripheral neuropathy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737861
- Sponsor's protocol ID
- REC/0262 Malaika Shahid
- Status last verified
- Aug 2025
- First submitted
- 12 Dec 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akbari NJ, Naimi SS. The effect of exercise therapy on balance in patients with diabetic peripheral neuropathy: a systematic review. J Diabetes Metab Disord. 2022 Jul 4;21(2):1861-1871. doi: 10.1007/s40200-022-01077-1. eCollection 2022 Dec.
PubMed 36404857Gomes-Neto M, de Sa-Caputo DDC, Paineiras-Domingos LL, Brandao AA, Neves MF, Marin PJ, Sanudo B, Bernardo-Filho M. Effects of Whole-Body Vibration in Older Adult Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Can J Diabetes. 2019 Oct;43(7):524-529.e2. doi: 10.1016/j.jcjd.2019.03.008. Epub 2019 Mar 27.
PubMed 31104903Ahmad AM, Mohammed AA, Khalifa WA, Ali HM, Abdel-Aziz A. Effect of Buerger-Allen exercise on wound healing in patients with diabetic foot ulcers: a randomised controlled trial. J Wound Care. 2024 Apr 2;33(Sup4a):xci-xcviii. doi: 10.12968/jowc.2024.33.Sup4a.xci.
PubMed 38588058Kessler NJ, Lockard MM, Fischer J. Whole body vibration improves symptoms of diabetic peripheral neuropathy. J Bodyw Mov Ther. 2020 Apr;24(2):1-3. doi: 10.1016/j.jbmt.2020.01.004. Epub 2020 Feb 11.
PubMed 32507132Jamal A, Ahmad I, Ahamed N, Azharuddin M, Alam F, Hussain ME. Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. J Diabetes Metab Disord. 2019 Dec 21;19(1):61-69. doi: 10.1007/s40200-019-00476-1. eCollection 2020 Jun.
PubMed 32550157Radhika J, Poomalai G, Nalini S, Revathi R. Effectiveness of Buerger-Allen Exercise on Lower Extremity Perfusion and Peripheral Neuropathy Symptoms among Patients with Diabetes Mellitus. Iran J Nurs Midwifery Res. 2020 Jun 17;25(4):291-295. doi: 10.4103/ijnmr.IJNMR_63_19. eCollection 2020 Jul-Aug.
PubMed 33014740
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Buerger Exercises With Whole Body Vibration on Pain, Balance and Lower Limb Perfusion in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06737861
- Acronym / sponsor ID
- REC/0262 Malaika Shahid
- Keywords
- Buerger Exercises, Whole Body Vibration Therapy, Diabetic peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 17 Dec 2024 (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 goal of this clinical trial is to determine if a combined intervention of Buerger exercises and whole-body vibration therapy can improve pain, circulation, and balance in adults with diabetic peripheral neuropathy.
Participants will:
Perform Buerger exercises three times daily in both groups. Receive whole-body vibration therapy three times per week (intervention group only).
Complete assessments at baseline, the 4th, 8th, 12th weeks, and a follow-up at the 16th week.
Outcome measures include pain rating, ankle-brachial index, balance scale, and timed mobility test. Statistical analyses will assess within-group and between-group effects based on data distribution.
Detailed description
This study, titled "Effects of Buerger Exercises with Whole Body Vibration on Pain, Balance, and Lower Limb Perfusion in Patients with Diabetic Peripheral Neuropathy," aims to assess the combined effectiveness of Buerger exercises and Whole-Body Vibration (WBV) therapy in addressing diabetic peripheral neuropathy (DPN). DPN is a common complication of diabetes mellitus, affecting roughly 50% of diabetic individuals globally and leading to sensory impairments, pain, mobility issues, and an elevated risk for severe foot complications. In Pakistan, where a large population suffers from diabetes, there is an urgent need for effective interventions for DPN. Existing research has shown that Buerger exercises alone are beneficial in improving lower limb circulation, the ankle-brachial index, and capillary refill time, while also reducing neuropathy risk by promoting blood circulation to the lower limbs. Separately, WBV therapy has demonstrated improvements in sensory perception, neuropathy scores, balance, and quality of life, as well as enhanced muscle strength and reflex responses through motor unit activation. Despite this evidence, the combined effect of these two interventions has not been studied extensively, creating a research gap regarding their potential synergistic benefits. This study seeks to fill that gap by evaluating outcomes in pain, balance, and circulation among DPN patients receiving both interventions, with the hypothesis that the combination may be more effective than Buerger exercises alone.
This randomized controlled trial (RCT) will be conducted at Civil Hospital Sialkot and Social Security Hospital Sialkot and is expected to last ten months. Participants, aged 50-70 and diagnosed with DPN, will be randomly assigned to two groups: an intervention group that receives both Buerger exercises and WBV therapy, and a control group performing only Buerger exercises. WBV therapy sessions will occur three times weekly at a frequency of 25 Hz, each lasting 12 minutes with a protocol of four 3-minute bouts. The Buerger exercises will be performed daily by both groups, with three cycles per session and three sessions per day. Outcomes will be measured using the Numeric Pain Rating Scale (NPRS) for pain assessment, the Ankle-Brachial Index (ABI) for lower limb perfusion, the Berg Balance Scale (BBS) for balance, and the Timed Up and Go Test (TUGT) for functional mobility. Data collection will take place at baseline, the 4th, 8th, and 12th weeks, and there will be a follow-up at the 16th week to determine if the benefits are sustained.
The study will recruit participants who meet specific inclusion criteria, such as having an HbA1c level higher than 6.7 mmol/L and MNSI scores indicating DPN, while excluding those with severe pain, cardiovascular conditions, deep vein thrombosis, or advanced diabetes complications like diabetic foot. A single-blinded approach will be used to ensure that outcome assessors are not aware of the participant's group allocation. Data will be analyzed using SPSS-27, with normality checks via Kolmogorov-Smirnov and Shapiro-Wilk tests. If data is normally distributed, within-group comparisons will use Repeated Measures ANOVA and between-group comparisons will use one-way ANOVA; if data is not normally distributed, the Mann-Whitney U test will be used for between-group comparisons and the Friedman test for within-group comparisons.
This study is significant in that it will address a clinical gap by evaluating the combined impact of Buerger exercises and WBV therapy on pain, balance, and circulation in individuals with DPN. If successful, it could offer a more effective treatment option to improve quality of life and functionality in this patient population. The study timeline includes major milestones such as title approval, synopsis defense, data collection, analysis, and a final report, all aimed at completing the study within ten months after approval. Ethical considerations have been meticulously planned, with informed consent processes in both English and Urdu to ensure participants' understanding and voluntary involvement. This research has the potential to provide meaningful insights into a novel intervention strategy for DPN management, which could be beneficial in both clinical practice and future research applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- interventional study model for this study is a parallel-group randomized controlled trial (RCT). This model involves two distinct groups: Intervention Group: Participants receive both Buerger exercises and Whole Body Vibration (WBV) therapy. Control Group: Participants receive only Buerger exercises without WBV therapy. Each participant is assigned randomly to one of these groups, ensuring that comparisons between the combined therapy and single therapy are unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the distinct and combined effects of the two therapies on pain, balance, and lower limb perfusion in patients with diabetic peripheral neuropathy.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Group ABuerger exercises and Whole Body Vibration (WBV) exercise group |
| Group B | Active comparator | Other: Group BBuerger exercises group |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with both genders male and female will be included in the study.
- The Age limit for the participants will be 50-70 years.
- Patients diagnosed with diabetes from last 5 Years.
- The participants with Hb1Ac higher than 6.7mmol/L.
- Patients diagnosed with diabetic peripheral neuropathy with scores ≥ 4 on Michigan Neuropathy Screening Instrument (MNSI).
Key exclusion criteria (6 listed)
- The patients with Numeric Pain Rating Scale values greater than 4.
- Patients with severe cardiovascular or musculoskeletal conditions contraindicating exercise.
- Patients with serious mental problems or inability to communicate.
- Patients with Deep venous thrombosis.
- Patients with Diabetic foot ulcers or foot gangrene.
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 |
|---|---|---|
| Group AAlso: Buerger exercises with Whole Body VibrationParticipants will perform Buerger exercises three times daily, with each session including three cycles. Additionally, they will receive Whole Body Vibration therapy at a frequency of 25 Hz, three times per week. Each WBV session will last 12 minutes, divided into four 3-minute bouts, aiming to improve pain, balance, and lower limb circulation in diabetic peripheral neuropathy patients. | Other | Group A |
| Group BAlso: Buerger exercisesParticipants will perform Buerger exercises three times daily, with each session consisting of three cycles. This exercise regimen is aimed at assessing its effectiveness on pain, balance, and circulation in diabetic peripheral neuropathy patients, serving as a comparison to the combined intervention with WBV therapy. | Other | Group B |
Primary outcome
Ankle Brachial Index (ABI)
Time frame: Assessment at baseline after, 4th, 8th, 12th and 16th week
The ABI is a non-invasive measure of lower limb perfusion, calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure. An improvement in ABI suggests better blood circulation, which is a key outcome for assessing the intervention's effect on lower limb vascular health.
2 secondary outcomes
Numeric Pain rating Scale (NPRS)
Time frame: Assessment at baseline after, 4th, 8th, 12th and 16th week
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Assessment at baseline after, 4th, 8th, 12th and 16th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 36404857Akbari NJ, Naimi SS. The effect of exercise therapy on balance in patients with diabetic peripheral neuropathy: a systematic review. J Diabetes Metab Disord. 2022 Jul 4;21(2):1861-1871. doi: 10.1007/s40200-022-01077-1. eCollection 2022 Dec.
- Background: PubMed 31104903Gomes-Neto M, de Sa-Caputo DDC, Paineiras-Domingos LL, Brandao AA, Neves MF, Marin PJ, Sanudo B, Bernardo-Filho M. Effects of Whole-Body Vibration in Older Adult Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Can J Diabetes. 2019 Oct;43(7):524-529.e2. doi: 10.1016/j.jcjd.2019.03.008. Epub 2019 Mar 27.
- Background: PubMed 38588058Ahmad AM, Mohammed AA, Khalifa WA, Ali HM, Abdel-Aziz A. Effect of Buerger-Allen exercise on wound healing in patients with diabetic foot ulcers: a randomised controlled trial. J Wound Care. 2024 Apr 2;33(Sup4a):xci-xcviii. doi: 10.12968/jowc.2024.33.Sup4a.xci.
- Background: PubMed 32507132Kessler NJ, Lockard MM, Fischer J. Whole body vibration improves symptoms of diabetic peripheral neuropathy. J Bodyw Mov Ther. 2020 Apr;24(2):1-3. doi: 10.1016/j.jbmt.2020.01.004. Epub 2020 Feb 11.
- Background: PubMed 32550157Jamal A, Ahmad I, Ahamed N, Azharuddin M, Alam F, Hussain ME. Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. J Diabetes Metab Disord. 2019 Dec 21;19(1):61-69. doi: 10.1007/s40200-019-00476-1. eCollection 2020 Jun.
- Background: PubMed 33014740Radhika J, Poomalai G, Nalini S, Revathi R. Effectiveness of Buerger-Allen Exercise on Lower Extremity Perfusion and Peripheral Neuropathy Symptoms among Patients with Diabetes Mellitus. Iran J Nurs Midwifery Res. 2020 Jun 17;25(4):291-295. doi: 10.4103/ijnmr.IJNMR_63_19. eCollection 2020 Jul-Aug.
- 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.
Aruba Saeed, PhD 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 Group A and Group B in people with Diabetic Peripheral Neuropathic Pain and Balance Changes, 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 7 inclusion and 6 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 22 Aug 2025. 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?
Ankle Brachial Index (ABI) (time frame: Assessment at baseline after, 4th, 8th, 12th and 16th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737861, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.