Peripheral Diabetic NeuropathyNCT06066944
Effect of Thai Foot Massage on Type 2 Diabetes Peripheral Neuropathy
A study testing Thai Foot Massage in people with Peripheral Diabetic Neuropathy, run by University of Health Sciences Lahore.
Trial summary
The goal of this clinical trial is to examine the effect of Thai-Foot Massage on type 2 diabetes peripheral neuropathy. The main question is to answer the role of massage in improving peripheral neuropathy. Thai Foot Massage will be administered by the researcher every alternate day for 15 days. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Peripheral Diabetic Neuropathy
- What is being tested?
- Thai Foot Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2025to 10 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range, 40 to 65, to ensure a consistent demographic.
- Both genders will be part of the study.
- Participants must have a confirmed medical diagnosis of Type 2 Diabetes by the physician and do not have an ulcer or amputation in either foot.
- A score on the Ipswich touch test less than 4/6 will be included.
- Patients must have a level of glycated hemoglobin HbA1C more than 7.
- Individuals receiving treatment for diabetes mellitus, which may include oral hypoglycemic agents, insulin, or both."
Who cannot join
- Individuals with pre-existing neurological conditions unrelated to diabetes or peripheral neuropathy.
- Participants having severe diabetic complications such as advanced nephropathy, retinopathy or vascular disease will not be included in the study.
- Individuals with foot ulcers, infections, or any medical conditions that prevent them from receiving foot massage safely
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immediate and Prolonged Effects of Thai Foot Massage on Pain, Range of Motion and Somatosensory Reception Among Patients With Type 2 Diabetes Peripheral Neuropathy.
The goal of this clinical trial is to examine the effect of Thai-Foot Massage on type 2 diabetes peripheral neuropathy. The main question is to answer the role of massage in improving peripheral neuropathy. Thai Foot Massage will be administered by the researcher every alternate day for 15 days. Researchers will compare the intervention group with the control group (without intervention) to see the improvement in Somatosensory Reception, Range of Motion, and peripheral neuropathy-induced Pain.
Read the detailed description
Type 2 diabetes is a chronic metabolic disorder associated with elevated blood sugar levels and various complications, including peripheral neuropathy. This condition damages the nerves controlling sensation, often leading to foot-related issues such as limited range of motion, pain, and Somatosensory Reception deficit. These foot problems pose a significant concern for individuals with diabetes, affecting their overall foot health. Engaging in physical activity programs has been shown to reduce hospitalizations and severe complications in diabetes patients. Foot massage is a specific physical activity aimed at preventing podiatry issues. The study's hypothesis questions whether Thai Foot Massage has immediate and prolonged effects on foot pain, range of motion, and Somatosensory Reception among patients with Type 2 Diabetes Peripheral Neuropathy. This research seeks to determine the impact of Thai Foot Massage on these parameters. Type 2 diabetes and peripheral neuropathy are growing global health concerns and claim a significant social and financial burden. Diabetes Peripheral Neuropathy (DPN) has an impact on quality of life. This study aims to evaluate non-pharmacological interventions to prevent neuropathic complications, including diabetic foot problems and limb amputation. The research design chosen for this study is a Randomized Controlled Trial, recognized for establishing cause-and-effect relationships. The sample will be collected through a non-probability purposive sampling technique and will consist of individuals diagnosed with Type 2 diabetes experiencing peripheral neuropathy symptoms by calculating IpTT score ≤ 4/6. The study will be done at the University of Health Sciences in collaboration with the Diabetic Clinic District Headquarters Shiekhupura. A sample size of 78 participants, with a 5% attrition rate, will be divided equally between intervention and control groups using randomization through a lottery method. Statistical analysis will be performed using SPSS version 27, describing categorical variables through frequency and percentage. The association of qualitative data will be assessed with Chi-square, while an independent t-test and repeated measures of ANOVA will compare the two groups and measure time effects for normal data. In short, this study aims to enhance our understanding of how Thai Foot Massage can impact pain, range of motion, and somatosensory reception in patients with Type 2 diabetes and peripheral neuropathy. The findings may offer valuable insights into non-pharmacological interventions for improving foot health in this population.
- Conditions
- Peripheral Diabetic Neuropathy
- Being tested
- Thai Foot Massage
- Keywords
- Peripheral neuropathy, Thai Foot Massage, Range of Motion, Ipswich Touch Test (IpTT), Somatosensory Reception
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thai Foot MassageOther
Also called Control group will continue with the standard care advised by the physician
It is the application of Massage through specific techniques and pressure to the feet and lower legs to promote relaxation, improve circulation, and enhance overall well-being. It is a traditional therapeutic practice originating from Thailand and is often performed by trained practitioners. Thai foot massage is often based on traditional Thai massage techniques. The researcher is duly certified for the administration of Thai Foot Massage.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The experimental group will receive a Thai Foot Massage every alternate day for 30 minutes for 15 days. Receives: Other: Thai Foot Massage |
| Group B | No intervention | Participants in the control group will continue with the standard treatment regimen prescribed by the physician at the diabetic clinic. Baseline data will be collected as conducted for the experimental group. After the completion of the study, if the intervention will prove effective, the Thai foot massage will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipswich Touch Test Score (IpTT)
To measure the somatosensory level, Ipswich Touch Test (IpTT) is a reliable and valid test to assess the sensory deficit in diabetic-related neuropathy patients. The highest score is 6. 6/6 means no neuropathy and 0/6 means worse possible neuropathy.
Measured: 1 Months
Measure the Range of Motion
Range of motion refers to the extent of movement that can be achieved at a specific joint. In this study, the range of motion of the foot and ankle joints will be measured using goniometry, a technique that involves using a universal goniometer to measure the angles of joint movement. ROM will be assessed for the ankle joint, in degrees of dorsiflexion and plantarflexion.
Measured: 1 Months
Measure the intensity of neuropathy induced pain
Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, reported by patients. In this study pain refers to the unpleasant sensations caused by type 2 diabetes peripheral neuropathy. Pain will be measured through numeric rating pain scale, which ranges from 0 to 10, where "0" represent No Pain and 10 represent worse possible pain. Pain can categorize according to pain score.
Mild pain: A score of 1 to 3 Moderate Pain: A score of 4 to 6. Severe Pain: A score of 7 to 10.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start25 Jan 2025 (estimated)
- Primary completion25 Apr 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to the intervention and control group randomly.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azra Khanum, University of Health Sciences Lahore
- Investigators
- Azra Khanum, 1, Principal investigator, PG Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066944
- Sponsor's protocol ID
- Foot Massage RCT 001
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Prolonged Effects of Thai Foot Massage on Pain, Range of Motion and Somatosensory Reception Among Patients With Type 2 Diabetes Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT06066944
- Acronym / sponsor ID
- Foot Massage RCT 001
- Conditions
- Peripheral Diabetic Neuropathy
- Keywords
- Peripheral neuropathy, Thai Foot Massage, Range of Motion, Ipswich Touch Test (IpTT), Somatosensory Reception
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 25 Jan 2025 (estimated)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 4 Oct 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 goal of this clinical trial is to examine the effect of Thai-Foot Massage on type 2 diabetes peripheral neuropathy. The main question is to answer the role of massage in improving peripheral neuropathy. Thai Foot Massage will be administered by the researcher every alternate day for 15 days. Researchers will compare the intervention group with the control group (without intervention) to see the improvement in Somatosensory Reception, Range of Motion, and peripheral neuropathy-induced Pain.
Detailed description
Type 2 diabetes is a chronic metabolic disorder associated with elevated blood sugar levels and various complications, including peripheral neuropathy. This condition damages the nerves controlling sensation, often leading to foot-related issues such as limited range of motion, pain, and Somatosensory Reception deficit. These foot problems pose a significant concern for individuals with diabetes, affecting their overall foot health. Engaging in physical activity programs has been shown to reduce hospitalizations and severe complications in diabetes patients. Foot massage is a specific physical activity aimed at preventing podiatry issues. The study's hypothesis questions whether Thai Foot Massage has immediate and prolonged effects on foot pain, range of motion, and Somatosensory Reception among patients with Type 2 Diabetes Peripheral Neuropathy. This research seeks to determine the impact of Thai Foot Massage on these parameters. Type 2 diabetes and peripheral neuropathy are growing global health concerns and claim a significant social and financial burden. Diabetes Peripheral Neuropathy (DPN) has an impact on quality of life. This study aims to evaluate non-pharmacological interventions to prevent neuropathic complications, including diabetic foot problems and limb amputation. The research design chosen for this study is a Randomized Controlled Trial, recognized for establishing cause-and-effect relationships. The sample will be collected through a non-probability purposive sampling technique and will consist of individuals diagnosed with Type 2 diabetes experiencing peripheral neuropathy symptoms by calculating IpTT score ≤ 4/6. The study will be done at the University of Health Sciences in collaboration with the Diabetic Clinic District Headquarters Shiekhupura. A sample size of 78 participants, with a 5% attrition rate, will be divided equally between intervention and control groups using randomization through a lottery method. Statistical analysis will be performed using SPSS version 27, describing categorical variables through frequency and percentage. The association of qualitative data will be assessed with Chi-square, while an independent t-test and repeated measures of ANOVA will compare the two groups and measure time effects for normal data. In short, this study aims to enhance our understanding of how Thai Foot Massage can impact pain, range of motion, and somatosensory reception in patients with Type 2 diabetes and peripheral neuropathy. The findings may offer valuable insights into non-pharmacological interventions for improving foot health in this population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to the intervention and control group randomly.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Thai Foot MassageThe experimental group will receive a Thai Foot Massage every alternate day for 30 minutes for 15 days. |
| Group B | No intervention | –Participants in the control group will continue with the standard treatment regimen prescribed by the physician at the diabetic clinic. Baseline data will be collected as conducted for the experimental group. After the completion of the study, if the intervention will prove effective, the Thai foot massage will be applied to the control group. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range, 40 to 65, to ensure a consistent demographic.
- Both genders will be part of the study.
- Participants must have a confirmed medical diagnosis of Type 2 Diabetes by the physician and do not have an ulcer or amputation in either foot.
- A score on the Ipswich touch test less than 4/6 will be included.
- Patients must have a level of glycated hemoglobin HbA1C more than 7.
Key exclusion criteria (3 listed)
- Individuals with pre-existing neurological conditions unrelated to diabetes or peripheral neuropathy.
- Participants having severe diabetic complications such as advanced nephropathy, retinopathy or vascular disease will not be included in the study.
- Individuals with foot ulcers, infections, or any medical conditions that prevent them from receiving foot massage safely
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 |
|---|---|---|
| Thai Foot MassageAlso: Control group will continue with the standard care advised by the physicianIt is the application of Massage through specific techniques and pressure to the feet and lower legs to promote relaxation, improve circulation, and enhance overall well-being. It is a traditional therapeutic practice originating from Thailand and is often performed by trained practitioners. Thai foot massage is often based on traditional Thai massage techniques. The researcher is duly certified for the administration of Thai Foot Massage. | Other | Group A |
Primary outcome
Ipswich Touch Test Score (IpTT)
Time frame: 1 Months
To measure the somatosensory level, Ipswich Touch Test (IpTT) is a reliable and valid test to assess the sensory deficit in diabetic-related neuropathy patients. The highest score is 6. 6/6 means no neuropathy and 0/6 means worse possible neuropathy.
Measure the Range of Motion
Time frame: 1 Months
Range of motion refers to the extent of movement that can be achieved at a specific joint. In this study, the range of motion of the foot and ankle joints will be measured using goniometry, a technique that involves using a universal goniometer to measure the angles of joint movement. ROM will be assessed for the ankle joint, in degrees of dorsiflexion and plantarflexion.
Measure the intensity of neuropathy induced pain
Time frame: 1 Month
Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, reported by patients. In this study pain refers to the unpleasant sensations caused by type 2 diabetes peripheral neuropathy. Pain will be measured through numeric rating pain scale, which ranges from 0 to 10, where "0" represent No Pain and 10 represent worse possible pain. Pain can categorize according to pain score. Mild pain: A score of 1 to 3 Moderate Pain: A score of 4 to 6. Severe Pain: A score of 7 to 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- 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.
Azra Khanum, 1 principal investigator
PG Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Thai Foot Massage in people with Peripheral Diabetic Neuropathy, run by University of Health Sciences Lahore.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azra Khanum, 1 (03328600744, shanji755@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipswich Touch Test Score (IpTT) (time frame: 1 Months). 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?
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 3 Jan 2025.