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Effects of Self-Thai Foot Massage on Pain, Range of Motion and Functional Disability in Type 2 DM

Primary Purpose

Peripheral Diabetic Neuropathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-Thai Foot Massage
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peripheral Diabetic Neuropathy focused on measuring Peripheral neuropathy, Selt-Thai Foot Massage, Range of Motion, Foot and Ankle Disability Index

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must have a confirmed medical diagnosis of Type 2 Diabetes by the physician. Patients with (Foot and ankle Disability Index) FADI score of less than 80 will be included. Individuals receiving treatment for diabetes mellitus, which may include oral hypoglycemic agents, insulin, or both." Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group B

    Group A

    Arm Description

    The experimental group will receive a Self-Thai Foot Massage on every alternate day for 15 days for 30 minutes.

    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 Self-Thai foot massage will be taught to the control group.

    Outcomes

    Primary Outcome Measures

    Measure the level of Foot and Ankle Disability Index
    Functional disability refers to the limitations or difficulties experienced by patients with type 2 diabetes and peripheral neuropathy in performing daily activities. It will be evaluated using standardized assessment tools The Foot & Ankle Disability Index (FADI) Score This tool consists of a series of questions related to various functional activities, and patients will provide responses indicating the extent to which their condition affects their ability to perform each activity, ranging from no difficulty to extreme difficulty. The FADI is scored out of 104, with a score of 0 indicating maximum disability and a score of 104 indicating no disability. A FADI score ranging from 80% to 104% of the maximum possible score is considered indicative of mild disability A FADI score between 50% and 79% of the maximum possible score is often categorized as an irate disability FADI score below 50% of the maximum possible score is generally indicative of severe disability.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    October 12, 2023
    Sponsor
    University of Health Sciences Lahore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06066944
    Brief Title
    Effects of Self-Thai Foot Massage on Pain, Range of Motion and Functional Disability in Type 2 DM
    Official Title
    Immediate and Prolonged Effects of Self-Thai Foot Massage on Pain, Range of Motion and Functional Disability Among Patients With Type 2 Diabetes Peripheral Neuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 5, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Health Sciences Lahore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to examine the effect of Self-Thai Foot Massage in type 2 diabetes peripheral neuropathy. The main question is to answer the role of massage in the improvement of peripheral neuropathy. Participants will be taught to perform the Self-Thai Foot Massage at every alternate day for 15 days. Researchers will compare the intervention group with control group (without intervention) to see the improvement in Foot and Ankle Disability Index, 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 functional disabilities. 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 Self-Thai Foot Massage has immediate and prolonged effects on foot pain, range of motion, and functional disabilities among patients with Type 2 Diabetes Peripheral Neuropathy. This research seeks to determine the impact of Self-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 as calculated FADI score ≤ 80. The study will take place at the University of Health Sciences in collaboration with Diabetic Clinic Services Hospital Lahore. 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 26, 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 summary, this study aims to enhance our understanding of how Self-Thai Foot Massage can impact pain, range of motion, and functional disabilities 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Diabetic Neuropathy
    Keywords
    Peripheral neuropathy, Selt-Thai Foot Massage, Range of Motion, Foot and Ankle Disability Index

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be assigned to the intervention and control group randomly.
    Masking
    None (Open Label)
    Masking Description
    A senior physiotherapist will be hired to assess the outcome measures.
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive a Self-Thai Foot Massage on every alternate day for 15 days for 30 minutes.
    Arm Title
    Group A
    Arm Type
    No Intervention
    Arm Description
    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 Self-Thai foot massage will be taught to the control group.
    Intervention Type
    Other
    Intervention Name(s)
    Self-Thai Foot Massage
    Other Intervention Name(s)
    Control group will continue with the standard care advised by the physician
    Intervention Description
    It is a specific technique 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. Self-Thai foot massage is often based on traditional Thai massage techniques but adapted for self-application.
    Primary Outcome Measure Information:
    Title
    Measure the level of Foot and Ankle Disability Index
    Description
    Functional disability refers to the limitations or difficulties experienced by patients with type 2 diabetes and peripheral neuropathy in performing daily activities. It will be evaluated using standardized assessment tools The Foot & Ankle Disability Index (FADI) Score This tool consists of a series of questions related to various functional activities, and patients will provide responses indicating the extent to which their condition affects their ability to perform each activity, ranging from no difficulty to extreme difficulty. The FADI is scored out of 104, with a score of 0 indicating maximum disability and a score of 104 indicating no disability. A FADI score ranging from 80% to 104% of the maximum possible score is considered indicative of mild disability A FADI score between 50% and 79% of the maximum possible score is often categorized as an irate disability FADI score below 50% of the maximum possible score is generally indicative of severe disability.
    Time Frame
    1 Months
    Title
    Measure the Range of Motion
    Description
    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.
    Time Frame
    1 Months
    Title
    Measure the intensity of neuropathy induced pain
    Description
    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.
    Time Frame
    1 Month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must have a confirmed medical diagnosis of Type 2 Diabetes by the physician. Patients with (Foot and ankle Disability Index) FADI score of less than 80 will be included. Individuals receiving treatment for diabetes mellitus, which may include oral hypoglycemic agents, insulin, or both." Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Azra Khanum, 1
    Phone
    03328600744
    Email
    shanji755@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad Younis, 2
    Phone
    03324712073
    Email
    azrakhanum265@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Azra Khanum, 1
    Organizational Affiliation
    PG Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Self-Thai Foot Massage on Pain, Range of Motion and Functional Disability in Type 2 DM

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