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NCT Number: NCT06001203

Foot Reflexology and Pain and Ankle Brachial Index and Walking Impairement

This randomized controlled study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Ankara, Etimesgut, Turkey (Türkiye)

About this study

Patients with PAH may experience pain in the legs, cramps, pain or aching symptoms (claudication) in the hip, thigh or leg calf, along with compulsive movements such as walking. Reflexology is reported to have effects such as protecting the tissue integrity of the feet, increasing skin turgor, reducing neuropathic pain and increasing peripheral blood flow. For this reason, this study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients over 18 years of age with PAH;
  • no fractures or open wounds in both lower extremities;
  • absence of unilateral or bilateral amputation of the lower extremities

Exclusion criteria

  • having an acute infection with fever;
  • requiring an acute surgical condition
  • undergoing femoral-popliteal bypass surgery
  • Having a verbal communication problem such as Alzheimer's or dementia

Treatment and study plan

Reflexology

Procedure

Reflexology is a method that creates nervous, hormonal and energetic effects in the body using pressure, rubbing and stretching applied with special hand and finger techniques to reflex points corresponding to all parts, organs and systems of the body in the ears, hands and feet

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session

    Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)

  2. Walking Impairment Questionnaire

    Time frame: Baseline, after 2 days second reflexology sessions

    The "Walking Impairment Questionnaire" is a self-report tool that evaluates walking distance and capacity. While the first 7 questions of the tool constitute the part where claudication and differential diagnosis are evaluated individually, the following 14 items are evaluated from 0 (can't do, very difficult) to 4 (no difficulty) on the Likert scale. The scale's walking distance, walking speed and stair climbing subscales are evaluated by evaluating the weights of each question, and total and subscale scores are calculated and evaluated between 0 and 100 points. A low score indicates poor walking performance.

  3. Ankle Brachial Index

    Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session

    Ankle-brachial index is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.

Secondary outcomes

  1. Toe oxygen saturation level

    Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session

    Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body.

  2. Rate of Participants Edema level

    Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session

    Rate of Participants Edema level is measured from the ankle and calf with a tape measure.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

The Effect of Foot Reflexology on Pain, Walking Impairement and Ankle Brachial Index Level in Patients With Peripheral Artery Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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