Comparison Of The Efficiencies Of Peloid and Paraffine Treatments In Patients With Hallux Rigidus

NCT05641038 | Completed

• 1 other identifier: beyhekimtrh
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In the study, the effects of peloid and paraffin treatments applied to symptomatic hallux rigidus patients on pain, functional status, quality of life and joint range of motion were evaluated and their effectiveness was compared.

Conditions

Hallux Rigidus

Keywords

hallux rigidus; paraffin therapy; peloid therapy; exercise

Outcome Measures

Primary Outcomes (13)

• Descriptive Characteristics of the Patients

  A short questionnaire was created to determine the sociodemographic characteristics of the patients.

  Just before the treatment, both groups will be asked in the form of a short questionnaire.

• Evaluation of Pain Severity

  The pain level of the patients was determined by a visual analog scale(VAS). The patient was asked to mark the value corresponding to resting pain and pain during walking on the scale.

  Patients were evaluated just before treatment. (1st measurement)

• Evaluation of Functionality and Quality of Life

  Foot-ankle outcome score (FAOS) is an international questionnaire used to assess

  Patients were evaluated just before treatment. (1st measurement)

• Evaluation of Quality of Life

  Quality of life was evaluated with the SF-36 health questionnaire. The SF-36 is a form of 36 questions consisting of 8 subgroups, which is used to measure the general quality of life. It has eight subscales (general health, physical function, physical condition, pain, life functions, social functions, emotional status, mental health) and 2 specific scales (mental health and physical health).

  Patients were evaluated just before treatment. (1st measurement)

• Joint Range of Motion Measurement

  Dorsiflexion and plantarflexion angles of the 1st MTP joint in both feet of the patients were measured with a goniometer and noted. In addition, the stages of disease for the patients were determined according to the Coughlin and Shurnas staging system.

  Patients were evaluated just before treatment. (1st measurement)

• Evaluation of Pain Severity

  The pain level of the patients was determined by a visual analog scale(VAS). The patient was asked to mark the value corresponding to resting pain and pain during walking on the scale.

  Patients were evaluated immediately after treatment. (2nd measurement)

• Evaluation of Functionality and Quality of Life

  Foot-ankle outcome score (FAOS) is an international questionnaire used to assess functionality and quality of life. The Turkish validity and reliability of this form were studied. This test consists of 44 questions in total. Headings include symptoms, pain, work, and daily life, sports, and recreational activities, and quality of life.

  Patients were evaluated immediately after treatment. (2nd measurement)

• Evaluation of Quality of Life

  Quality of life was evaluated with the SF-36 health questionnaire. The SF-36 is a form of 36 questions consisting of 8 subgroups, which is used to measure the general quality of life. It has eight subscales (general health, physical function, physical condition, pain, life functions, social functions, emotional status, mental health) and 2 specific scales (mental health and physical health).

  Patients were evaluated immediately after treatment. (2nd measurement)

• Joint Range of Motion Measurement

  Dorsiflexion and plantarflexion angles of the 1st MTP joint in both feet of the patients were measured with a goniometer and noted. In addition, the stages of disease for the patients were determined according to the Coughlin and Shurnas staging system.

  Patients were evaluated immediately after treatment. (2nd measurement)

• Evaluation of Pain Severity

  The pain level of the patients was determined by a visual analog scale(VAS). The patient was asked to mark the value corresponding to resting pain and pain during walking on the scale.

  The patients were evaluated 1 month after the treatment. (3rd measurement)

• Evaluation of Functionality and Quality of Life

  Foot-ankle outcome score (FAOS) is an international questionnaire used to assess functionality and quality of life. The Turkish validity and reliability of this form were studied. This test consists of 44 questions in total. Headings include symptoms, pain, work, and daily life, sports, and recreational activities, and quality of life.

  The patients were evaluated 1 month after the treatment. (3rd measurement)

• Evaluation of Quality of Life

  Quality of life was evaluated with the SF-36 health questionnaire. The SF-36 is a form of 36 questions consisting of 8 subgroups, which is used to measure the general quality of life. It has eight subscales (general health, physical function, physical condition, pain, life functions, social functions, emotional status, mental health) and 2 specific scales (mental health and physical health).

  The patients were evaluated 1 month after the treatment. (3rd measurement)

• Joint Range of Motion Measurement

  Dorsiflexion and plantarflexion angles of the 1st MTP joint in both feet of the patients were measured with a goniometer and noted. In addition, the stages of disease for the patients were determined according to the Coughlin and Shurnas staging system.

  The patients were evaluated 1 month after the treatment. (3rd measurement)

Study Arms (2)

Group 1 Peloid treatment

ACTIVE COMPARATOR

The patients in the first group; Peloid was applied to both feet at 42 °C for 2 weeks, 5 days a week, 10 sessions in total, 20 minutes each session.

Other: Peloid treatment

Group 2 Paraffin treatment

ACTIVE COMPARATOR

The patients in the second group were given paraffin treatment on both feet by dipping method, for 2 weeks, 5 days a week, 10 sessions in total, 20 minutes each session.

Other: Paraffin treatment

Interventions

Peloid treatment OTHER

The patients in the first group; Peloid was applied to both feet at 42 °C for 2 weeks, 5 days a week, 10 sessions in total, 20 minutes each session. Peloid was applied in a layer of approximately 1.5-2 cm thick, then the foot was wrapped in a nylon bag and covered with a towel. After 20 minutes of application, the peloid layer was removed and disposed of in medical waste. The treatment area was cleaned with soft cloths moistened with hot water and the session was ended. In addition to peloid therapy, a home exercise program including joint range of motion, stretching and strengthening exercises for the 1st MTF with 3 sets of 10 repetitions was described for the patients to do simultaneously.

Group 1 Peloid treatment

Paraffin treatment OTHER

The patients in the second group were given paraffin treatment on both feet by dipping method, for 2 weeks, 5 days a week, 10 sessions in total, 20 minutes each session. After the foot was dipped and removed 10 times, it was wrapped in a nylon bag and left for 20 minutes. Then the paraffin was peeled off the feet and disposed of in medical waste. Likewise, a home exercise program including joint range of motion, stretching and strengthening exercises for the 1st MTF with 3 sets of 10 repetitions was described for them to do simultaneously.

Group 2 Paraffin treatment

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain-limitation in the 1st MTF joint for three months or longer,
• Being over 35 years old,
• or more severe pain according to VAS,
• Localized tenderness over the 1st MTF on palpation.

You may not qualify if:

• Having neuropathic or radicular pain,
• History of acute trauma,
• Previous surgical intervention on the foot or non-operative treatment within 6 months (corticosteroid injection, physical therapy applications, shoe modifications, etc.),
• Having rheumatological diseases such as rheumatoid arthritis, psoriatic arthritis, gout,
• Having a malignancy,
• Having a progressive neurological disease that causes sensory defects,
• Being allergic to peloid therapy,
• Being pregnant
• Having a communication problem.

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Selçuklu, Konya, Turkey (Türkiye)

Location

Related Publications (25)

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MeSH Terms

Conditions

Hallux Rigidus; Motor Activity

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases; Behavior

Study Officials

• seda çıra

  assistant doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Doctor

Model Details: The study was designed as prospective, case-control and hospital-based.

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: December 7, 2022
• Study Start: May 8, 2019
• Primary Completion: June 22, 2021
• Study Completion: August 3, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)