Clinical trial NCT05641038: Comparison Of The Efficiencies Of Peloid and Paraffine Treatments In Patients With Hallux Rigidus
Official title: Comparison Of The Efficiencies Of Peloid Therapy and Paraffine Treatments In Patients With Hallux Rigidus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Rigidus
Keywords: hallux rigidus
paraffin therapy
peloid therapy
exercise
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as prospective, case-control and hospital-based.
Primary purpose: TREATMENT

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.

Detailed description: Hallux rigidus(HR); It is a pathology seen in the first Metatarsophalangeal (MTF) joint, characterized by pain, dorsal osteophytes, and dorsiflexion difficulties due to progressive degenerative arthritis. (1) The most common deformity of the first MTF joint is hallux valgus, and the second most common deformity is HR. Its incidence is higher in women than in men.(2, 3) Clinically, HR typically has insidious onset pain in the MTF joint when walking and a decrease in joint range of motion (ROM).(4) X-rays are used in radiological evaluation; narrowing of the joint space, osteophytes in the head of the metatarsal and proximal phalanx, and deterioration of the nonuniform cartilage can be observed. (5) The Coughlin and Shurnas staging system, which was created in 1999 by adding range of motion and patient's symptoms to radiological findings, is one of the most preferred.(6) This staging system was used in the staging of the patients in our study.

Treatment of HR varies according to the patient's clinic and the stage of the disease. The preferred treatment option in the early period is conservative methods. Nonsteroidal anti-inflammatory drugs (NSAI) can be used to alleviate synovitis and joint inflammation. (7) Other non-operative treatment modalities of HR include physical therapy modalities (hot-cold therapy, electrotherapy), exercise (stretching-strengthening exercises), bracing, manipulation. ..etc.(8,9) However, hard-soled shoes with a deep and wide front are recommended for activity modification and reduction of dorsal compression. Dynamic splinting can be applied to patients to increase dorsiflexion. (10) Intra-articular steroid, hyaluronic acid or platelet rich plasma (PRP) injection can be applied to patients who do not respond to these treatments. (8,11) There are many surgical methods defined for the treatment of HR. These; joint debridement, osteophyte excision, resection arthroplasty, interposition arthroplasty, cheilectomy, proximal phalangeal or metatarsal osteotomy, arthrodesis and implant arthroplasty.(12) Paraffin therapy is one of the superficial heating treatment methods. The melting point of solid paraffin is 70-80 degree. This temperature is reduced to 50-55 degree by adding 1/4 - 1/7 liquid paraffin or mineral oil. (13) There are two application methods, immersion and brushing. The immersion method is applied to the extremities, that is, for the hands, feet and arms. Brushing method is more suitable for other parts of the body such as hips, shoulders and back. With paraffin treatment, a very intense heat transfer is provided to the body. It is known that paraffin therapy also creates an increase in temperature in the joint capsule and muscles. (14) Peloids are mixtures of organic and/or inorganic substances formed as a result of biological, climatological and/or geological events. Peloid therapy is a special balneotherapy method made with natural mud.(15,16) Peloids can be applied in the form of baths (full, half, sitting and extremity baths), packs, tampons, kneading and masks. The most commonly used method in peloid therapy is packaged applications. (17) They provide relief of muscle spasm and reduction of pain with their mechanical effects. In the venous system, blood is directed towards the heart from the peripheral veins. There is a decrease in peripheral vein tone, a decrease in diastolic pressure, and a slight increase in systolic blood pressure. Vasodilation occurs in the relevant deep parts of the body with the cutaneous reflex that arises with stimulation in the parts of the body that come into contact with the peloid, muscle spasm, which is mostly thought to be due to ischemia, is resolved by thermic effect and vasodilation, vasodilation helps to clear the metabolic wastes that may cause pain from the tissue and as a result, the pain disappears. It causes relaxation in muscles, soft tissues (such as tendons, ligaments, fascia and joint capsule), raises the pain threshold at nerve endings and provokes a series of neuroendocrine reactions. In addition, hot applications have an anti-inflammatory effect in chronic inflammations. (16,18) The organic (bitumen, pectin, cellulose, lignin, humin, sulfoglycolipids, humic, fulvic and ulmic acids) and inorganic (sulphur, sodium and magnesium chloride, sulfate, iodine, bromine, zinc and selenium) substances contained in the peloid also cause many effects in the body. . The absorption of these substances through the skin causes vasodilation, relaxation in smooth muscles, inhibition of inflammation in Langerhans cells in the skin, stopping the breakdown of arachidonic acid into prostaglandins, suppressing hyaluronidase activity, and antioxidant, antiviral and anti-inflammatory effects.(19,20) Thermal mud baths activate the pathway. It has been shown to cause an increase in various hormones, a decrease in important mediators in inflammation and pain, a decrease in mediators involved in cartilage destruction, and an increase in antioxidant activity.(21) It is used in the treatment of many diseases; especially such as chronic low back and neck pain, degenerative joint diseases, soft tissue rheumatism, discopathies and arthralgias. (22-25) There are no comprehensive and adequate studies conducted in patients with symptomatic HR with paraffin administration and peloid therapy. It is thought that peloid and paraffin treatments may have a positive effect on pain, functional status and quality of life in patients with HR. The aim of this study; to investigate the effectiveness of peloid and paraffin treatments on pain, functional status and quality of life in the treatment of symptomatic HR and to compare the results.

In the study, patients who applied to our Health Sciences University Konya Physical Medicine and Rehabilitation polyclinics and were diagnosed with HR clinically and/or radiologically and sent for treatment were examined. Among these patients, 80 patients were included in the study according to the inclusion and exclusion criteria. The patients were divided into two groups of 40 each as peloid therapy and paraffin therapy. Detailed histories of the patients were taken and their sociodemographic and clinical characteristics were recorded. Peloid treatment was given to the first group for 2 weeks, 5 days a week, for a total of 10 sessions. The second group was given paraffin treatment for 2 weeks, 5 days a week, for a total of 10 sessions. A home exercise program including ROM, stretching and strengthening exercises was added to both treatment groups.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Descriptive Characteristics of the Patients
timeFrame: Just before the treatment, both groups will be asked in the form of a short questionnaire.
measure: Evaluation of Pain Severity
timeFrame: Patients were evaluated just before treatment. (1st measurement)
measure: Evaluation of Functionality and Quality of Life
timeFrame: Patients were evaluated just before treatment. (1st measurement)
measure: Evaluation of Quality of Life
timeFrame: Patients were evaluated just before treatment. (1st measurement)
measure: Joint Range of Motion Measurement
timeFrame: Patients were evaluated just before treatment. (1st measurement)
measure: Evaluation of Pain Severity
timeFrame: Patients were evaluated immediately after treatment. (2nd measurement)
measure: Evaluation of Functionality and Quality of Life
timeFrame: Patients were evaluated immediately after treatment. (2nd measurement)
measure: Evaluation of Quality of Life
timeFrame: Patients were evaluated immediately after treatment. (2nd measurement)
measure: Joint Range of Motion Measurement
timeFrame: Patients were evaluated immediately after treatment. (2nd measurement)
measure: Evaluation of Pain Severity
timeFrame: The patients were evaluated 1 month after the treatment. (3rd measurement)
measure: Evaluation of Functionality and Quality of Life
timeFrame: The patients were evaluated 1 month after the treatment. (3rd measurement)
measure: Evaluation of Quality of Life
timeFrame: The patients were evaluated 1 month after the treatment. (3rd measurement)
measure: Joint Range of Motion Measurement
timeFrame: The patients were evaluated 1 month after the treatment. (3rd measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
state: Konya
Study officials:
affiliation: assistant doctor
name: seda çıra
role: PRINCIPAL_INVESTIGATOR
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