Hallux RigidusNCT05641038
Comparison Of The Efficiencies Of Peloid and Paraffine Treatments In Patients With Hallux Rigidus
A study testing Peloid treatment and Paraffin treatment in people with Hallux Rigidus, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- Peloid treatment and Paraffin treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2019to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Being allergic to peloid therapy,
- Being pregnant
- Having a communication problem.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
Selçuklu, Konya
About this study
Official title: Comparison Of The Efficiencies Of Peloid Therapy and Paraffine Treatments In Patients With Hallux Rigidus
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.
Read the 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.
- Conditions
- Hallux Rigidus
- Being tested
- Peloid treatment, Paraffin treatment
- Keywords
- hallux rigidus, paraffin therapy, peloid therapy, exercise
- Medical subject headings
- Hallux Rigidus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peloid treatmentOther
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.
Paraffin treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Paraffin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Characteristics of the Patients
A short questionnaire was created to determine the sociodemographic characteristics of the patients.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: The patients were evaluated 1 month after the treatment. (3rd measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start8 May 2019
- Primary completion22 Jun 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Hallux RigidusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as prospective, case-control and hospital-based.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda ÇIRA, Konya Meram State Hospital
- Investigators
- seda çıra, Principal investigator, assistant doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641038
- Sponsor's protocol ID
- beyhekimtrh
- Status last verified
- Dec 2022
- First submitted
- 2 Jan 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wülker NJIA, Zollinger-Kies H: Fußchirurgie. Hallux rigidus. 2004;1:99-103.
Berlet GC, Hyer CF, Lee TH, Philbin TM, Hartman JF, Wright ML. Interpositional arthroplasty of the first MTP joint using a regenerative tissue matrix for the treatment of advanced hallux rigidus. Foot Ankle Int. 2008 Jan;29(1):10-21. doi: 10.3113/FAI.2008.0010.
PubMed 18275731Thermann H, Becher C, Kilger RJTiF, Surgery A. Hallux rigidus treatment with cheilectomy, extensive plantar release, and additional microfracture technique. 2004;3(4):210-5.
Dülgeroğlu TC, DEMİRKIRAN ND, Erduran M. İleri evre halluks rijiduslu hastalarda yerli üretim total eklem artroplastisi ile tedavi sonuçlarımız. Pamukkale Tıp Dergisi.12(2):215-24.
Uzunca KJTJoPM, Dergisi RTFTvR. Ayak Bileği ve Ayak Osteoartritleri. 2009;55.
Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003 Nov;85(11):2072-88.
PubMed 14630834Meriç G, Budeyri A, Başdelioğlu K, Demir A, UYSAL AEJBSBD. HALLUKS RİJİDUSTA KULLANILAN TEDAVİ SEÇENEKLERİ.1(2):85-9.
Zammit GV, Menz HB, Munteanu SE, Landorf KB, Gilheany MF. Interventions for treating osteoarthritis of the big toe joint. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007809. doi: 10.1002/14651858.CD007809.pub2.
PubMed 20824867Polzer H, Polzer S, Brumann M, Mutschler W, Regauer M. Hallux rigidus: Joint preserving alternatives to arthrodesis - a review of the literature. World J Orthop. 2014 Jan 18;5(1):6-13. doi: 10.5312/wjo.v5.i1.6. eCollection 2014 Jan 18.
PubMed 24649409Kalish S, Willis FBJTF, Journal AO. Hallux limitus and dynamic splinting: a retrospective series. 2009;2(4):1.
OKUR SÇ, FİRDİN F, ÖZTÜRK SK, EDEMCİ ŞJBTT, Regülasyon ve Nöral Terapi Dergisi. HALLUKS RİJİDUS TEDAVİSİNDE MANUAL MOBİLİZASYON TEKNİKLERİNİN ETKİNLİĞİNİN DEĞERLENDİRİLMESİ: VAKA SERİSİ.12(3):14-7.
Kılıçoğlu Ö. Ayak başparmağının hastalıkları: Halluks valgus ve halluks rigidus.
Stillwell G. General principles of thermotherapy. Therapeutic Heat and Cold: E. Licht New Haven (Conn.); 1965. p. 232-65.
Oğuz h. Oğuz H, Dursun E, Dursun N, Tıbbi Rehabilitasyon. Öztürk C, Akşit R, Tedavide sıcak ve soğuk. Nobel tıp kitabevi, 2004; 333-353
UN Ö. Kaplıca Tedavisi. In: Tuna N, Eds. Romatizmal Hastalıklar. Ankara: Hacettepe Taş Kitapçılık; 1994. s. 229-42.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Efficiencies Of Peloid Therapy and Paraffine Treatments In Patients With Hallux Rigidus
- ClinicalTrials.gov ID
- NCT05641038
- Acronym / sponsor ID
- beyhekimtrh
- Conditions
- Hallux Rigidus
- Keywords
- hallux rigidus, paraffin therapy, peloid therapy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 7 Dec 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was designed as prospective, case-control and hospital-based.
| Arm | Type | Receives |
|---|---|---|
| Group 1 Peloid treatment | Active comparator | Other: Peloid treatmentThe 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. |
| Group 2 Paraffin treatment | Active comparator | Other: Paraffin treatmentThe 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
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 |
|---|---|---|
| Peloid treatmentThe 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. | Other | Group 1 Peloid treatment |
| Paraffin treatmentThe 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. | Other | Group 2 Paraffin treatment |
Primary outcome
Descriptive Characteristics of the Patients
Time frame: Just before the treatment, both groups will be asked in the form of a short questionnaire.
A short questionnaire was created to determine the sociodemographic characteristics of the patients.
Evaluation of Pain Severity
Time frame: Patients were evaluated just before treatment. (1st measurement)
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.
Evaluation of Functionality and Quality of Life
Time frame: Patients were evaluated just before treatment. (1st measurement)
Foot-ankle outcome score (FAOS) is an international questionnaire used to assess
Evaluation of Quality of Life
Time frame: Patients were evaluated just before treatment. (1st measurement)
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).
Joint Range of Motion Measurement
Time frame: Patients were evaluated just before treatment. (1st 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.
Evaluation of Pain Severity
Time frame: Patients were evaluated immediately after treatment. (2nd measurement)
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.
Evaluation of Functionality and Quality of Life
Time frame: Patients were evaluated immediately after treatment. (2nd measurement)
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.
Evaluation of Quality of Life
Time frame: Patients were evaluated immediately after treatment. (2nd measurement)
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).
Joint Range of Motion Measurement
Time frame: Patients were evaluated immediately after treatment. (2nd 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.
Evaluation of Pain Severity
Time frame: The patients were evaluated 1 month after the treatment. (3rd measurement)
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.
Evaluation of Functionality and Quality of Life
Time frame: The patients were evaluated 1 month after the treatment. (3rd measurement)
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.
Evaluation of Quality of Life
Time frame: The patients were evaluated 1 month after the treatment. (3rd measurement)
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).
Joint Range of Motion Measurement
Time frame: The patients were evaluated 1 month after the treatment. (3rd 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- BackgroundWülker NJIA, Zollinger-Kies H: Fußchirurgie. Hallux rigidus. 2004;1:99-103.
- Background: PubMed 18275731Berlet GC, Hyer CF, Lee TH, Philbin TM, Hartman JF, Wright ML. Interpositional arthroplasty of the first MTP joint using a regenerative tissue matrix for the treatment of advanced hallux rigidus. Foot Ankle Int. 2008 Jan;29(1):10-21. doi: 10.3113/FAI.2008.0010.
- BackgroundThermann H, Becher C, Kilger RJTiF, Surgery A. Hallux rigidus treatment with cheilectomy, extensive plantar release, and additional microfracture technique. 2004;3(4):210-5.
- BackgroundDülgeroğlu TC, DEMİRKIRAN ND, Erduran M. İleri evre halluks rijiduslu hastalarda yerli üretim total eklem artroplastisi ile tedavi sonuçlarımız. Pamukkale Tıp Dergisi.12(2):215-24.
- BackgroundUzunca KJTJoPM, Dergisi RTFTvR. Ayak Bileği ve Ayak Osteoartritleri. 2009;55.
- Background: PubMed 14630834Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003 Nov;85(11):2072-88.
- BackgroundMeriç G, Budeyri A, Başdelioğlu K, Demir A, UYSAL AEJBSBD. HALLUKS RİJİDUSTA KULLANILAN TEDAVİ SEÇENEKLERİ.1(2):85-9.
- Background: PubMed 20824867Zammit GV, Menz HB, Munteanu SE, Landorf KB, Gilheany MF. Interventions for treating osteoarthritis of the big toe joint. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007809. doi: 10.1002/14651858.CD007809.pub2.
- Background: PubMed 24649409Polzer H, Polzer S, Brumann M, Mutschler W, Regauer M. Hallux rigidus: Joint preserving alternatives to arthrodesis - a review of the literature. World J Orthop. 2014 Jan 18;5(1):6-13. doi: 10.5312/wjo.v5.i1.6. eCollection 2014 Jan 18.
- BackgroundKalish S, Willis FBJTF, Journal AO. Hallux limitus and dynamic splinting: a retrospective series. 2009;2(4):1.
- BackgroundOKUR SÇ, FİRDİN F, ÖZTÜRK SK, EDEMCİ ŞJBTT, Regülasyon ve Nöral Terapi Dergisi. HALLUKS RİJİDUS TEDAVİSİNDE MANUAL MOBİLİZASYON TEKNİKLERİNİN ETKİNLİĞİNİN DEĞERLENDİRİLMESİ: VAKA SERİSİ.12(3):14-7.
- BackgroundKılıçoğlu Ö. Ayak başparmağının hastalıkları: Halluks valgus ve halluks rigidus.
- 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. This study is not recruiting at the moment.
seda çıra principal investigator
assistant doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peloid treatment and Paraffin treatment in people with Hallux Rigidus, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive Characteristics of the Patients (time frame: Just before the treatment, both groups will be asked in the form of a short questionnaire.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641038, which also lists 25 linked publications.
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 7 Dec 2022.