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

Hallux Rigidus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641038
• Other study ID #: beyhekimtrh
• Status: Completed
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: August 3, 2021

Study information

• Verified date: December 2022
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 3, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Intervention

Other:
• Peloid treatment
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 treatment
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.

Locations

Country	Name	City	State
Turkey	Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic	Selçuklu	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (25)

Ardic F, Ozgen M, Aybek H, Rota S, Cubukcu D, Gokgoz A. Effects of balneotherapy on serum IL-1, PGE2 and LTB4 levels in fibromyalgia patients. Rheumatol Int. 2007 Mar;27(5):441-6. doi: 10.1007/s00296-006-0237-x. — View Citation

Bellometti S, Richelmi P, Tassoni T, Berte F. Production of matrix metalloproteinases and their inhibitors in osteoarthritic patients undergoing mud bath therapy. Int J Clin Pharmacol Res. 2005;25(2):77-94. — View Citation

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. — View Citation

Codish S, Abu-Shakra M, Flusser D, Friger M, Sukenik S. Mud compress therapy for the hands of patients with rheumatoid arthritis. Rheumatol Int. 2005 Jan;25(1):49-54. doi: 10.1007/s00296-003-0402-4. Epub 2003 Nov 14. — View Citation

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. — View Citation

Dülgeroglu TC, DEMIRKIRAN ND, Erduran M. Ileri evre halluks rijiduslu hastalarda yerli üretim total eklem artroplastisi ile tedavi sonuçlarimiz. Pamukkale Tip Dergisi.12(2):215-24.

Elkayam O, Ophir J, Brener S, Paran D, Wigler I, Efron D, Even-Paz Z, Politi Y, Yaron M. Immediate and delayed effects of treatment at the Dead Sea in patients with psoriatic arthritis. Rheumatol Int. 2000;19(3):77-82. doi: 10.1007/s002960050107. — View Citation

Flusser D, Abu-Shakra M, Friger M, Codish S, Sukenik S. Therapy with mud compresses for knee osteoarthritis: comparison of natural mud preparations with mineral-depleted mud. J Clin Rheumatol. 2002 Aug;8(4):197-203. doi: 10.1097/00124743-200208000-00003. — View Citation

Fraioli A, Serio A, Mennuni G, Ceccarelli F, Petraccia L, Fontana M, Grassi M, Valesini G. A study on the efficacy of treatment with mud packs and baths with Sillene mineral water (Chianciano Spa Italy) in patients suffering from knee osteoarthritis. Rheumatol Int. 2011 Oct;31(10):1333-40. doi: 10.1007/s00296-010-1475-5. — View Citation

H. G. Peloidoterapi, Etki, Mekanizmasi ve Uygulama Yöntemleri. Içinde Karagülle M, editor. Tibbi Ekoloji ve Hidroklimatoloji. Istanbul: Nobel Tip Kitabevleri; 2013. 13-18. .

Kalish S, Willis FBJTF, Journal AO. Hallux limitus and dynamic splinting: a retrospective series. 2009;2(4):1.

Kiliçoglu Ö. Ayak basparmaginin hastaliklari: Halluks valgus ve halluks rigidus.

M.Z. K. Kaplica Tedavisi, Balneoterapi ve Klimaterapi. Içinde Dogan M Karagülle MZ, editör. Kaplica Tibbi ve Türkiye Kaplica Rehberi. Istanbul: Nobel Tip kitabevleri. 2002. 1-22.

Meriç G, Budeyri A, Basdelioglu K, Demir A, UYSAL AEJBSBD. HALLUKS RIJIDUSTA KULLANILAN TEDAVI SEÇENEKLERI.1(2):85-9.

MZ K. H G. Peloidler, In: Karagülle MZ (eds). Balneoloji ve Kaplica Tibbi, Nobel Tip Kitabevleri, p: 97-112, Istanbul, 2002 40.

Odabasi E, Turan M, Erdem H, Tekbas F. Does mud pack treatment have any chemical effect? A randomized controlled clinical study. J Altern Complement Med. 2008 Jun;14(5):559-65. doi: 10.1089/acm.2008.0003. — View Citation

Oguz h. Oguz H, Dursun E, Dursun N, Tibbi Rehabilitasyon. Öztürk C, Aksit R, Tedavide sicak ve soguk. Nobel tip kitabevi, 2004; 333-353

OKUR SÇ, FIRDIN F, ÖZTÜRK SK, EDEMCI SJBTT, Regülasyon ve Nöral Terapi Dergisi. HALLUKS RIJIDUS TEDAVISINDE MANUAL MOBILIZASYON TEKNIKLERININ ETKINLIGININ DEGERLENDIRILMESI: VAKA SERISI.12(3):14-7.

Polzer 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. — View Citation

Stillwell G. General principles of thermotherapy. Therapeutic Heat and Cold: E. Licht New Haven (Conn.); 1965. p. 232-65.

Thermann H, Becher C, Kilger RJTiF, Surgery A. Hallux rigidus treatment with cheilectomy, extensive plantar release, and additional microfracture technique. 2004;3(4):210-5.

UN Ö. Kaplica Tedavisi. In: Tuna N, Eds. Romatizmal Hastaliklar. Ankara: Hacettepe Tas Kitapçilik; 1994. s. 229-42.

Uzunca KJTJoPM, Dergisi RTFTvR. Ayak Bilegi ve Ayak Osteoartritleri. 2009;55.

Wülker NJIA, Zollinger-Kies H: Fußchirurgie. Hallux rigidus. 2004;1:99-103.

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)