Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis

Study Overview
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Brief Summary
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Patients with hand osteoarthritis will be randomized into two groups, paraffin wax and prolotherapy group. Patients will be evaluated before and after treatment , after 2 weeks 4 weeks and 3 months after treatment. Evaluation parameters are visual analog scale, Duruoz hand index scales, grip strength, lateral pinch, two point pinch and three point pinch strengths.

Detailed Description
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This study is a randomized clinical trial. 40 Patients with hand osteoarthritis will be randomized into 2 groups, paraffin wax and prolotherapy group.Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session. Prolotherapy is a nonsurgical regenerative injection technique that introduces small amounts of an irritant solution to the site of painful and degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces during several treatment sessions to promote growth of normal cells and tissues.Hypertonic dextrose solution is most common used agent. In prolotherapy group, %15 dextrose solution will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period. Grip strength, lateral pinch, two point pinch, three point pinch strengths, Visual analog scale (VAS), Duruoz Hand Index scales will be assessed before the intervention and after two weeks, 4 weeks and 3 months after intervention .

Official Title
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Which is More Effective: Prolotherapy or Paraffin Waxes for Hand Ostearthritis

Conditions
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Hand Osteoarthritis

Intervention / Treatment
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* Other: Paraffin wax
* Drug: Prolotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hand osteoarthritis defined according to American College of Rheumatology criteria Older than 40 years Exclusion Criteria: Carpal tunnel syndrome De quervain tenosynovitis Dupuytren's contracture Secondary osteoarthritis due to Rheumatoid arthritis, chondrocalcinosis, Psoriatic arthritis, hemachromatosis Trigger finger

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paraffin wax group<br>Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session. | Other: Paraffin wax<br>* Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session.<br>* Other names: paraffin;|
| Experimental: Prolotherapy group<br>Drug = prolotherapy (%15 dextrose solution) into hand joints %15 dextrose solution will be injected into medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period. | Drug: Prolotherapy<br>* . Prolotherapy is a nonsurgical regenerative injection technique that introduces small amounts of an irritant solution to the site of painful and degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces during several treatment sessions to promote growth of normal cells and tissues.Hypertonic dextrose solution is most common used agent. In prolotheraphy group, %15 dextrose solution will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changed pain score >%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months | Pain is measured by visual analog scale (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). The patients' pain in paraffin wax group are assessed by VAS in 3 months. Changed pain score >%20 VAS is one of the primary outcomes | 3 months | 
| Changed pain score >%20 in hand osteoarthritis in prolotherapy group measured by Visual Analogue Scale | pain change is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). Changed pain score >%20 VAS in prolotherapy group are assessed in 3 months. | 3 months | 
| Comparison of effect of prolotherapy and paraffin wax on pain score change | VAS score changes of two groups will be compared | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duruoz Hand Index Scale | The DHI is a self-report questionnaire which was developed about 15 years ago to evaluate the capacity to carry out manual functional activities with no assistance or aids in patients with rheumatoid arthritis . It consists of 18 questions regarding manual tasks which are frequently carried out while cooking, washing, dressing, etc. The patient is asked to evaluate the difficulty which he/she has in carrying out these tasks (from 0: no difficulty, to 4: nearly impossible) The psychometric properties of this scale have been evaluated in patients with rheumatoid arthritis, scleroderma, hand osteoarthritis, stroke, trauma , diabetes and patients on haemodialysis. Duruoz Hand Index Scales of both groups before the treatment, 3 months after treatment will be compared | 3 months | 
| Grip strength, lateral pinch strength, three point strength, two point pinch strength | Grip strength, lateral pinch strength, three point strength, two point pinch strength is measured by dynamometer in both groups before and after treatment. Effect of therapy on strength of hands will be compared | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paraffin, prolotherapy, hand osteoarthritis