Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Other: Paraffin wax; Drug: Prolotherapy

Detailed Description

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 .

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34147
    • University of Health Sciences Bakirkoy Dr Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paraffin wax 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.	Other: Paraffin wax; 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 Names: paraffin
Experimental: Prolotherapy group; 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; . 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Principal Investigator: Işıl Üstün, Bakırköy Dr. Sadi Konuk Training and Research Hospital; Study Director: Sibel Çağlar Okur, Dr Sadi Konuk Training and Research Hospital

Publications and helpful links

General Publications

• Dilek B, Gozum M, Sahin E, Baydar M, Ergor G, El O, Bircan C, Gulbahar S. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):642-9. doi: 10.1016/j.apmr.2012.11.024. Epub 2012 Nov 24.
• Jahangiri A, Moghaddam FR, Najafi S. Hypertonic dextrose versus corticosteroid local injection for the treatment of osteoarthritis in the first carpometacarpal joint: a double-blind randomized clinical trial. J Orthop Sci. 2014 Sep;19(5):737-43. doi: 10.1007/s00776-014-0587-2. Epub 2014 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: paraffin; prolotherapy; hand osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2018/419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No