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NCT Number: NCT03839108

Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis

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.

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Key information

Conditions

Hand Osteoarthritis

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paraffin wax

Other

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

prolotherapy

Drug

. 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

Primary outcomes

  1. Changed pain score >%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months

    Time frame: 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

  2. Changed pain score >%20 in hand osteoarthritis in prolotherapy group measured by Visual Analogue Scale

    Time frame: 3 months

    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. Comparison of effect of prolotherapy and paraffin wax on pain score change

    Time frame: 3 months

    VAS score changes of two groups will be compared

Secondary outcomes

  1. Duruoz Hand Index Scale

    Time frame: 3 months

    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

  2. Grip strength, lateral pinch strength, three point strength, two point pinch strength

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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