Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis

NCT03839108 | Completed

• 1 other identifier: 2018/419
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Osteoarthritis

Keywords

paraffin; prolotherapy; hand osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Duruoz Hand Index Scale

  3 months

• Grip strength, lateral pinch strength, three point strength, two point pinch strength

  3 months

Study Arms (2)

Paraffin wax group

ACTIVE COMPARATOR

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

Prolotherapy group

EXPERIMENTAL

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

Interventions

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.

Also known as: paraffin

Paraffin wax group

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

Prolotherapy group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hand osteoarthritis defined according to American College of Rheumatology criteria
• Older than 40 years

You may not qualify if:

• Carpal tunnel syndrome
• De quervain tenosynovitis
• Dupuytren's contracture
• Secondary osteoarthritis due to Rheumatoid arthritis, chondrocalcinosis, Psoriatic arthritis, hemachromatosis
• Trigger finger

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

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

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23187044 BACKGROUND

• 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.

  PMID: 25158896 BACKGROUND

MeSH Terms

Interventions

Paraffin; Prolotherapy

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals; Complementary Therapies; Therapeutics

Study Officials

• Işıl Üstün

  Bakırköy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Sibel Çağlar Okur

  Dr Sadi Konuk Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: randomised single blind study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 15, 2019
• Study Start: December 14, 2018
• Primary Completion: December 15, 2018
• Study Completion: March 15, 2020
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)