Clinical trial NCT03839108: Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis
Official title: Which is More Effective: Prolotherapy or Paraffin Waxes for Hand Ostearthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Osteoarthritis
Keywords: paraffin
prolotherapy
hand osteoarthritis
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2019-02-15
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Changed pain score >%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months
timeFrame: 3 months
measure: Changed pain score >%20 in hand osteoarthritis in prolotherapy group measured by Visual Analogue Scale
timeFrame: 3 months
measure: Comparison of effect of prolotherapy and paraffin wax on pain score change
timeFrame: 3 months
Secondary outcomes:
measure: Duruoz Hand Index Scale
timeFrame: 3 months
measure: Grip strength, lateral pinch strength, three point strength, two point pinch strength
timeFrame: 3 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences Bakirkoy Dr Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Bakırköy Dr. Sadi Konuk Training and Research Hospital
name: Işıl Üstün
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr Sadi Konuk Training and Research Hospital
name: Sibel Çağlar Okur
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.