Which is More Effective: Prolotherapy or Paraffin Waxes for Hand Ostearthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Changed pain score >%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
randomised single blind study
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Paraffin wax (Other)
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.
Intervention: Prolotherapy (Drug)
Outcomes
Primary Outcomes
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
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.
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
- Grip strength, lateral pinch strength, three point strength, two point pinch strength(3 months)
- Duruoz Hand Index Scale(3 months)
Investigators
Işıl Üstün
Principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital