Clinical trial
Which is More Effective: Prolotherapy or Paraffin Waxes for Hand Ostearthritis
Name
2018/419
Description
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.
Trial arms
Trial start
2018-12-14
Estimated PCD
2018-12-15
Trial end
2020-03-15
Status
Completed
Treatment
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.
Arms:
Paraffin wax group
Other names:
paraffin
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
Arms:
Prolotherapy group
Size
42
Primary endpoint
Changed pain score >%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months
3 months
Changed pain score >%20 in hand osteoarthritis in prolotherapy group measured by Visual Analogue Scale
3 months
Comparison of effect of prolotherapy and paraffin wax on pain score change
3 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'randomised single blind study', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}
Updated at
2023-09-01
1 organization
1 product
1 indication
Product
ProlotherapyIndication
Osteoarthritis of the Hand