Hand OsteoarthritisNCT03839108
Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis
A study testing Paraffin wax and Prolotherapy in people with Hand Osteoarthritis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Paraffin wax and Prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2018to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hand osteoarthritis defined according to American College of Rheumatology criteria
- Older than 40 years
Who cannot join
- Carpal tunnel syndrome
- De quervain tenosynovitis
- Dupuytren's contracture
- Secondary osteoarthritis due to Rheumatoid arthritis, chondrocalcinosis, Psoriatic arthritis, hemachromatosis
- Trigger finger
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: Which is More Effective: Prolotherapy or Paraffin Waxes for Hand Ostearthritis
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.
Read the 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 .
- Conditions
- Hand Osteoarthritis
- Being tested
- Paraffin wax, Prolotherapy
- Keywords
- paraffin, prolotherapy, hand osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraffin waxOther
Also called paraffin
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.
ProlotherapyDrug
. 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months
Comparison of effect of prolotherapy and paraffin wax on pain score change
VAS score changes of two groups will be compared
Measured: 3 months
Secondary outcomes (2)
Duruoz Hand Index Scale
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
Measured: 3 months
Grip strength, lateral pinch strength, three point strength, two point pinch strength
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start14 Dec 2018
- Primary completion15 Dec 2018
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Işıl Üstün, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Işıl Üstün, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training HospitalSibel Çağlar Okur, Study director, Dr Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839108
- Sponsor's protocol ID
- 2018/419
- Status last verified
- Aug 2023
- First submitted
- 5 Feb 2019
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers
Publications
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.
PubMed 23187044Jahangiri 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.
PubMed 25158896
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which is More Effective: Prolotherapy or Paraffin Waxes for Hand Ostearthritis
- ClinicalTrials.gov ID
- NCT03839108
- Acronym / sponsor ID
- 2018/419
- Conditions
- Hand Osteoarthritis
- Keywords
- paraffin, prolotherapy, hand osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paraffin wax group | Active comparator | Other: Paraffin waxParaffin 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 group | Experimental | Drug: ProlotherapyDrug = 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hand osteoarthritis defined according to American College of Rheumatology criteria
- Older than 40 years
Key exclusion criteria (5 listed)
- Carpal tunnel syndrome
- De quervain tenosynovitis
- Dupuytren's contracture
- Secondary osteoarthritis due to Rheumatoid arthritis, chondrocalcinosis, Psoriatic arthritis, hemachromatosis
- Trigger finger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraffin waxAlso: paraffinParaffin 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 group |
| 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 | Drug | Prolotherapy group |
Primary outcome
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
2 secondary outcomes
Duruoz Hand Index Scale
Time frame: 3 months
Grip strength, lateral pinch strength, three point strength, two point pinch strength
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 23187044Dilek 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.
- Background: PubMed 25158896Jahangiri 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.
- Individual participant dataSharing planned: No. Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Işıl Üstün principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sibel Çağlar Okur study director
Dr Sadi Konuk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin wax and Prolotherapy in people with Hand Osteoarthritis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed pain score >%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839108, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.