Thumb Carpometacarpal Joint OsteoarthritisNCT00685880
Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
A study testing Prolotherapy (10% dextrose solution) and Betamethasone in people with Thumb Carpometacarpal Joint Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thumb Carpometacarpal Joint Osteoarthritis
- What is being tested?
- Prolotherapy (10% dextrose solution) and Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >45
- Ability to make follow-up visits over the 6 month protocol
- Ability to give informed consent
- Eaton grade 2-3 thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on visual analogue scale with symptoms present greater then 6 months.
Who cannot join
- Recent trauma to the hand or wrist or fractures eeen on radiographs
- Eaton grade 1, or 4 joints affected
- Metabolic bone disease
- Recent systemic or localized infection (within last 2 weeks)
- History of rheumatologic disease
- Allergies to injected solutions
- Thumb carpo-metacarpal joint injections in the prior 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.
Read the detailed description
Dextrose prolotherapy has been shown to decrease anterior cruciate ligament (ACL) laxity and decrease knee joint pain. Similar to ACL laxity leading to knee osteoarthritis, laxity of the "beak" ligament can lead to worsening thumb CMC osteoarthritis. We hypothesize that dextrose intra-articular prolotherapy will have similar results in treating the pain and instability related to symptomatic thumb CMC osteoarthritis. This will be a prospective randomized double blind comparison study comparing Celestone to Dextrose intra-articular injections as adjuncts to hand therapy for the treatment of symptomatic thumb CMC osteoarthritis. Twenty patients will be randomized to each treatment arm to provide enough power to show a 20% change in visual analogue scale (VAS) for pain to be significant. We will utilize the ultrasound guided injection protocol described by the co-investigators for both treatment arms to ensure proper placement of the respective solutions. We will measure various grip strengths, and VAS pain scales prior to the first injection, prior to the second injection at 6 weeks and at the final visit at 6 months. A telephone follow-up with pain scale will be administered at 3 months. A Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire measuring upper extremity functional impairment will be obtained at initial and final visits.
- Being tested
- Prolotherapy (10% dextrose solution), Betamethasone
- Keywords
- thumb carpo metacarpal joint osteoarthritis, prolotherapy, intra articular steroid, hand therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolotherapy (10% dextrose solution)Drug
Dextrose diluted with sterile water.
BetamethasoneDrug
Also called Celestone Soluspan
CELESTONE® SOLUSPAN® * (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection.
| Study group | Role | What they receive |
|---|---|---|
| Prolotherapy group | Experimental | Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Receives: Drug: Prolotherapy (10% dextrose solution) |
| Corticosteroid Group | Active comparator | Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Decreased Pain Score >20%
Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.
Measured: baseline, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Unable to recruit adequate numbers of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Thumb Carpometacarpal Joint OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Michael J. Gruba, M.D., Principal investigator, Mayo Clinic Physical Medicine & Rehabilitation Residency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685880
- Sponsor's protocol ID
- 07-006348
- Status last verified
- Jul 2012
- First submitted
- 26 May 2008
- Last updated
- 30 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Asakawa H, Miyagawa J, Higashiyama S, Goishi K, Hanafusa T, Kuwajima M, Taniguchi N, Matsuzawa Y. High glucose and hyperosmolarity increase heparin-binding epidermal growth factor-like growth factor (HB-EGF) production in cultured human aortic endothelial cells. Cell Biochem Funct. 1996 Sep;14(3):181-6. doi: 10.1002/cbf.666.
PubMed 8888571Berggren M, Joost-Davidsson A, Lindstrand J, Nylander G, Povlsen B. Reduction in the need for operation after conservative treatment of osteoarthritis of the first carpometacarpal joint: a seven year prospective study. Scand J Plast Reconstr Surg Hand Surg. 2001 Dec;35(4):415-7. doi: 10.1080/028443101317149381.
PubMed 11878178Clarkson MR, Murphy M, Gupta S, Lambe T, Mackenzie HS, Godson C, Martin F, Brady HR. High glucose-altered gene expression in mesangial cells. Actin-regulatory protein gene expression is triggered by oxidative stress and cytoskeletal disassembly. J Biol Chem. 2002 Mar 22;277(12):9707-12. doi: 10.1074/jbc.M109172200. Epub 2002 Jan 9.
PubMed 11784718Dagenais S, Ogunseitan O, Haldeman S, Wooley JR, Newcomb RL. Side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain: A survey of practitioners. Arch Phys Med Rehabil. 2006 Jul;87(7):909-13. doi: 10.1016/j.apmr.2006.03.017.
PubMed 16813776Day CS, Gelberman R, Patel AA, Vogt MT, Ditsios K, Boyer MI. Basal joint osteoarthritis of the thumb: a prospective trial of steroid injection and splinting. J Hand Surg Am. 2004 Mar;29(2):247-51. doi: 10.1016/j.jhsa.2003.12.002.
PubMed 15043897Di Paolo S, Gesualdo L, Ranieri E, Grandaliano G, Schena FP. High glucose concentration induces the overexpression of transforming growth factor-beta through the activation of a platelet-derived growth factor loop in human mesangial cells. Am J Pathol. 1996 Dec;149(6):2095-106.
PubMed 8952542Glickel SZ. Clinical assessment of the thumb trapeziometacarpal joint. Hand Clin. 2001 May;17(2):185-95.
PubMed 11478041Hackett, G. (1956). Ligament and Tendon Relaxation Treated by Prolotherapy. Springfield, IL, Charles C Thomas.
Han DC, Isono M, Hoffman BB, Ziyadeh FN. High glucose stimulates proliferation and collagen type I synthesis in renal cortical fibroblasts: mediation by autocrine activation of TGF-beta. J Am Soc Nephrol. 1999 Sep;10(9):1891-9. doi: 10.1681/ASN.V1091891.
PubMed 10477140Jones SC, Saunders HJ, Qi W, Pollock CA. Intermittent high glucose enhances cell growth and collagen synthesis in cultured human tubulointerstitial cells. Diabetologia. 1999 Sep;42(9):1113-9. doi: 10.1007/s001250051279.
PubMed 10447524Joshi R. Intraarticular corticosteroid injection for first carpometacarpal osteoarthritis. J Rheumatol. 2005 Jul;32(7):1305-6.
PubMed 15996069Liu YK, Tipton CM, Matthes RD, Bedford TG, Maynard JA, Walmer HC. An in situ study of the influence of a sclerosing solution in rabbit medial collateral ligaments and its junction strength. Connect Tissue Res. 1983;11(2-3):95-102. doi: 10.3109/03008208309004846.
PubMed 6224646Meenagh GK, Patton J, Kynes C, Wright GD. A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. Ann Rheum Dis. 2004 Oct;63(10):1260-3. doi: 10.1136/ard.2003.015438.
PubMed 15361383Murphy M, Godson C, Cannon S, Kato S, Mackenzie HS, Martin F, Brady HR. Suppression subtractive hybridization identifies high glucose levels as a stimulus for expression of connective tissue growth factor and other genes in human mesangial cells. J Biol Chem. 1999 Feb 26;274(9):5830-4. doi: 10.1074/jbc.274.9.5830.
PubMed 10026205Otsuka Y, Mizuta H, Takagi K, Iyama K, Yoshitake Y, Nishikawa K, Suzuki F, Hiraki Y. Requirement of fibroblast growth factor signaling for regeneration of epiphyseal morphology in rabbit full-thickness defects of articular cartilage. Dev Growth Differ. 1997 Apr;39(2):143-56. doi: 10.1046/j.1440-169x.1997.t01-1-00003.x.
PubMed 9108328
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis
- ClinicalTrials.gov ID
- NCT00685880
- Acronym / sponsor ID
- 07-006348
- Keywords
- thumb carpo metacarpal joint osteoarthritis, prolotherapy, intra articular steroid, hand therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit adequate numbers of patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Posted 30 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.
Detailed description
Dextrose prolotherapy has been shown to decrease anterior cruciate ligament (ACL) laxity and decrease knee joint pain. Similar to ACL laxity leading to knee osteoarthritis, laxity of the "beak" ligament can lead to worsening thumb CMC osteoarthritis. We hypothesize that dextrose intra-articular prolotherapy will have similar results in treating the pain and instability related to symptomatic thumb CMC osteoarthritis. This will be a prospective randomized double blind comparison study comparing Celestone to Dextrose intra-articular injections as adjuncts to hand therapy for the treatment of symptomatic thumb CMC osteoarthritis. Twenty patients will be randomized to each treatment arm to provide enough power to show a 20% change in visual analogue scale (VAS) for pain to be significant. We will utilize the ultrasound guided injection protocol described by the co-investigators for both treatment arms to ensure proper placement of the respective solutions. We will measure various grip strengths, and VAS pain scales prior to the first injection, prior to the second injection at 6 weeks and at the final visit at 6 months. A telephone follow-up with pain scale will be administered at 3 months. A Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire measuring upper extremity functional impairment will be obtained at initial and final visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolotherapy group | Experimental | Drug: Prolotherapy (10% dextrose solution)Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. |
| Corticosteroid Group | Active comparator | Drug: BetamethasoneSubjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >45
- Ability to make follow-up visits over the 6 month protocol
- Ability to give informed consent
- Eaton grade 2-3 thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on visual analogue scale with symptoms present greater then 6 months.
Key exclusion criteria (7 listed)
- Recent trauma to the hand or wrist or fractures eeen on radiographs
- Eaton grade 1, or 4 joints affected
- Metabolic bone disease
- Recent systemic or localized infection (within last 2 weeks)
- History of rheumatologic disease
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 |
|---|---|---|
| Prolotherapy (10% dextrose solution)Dextrose diluted with sterile water. | Drug | Prolotherapy group |
| BetamethasoneAlso: Celestone SoluspanCELESTONE® SOLUSPAN® * (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection. | Drug | Corticosteroid Group |
Primary outcome
Number of Participants With a Decreased Pain Score >20%
Time frame: baseline, 6 month follow-up
Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8888571Asakawa H, Miyagawa J, Higashiyama S, Goishi K, Hanafusa T, Kuwajima M, Taniguchi N, Matsuzawa Y. High glucose and hyperosmolarity increase heparin-binding epidermal growth factor-like growth factor (HB-EGF) production in cultured human aortic endothelial cells. Cell Biochem Funct. 1996 Sep;14(3):181-6. doi: 10.1002/cbf.666.
- Background: PubMed 11878178Berggren M, Joost-Davidsson A, Lindstrand J, Nylander G, Povlsen B. Reduction in the need for operation after conservative treatment of osteoarthritis of the first carpometacarpal joint: a seven year prospective study. Scand J Plast Reconstr Surg Hand Surg. 2001 Dec;35(4):415-7. doi: 10.1080/028443101317149381.
- Background: PubMed 11784718Clarkson MR, Murphy M, Gupta S, Lambe T, Mackenzie HS, Godson C, Martin F, Brady HR. High glucose-altered gene expression in mesangial cells. Actin-regulatory protein gene expression is triggered by oxidative stress and cytoskeletal disassembly. J Biol Chem. 2002 Mar 22;277(12):9707-12. doi: 10.1074/jbc.M109172200. Epub 2002 Jan 9.
- Background: PubMed 16813776Dagenais S, Ogunseitan O, Haldeman S, Wooley JR, Newcomb RL. Side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain: A survey of practitioners. Arch Phys Med Rehabil. 2006 Jul;87(7):909-13. doi: 10.1016/j.apmr.2006.03.017.
- Background: PubMed 15043897Day CS, Gelberman R, Patel AA, Vogt MT, Ditsios K, Boyer MI. Basal joint osteoarthritis of the thumb: a prospective trial of steroid injection and splinting. J Hand Surg Am. 2004 Mar;29(2):247-51. doi: 10.1016/j.jhsa.2003.12.002.
- Background: PubMed 8952542Di Paolo S, Gesualdo L, Ranieri E, Grandaliano G, Schena FP. High glucose concentration induces the overexpression of transforming growth factor-beta through the activation of a platelet-derived growth factor loop in human mesangial cells. Am J Pathol. 1996 Dec;149(6):2095-106.
- Background: PubMed 11478041Glickel SZ. Clinical assessment of the thumb trapeziometacarpal joint. Hand Clin. 2001 May;17(2):185-95.
- BackgroundHackett, G. (1956). Ligament and Tendon Relaxation Treated by Prolotherapy. Springfield, IL, Charles C Thomas.
- Background: PubMed 10477140Han DC, Isono M, Hoffman BB, Ziyadeh FN. High glucose stimulates proliferation and collagen type I synthesis in renal cortical fibroblasts: mediation by autocrine activation of TGF-beta. J Am Soc Nephrol. 1999 Sep;10(9):1891-9. doi: 10.1681/ASN.V1091891.
- Background: PubMed 10447524Jones SC, Saunders HJ, Qi W, Pollock CA. Intermittent high glucose enhances cell growth and collagen synthesis in cultured human tubulointerstitial cells. Diabetologia. 1999 Sep;42(9):1113-9. doi: 10.1007/s001250051279.
- Background: PubMed 15996069Joshi R. Intraarticular corticosteroid injection for first carpometacarpal osteoarthritis. J Rheumatol. 2005 Jul;32(7):1305-6.
- Background: PubMed 6224646Liu YK, Tipton CM, Matthes RD, Bedford TG, Maynard JA, Walmer HC. An in situ study of the influence of a sclerosing solution in rabbit medial collateral ligaments and its junction strength. Connect Tissue Res. 1983;11(2-3):95-102. doi: 10.3109/03008208309004846.
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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.
Michael J. Gruba, M.D. principal investigator
Mayo Clinic Physical Medicine & Rehabilitation Residency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolotherapy (10% dextrose solution) and Betamethasone in people with Thumb Carpometacarpal Joint Osteoarthritis, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Aug 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Decreased Pain Score >20% (time frame: baseline, 6 month follow-up). 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 NCT00685880, which also lists 28 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 30 Aug 2012.