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Unable to recruit adequate numbers of patients
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolotherapy group | Experimental | Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. |
|
| Corticosteroid Group | Active Comparator | Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolotherapy (10% dextrose solution) | Drug | Dextrose diluted with sterile water. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. Gruba, M.D. | Mayo Clinic Physical Medicine & Rehabilitation Residency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8888571 | Background | 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. | |
| 11878178 |
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Subjects were recruited from the pool of referrals to the Mayo Hand Clinic who are interested in receiving an injection for their pain, agree to comply with the standardized hand therapy program, meet the inclusion/exclusion criteria and are able to make the scheduled follow-up visits from Mayo 2008 to July 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prolotherapy Group | Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. |
| FG001 | Corticosteroid Group | Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prolotherapy Group | Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. |
| BG001 | Corticosteroid Group | Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | baseline, 6 month follow-up |
|
Subjects will be followed for adverse events for six months following the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prolotherapy Group | Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. |
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Early termination due to low enrollment; no subject data was analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey S. Brault | Mayo Clinic | 507-284-1643 | brault.jeffrey@mayo.edu |
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| ID | Term |
|---|---|
| D000075527 | Prolotherapy |
| D001623 | Betamethasone |
| C018230 | betamethasone acetate phosphate |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Betamethasone |
| Drug |
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. |
|
|
| Berggren 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. |
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| Background | Hackett, G. (1956). Ligament and Tendon Relaxation Treated by Prolotherapy. Springfield, IL, Charles C Thomas. |
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| Background | Reeves, K. (2000). Prolotherapy: Basic Science, Clinical Studies, and Technique. Pain Procedures in Clinical Practice. T. A. Lennard. Philadelphia, PA, Hanley and Belfus, INC.: 172-90. |
| 10710805 | Background | Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med. 2000 Mar;6(2):68-74, 77-80. |
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| 12776476 | Background | Reeves KD, Hassanein KM. Long-term effects of dextrose prolotherapy for anterior cruciate ligament laxity. Altern Ther Health Med. 2003 May-Jun;9(3):58-62. |
| 8638660 | Background | Roos MD, Han IO, Paterson AJ, Kudlow JE. Role of glucosamine synthesis in the stimulation of TGF-alpha gene transcription by glucose and EGF. Am J Physiol. 1996 Mar;270(3 Pt 1):C803-11. doi: 10.1152/ajpcell.1996.270.3.C803. |
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| 12446258 | Background | Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002 Dec 1;156(11):1021-7. doi: 10.1093/aje/kwf141. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Corticosteroid Group | Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. | 0 | 2 | 0 | 2 |
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| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |