Hand Osteoarthritis
RCT # 1: Reeves KD, Hassanein K. Randomized prospective placebo controlled double blind study of dextrose prolotherapy for osteoarthritic thumbs and finger (DIP, PIP and Trapeziometacarpal) joints: Evidence of Clinical Efficacy. Jnl Alt Compl Med 2000;6(4):311-320.
ABSTRACT
OBJECTIVES: To determine the clinical benefit of dextrose prolotherapy (injection of growth factors or growth factor stimulators) in osteoarthritic finger joints.
DESIGN: Prospective randomized double-blind placebo-controlled trial.
SETTINGS/LOCATION: Outpatient physical medicine clinic.
SUBJECTS: Six months of pain history was required in each joint studied as well as one of the following: grade 2 or 3 osteophyte, grade 2 or 3 joint narrowing, or grade 1 osteophyte plus grade 1 joint narrowing. Distal interphalangeal (DIP), proximal interphalangeal (PIP), and trapeziometacarpal (thumb CMC) joints were eligible. Thirteen patients (with seventy-four symptomatic osteoarthitic joints) received active treatment, and fourteen patients (with seventy-six symptomatic osteoarthritic joints) served as controls.
INTERVENTION: One half milliliter (0.5 mL) of either 10% dextrose and 0.075% xylocaine in bacteriostatic water (active solution) or 0.075% xylocaine in bacteriostatic water (control solution) was injected on medial and lateral aspects of each affected joint. This was done at 0, 2, and 4 months with assessment at 6 months after first injection.
OUTCOME MEASURES: One-hundred millimeter (100 mm) Visual Analogue Scale (VAS) for pain at rest, pain with joint movement and pain with grip, and goniometrically-measured joint flexion. RESULTS: Pain at rest and with grip improved more in the dextrose group but not significantly. Improvement in pain with movement of fingers improved significantly more in the dextrose group (42% versus 15% with a p value of .027). Flexion range of motion improved more in the dextrose group (p = .003). Side effects were minimal.
CONCLUSION: Dextrose prolotherapy was clinically effective and safe in the treatment of pain with joint movement and range limitation in osteoarthritic finger joints.
SUPPLEMENTARY NOTES: DPT was compared to lidocaine injection in a masked 2 arm trial. Participants with chronic thumb or finger pain and radiographic hand OA received treatment at 0, 2 and 4 months, with optional open label dextrose injection after 6 months. All symptomatic joints were treated and participants were analyzed based on the average change across all joints treated, with effects assessed at 6 (blinded) and 12 months (open label) using a 0-10 Numerical Rating Scale (NRS) pain score and flexion range of motion. Participants were similar statistically at baseline. The DPT group improved more in pain on movement (1.9±1.5 points [42%] vs 0.6±1.0 points [14%] (p=.027) and flexion range of motion (+8.0±3.6 degrees vs -8.8±2.9 degrees; p=<.01) than the lidocaine group at 6 months. (Figures 10-11) DPT administration to the lidocaine group after 6 months resulted in a similar pattern of improvement as the original dextrose group.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
ABSTRACT
OBJECTIVES: To determine the clinical benefit of dextrose prolotherapy (injection of growth factors or growth factor stimulators) in osteoarthritic finger joints.
DESIGN: Prospective randomized double-blind placebo-controlled trial.
SETTINGS/LOCATION: Outpatient physical medicine clinic.
SUBJECTS: Six months of pain history was required in each joint studied as well as one of the following: grade 2 or 3 osteophyte, grade 2 or 3 joint narrowing, or grade 1 osteophyte plus grade 1 joint narrowing. Distal interphalangeal (DIP), proximal interphalangeal (PIP), and trapeziometacarpal (thumb CMC) joints were eligible. Thirteen patients (with seventy-four symptomatic osteoarthitic joints) received active treatment, and fourteen patients (with seventy-six symptomatic osteoarthritic joints) served as controls.
INTERVENTION: One half milliliter (0.5 mL) of either 10% dextrose and 0.075% xylocaine in bacteriostatic water (active solution) or 0.075% xylocaine in bacteriostatic water (control solution) was injected on medial and lateral aspects of each affected joint. This was done at 0, 2, and 4 months with assessment at 6 months after first injection.
OUTCOME MEASURES: One-hundred millimeter (100 mm) Visual Analogue Scale (VAS) for pain at rest, pain with joint movement and pain with grip, and goniometrically-measured joint flexion. RESULTS: Pain at rest and with grip improved more in the dextrose group but not significantly. Improvement in pain with movement of fingers improved significantly more in the dextrose group (42% versus 15% with a p value of .027). Flexion range of motion improved more in the dextrose group (p = .003). Side effects were minimal.
CONCLUSION: Dextrose prolotherapy was clinically effective and safe in the treatment of pain with joint movement and range limitation in osteoarthritic finger joints.
SUPPLEMENTARY NOTES: DPT was compared to lidocaine injection in a masked 2 arm trial. Participants with chronic thumb or finger pain and radiographic hand OA received treatment at 0, 2 and 4 months, with optional open label dextrose injection after 6 months. All symptomatic joints were treated and participants were analyzed based on the average change across all joints treated, with effects assessed at 6 (blinded) and 12 months (open label) using a 0-10 Numerical Rating Scale (NRS) pain score and flexion range of motion. Participants were similar statistically at baseline. The DPT group improved more in pain on movement (1.9±1.5 points [42%] vs 0.6±1.0 points [14%] (p=.027) and flexion range of motion (+8.0±3.6 degrees vs -8.8±2.9 degrees; p=<.01) than the lidocaine group at 6 months. (Figures 10-11) DPT administration to the lidocaine group after 6 months resulted in a similar pattern of improvement as the original dextrose group.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
Sequence Generation |
Allocation Concealment |
Blinding of Participants & Researchers |
Blinding of Outcome Assessment |
Incomplete Outcome Data Addressed |
Selective Data Reporting |
Low |
Unclear |
Low |
Low |
Low |
Unclear |
A random number table was utilized. |
Clinicians and research coordinator masked. Assignments not made off site. |
Solutions identical in color and viscosity. |
Assessor and database coordinator were masked. |
<10 lost to follow-up. Intention to treat utilized. |
No published protocol before initiation. |
SUMMARY Reeves et al hand RCT
This is a small study, but it was powered enough for significant results. Given an overall low to median bias rating, this qualifies as level 1b evidence of efficacy of PIP, DIP or TMC thumb injection with 12.5% dextrose versus anesthetic needling of the joint medially and laterally. For practical application of this protocol, the practitioners should apply small subcutaneous anesthetic blebs with a 30 gauge needle prior to small needle injection for optimum comfort. Lateral injection without ultrasound guidance in not likely intraarticular in mos cases, as much of the dextrose would have been injected pericapsular, both medially and laterally. However, a signifant amount of nociceptive source appears to be around the capsule of the joint with fingers, similar to the knee.
This is a small study, but it was powered enough for significant results. Given an overall low to median bias rating, this qualifies as level 1b evidence of efficacy of PIP, DIP or TMC thumb injection with 12.5% dextrose versus anesthetic needling of the joint medially and laterally. For practical application of this protocol, the practitioners should apply small subcutaneous anesthetic blebs with a 30 gauge needle prior to small needle injection for optimum comfort. Lateral injection without ultrasound guidance in not likely intraarticular in mos cases, as much of the dextrose would have been injected pericapsular, both medially and laterally. However, a signifant amount of nociceptive source appears to be around the capsule of the joint with fingers, similar to the knee.
RCT # 2: Jahangiri 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;19(5):737-743.
ABSTRACT
Purpose: To compare the advantages of prolotherapy in the treatment of first carpometacarpal osteoarthritis (OA) with those of corticosteroid local injection in the short and long term.
Methods: We performed a randomized controlled trial from March 2010 to March 2011 in an outpatient clinic at a university hospital. Sixty participants (60 hands) with OA of the first carpometacarpal joint were assigned equally to two groups. For the corticosteroid group, after 2 monthly saline placebo injections, a single dose of 40 mg methyl- prednisolone acetate (0.5 ml) mixed with 0.5 ml of 2 % lidocaine was injected. For the dextrose (DX) group, 0.5 ml of 20 % DX was mixed with 0.5 ml of 2 % lidocaine and the injection was repeated monthly for 3 months. Pain intensity, hand function and the strength of lateral pinch grip were measured at the baseline and at 1, 2, and 6 months after the treatment.
Results Mean age (STD) was 63.6 (9.7) years, and mean (STD) visual analog scale (VAS) was 6 (2). The two groups were comparable at 2 months, but significantly different at 1 month, with better results for corticosteroid, and at 6 months with apparently more favorable outcome for DX [mean difference (95 % CI) in VAS = 1.1 (0.2, 2.0), p = 0.02]. After 6 months of treatment, both DX and corticosteroid injection increased functional level, but DX seemed to be more effective [mean difference (95 % CI) in total function score = 1.0 (0.2, 1.8), p = 0.01].
Discussion For the long term, DX seems to be more advantageous, while the two treatments were comparable in the short term. Because of the satisfactory pain relief and restoring of function, we would prefer DX prolotherapy for the treatment of patients with OA.
Level of evidence Therapeutic studies--investigating the results of treatment; level I.
SUPPLEMENTARY NOTES: Jahangiri et al compared dextrose prolotherapy to steroid injection in a 2 arm blinded trial. Participants in both groups with chronic thumb pain and osteoarthritis of the trapeziometacarpal joint received 1 ml intra and 1 ml extraarticular injection through the anatomic snuff box at 0, 1 and 2 months. The steroid group received anesthetic injection only at 0 and 1 months and steroid/anesthetic injection at 2 months. Effects were assessed at 6 months by a 0-10 Visual Analog Scale (VAS) for pain, a Health Assessment Questionnaire Disability Index (HAQ-DI), and lateral pinch strength. in pounds by a hydraulic pinch gauge. Participants had statistically similar baseline characteristics. At 6 months the dextrose prolotherapy group improved more in pain on movement (3.8±0.9 points [76%] vs 2.1±1.0 points[46%]; p=.02) and hand function (Health Assessment Questionnaire Disability Index (HAQ-DI) function score (3.0±2.2 points[65%] vs 1.77±1.0 points[41%]; p=.01) than the steroid group.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
ABSTRACT
Purpose: To compare the advantages of prolotherapy in the treatment of first carpometacarpal osteoarthritis (OA) with those of corticosteroid local injection in the short and long term.
Methods: We performed a randomized controlled trial from March 2010 to March 2011 in an outpatient clinic at a university hospital. Sixty participants (60 hands) with OA of the first carpometacarpal joint were assigned equally to two groups. For the corticosteroid group, after 2 monthly saline placebo injections, a single dose of 40 mg methyl- prednisolone acetate (0.5 ml) mixed with 0.5 ml of 2 % lidocaine was injected. For the dextrose (DX) group, 0.5 ml of 20 % DX was mixed with 0.5 ml of 2 % lidocaine and the injection was repeated monthly for 3 months. Pain intensity, hand function and the strength of lateral pinch grip were measured at the baseline and at 1, 2, and 6 months after the treatment.
Results Mean age (STD) was 63.6 (9.7) years, and mean (STD) visual analog scale (VAS) was 6 (2). The two groups were comparable at 2 months, but significantly different at 1 month, with better results for corticosteroid, and at 6 months with apparently more favorable outcome for DX [mean difference (95 % CI) in VAS = 1.1 (0.2, 2.0), p = 0.02]. After 6 months of treatment, both DX and corticosteroid injection increased functional level, but DX seemed to be more effective [mean difference (95 % CI) in total function score = 1.0 (0.2, 1.8), p = 0.01].
Discussion For the long term, DX seems to be more advantageous, while the two treatments were comparable in the short term. Because of the satisfactory pain relief and restoring of function, we would prefer DX prolotherapy for the treatment of patients with OA.
Level of evidence Therapeutic studies--investigating the results of treatment; level I.
SUPPLEMENTARY NOTES: Jahangiri et al compared dextrose prolotherapy to steroid injection in a 2 arm blinded trial. Participants in both groups with chronic thumb pain and osteoarthritis of the trapeziometacarpal joint received 1 ml intra and 1 ml extraarticular injection through the anatomic snuff box at 0, 1 and 2 months. The steroid group received anesthetic injection only at 0 and 1 months and steroid/anesthetic injection at 2 months. Effects were assessed at 6 months by a 0-10 Visual Analog Scale (VAS) for pain, a Health Assessment Questionnaire Disability Index (HAQ-DI), and lateral pinch strength. in pounds by a hydraulic pinch gauge. Participants had statistically similar baseline characteristics. At 6 months the dextrose prolotherapy group improved more in pain on movement (3.8±0.9 points [76%] vs 2.1±1.0 points[46%]; p=.02) and hand function (Health Assessment Questionnaire Disability Index (HAQ-DI) function score (3.0±2.2 points[65%] vs 1.77±1.0 points[41%]; p=.01) than the steroid group.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
Sequence Generation |
Allocation Concealment |
Blinding of Participants & Researchers |
Blinding of Outcome Assessment |
Incomplete Outcome Data Addressed |
Selective Data Reporting |
Low |
Low |
Unclear |
Unclear |
Low |
|
Computer generated randomization |
Sequentially numbered sealed envelopes used for assignment |
Information was not reported |
Clinician masked to group but who assessed outcome is not stated. |
5/60 lost to follow-up (<10%) |
Clinical Trial Registration available) |
SUMMARY Jahangiri et al thumb RCT
This is a small to medium sized study, powered enough for significant results. Given an overall low to median bias rating, this qualifies as level 1b evidence of efficacy of TMC thumb injection with 12.5% dextrose versus steroid injection of the TMC with anesthetic. joint medially and laterally.
This is a small to medium sized study, powered enough for significant results. Given an overall low to median bias rating, this qualifies as level 1b evidence of efficacy of TMC thumb injection with 12.5% dextrose versus steroid injection of the TMC with anesthetic. joint medially and laterally.
A literature search in October 2020 did not reveal additional RCTs related to hand osteoarthritis. A metaanalysis from 2016 is listed below. Note there are in general far too many metanalyses to review, so they are not generally going to be included in the literature review updates. In general they reinforce level B evidence
Metaanalysis: Hung CY, Hsiao MY, Chang KV, Han DS, Wang TG.Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. J Pain Res. 2016;9:847-857.
BACKGROUND: Increasing evidence has supported the use of dextrose prolotherapy for patients with osteoarthritis. However, the real benefits may be affected by differences in injection protocols, comparative regimens, and evaluation scales.
METHODS: PubMed and Scopus were searched from the earliest record until February 2016. One single-arm study and five randomized controlled trials were included, comprising 326 participants. We estimated the effect sizes of pain reduction before and after serial dextroseinjections and compared the values between dextrose prolotherapy, comparative regimens, and exercise 6 months after the initial injection.
RESULTS: Regarding the treatment arm using dextrose prolotherapy, the effect sizes compared with baseline were 0.65 (95% confidence interval [CI], 0.14-1.17), 0.84 (95% CI, 0.40-1.27), 0.85 (95% CI, 0.60-1.10), and 0.87 (95% CI, 0.53-1.21) after the first, second, third, and fourth or more injections, respectively. The overall effect of dextrose was better than control injections (effect size, 0.36; 95% CI, 0.10-0.63). Dextrose prolotherapy had a superior effect compared with local anesthesia (effect size, 0.38; 95% CI, 0.07-0.70) and exercise (effect size, 0.71; 95% CI, 0.30-1.11). There was an insignificant advantage of dextrose over corticosteroids (effect size, 0.31; 95% CI, -0.18 to 0.80) which was only estimated from one study.
CONCLUSION: Dextrose injections decreased pain in osteoarthritis patients but did not exhibit a positive dose-response relationship following serial injections. Dextrose prolotherapy was found to provide a better therapeutic effect than exercise, local anesthetics, and probably corticosteroids when patients were retested 6 months following the initial injection.
SUMMARY: Hung et al hand and knee OA metaanalysis
Hung et al, in a systematic review and meta-analysis including both hand osteoarthritis (HOA) and KOA studies concluded that “Dextrose injection reduced pain in patients with hand and knee osteoarthritis. Dextrose prolotherapy was more effective than local anesthetics injection and exercise. Subgroup analysis further showed that the effect of prolotherapy did not differ between hand and knee osteoarthritis.” This is level B evidence for prolotherapy efficacy.
BACKGROUND: Increasing evidence has supported the use of dextrose prolotherapy for patients with osteoarthritis. However, the real benefits may be affected by differences in injection protocols, comparative regimens, and evaluation scales.
METHODS: PubMed and Scopus were searched from the earliest record until February 2016. One single-arm study and five randomized controlled trials were included, comprising 326 participants. We estimated the effect sizes of pain reduction before and after serial dextroseinjections and compared the values between dextrose prolotherapy, comparative regimens, and exercise 6 months after the initial injection.
RESULTS: Regarding the treatment arm using dextrose prolotherapy, the effect sizes compared with baseline were 0.65 (95% confidence interval [CI], 0.14-1.17), 0.84 (95% CI, 0.40-1.27), 0.85 (95% CI, 0.60-1.10), and 0.87 (95% CI, 0.53-1.21) after the first, second, third, and fourth or more injections, respectively. The overall effect of dextrose was better than control injections (effect size, 0.36; 95% CI, 0.10-0.63). Dextrose prolotherapy had a superior effect compared with local anesthesia (effect size, 0.38; 95% CI, 0.07-0.70) and exercise (effect size, 0.71; 95% CI, 0.30-1.11). There was an insignificant advantage of dextrose over corticosteroids (effect size, 0.31; 95% CI, -0.18 to 0.80) which was only estimated from one study.
CONCLUSION: Dextrose injections decreased pain in osteoarthritis patients but did not exhibit a positive dose-response relationship following serial injections. Dextrose prolotherapy was found to provide a better therapeutic effect than exercise, local anesthetics, and probably corticosteroids when patients were retested 6 months following the initial injection.
SUMMARY: Hung et al hand and knee OA metaanalysis
Hung et al, in a systematic review and meta-analysis including both hand osteoarthritis (HOA) and KOA studies concluded that “Dextrose injection reduced pain in patients with hand and knee osteoarthritis. Dextrose prolotherapy was more effective than local anesthetics injection and exercise. Subgroup analysis further showed that the effect of prolotherapy did not differ between hand and knee osteoarthritis.” This is level B evidence for prolotherapy efficacy.