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Prolotherapy for Pain Relief

June 12, 2013 Written by JP       [Font too small?]

In the Los Angeles area, there’s a popular weekend radio problem hosted by a physician who specializes in a form of treatment known as prolotherapy. After hearing the show for the first time, a client inquired about the science behind this unconventional technique which involves the injection of a “sugar-water” solution into joint, ligament and tendinous spaces. How is it possible that injecting a mixture consisting primarily of dextrose and water can help improve inflammatory conditions such as low back pain, osteoarthritis and tendinopathy, while at the same time promoting a healing reaction? Admittedly, this sounds counterintuitive. Injections, in and of themselves, evoke pain. Dextrose, a high glycemic variety of sugar, is typically associated with ill effects. In prolotherapy, this combination is turned on its head. Research reveals that immediately following each injection, localized inflammation does, in fact, occur. However, as time goes on, this initial inflammation shifts to pain modulation and encourages the proliferation of new tissue via the induction of tissue growth factors

Prolotherapy isn’t exactly a perfect candidate for an “alternative” or “complementary” treatment. In addition to dextrose and water, prolotherapy injections often contain a small amount of lidocaine, a local anesthetic of synthetic origin. What’s more, with the exception of B vitamin shots, injections are rarely employed at all in holistic circles. From an allopathic or conventional medical perspective, prolotherapy hasn’t been taken very seriously due to a paucity of controlled, scientific studies to verify its efficacy and safety. However, over the past several years, some integrative practitioners have begun to consider and recommend prolotherapy thanks to a new batch of promising, well designed clinical trials.

The latest and most high profile examination of prolotherapy appears in the May-June issue of the Annals of Family Medicine. In the randomized study, participants with knee osteoarthritis were administered dextrose prolotherapy, placebo (saline) injections or at-home exercises. Over a 17 week period, up to 5 prolotherapy sessions were given to the experimental and saline groups. All of the study volunteers were followed over a 52 week period. Those receiving the dextrose prolotherapy improved to a greater extent than the exercise and saline comparison groups. The benefits were assessed by using a symptom ranking scale (WOMAC index) and measures of individual pain perception (KPS or knee pain scale). According to the authors of the paper, patient satisfaction was “high” and no adverse reactions were reported. The concluding remarks state, “Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises”. Previous investigations support the utility of prolotherapy for knee osteroarthritis and go on to describe several other conditions which are also responsive including Achilles tendinosis, lateral epicondylosis or “tennis elbow”, sacroiliac joint pain and TMJ (temporomandibular joint dislocation).

Note: Please check out the “Comments & Updates” section of this blog – at the bottom of the page. You can find the latest research about this topic there!

To learn more about the studies referenced in today’s column, please click on the following links:

Study 1 - American Family Physician: Prolotherapy for Chronic Musculoskeletal (link)

Study 2 - Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized (link)

Study 3 - Hypertonic Dextrose Injections (Prolotherapy) for Knee Osteoarthritis(link)

Study 4 – Prolotherapy Injections and Eccentric Loading Exercises for Painful (link)

Study 5 - Hypertonic Dextrose and Morrhuate Sodium Injections (Prolotherapy) (link)

Study 6 - Prolotherapy Versus Corticosteroid Injections for the Treatment of (link)

Study 7 - The Efficacy of Prolotherapy for Lateral Epicondylosis: A Pilot Study (link)

Study 8 – A Randomized Controlled Trial of Intra-Articular Prolotherapy Vs Steroid (link)

Study 9 - Short-term Results of Prolotherapy in the Management of TMJ (link)

Study 10 - The Efficacy of Dextrose Prolotherapy for Temporomandibular Joint (link)

Prolotherapy Improves Arthritic Symptoms (WOMAC Score)

Source: Ann Fam Med. 2013 May-Jun;11(3):229-37 (link)

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10 Comments & Updates to “Prolotherapy for Pain Relief”

  1. JP Says:

    Update:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4357593/

    Ther Adv Musculoskelet Dis. 2015 Apr; 7(2): 35–44.

    Therapeutic effects of prolotherapy with intra-articular dextrose injection in patients with moderate knee osteoarthritis: a single-arm study with 6 months follow up

    Objectives: Prolotherapy is an injection-based complementary treatment, which has shown promising results in the treatment of different musculoskeletal disorders. The aim of this study was to determine the therapeutic efficacy of dextrose prolotherapy on pain, range of motion, and function in patients with knee osteoarthritis (OA).

    Methods: In this single-arm prospective study, participants with symptomatic moderate knee osteoarthritis underwent prolotherapy with intra-articular injection of 20% dextrose water at baseline, and at 4 weeks and 8 weeks later. Patients were followed for 24 weeks. Pain severity at rest and activity, according to the visual analog scale (VAS), articular range of motion (ROM), and Western Ontario and McMaster Universities arthritis index (WOMAC) scores were measured at baseline, 4, 8, and 24 weeks later.

    Results: A total of 24 female patients (average age: 58.37 ± 11.8 years old) received 3-monthly injection therapies. Before the treatment, the mean articular range of motion was 105.41 ± 11.22°. Mean VAS scale at rest and activity was 8.83 ± 1.37 and 9.37 ± 1.31, respectively. At the end of week 24, knee ROM increased by 8°. Pain severity in rest and activity decreased to 4.87 ± 1.39, 45.86%, and 44.23%, respectively (p < 0.001). Total WOMAC score and its subcategories showed a continuous improvement trend in all the evaluation sessions, so that at the end of the study, the total score decreased by 30.5 ± 14.27 points (49.58%) (p < 0.001). Improvements of all parameters were considerable until week 8, and were maintained throughout the study period.

    Conclusions: Prolotherapy with three intra-articular injections of hypertonic dextrose given 4 weeks apart for selected patients with knee OA, resulted in significant improvement of validated pain, ROM, and WOMAC-based function scores, when baseline levels were compared at 24 weeks. Further studies with randomized controlled trials involving a comparison group are suggested to confirm these findings.

    Be well!

    JP

  2. JP Says:

    Update 05/06/15:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235087/

    J Res Med Sci. 2014 Aug;19(8):696-702.

    Investigation the efficacy of intra-articular prolotherapy with erythropoietin and dextrose and intra-articular pulsed radiofrequency on pain level reduction and range of motion improvement in primary osteoarthritis of knee.

    BACKGROUND: Osteoarthritis is one of the most common diseases and the knee is the most commonly affected joint. Intra-articular prolotherapy is being utilized in acute and chronic pain management setting. This study was designed to compare the efficacy of three methods of intra-articular knee joint therapies with erythropoietin, dextrose, and pulsed radiofrequency.

    MATERIALS AND METHODS: After approval by the Ethics Committee and explaining the therapeutic method to volunteers, 70 patients who were suffering from primary knee osteoarthrosis went through one of the treatment methods (erythropoietin, dextrose, and pulsed radiofrequency). The study was double-blind randomized clinical trial performed from December 2012 to July 2013. Patients’ pain level was assessed through the visual analog pain scale (VAS), and range of motion (ROM) was measured by goniometric method. Furthermore, patients’ satisfaction was assessed before and after different treatment methods in weeks 2, 4, and 12. For analysis, Chi-square, one-way ANOVA, and repeated measured ANOVA were utilized.

    RESULTS: The demographic results among the three groups did not indicate any statistical difference. The mean VAS in erythropoietin group in the 2(nd), 4(th), and 12(th) weeks was 3.15 ± 1.08, 3.15 ± 1.08, and 3.5 ± 1.23, respectively (P ≤ 0.005). Knee joint ROM in the erythropoietin group in the 2(nd), 4(th), and 12(th) weeks was 124 ± 1.50, 124 ± 1.4, and 123 ± 1.53 respectively (P ≤ 0.005). Satisfaction score in the 12(th) week in erythropoietin group was extremely satisfied 15%, satisfied 55%, and moderately satisfied 30%, (P = 0.005). No specific side-effects were observed.

    CONCLUSION: Intra-articular prolotherapy with erythropoietin was more effective in terms of pain level reduction and ROM improvement compared with dextrose and pulsed radiofrequency.

    Be well!

    JP

  3. JP Says:

    Update 05/06/15:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4011421/

    J Altern Complement Med. 2014 May;20(5):383-91.

    Dextrose and morrhuate sodium injections (prolotherapy) for knee osteoarthritis: a prospective open-label trial.

    OBJECTIVES: This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status.

    DESIGN: This was a prospective three-arm uncontrolled study with 1-year follow-up.

    SETTING: The setting was outpatient.

    PARTICIPANTS: The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined).

    INTERVENTION: The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach.

    OUTCOME MEASURES: The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction.

    RESULTS: The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events.

    CONCLUSIONS: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.

    Be well!

    JP

  4. JP Says:

    Update 05/22/15:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4357593/

    Ther Adv Musculoskelet Dis. 2015 Apr;7(2):35-44.

    Therapeutic effects of prolotherapy with intra-articular dextrose injection in patients with moderate knee osteoarthritis: a single-arm study with 6 months follow up.

    OBJECTIVES: Prolotherapy is an injection-based complementary treatment, which has shown promising results in the treatment of different musculoskeletal disorders. The aim of this study was to determine the therapeutic efficacy of dextrose prolotherapy on pain, range of motion, and function in patients with knee osteoarthritis (OA).

    METHODS: In this single-arm prospective study, participants with symptomatic moderate knee osteoarthritis underwent prolotherapy with intra-articular injection of 20% dextrose water at baseline, and at 4 weeks and 8 weeks later. Patients were followed for 24 weeks. Pain severity at rest and activity, according to the visual analog scale (VAS), articular range of motion (ROM), and Western Ontario and McMaster Universities arthritis index (WOMAC) scores were measured at baseline, 4, 8, and 24 weeks later.

    RESULTS: A total of 24 female patients (average age: 58.37 ± 11.8 years old) received 3-monthly injection therapies. Before the treatment, the mean articular range of motion was 105.41 ± 11.22°. Mean VAS scale at rest and activity was 8.83 ± 1.37 and 9.37 ± 1.31, respectively. At the end of week 24, knee ROM increased by 8°. Pain severity in rest and activity decreased to 4.87 ± 1.39, 45.86%, and 44.23%, respectively (p < 0.001). Total WOMAC score and its subcategories showed a continuous improvement trend in all the evaluation sessions, so that at the end of the study, the total score decreased by 30.5 ± 14.27 points (49.58%) (p < 0.001). Improvements of all parameters were considerable until week 8, and were maintained throughout the study period.

    CONCLUSIONS: Prolotherapy with three intra-articular injections of hypertonic dextrose given 4 weeks apart for selected patients with knee OA, resulted in significant improvement of validated pain, ROM, and WOMAC-based function scores, when baseline levels were compared at 24 weeks. Further studies with randomized controlled trials involving a comparison group are suggested to confirm these findings.

    Be well!

    JP

  5. JP Says:

    Updated 07/20/15:

    http://www.complementarytherapiesinmedicine.com/article/S0965-2299%2815%2900061-8/abstract

    Complement Ther Med. 2015 Jun;23(3):388-95.

    Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes.

    OBJECTIVE: Knee osteoarthritis (OA) is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. Recent 52-week randomized controlled and open label studies have reported improvement of knee OA-specific outcomes compared to baseline status, and blinded saline control injections and at-home exercise therapy (p<0.05). However, long term effects of prolotherapy for knee OA are unknown. We therefore assessed long-term effects of prolotherapy on knee pain, function and stiffness among adults with knee OA.

    DESIGN: Post clinical-trial, open-label follow-up study.

    SETTING: Outpatient; adults with mild-to-severe knee OA completing a 52-week prolotherapy study were enrolled.

    INTERVENTION AND OUTCOME MEASURES: Participants received 3-5 monthly interventions and were assessed using the validated Western Ontario McMaster University Osteoarthritis Index, (WOMAC, 0-100 points), at baseline, 12, 26, 52 weeks, and 2.5 years.

    RESULTS: 65 participants (58±7.4 years old, 38 female) received 4.6±0.69 injection sessions in the initial 17-week treatment period. They reported progressive improvement in WOMAC scores at all time points in excess of minimal clinical important improvement benchmarks during the initial 52-week study period, from 13.8±17.4 points (23.6%) at 12 weeks, to 20.9±2.8 points, (p<0.05; 35.8% improvement) at 2.5±0.6 years (range 1.6-3.5 years) in the current follow-up analysis. Among assessed covariates, none were predictive of improvement in the WOMAC score.

    CONCLUSIONS: Prolotherapy resulted in safe, significant, progressive improvement of knee pain, function and stiffness scores among most participants through a mean follow-up of 2.5 years and may be an appropriate therapy for patients with knee OA refractory to other conservative care.

    Be well!

    JP

  6. JP Says:

    Updated 08/25/15:

    http://www.ncbi.nlm.nih.gov/pubmed/26301385

    Arch Phys Med Rehabil. 2015 Aug 21.

    Dextrose Prolotherapy versus Control Injections in Painful Rotator Cuff Tendinopathy.

    OBJECTIVE: To compare the effect of dextrose prolotherapy on pain levels and degenerative changes in painful rotator cuff tendinopathy against two potentially active control injection procedures.

    DESIGN: Randomized controlled trial, blinded to participants and evaluators.

    SETTING: Outpatient pain medicine practice.

    PARTICIPANTS: Chronic shoulder pain, examination findings of rotator cuff tendinopathy, and ultrasound-confirmed supraspinatus tendinosis/tear.

    INTERVENTIONS: Three monthly injections either onto painful entheses with dextrose (Enth-Dex), onto entheses with saline (Enth-Sal), or above entheses with saline. (Superfic-Sal). All solutions included 0.1% lidocaine. All participants received concurrent programmed physical therapy.

    MAIN OUTCOME MEASURES: Primary: Participants achieving an improvement in maximal current shoulder pain ≥ 2.8 or not. (Twice the minimal clinically important difference for (Visual Analog Scale) VAS pain. Secondary: Improvement in the Ultrasound Pathology Rating Scale (USPRS) and a 0-10 satisfaction score (10 = completely satisfied).

    RESULTS: The 73 participants had moderate to severe shoulder pain (7.0±2.0) for 7.6±9.6 years. There were no baseline differences between groups. Blinding was effective. At 9 month follow-up 59 percent of Enth-Dex participants maintained ≥ 2.8 improvement in pain compared to Enth-Saline (37%;p=.088) and Superfic-Saline (27%;p=.017). Enth-Dex participants’ satisfaction was 6.7±3.2 compared to Enth-Saline (4.7±4.1;p=.079) and Superfic-Saline (3.9±3.1;p=.003). USPRS findings were not different between groups (p = .734).

    CONCLUSIONS: In participants with painful rotator cuff tendinopathy who receive physical therapy, injection of hypertonic dextrose on painful entheses resulted in superior long term pain improvement and patient satisfaction compared with blinded saline injection over painful entheses, with intermediate results for entheses injection with saline. These differences could not be attributed to a regenerative effect. Dextrose prolotherapy may improve upon standard care of painful rotator cuff tendinopathy for certain patients.

    Be well!

    JP

  7. JP Says:

    Updated 10/20/15:

    http://www.ncbi.nlm.nih.gov/pubmed/26478881

    Med J Islam Repub Iran. 2015 Jun 27;29:223.

    Treatment of knee osteoarthritis with platelet-rich plasma in comparison with transcutaneous electrical nerve stimulation plus exercise: a randomized clinical trial.

    Angoorani H1, Mazaherinezhad A2, Marjomaki O3, Younespour S4.

    BACKGROUND: Osteoarthritis is a disabling musculoskeletal disease with no definite treatment. This study compared the effect of Platelet-rich plasma (PRP) and Transcutaneous Electrical Nerve Stimulation (TENS) plus exercise in the treatment of patients with knee joint osteoarthritis.

    METHODS: 54 eligible patients with knee osteoarthritis were randomly allocated into two groups. (IRCT2012110611382N) Group A (27 patients) received 2 injections of PRP (4 weeks apart) and group B (27 patients) received 10 sessions of TENS as well as exercise during the study period. Clinical outcome was evaluated using the Knee injury and Osteoarthritis Outcome Scores (KOOS) questionnaire before the treatment, 4 weeks, and 8 weeks after that the treatment. Pain was also assessed using a visual analog scale (VAS). Time to an intolerable knee pain during treadmill workout was also evaluated using an objective test.

    RESULTS: In the PRP group, the mean KOOS symptom score improved significantly from baseline to the end of study, while the change was not significant over this period for the group B. In both groups, significant reductions were observed in VAS scores from baseline till the end of study. The mean time to feel intolerable knee pain during treadmill work out of PRP group increased significantly from baseline to week 4, but no significant changes were found in this parameter over the time of study in the group B.

    CONCLUSION: Intraarticular injection of PRP is an effective, safe method for short-term treatment of patients with knee joint osteoarthritis.

    Be well!

    JP

  8. JP Says:

    Updated 04/09/16:

    http://www.ncbi.nlm.nih.gov/pubmed/27058744

    PM R. 2016 Apr 4. pii: S1934-1482(16)30054-5.

    The Chondrogenic Effect of Intra-articular Hypertonic-dextrose (prolotherapy) in Severe Knee Osteoarthritis.

    BACKGROUND: Dextrose injection is reported to improve KOA-related clinical outcomes, but its effect on articular cartilage is unknown. A chondrogenic effect of dextrose injection has been proposed.

    OBJECTIVE: To assess biological and clinical effects of intra-articular hypertonic dextrose injections (prolotherapy) in painful knee osteoarthritis (KOA).

    DESIGN: Case series with blinded arthroscopic evaluation before and after treatment.

    SETTING: Physical medicine and day surgery practice.

    PARTICIPANTS: Symptomatic KOA for at least 6 months, arthroscopy-confirmed medial compartment exposed subchondral bone, and temporary pain relief with intra-articular lidocaine injection.

    INTERVENTION: Four to six monthly 10 mL intra-articular injections with 12.5% dextrose.

    MAIN OUTCOME MEASURES: Visual cartilage growth assessment of 9 standardized medial condyle zones in each of 6 participants by three arthroscopy readers masked to pre/post injection status (total 54 zones evaluated per reader); biopsy of a cartilage growth-area post-treatment, evaluated using H&E and Safranin-O stains, quantitative polarized light microscopy, and immunohistologic cartilage typing; self-reported knee specific quality of life using the Western Ontario McMaster University Osteoarthritis Index (WOMAC, 0-100 points).

    RESULTS: Six participants (1 female) with median age of 71, WOMAC composite score of 57.5 points and a 9-year pain duration received a median 6 dextrose injections and follow-up arthroscopy at 7.75 (4.5-9.5) months. In 19 of 54 zone comparisons all three readers agreed that the post-treatment zone showed cartilage growth compared with the pre-treatment zone. Biopsy specimens showed metabolically active cartilage with variable cellular organization, fiber parallelism, and cartilage typing patterns consistent with fibro- and hyaline-like cartilage. Compared with baseline status, the median WOMAC score improved 13 points (p=.013). Self-limited soreness after methylene-blue instillation was noted.

    CONCLUSIONS: Positive clinical and chondrogenic effects were seen after prolotherapy with hypertonic dextrose injection in symptomatic grade IV KOA participants suggesting disease-modifying effects and the need for confirmation in controlled studies. Minimally invasive arthroscopy (single-compartment, single-portal) enabled collection of robust intra-articular data.

    Be well!

    JP

  9. joyce martino Says:

    Back about 10 yrs ago I was getting work to rehab two shoulder injuries and came upon a Sports Medicine MD and had never heard of Prolo work. It was all new to me, but I was willing to try and I think he charged me $150 for the session. The sessions was 8 jabs in my shoulder of dextrose prolo and I did get 3 yrs of pain free relief. It was truly a miracle. I’ve since then had other sessions for lower back and knee and had so so results, of course OA is advancing in my body. I’m 80 soon so I was about 70 whenn I got the first round of Prolo.

    I believe in it and only wish I had $$$$ to do more.

  10. JP Says:

    Updated 04/21/18:

    Thank you for sharing your experience, Joyce!

    Currently, are you doing anything to address the OA? Feel free to email me at jp@healthyfellow.com if you’d like to discuss. There are more (natural) options than ever before.

    Be well!

    JP

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