ROTATOR CUFF TENDINOPATHY
RCT # 1: Bertrand H, Reeves KD, Bennett CJ, et al. Dextrose Prolotherapy Versus Control Injections in Painful Rotator Cuff Tendinopathy. Arch Phys Med Rehabil 2016;97:17-25.
ABSTRACT
OBJECTIVE: To compare the effect of dextrose prolotherapy on pain levels and degenerative changes in painful rotator cuff tendinopathyagainst 2 potentially active control injection procedures.
DESIGN: Randomized controlled trial, blinded to participants and evaluators.
SETTING: Outpatient pain medicine practice.
PARTICIPANTS: Persons (N=73) with chronic shoulder pain, examination findings of rotator cuff tendinopathy, and ultrasound-confirmed supraspinatus tendinosis/tear.
INTERVENTIONS: Three monthly injections either (1) onto painful entheses with dextrose (Enthesis-Dextrose), (2) onto entheses with saline (Enthesis-Saline), or (3) above entheses with saline (Superficial-Saline). 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 (twice the minimal clinically important difference for visual analog scale pain) or not. Secondary: improvement in the Ultrasound Shoulder Pathology Rating Scale (USPRS) and a 0-to-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% of Enthesis-Dextrose participants maintained ≥2.8 improvement in pain compared with Enthesis-Saline (37%; P=.088) and Superficial-Saline (27%; P=.017). Enthesis-Dextrose participants' satisfaction was 6.7±3.2 compared with Enthesis-Saline (4.7±4.1; P=.079) and Superficial-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 painfulentheses resulted in superior long-term pain improvement and patient satisfaction compared with blinded saline injection over painfulentheses, with intermediate results for entheses injection with saline. These differences could not be attributed to a regenerative effect. Dextrose prolotherapy may improve on the standard care of painful rotator cuff tendinopathy for certain patients.
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
OBJECTIVE: To compare the effect of dextrose prolotherapy on pain levels and degenerative changes in painful rotator cuff tendinopathyagainst 2 potentially active control injection procedures.
DESIGN: Randomized controlled trial, blinded to participants and evaluators.
SETTING: Outpatient pain medicine practice.
PARTICIPANTS: Persons (N=73) with chronic shoulder pain, examination findings of rotator cuff tendinopathy, and ultrasound-confirmed supraspinatus tendinosis/tear.
INTERVENTIONS: Three monthly injections either (1) onto painful entheses with dextrose (Enthesis-Dextrose), (2) onto entheses with saline (Enthesis-Saline), or (3) above entheses with saline (Superficial-Saline). 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 (twice the minimal clinically important difference for visual analog scale pain) or not. Secondary: improvement in the Ultrasound Shoulder Pathology Rating Scale (USPRS) and a 0-to-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% of Enthesis-Dextrose participants maintained ≥2.8 improvement in pain compared with Enthesis-Saline (37%; P=.088) and Superficial-Saline (27%; P=.017). Enthesis-Dextrose participants' satisfaction was 6.7±3.2 compared with Enthesis-Saline (4.7±4.1; P=.079) and Superficial-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 painfulentheses resulted in superior long-term pain improvement and patient satisfaction compared with blinded saline injection over painfulentheses, with intermediate results for entheses injection with saline. These differences could not be attributed to a regenerative effect. Dextrose prolotherapy may improve on the standard care of painful rotator cuff tendinopathy for certain patients.
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 |
Low |
Low |
Low |
Unclear |
Randomization by blocks of 3 |
Allocation by off-site pharmacists |
The solutions were identical, participants and injectors were blinded |
Outcome assessor blinded |
Loss to follow up: 5/77 [6.5%}) Intention to treat utilized |
Measures agree with Clinical trial registration |
SUMMARY Bertrand et al rotator cuff tendinopathy RCT
Bertrand et al. conducted a 3-arm blinded RCT comparing DPT (group one) to lidocaine alone on entheses (group two) to lidocaine alone with superficial injections without touching the entheses (group three). Participants with chronic shoulder pain and confirmation of rotator cuff tendinopathy by clinical examination and ultrasound confirmation received injections at 0, 1 and 2 months, and all received physical therapy during the period of injection. The primary outcome measure was achieving an improvement in maximal current shoulder pain ≥ 2.8 points on a 0-10 VAS score, which is twice the MCID for shoulder pain improvement in rotator cuff tendinopathy. Data was collected at 0 and 9 months for pain improvement and for 0-10 participant satisfaction (10= completely satisfied.)
Participants had statistically similar baseline characteristics. A post-treatment questionnaire indicated that blinding of participants was effective. The percentage of participants reaching shoulder pain improvement ≥ 2.8 points on the 0-10 VAS at 9 months favored DPT over the superficial lidocaine injection control, (59% vs 27%; p=.017) (Figure 38) but not the lidocaine enthesis injection group. (59% vs 37%; p =.088) Patient satisfaction was greater in the DPT group than with superficial lidocaine injection, (6.7±3.2 vs 3.9±3.1; p=.003), but not compared to lidocaine enthesis injection (6.7±3.2 vs 4.7±4.1; p=.079).
Bertrand et al. conducted a 3-arm blinded RCT comparing DPT (group one) to lidocaine alone on entheses (group two) to lidocaine alone with superficial injections without touching the entheses (group three). Participants with chronic shoulder pain and confirmation of rotator cuff tendinopathy by clinical examination and ultrasound confirmation received injections at 0, 1 and 2 months, and all received physical therapy during the period of injection. The primary outcome measure was achieving an improvement in maximal current shoulder pain ≥ 2.8 points on a 0-10 VAS score, which is twice the MCID for shoulder pain improvement in rotator cuff tendinopathy. Data was collected at 0 and 9 months for pain improvement and for 0-10 participant satisfaction (10= completely satisfied.)
Participants had statistically similar baseline characteristics. A post-treatment questionnaire indicated that blinding of participants was effective. The percentage of participants reaching shoulder pain improvement ≥ 2.8 points on the 0-10 VAS at 9 months favored DPT over the superficial lidocaine injection control, (59% vs 27%; p=.017) (Figure 38) but not the lidocaine enthesis injection group. (59% vs 37%; p =.088) Patient satisfaction was greater in the DPT group than with superficial lidocaine injection, (6.7±3.2 vs 3.9±3.1; p=.003), but not compared to lidocaine enthesis injection (6.7±3.2 vs 4.7±4.1; p=.079).
RCT # 2: Seven MM, Ersen O, Akpancar S, et al. Effectiveness of prolotherapy in the treatment of chronic rotator cuff lesions. Orthop Traumatol Surg Res. 2017;103(3):427-433.
ABSTRACT
BACKGROUND: Rotator cuff lesions are one of the major causes of shoulder pain and dysfunction. Numerous non-surgical treatment modalities have been described for chronic rotator cuff lesions, but the debate continues over the optimal procedure. The aim of this report is to present the results of prolotherapy in he treatment of chronic refractory rotator cuff lesions.
HYPOTHESIS: Dextrose prolotherapy will reduce pain and improve shoulder function and patient satisfaction.
MATERIAL AND METHODS: We recruited 120 patients with chronic rotator cuff lesions and symptoms that persisted for longer than 6 months. Patients were divided into two groups: one treated with exercise (control group; n=60) and the other treated with prolotherapy injection (prolotherapy group; n=60). In the latter, ultrasound-guided prolotherapy injections were applied under aseptic conditions. In the former, patients received a physiotherapy protocol three sessions weekly for 12 weeks. Both groups were instructed to carry out a home exercise program. Clinical assessment of shoulder function was performed using a visual analog scale (VAS) for pain, Shoulder Pain and Disability Index (SPADI), Western Ontario Rotatory Cuff (WORC) Index, patient satisfaction, and shoulder range of motion. Patients were examined at baseline, weeks 3, 6, and 12, and last follow-up (minimum of one year).
RESULTS: A total of 101 patients (44 controls and 57 in the prolotherapy group) completed all study protocols and were included in the study. Using a within-group comparison, both groups achieved significant improvements over baseline, as measured by the VAS, SPADI, WORC index, and shoulder range of motion (P<0.001). Using a between-group comparison, a significant difference was found in the VAS scores at baseline, weeks 3, 6, and 12, and last follow-up. In addition, significant differences were found in the SPADIs and WORC indices at weeks 6 and 12 and the last follow-up. Significant differences were found in shoulder abduction and flexion at week 12 and last follow-up, and in internal rotation at last follow-up. However, no significant was found in external rotation at any follow-up period. In the prolotherapy group, 53 patients (92.9%) reported excellent or good outcomes; in the control group, 25 patients (56.8%) reported excellent or good outcomes.
CONCLUSION: Prolotherapy is an easily applicable and satisfying auxiliary method in the treatment of chronic rotatory cuff lesions.
RISK OF BIAS TABLE USING COCHRANE CRITERIA
ABSTRACT
BACKGROUND: Rotator cuff lesions are one of the major causes of shoulder pain and dysfunction. Numerous non-surgical treatment modalities have been described for chronic rotator cuff lesions, but the debate continues over the optimal procedure. The aim of this report is to present the results of prolotherapy in he treatment of chronic refractory rotator cuff lesions.
HYPOTHESIS: Dextrose prolotherapy will reduce pain and improve shoulder function and patient satisfaction.
MATERIAL AND METHODS: We recruited 120 patients with chronic rotator cuff lesions and symptoms that persisted for longer than 6 months. Patients were divided into two groups: one treated with exercise (control group; n=60) and the other treated with prolotherapy injection (prolotherapy group; n=60). In the latter, ultrasound-guided prolotherapy injections were applied under aseptic conditions. In the former, patients received a physiotherapy protocol three sessions weekly for 12 weeks. Both groups were instructed to carry out a home exercise program. Clinical assessment of shoulder function was performed using a visual analog scale (VAS) for pain, Shoulder Pain and Disability Index (SPADI), Western Ontario Rotatory Cuff (WORC) Index, patient satisfaction, and shoulder range of motion. Patients were examined at baseline, weeks 3, 6, and 12, and last follow-up (minimum of one year).
RESULTS: A total of 101 patients (44 controls and 57 in the prolotherapy group) completed all study protocols and were included in the study. Using a within-group comparison, both groups achieved significant improvements over baseline, as measured by the VAS, SPADI, WORC index, and shoulder range of motion (P<0.001). Using a between-group comparison, a significant difference was found in the VAS scores at baseline, weeks 3, 6, and 12, and last follow-up. In addition, significant differences were found in the SPADIs and WORC indices at weeks 6 and 12 and the last follow-up. Significant differences were found in shoulder abduction and flexion at week 12 and last follow-up, and in internal rotation at last follow-up. However, no significant was found in external rotation at any follow-up period. In the prolotherapy group, 53 patients (92.9%) reported excellent or good outcomes; in the control group, 25 patients (56.8%) reported excellent or good outcomes.
CONCLUSION: Prolotherapy is an easily applicable and satisfying auxiliary method in the treatment of chronic rotatory cuff lesions.
RISK OF BIAS TABLE USING COCHRANE CRITERIA
Sequence Generation |
Allocation Concealment |
Blinding of Participants & Researchers |
Blinding of Outcome Assessment |
Incomplete Outcome Data Addressed |
Selective Data Reporting |
Low |
Unclear |
High |
Low |
Intermediate |
Intermediate |
Computer generated random list |
No indication of allocation concealment |
Open label study |
Evaluator masked as to treatment group |
3/60 lost in prolotherapy group and 16/60 (27%) in control group. |
Pre publication of protocol not located |
SUMMARY Seven et al. rotator cuff tendinopathy RCT
This study with moderate bias had substantial bias with dropout in the control physiotherapy group. However, that would favor control group outcomes over prolotherapy. Both groups improved remarkably. VAS pain improvements and SPADI improvement were 89% (7.9 to 0.9) and 90% (74.8 to 7.7) in the dextrose prolotherapy group and 49% (7.4 to 3.8) and 49% (68.6 to 35.0) in the phyiotherapy control. These results are better than other published studies with similar protocol and significatly so, raising the question about another source of bias (such as areporting bias). Nevertheless the DPT group significantly outperformed control physiotherapy.
This study with moderate bias had substantial bias with dropout in the control physiotherapy group. However, that would favor control group outcomes over prolotherapy. Both groups improved remarkably. VAS pain improvements and SPADI improvement were 89% (7.9 to 0.9) and 90% (74.8 to 7.7) in the dextrose prolotherapy group and 49% (7.4 to 3.8) and 49% (68.6 to 35.0) in the phyiotherapy control. These results are better than other published studies with similar protocol and significatly so, raising the question about another source of bias (such as areporting bias). Nevertheless the DPT group significantly outperformed control physiotherapy.
In a literature review conducted in December of 2018, no additional RCTs for DPT related to rotator cuff tendinopathy were found.
Pertinent metaanalyses: Two general reviews of prolotherapy have been published, Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016;9:139-159. Reeves KD, Sit RWS, Rabago D. A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am. 2016;27(4):783-823
These reviews both reinforce the SOR B findings for use of prolotherapy in painful rotator cuff tendinopathy
These reviews both reinforce the SOR B findings for use of prolotherapy in painful rotator cuff tendinopathy