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Comparison between platelet rich plasma injection, corticosteroid injection and short-wave diathermy in the management of pain and the improvement of functional outcome in the patients suffering from adhesive capsulitis of the shoulder: a randomized controlled trial

Adhesive capsulitis of shoulder is characterized by insidious onset of pain and progressive loss of both active and passive range of motion of the shoulder joint. The incidence in general population is 3-5% and about 20% in patients with diabetes. It usually develops between 40-70 years of age. The underlying pathology is soft tissue fibrosis and inflammation of rotator interval, capsules and ligament. Various treatment options like intra-articular injection of corticosteroid, hyaluronic acid, deep heat modalities, manipulation under anesthesia, hydro dilation, arthroscopic release has been tried but none of them proved to superior in managing the condition successfully. Platelet rich plasma (PRP) is a sample of autologous blood with concentration of platelets above baseline, has emerged as a new treatment modality and it stimulates the revascularization of soft tissues and increases concentration of growth factors to improve and accelerate tendon healing. Based on this background of ABSTRACT


INTRODUCTION
Adhesive capsulitis of shoulder is characterized by insidious onset of pain and progressive loss of both active and passive range of motion of the shoulder joint. The incidence in general population is 3-5% and about 20% in patients with diabetes. It usually develops between 40-70 years of age. The underlying pathology is soft tissue fibrosis and inflammation of rotator interval, capsules and ligament. Various treatment options like intra-articular injection of corticosteroid, hyaluronic acid, deep heat modalities, manipulation under anesthesia, hydro dilation, arthroscopic release has been tried but none of them proved to superior in managing the condition successfully. 1,2 Platelet rich plasma (PRP) is a sample of autologous blood with concentration of platelets above baseline, has emerged as a new treatment modality and it stimulates the revascularization of soft tissues and increases concentration of growth factors to improve and accelerate tendon healing. 3 Based on this background of lack of enough evidence regarding the treatment modalities there is need to check the efficacy of PRP and compare it with corticosteroid and short-wave diathermy as a safe treatment modality.

METHODS
A randomized controlled trial was done in the Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences (RIMS), Imphal from February 2019 to January 2020. One ninety-five patients diagnosed with adhesive capsulitis of shoulder were recruited for the study from the Outpatient department (OPD) patients. Informed consent was taken from all participants before starting the study.
The inclusion criteria were age over 18 years, shoulder pain for at least 1 month with restriction of >1/3rd of the shoulder range of motion, normal anterior-posterior radiograph of shoulder joint and willingness to participate in the study. The exclusion criteria were unwillingness to participate in the study, intrinsic glenohumeral pathology, history of shoulder trauma/surgery, history of injection in the involved shoulder in last six months or non-steroidal anti-inflammatory drug intake in last seven days, patients with hematological disorder or on anti-platelet or anticoagulation therapy and pregnancy or breastfeeding.
A total of 195 patients were randomized into three groups (A, B, C) using computer generated random number table. Subjects in group A and B received one intra-articular injection of 2 ml PRP and 2 ml of 80 mg methylprednisolone acetate respectively via anterior approach under strict aseptic condition. After injections patients were advised to limit shoulder movement for at least 24 hours and to use cold compress and paracetamol for pain. Patients with group C received 15 minutes of short-wave diathermy (27.12 MHz, continuous mode) daily for 10 days. All participants (group A, B, C) were taught a 10 minutes exercise therapy comprising of pendulum exercises, stretching exercises and were instructed to perform the exercises twice daily at home. After baseline evaluation and intervention all subjects were followed up at 3, 6 and 12 weeks. Primary outcome measure used was improvement in the active range of motion (assessed using clinical goniometer) and secondary outcome measures were Visual analogue scale (VAS) for pain and a shortened version of disabilities of the arm, shoulder and hand (Quick DASH) for function.

Statistical analysis
Data were entered and analyzed by using Statistical package for the social sciences (SPSS) version 21. Chisquare test was used for the comparison of binomial variance. All continuous data were assessed and expressed as mean and standard deviation of mean. Within each group change in the mean values of continuous variable was compared using analysis of variance (ANOVA) test. P-value <0.05 was taken as significant. 3 patients in group A, 5 patients in group B and 7 patients in group C were lost to follow-up. So, analysis was done on 180 patients.

RESULTS
For Gender and side involved chi-square test and for other parameters one-way ANOVA with Bonferroni correction.  Table 2: Active range of motion of shoulder in degrees [mean (SD)] in the three study groups at baseline, 3 weeks, 6 weeks and 12 weeks. One-way ANOVA with Bonferroni correction between groups and repeated ANOVA within the group. Table 3 shows improvement in passive range of motion similar to active motion with significant improvement seen at 12 weeks. One-way ANOVA with Bonferroni correction between groups and repeated ANOVA within the group. Table 4 shows that VAS and Quick DASH scores showed significant improvement at each follow up interval in all the groups when compared to baseline and significant difference between three groups at 12 weeks follow up.

DISCUSSION
The uniqueness of this this study was that the group receiving PRP which was prepared by a simple technique. Total number of platelets in PRP preparation was 6.6±1.6 times higher than whole blood values. Our study demonstrates that PRP can be prepared by a simple technique and is better than steroid and short-wave diathermy in relieving pain, improving range of motion, pain and function. Evidence for the use of PRP in clinical conditions is growing and this study adds to the pool of this growing literature. 4 Systematic review by Griesser et al showed significant but transient improvement in abduction and forward elevation and significant short as well as long term dimunition of pain measured by VAS and Shoulder pain and disability index (SPADI). 5

CONCLUSION
Single injection of PRP is significantly more effective in reducing pain and improving functional outcome at 12 weeks compared to single dose of corticosteroid injection and short-wave diathermy.