NHR Oct-Dec 2018: Original Research: Utility of homoeopathic medicines in treatment of frozen shoulder: An open, observational clinical trial

Utility of homoeopathic medicines in treatment of frozen shoulder: An open, observational clinical trial


Nitin Magotra*1, Nitika Sharma2, James Michael1, Nivedita Kundu1, Arunava Nath1, Subhranil Saha3

  1. Postgraduate Trainee, Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Govt. of India
  2. Medical Officer, ESIC Hospital, Jammu
  3. Independent Researcher, Shibpur, Howrah, West Bengal, India

*Correspondence: nitin_magotra21@yahoo.com


Abstract

Background: Frozen shoulder is a commonly encountered condition in clinical practice. Homoeopathy remains one of the most sought after therapies on account of pain and disability of the shoulder joints, and troublesome side-effects and dissatisfaction with the mainstream therapies; however, remained under-researched systematically. We evaluated whether individualized homoeopathy (IH) could produce a significant treatment effect in the patients suffering from frozen shoulder.

Methods: This open, observational, non-randomized, non-controlled, clinical trial of pre-post comparison design was carried out on 40 patients suffering from frozen shoulder at National Institute of Homoeopathy. Oxford Shoulder Score (OSS) and Shoulder Pain and Disability Index (SPADI) were used as the primary and secondary outcome measures respectively, assessed at baseline and after 3 months of treatment. Medicines were prescribed on the basis of homoeopathic principles.

Results: Ten patients dropped out, 30 completed the trial. Protocol-compliant sample (n=30) was analyzed in the end. There were statistically significant reductions of both OSS score [42.5 ± 5.5 vs. 28.5 ± 6.8; mean reduction 14.0, 95% CI 11.4 to 16.6, P < 0.001] and SPADI score [103.7 ± 17.2 vs. 52.1 ± 22.7; mean reduction 51.6, 95% CI 43.1 to 60.1, P < 0.001] after 3 months of individualized homoeopathic treatment.

Conclusion: The study results were quite encouraging and individualized homoeopathic medicines seemed to be a promising treatment option for frozen shoulder. Randomized trials are warranted.

Keywords: Frozen shoulder; Homoeopathy; Oxford Shoulder Score; Shoulder Pain and Disability Index; Observational trial


Introduction

Of all the joints in the human body, the shoulder has the greatest range of motion. This allows complex movements and functions to be carried out, and is of vital importance to the activities of daily living and work. Any restriction or pain that involves the joint puts a huge amount of strain on patients, especially those who are in their most productive years of life. Frozen shoulder, a frequently encountered disorder of the shoulder, has been well recognized since the early 1900s. Although benign, it has great impact on the quality of life of patients. Frozen shoulder, a term coined by Codman in 1934, is an orthopedic condition that is commonly encountered in general practice. Codman used this term to describe a condition with symptoms of shoulder pain and discomfort that is slow in onset and located around the deltoid insertion [1]. Frozen shoulder also known as peri-arthritis or adhesive capsulitis is the painful condition of the shoulder joint where the gleno-humeral joint becomes painful and stiff because of the resilience of the joint capsule, possibly with adhesions between its folds. It produces pain and stiffness of the shoulder. In early stages, pain is worst at night, and stiffness limited to abduction and internal rotation of the shoulder. Later, the pain is present at all times and all movements of the shoulder are severely limited. Often, there is a history of preceding trauma. The disease is commoner in diabetics [2]. It mainly affects individuals 40-60 years of age, with a female predominance. The exact incidence and prevalence of frozen shoulder are unknown, but various authors have quoted figures of 2-5% in the general population [1]. Nevertheless, those with diabetes, prolonged shoulder immobility (trauma, overuse injuries or surgery) or systemic diseases (hyperthyroidism, hypothyroidism, cardiovascular disease or Parkinson’s disease) are at a higher risk. In addition, there is evidence that protease inhibitors used for antiretroviral therapy have been associated with the development of frozen shoulder [1].

Despite over a hundred years of treating frozen shoulder, the definition, diagnosis, pathology and most efficacious treatments are still unclear. Systemic reviews of current treatments for frozen shoulder examine the evidence base behind physiotherapy, both oral and intra-articular steroid, hydro-dilatation, manipulation under anesthesia and arthroscopic capsular release. Frozen shoulder is a self-limiting condition, lasting on average 2-3 years, and some studies show 20-50% of sufferers continue to have pain and restricted movement beyond 3 years [3]. Homoeopathic medicines are claimed to be effective in treating frozen shoulder; however, has remained mostly anecdotal and systematic research evidences remained sparse. Even after a careful and extensive search into different electronic and bibliographic databases, no relevant research papers could be identified. So this study was undertaken to explore the possible effects of individualized homoeopathic medicines in relieving pain, stiffness and other symptoms, and reduction in limitation, and disability in activities of daily life in the patients suffering from frozen shoulder.

METHODS

Trial design: This open label, prospective, observational, non-randomized, non-controlled clinical trial of pre-post comparison design was conducted at the Organon of Medicine out -patient department of National Institute of Homoeopathy, Kolkata, India. The study protocol was approved by the Institutional Ethical Committee (IEC) [Ref. No. 5-023/NIH/PG/Ethical Comm. 2009/Vol. III/ 1949 (A/S); dated March 27, 2017]. The trial protocol (unpublished) and full dissertation was submitted as postgraduate thesis of the corresponding author to the West Bengal University of Health Sciences.

Participants: Inclusion criteria were the patients who have been radiologically diagnosed with frozen shoulder (2018/19 ICD-10-CM diagnosis code M 75.02), both sexes, aged between 18 and 65 years, and the patients willing to give written consent to participate in the trial. Exclusion criteria were the patients suffering from any life threatening illness or other systemic disease affecting quality of life or any vital organ failure, cases willing for or requiring immediate surgical intervention or already underwent any major shoulder surgery in last 6 months, undergoing homoeopathic treatment for chronic disease within last 6 months, diagnosed cases of unstable psychiatric illness, pregnant and lactating women, self-reported immune-compromised state, substance abuse and/or dependence, and the patients not willing to participate. Patients already taking any standard or other alternative therapy for frozen shoulder were included if agreed to discontinue for at least 1 month.

Intervention: Intervention was planned as administration of indicated homoeopathic medicines in centesimal or 50 millesimal potencies and in individualized dosage, as decided appropriate to the case or condition. In centesimal potencies, each dose consisted of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 90% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globule of poppy seed size (no.10) was dissolved in 50 ml distilled water with addition of 2 drops of 90% v/v ethanol, 10 doses were marked on the vial, each dose of 5 ml was instructed to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Each dose was directed to be taken orally on clean tongue with empty stomach. Duration of such therapy was 3 months. Medicines were obtained from SBL Pvt. Ltd. and Homoeopathy International® – Good Manufacturing Practice certified firms. Single individualized medicine was prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using RADAR® software when required with due consultation with Materia Medica. Subsequent prescriptions were generated as per Kent’s observations and Hering’s law. Participants were assessed by three homoeopaths at a time. Medicine was selected on each occasion by two homoeopaths, and in case of any differences in opinion, it was resolved by involvement of another homoeopath. All the homoeopaths involved were affiliated with respective state councils.

General management: All the participants were given general guidelines to remain active within the limits of pain, avoid activities which would make the pain worse (e.g. lifting heavy weights), consider alternative positions or ways to minimise pain, rest when needed, joint mobilization exercises and reassurance. They were advised to be present for monthly follow-ups.

Outcomes:

  • Primary outcome measure: Translated Bengali version of the Oxford Shoulder Score (OSS) questionnaire [4]
  • Secondary outcome measure: Translated Bengali version of the Shoulder Pain and Disability Index (SPADI) questionnaire [5]

Before this trial was initiated, the questionnaires underwent standardized forward-backward translation into local vernacular Bengali, was checked for face and content validity, and subjected to pilot testing and thereafter formal psychometric validity and reliability testing, but will be reported elsewhere and beyond the scope of this paper.

Sample size: No relevant data was available on reduction of OSS or SPADI scores by individualized homoeopathic treatment using an open observational study design over 3 months of intervention. Thus assuming a medium effect size (d) of 0.5, alpha = 0.05 and power of 85%, to detect a significant difference between two dependent means of OSS scores by paired t test, we would have required a sample size of 38. Keeping a provision for 5% drop-outs, target sample was 40.

Statistical methods: The analysis was carried out with per protocol approach; i.e. only the protocol-compliant sample entered into the final analysis. Data distribution was examined by histograms, Q-Q plots, Kolmogorov Smirnov test, and Shapiro Wilk test. The baseline descriptive data (categorical and continuous) were presented in terms of absolute values, percentages, means, and standard deviations. Non-parametric (Wilcoxon signed rank test) or parametric tests (Student’s t test) were planned to be used as inferential statistics as per normality of data distribution comparing dependent observation of continuous outcomes at baseline and after 3 months. P values less than 0.01 were considered as statistically significant. No interim and subgroup analyses were planned. SPSS®-IBM® v.20 for Windows was used for analysis of data. Reporting adhered to the CONSORT [6] and RedHot [7] guidelines for reporting trials, Mathie’s criteria for model validity of homoeopathic treatment [8, 9] (MVHT) and Saha’s criteria for reporting quality of homoeopathic individualization in clinical trials [10].

RESULTS

Participant flow: As per the pre-specified inclusion and exclusion criteria, 68 subjects suffering from frozen shoulder were screened; 28 were excluded on account of various reasons; 40 met the eligibility criteria and were enrolled into the trial. Following that, baseline socio-demographic and outcome data was obtained. After 3 months of intervention, outcome data was recorded again. During intervention, 10 dropped out; 30 completed the trial. (Figure 1)

Recruitment: Starting from May 2017, follow up of the last enrolled patient was completed by the end of June 2018.

Baseline data: Fourteen variables were studied for the baseline socio-demographic features of the subjects – age, gender, residence, religion, duration of suffering, food habit, risk factors, treatment taken, co-morbidities, body mass index (BMI), marital status, educational status, employment status, and family income status. (Table 1)

Numbers analyzed: Outcomes from 30 out of 40 subjects were complete and only those entered into the final analyses.

Data distribution: Data distribution seemed to be inconclusive from the histograms and Q-Q plots; however, the Kolmogorov-Smirnov test and the Shapiro-Wilk test revealed P values much less than α (=0.05) indicating stronger evidences against normal distribution. Thus, first non-parametric Wilcoxon signed rank test (Table 2) was planned to be performed; and if significance was detected, then post hoc parametric paired t test (Table 3).

Figure 1: Study flow diagram

Outcomes and estimation: Reductions in OSS score and SPADI pain score, SPADI disability score and SPADI total score were statistically significant, both by non-parametric Wilcoxon signed rank test (all P < 0.001) and by post hoc parametric paired t test (all P < 0.001) (Tables 2 and 3). The box and whisker plots revealed the changes in OSS and SPADI scores over 3 months (Fig. 2.1 – 2.4). The correlation between the changes in OSS scores and SPADI scores over 3 months of treatment suggested a strong positive correlation (Fig. 3).

Table 1: Baseline socio-demographic features (N=30)

Features N (%)
Age¥ (yrs; mean ± sd) 47.7 ± 7.8
Age groups (yrs)

§  30 – 40

§  41 – 50

§  51 and above

07 (23.0)

15 (50.0)

08 (27.0)

Gender

§  Male : Female

17 (57.0) : 13 (43.0)

Residence

§  Urban : Rural

10 (33.0) : 20 (67.0)

Religion

§  Hinduism : Islam

Duration of suffering¥ (yrs; mean ± sd) 5.6 ± 6.8
Food habit

§  Veg : Non-veg

04 (13) : 26 (87)

Risk factor

§  Smoking

05 (16.7)

Treatment taken

§  Allopathy

§  Homoeopathy

§  Both

14 (47.0)

03 (10.0)

07 (23.0)

Co-morbidities

§  Diabetes mellitus

§  Rheumatologic

§  Misellaneous

05 (17.0)

03 (10.0)

02 (06.0)

Body Mass Index¥ (mean ± sd) 24.1 ± 1.7
Body Mass Index classes

§  Normal

§  Overweight

21 (70.0)

09 (30.0)

Marital status

§  Single

§  Married

01 (03.0)

29 (27.0)

Educational status

§  10th std or below

§  12th std

§  Graduate or above

10 (33.0)

09 (30.0)

11 (37.0)

Employment status

§  Self-employed

§  Service

§  Unemployed

13 (43.0)

05 (17.0)

12 (40.0)

Family income status

§  Low (less than Rs. 10,000)

§  Medium (Rs. 10,000 – 30,000)

§  High (more than Rs. 30,000)

19 (63.0)

08 (27.0)

03 (10.0)

¥Continuous data presented as mean ± standard deviation; Categorical data presented as absolute values (percentages)

Table 2: Changes in outcomes over 3 months; non-parametric Wilcoxon signed rank test (N=30)

Outcomes Baseline;

Median (IQR)

After 3 months; Median (IQR) Z score P value
OSS score 42.0 (37.8 to 47.3) 27.0 (23.8 to 32.0) -4.705 < 0.001*
SPADI score

§  Pain

§  Disability

§  Total

42.5 (36.0 to 48.3)

63.0 (53.8 to 71.3)

104.0 (93.5 to 119.5)

18.0 (13.8 to 26.8)

28.0 (20.8 to 40.8)

46.0 (34.8 to 64.8)

-4.706

-4.784

-4.783

< 0.001*

< 0.001*

< 0.001*

* P < 0.05 two-tailed considered as statistically significant

Table 3: Changes in outcomes over time: post hoc pair-wise analysis by parametric paired t test (N=30)

Outcomes Baseline;

mean ± sd

After 3 months;

mean ± sd

Change (0-3 months);

mean ± sd (95% CI)

t29 score P value
OSS score 42.5 ± 5.5 28.5 ± 6.8 14.0 ± 7.0 (11.4 to 16.6) § 10.951 < 0.001*
SPADI score

§  Pain

§  Disability

§  Total

41.3 ± 20.6

62.3 ± 11.3

103.7 ± 17.2

20.6 ± 8.9

31.5 ± 15.1

52.1 ± 22.7

20.7 ± 1.8 (17.2 to 24.3)ψ

30.9 ± 14.9 (25.3 to 36.4)¥

51.6 ± 22.8 (43.1 to 60.1)*

11.844

11.331

12.384

< 0.001*

< 0.001*

< 0.001*

 

Figure 2: Box plots showing changes in outcomes over 3 months of treatment

Figure 3: Scatter plot showing correlations between change in OSS score and total SPADI score over 3 months of treatment; Pearson’s r = 0.724, P < 0.001

Medicines used: The following medicines were indicated – Rhus toxicodendron and Arnica montana (n=6 each, 20%), Sulphur (n=4, 13%), Medorrhinum and Ferrum metallicum (n=3 each, 10%), Ruta graviolens (n=2, 7%), and Calcarea carbonica, Causticum, Natrium muriaticum, Radium bromide, Sanguinaria canadensis, and Syphilinum (n=1 each, 3%). Percentages were calculated by dividing the number of prescriptions of each medicine by total number of prescriptions (i.e. 30) multiplied by 100. Out of 30, 5 (17%) medicines were prescribed in 50 millesimal potencies and the rest (n=25, 83%) in centesimal potencies.

Adverse events: Patients were instructed to report any harms, unintended effects, serious adverse events, and undue aggravations either directly in the outpatients or over phone, but not a single incidence was reported from either group.

DISCUSSION

Principal findings: An open observational clinical trial was carried out at National Institute of Homoeopathy on 40 subjects suffering from frozen shoulder and was treated with indicated homoeopathic medicines following homoeopathic principles. The OSS and SPADI scores were taken as the primary and secondary outcome measures respectively, measured at baseline and after 3 months of treatment. Statistically significant improvement was achieved in both the outcomes after homoeopathic treatment suggesting homoeopathy as a promising treatment option for frozen shoulder and suggesting further substantiation using methodologically sound trials.

Strengths of the study: The possible effects of homoeopathic treatment in individuals suffering from frozen shoulder was estimated systematically for the first time by using the Bengali translated version of OSS and SPADI scores, a multidimensional measure of perceived discomfort and disability. Changes in the outcomes over time correlated significantly, thus validating the study findings further. Homoeopathic treatment was based on the principles of individualization. Formal validity and reliability of the Bengali versions of OSS and SPADI has also been addressed prior to enrolment in this study, but will be reported elsewhere and beyond the scope of this paper. Another important strength was the participation of qualified and experienced homoeopaths schooled in and practicing “classical” homoeopathy. Our study was representative of individualized (“classical”) homoeopathy only. In a broader interpretation of the law of similar, medicines were selected for symptoms both typical of the diagnoses and outside the predominating pathologies (“constitutional”).

Weaknesses of the study: Though the trial was adequately powered to detect significant change in the specified outcome measures over 3 months, still the sample size was inadequate to make a definite conclusion regarding the effectiveness of homoeopathic treatment in frozen shoulder. The time period for the study was of short duration. The study was open and observational in design; hence did not involve any blinding, randomization or control. Thus efficacy data could not be generated and the effect sizes might have been overestimated. This might be partly explained by placebo and/or regression to the mean effects that our study was not designed to control. We also could not rule out the undisclosed use of concurrent therapeutic modalities, if any.

Unanswered questions and future research: The role of homoeopathic treatment on the radiological changes including bony and soft tissue changes could not be studied. The assessment for the same can be done in future. The trial would have been methodologically better if randomization and blinding techniques could have been included, thus warranting further efficacy or effectiveness trials to be undertaken. A comparative study can be carried out to assess whether treatment results vary with individualized medicines versus with specific medicines or effectiveness trials comparing centesimal and 50 millesimal potencies.

CONCLUSION

In this open label, prospective, observational, clinical trial of pre-post comparison design conducted on 40 subjects suffering from frozen shoulder revealed statistically significant improvement in both OSS and SPADI questionnaire scores after 3 months of individualized homoeopathic treatment. Further explorations by randomized trials are warranted.

Conflict of interest statement: The authors declare that they have no competing interests. The trial was carried out as the postgraduate thesis of the corresponding author under guidance of Prof. (Dr.) Samir Kr. Nanda, who was a permanent teaching faculty of the institute.

Funding: We received no funding for the study. Funding required for the project was borne by the authors themselves.

Authors’ contributions: NM and NS conceived and designed the study. NM, JM, NK, and AN collected data. SS ran the statistical analyses and interpreted the data. NM and SS prepared the manuscript. All the authors reviewed and approved the final manuscript.

Acknowledgements: We thank Dr. Samir Kr. Nanda and Dr. Subhas Singh for their valuable inputs in the study. The authors are grateful to the institutional heads of both academic and hospital section for their cooperation. We thank the fellow postgraduate trainees, staff, pharmacists, and the patients for their sincere participation in the study.

REFERENCES

  1. Wong PLK, Tan HCA. A review on frozen shoulder. Singapore Med J. 2010;51(9):694-697.
  2. J. Essential Orthopaedics. 3rd ed. New Delhi: Mehta Publishers; 2003, p. 258.
  3. van Kampen DA, Willems WJ, van Beers LWAH, Castelein RM, Scholtes VAB, Terwee CB. Determination and comparison of the smallest detectable change (SDC) and the minimal important change (MIC) of four-shoulder patient-reported outcome measures (PROMs). J Orthop Surg Res. 2013;8:40.
  4. Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996;78:593-600.
  5. Desai AS, Dramis A, Hearnden AJ. Critical appraisal of subjective outcome measures used in the assessment of shoulder disability. Ann R Coll Surg Engl. 2010;92:9-13.
  6. Schulz KF, Altman DG, Moher D, for the CONSORT group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
  7. Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Homeopathy 2007;96(1):42-45.
  8. Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Roniger H, Frye J, et al.  Model validity of randomised placebo-controlled trials of individualised homeopathic treatment. Homeopathy 2017;106(4):194-202.
  9. Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Frye J, Manchanda RK, et al. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med. 2016;25:120-125.
  10. Saha S, Koley M, Ganguly S, Rath P, Roy Chowdhury P, Hossain SI. Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting: a preliminary study. J Integr Med. 2014;12(1):13-19.

Cite this article as: Magotra N, Sharma N, Michael J, Kundu N, Nath A, Saha S. Utility of homoeopathic medicines in treatment of frozen shoulder: An open, observational clinical trial. National Homoeo Recorder 2018;14(4):34-43.
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