To Determine The Efficacy Of Individualised Homoeopathic Medicines In Reducing Chronic Plantar Heel Pain- A Randomised Double-Blind Placebo Control Trial

Aim:

• To evaluate the efficacy of Individualised homoeopathic medicines in Chronic plantar heel pain.

Primary objective:

• To determine the reduction in Chronic Plantar Heel Pain with Individualised Homoeopathic Medicines by using Foot Function Index (FFI) score.

Secondary objective:

• To determine the reduction in disability of patients with Chronic plantar heel pain by assessing the disability subscale of the FFI score.

• To determine the reduction in activity limitation of patients with Chronic plantar heel pain by assessing the activity limitation subscale of the FFI score.

• To evaluate the co-morbidities associated with the condition.

• To evaluate the recurrence of pain in the patients.

Null hypothesis(H0):

• Individualised homoeopathic medicines are not effective in reducing Chronic plantar heel pain.

Alternative hypothesis(H1):

• Individualised homoeopathic medicines are effective in reducing Chronic plantar heel pain.

Methods of data collection and outcome measurement:

A randomised, double-blind controlled trial study will be conducted in the National Homoeopathy Research Institute in Mental Health, Kottayam outpatient department. Cases from the Inpatient and outpatient departments of the Practice of medicine department can be included in the study. After detailed screening and Evaluation, all the baseline investigations and plain radiographs, patients fitting in the inclusion criteria will be informed about the trial, written consent will be taken, and they will be enrolled in the study. Patients will be randomised into two groups. Each patient will be allocated to either group A (Individualised Homoeopathic medication) or group B (Placebo only) as an intervention through a randomisation procedure. Block randomisation method with block size four will allocate data between groups randomly. The randomisation list was generated using https://www.sealedenvelope.com/simplerandomiser/v1/lists.Patients and physicians, including the investigator, will be blinded in all the processes to reduce the bias. Third-party will assign the particular individualised medicine or Placebo to the patients as per the randomisation. Coding will be done on the medication and the Placebo, which will be revealed after the trial. Each eligible participant satisfying the inclusion and exclusion criteria are subjected to a detailed case taking in a standardised case record made for the purpose after which the totality is formulated. The cases coming under both groups will be repertorized using Synthesis repertory on RADAR OPUS software, and medicine will be prescribed after consultation with the Materia medica. Individualised Homoeopathic medicines will be prescribed only to group A. Medicines will be administered as 5-6 globules of size no. 40 pills. Medicines will be administered from lower to higher potency( 6C, 12C, 30C, 200C,1M and 11 10M), and the dose and frequency of repetition will be determined according to Homoeopathic principles. Moreover, even after this, if there is no change, the case will be reviewed further to select the most appropriate remedy. As per the need and demand of the case, potency and repetition of medicine can be changed in the follow-ups. Any adverse reactions or serious adverse events noted after administration of Homoeopathic medicine will be reported to the institutional pharmaco-vigilance department. If any acute emergency or complications occur, they will be referred to higher centres and drop out from the study, and if returning for treatment, they will not be included in the research and will be given standard treatment. For the cases allocated in group B, Placebo will be administered. If in case, acute conditions develop, Homoeopathic medicine will be prescribed according to the acute totality. Each case will be reviewed every month. If there is any need, cases would be reviewed as per requirement. In addition, telephonic follow-ups may be done for the patient per the participant’s need. The outcome of the study will be assessed by considering symptomatic improvement of the patients by evaluating the Foot Function Index(FFI) score at the 6th month. Drop out Criteria: If the patient is not reporting for the follow-up consecutively for more than three visits, even after telephonic, the patient will be considered to have dropped out of the study. In case of any unforeseen medical emergency, the subject will be withdrawn from the study and treated as needed or referred to other lines of treatment. The FFI score of the patient will be recorded every month. The outcome measurement will be done by comparing the Foot Function Index scores of patients of both the control and placebo groups at baseline, 3rd month and 6th month. Changes in pain, disability and activity limitation in FFI score between groups will be compared using ANCOVA. Statistical analysis will be conducted using STATCRAFT 2.0.3 software. FFI score at baseline, 3rd month and 6th month will be considered for analysis.