Health Condition 1: M17- Osteoarthritis of knee
Conditions
Interventions
Intervention1: Arm 1 Homoeopathic intervention arm: Participants of this arm will be intervened by individualized homoeopathic medicines depending upon the presenting totality of symptoms in individua
Sponsors
Central Council for Research in Homoeopathy
Central Council for Research in Yoga and Naturopathy
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria includes the following - 1) Participants diagnosed as having osteoarthritis knee (one or both joints ) satisfying the ACR guidelines 2) Age between 35-70 years 3) On/off NSAIDs 4) Kellgren Lawrence grade 1 and 2 on X-ray 5) Patients undergoing physical exercises, quadriceps strengthening exercises for management of knee osteoarthritis.
Exclusion criteria
Exclusion criteria: Exclusion criteria includes the following - 1) Rheumatoid arthritis, fibromyalgia,recurrent or active pseudo-gout,cancer,any other serious medical condition such as uncontrolled diabetes mellitus , uncontrolled hypertension, any other auto-immune disorder or NSAIDs associated adverse events 2) Patients undergoing ancillary methods like use of paraffin,pulsed vibration therapy,use of transcutaneous electrical stimulation and supportive devices such as knee brace,cane and walker etc. 3) History of recent trauma to the lower limbs within last four weeks 4) History of stroke or paraplegia or hemiparesis or hemiplegia 5) History of ligament inury /tear in any knee joint 6) Oral steroids within the last four weeks 7) Intra articular injection in the last 4 to 6 months 8) Undergone arthroscopy of knee 9) Valgus deformity grade 3 and above 10) Participants having bone marrow density below (minus)2SD 11)Participants on chemotherapeutic agents and metabolites are to be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee injury & osteoarthritis outcome score 12 (KOOS-12) contains 4KOOS pain items,4KOOS function items and 4 KOOS quality of life items.KOOS-12 score ranges from 0 to 100 where 0 is the worst possible and 100 is the best possible scoreTimepoint: Knee injury & osteoarthritis outcome score 12 assessment will be done in all the 4 arms at the baseline and during each follow-up until 12 months from the time of enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication score - The frequency of consumption of conventional medicines (NSAIDs) for the complaints of osteoarthritis will depict the medication score & assessed by medication adherence questionnaire. The range of score is from minimum 0 to maximum 13. Higher the score indicates poorer adherence to the prescribed medication.Timepoint: Medication score will be assessed in all the four arms at baseline & during each follow up until 12 months from the time of enrollment.;Muscle strength - Back leg dynamometer will be used for quadriceps & hamstring muscle strength. Greater extend of pull on dynamometer depicts better muscle strengthTimepoint: Muscle strength will be assessed in all the four arms at baseline & during each follow up visit until 12 months from the time of enrollment;Pain visual analogue scale is a 10 cm long visual scale on which the participant draws a line to designate their level of pain at interview.Pain scale ranges from 0 to 10 wherein 0 indicates the best possible score & 10 indicates worse possible pain.Timepoint: Pain visual analogue scale assessment will be done in all 4 arms at the baseline & during each follow up until 12 months from the time of enrollment;Range of motion - Goniometry will be used to measure the flexion & extension of both the knees. Lesser degree of knee joint flexion indicates worse conditionTimepoint: Range of motion will be assessed in all the four arms at the baseline & during each follow up until 12 months from the time of enrollment;Walking time will be measured by noting the time taken for the participant to complete a 20 meters (6minutes)walk on a straight path. Lesser walking time includes good condition & greater walking time represents worse conditionTimepoint: Walking time assessment will be done in all the four arms at the baseline & during each follow up until 12 months from the time of enrollment | — |
Countries
India
Contacts
Public ContactDr Shaji Kumar RT
Central Council for Research in Homoeopathy
Outcome results
None listed