Evaluation of the effects of add on low level laser therapy on functional outcomes in janugata sandhivata (knee osteoarthritis) treated with whole system ayurveda a single blinded randomized controlled trial.

EVALUATION OF THE EFFECTS OF ADD ON LOW LEVEL LASER THERAPY ON FUNCTIONAL OUTCOMES IN JANUGATA SANDHIVATA (~KNEE OSTEOARTHRITIS) TREATED WITH WHOLE SYSTEM AYURVEDA: A SINGLE BLINDED RANDOMIZED CONTROL TRIAL

AIMS AND OBJECTIVES

AIM: To find out the additional benefits of Low level laser therapy LLLT on the patients of knee O.A

to receiving the whole system ayurveda intervention.

Primary objective:

To asses if the addition of LLLT is providing additional functional benefits to knee O.A patients in terms of functional outcome.

Secondary objective:

1. To asses if the benefit obtained by low level laser therapy LLLT in such patients are stable (for 2 months) after stopping of the LLLT.
2. To asses if the addition of laser therapy is safe in its application.
3. Min. number of sittings required to obtain the visible therapeutic responses as well as the maximum therapeutic response.
4. To study the drug and procedure related adverse drug reaction (ADR) during the trial period
5. To asses if there is any need of reduction in analgesics.

PLAN OF STUDY

 Selection of cases

1.    For the purpose of clinical trial, the patients of janugata sandhivata / knee O.A will be selected regardless of sex with will be selected randomly from O.P.D, I.P.D and Advanced Arthritis Research Clinic at state ayurvedic college and hospital, Lucknowand also the referred cases which fulfil the criteria.

 2.A careful history, physical examination and necessary investigation will be performed as Performa prepared for the present trial.

 INCLUSION CRITERIA

Patients who will be coming for the treatment of knee O.A in kayachikitsa OPD and A-ATARC OPD.

Patients who will be  diagnosed as having knee O.A on the basis of their clinical and radiological features.

Age: 31 to 70 years.

Sex: Both Male & Female.

Socio economic status: All

Patients who will give consent to participate in the study.

Patients who will be agree to stop all previous medications of knee OA.

  EXCLUSION CRITERIA

     Patients below 31 years and above 70 years of age.

Patients having severe destructive radiological changes.

Patients suffering from systemic disease like Carcinoma, uncontrolled diabetes, Tuberculosis etc.

Patients who have joint-related diseases other than knee osteoarthritis (OA).

Patients with traumatic knee O.A, gross deformity, meniscal tear etc.

Unwilling patients will be excluded.

Type of study - Two arm parallel randomized controlled study.

Period of study: 120 days (60 days interventionally+60 days after trial completion).

Follow up during trial period:  At 15 days interval.

Follow up after the trial period: One month following the completion of the two-month trial.

SAMPLE SIZE

Minimum 50 patients with approximately 10% of dropouts of janugata sandhivata from OPD, IPD and advance arthritis research Centre at SAC & H will be selected & divided into two groups with the help of computer-generated random table.

 4.     Group A– In this group patients will be treated with whole system of ayurveda and Low-Level Laser Therapy.

 5.    **Group B –**In this group patients will be treated with whole system of ayurveda and sham control.

    OUTCOME ASSESSEMENT



ASSESSMENT OF RESULTS:

For the gross assessment of result obtained, the response of the treatment will be determined in terms of degree of remission of sign and symptoms as:

1. Relieved: The patients having improvement > 75% symptomatically and in radiological and laboratory findings (if any).

2. Improved: The patients having improvement < 75% and > 40% symptomatically, Radiological and laboratory findings (if any)

3.Not Improved : Patients having improvement < 40% symptomatically and in Radiological and laboratory findings (if any).

4.Worsened Response :Patients having deterioration in their symptoms, and in Radiological and laboratory finding (if any).