A total of t patients with OA knees from the outpatient department of Dr John's Orthopedic Center, Bengaluru, were recruited for the study. A sample size of 250 was obtained on G power software by fixing the alpha at 0.05 powered at 0.8 and an effect size of 0.379 considering the mean and SD of an earlier study.[17
] A total of t of both genders in the age group of 35–80 years (59.56 ± 8.18) in the yoga group and (59.42 ± 10.66) control group with OA knees (one or both joints) satisfying theAmerican College of Rheumatology (ACR) Guidelines[18
] for diagnosis were included. The inclusion criteria were (i) persistent pain for 3 months prior to recruitment, (ii) moderate-to-severe pain on walking, (iii) Kellegren and Lawrence[19
] radiologic grading of II-IV in X-rays taken within 6 months prior to entry, and (iv) those fully ambulant, literate, and willing to participate in the study. Those with (i) grade I changes in -ray, (ii) acute knee pain, (iii) secondary osteoarthritis due to rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, or hemophilia, and (iv)those with major medical or psychiatric disorders were excluded.
The study was approved by the institutional review board (IRB) and ethical committee of SVYASA (Swami Vivekananda Yoga Anusandhana Samsthana) University. Signed informed consent was obtained from all the participants.
This was a prospective randomized parallel active control study on patients with OA knees in the age range of 35-80 years. Patients attending the outpatient department of Dr John's Orthopedic Center who satisfied the inclusion criteria were recruited for the study. After the initial screening for selection criteria, they were assigned to either the yoga group or control group. A computer-generated random number table (www.randomization.com
) was used for randomization. Numbered envelopes were used to conceal the sequence until the intervention was assigned. Both groups were given the conventional physiotherapy using transcutaneous electrical stimulation and ultrasound for 15 days.
Both groups had supervised practices at the center for 40 min daily (6 days/week) after physiotherapy (20 min) for 2 weeks. The yoga classes were conducted in the basement of the hospital where one hall is exclusively dedicated for yoga therapy. The study group was taught integrated yoga and the control group was taught the non-yogic physiotherapy exercises by certified therapists. After this, they were asked to practice daily at home for the next 3 months. Compliance was supervised by telephone calls once in 3 days and a weekly review was conducted once a week for 3 months. The daily review cards were checked for the regularity and doubts if any were clarified. The evaluation was conducted by the senior research fellow. All patients were asked to tick the practices daily after the home practice in the diary provided for the purpose; at every visit their clinical progress and therapy received on the day were documented. All assessments were carried out on 1st, 15th, and 90th days.
Blinding and masking
As this was an interventional study, double blinding was not possible. The answer sheets of the questionnaires were coded and analyzed only after the study was completed. Here, the statistician who did the randomization, data analysts, and the researcher who carried out the assessments were blinded to the treatment status of the subjects.
Intervention for the yoga group
The daily routine practiced at the center in the yoga group included 40 min of integrated yoga therapy practice after 20 min of physiotherapy with transcutaneous electrical stimulation and ultrasound for 2 weeks . The integrated yoga therapy practice included shithilikaranavyayamas (loosening practices), saktivikasaka (strengthening practices) followed by yogasanas and relaxation techniques with devotional songs. Later patients were advised to continue the integrated yoga therapy practice for 40 min at home for the next 10 weeks.
Yoga module for osteoarthritis knees
The concept used to develop a specific module of an integrated approach of yoga therapy for knee pain was taken from the traditional yoga scriptures (patanjali yoga sutras, yoga vasishtha
, and upanishads
) that highlight a holistic lifestyle for positive health at physical, mental, emotional, and intellectual levels.[20
] Yoga is defined as the mastery over the modifications of mind (chittavrittinirodhah
—definition of yoga by patanjali
). It helps to remove the unnecessary surges of neuromuscular activation resulting from heightened stress responses that may contribute to aging.[21
] The daily routine included a 40 min practice as follows:
- Yogic sukshmavyayamas (loosening and strengthening practices): These are safe, rhythmic, repetitive stretching movements synchronized with breathing. These practices mobilize the joints and strengthen the periarticular muscles.
- Relaxation techniques: Three types of guided relaxation techniques were interspersed between the physical practices of sukshmavyayamas and asanas.
- Asanas (physical postures): Asanas are featured by effortless maintenance in the final posture by internal awareness. We selected asanas in standing, supine and prone positions that would relax and strengthen the knee joints.
- Pranayama: The practice of voluntary regulated breathing while the mind is directed to the flow of breath is called Pranayama. These practices promote autonomic balance through mastery over the mind.
- Meditation: Patanjali defines meditation (dhyana) as effortless flow of a single thought like OM in the mind without distractions (pratyayaekataanatadhyanam). This has been shown to offer physiological benefits through alertful rest to the mind body complex.
Lectures and counseling: Yogic concepts of health and disease, yama, niyama, bhakti yoga, Jnana yoga, and karma yoga were presented in the theory classes. These sessions were aimed at understanding the need for lifestyle change, weight management, and prevent early aging by yogic self-management of psychosocial stresses.
Intervention for the control group
The daily routine practiced at the center in the control group included 40 min of therapeutic exercises after 20 min of physiotherapy with transcutaneous electrical stimulation and ultrasound for 2 weeks . These therapeutic exercises included loosening and strengthening practices for all the joints of the upper and lower limbs, brief period of rest, specific knee practices, and supine rest followed by light music. Later patient was advised to continue the therapeutic exercise practice of 40 min at home for the next 12 weeks.
Short Form 36) was used to assess QOL after the intervention in both groups on day 15 and 90. SF-36 is one of the popularly used self-evaluation questionnaire for the assessment of general.[24
] It contains 36 questions aimed at assessment of the participant's health under eight major categories: physical functioning, role limitations due to physical health, role limitations due to mental health, energy or fatigue, emotional well-being, social functioning, pain, and general health. The scores are then averaged accordingly under those headings.[25
The increase in scores indicates better for domains physical functioning, role of limitations in physical health, role of limitations in emotional problems, social functioning, pain reduction, general health, and for domains fatigue and emotional well-being the decrease in scores indicates better QOL. The internal consistency of the SF-36 Health Survey Questionnaire as determined by Cronbachs was high and ranged from 0.72-0.94.
The data were analyzed using SPSS Version 16. The baseline values of the two groups were checked for normal distribution by Shapiro–Wilk's test. Baseline matching was checked by the Mann–Whitney test. Wilcoxon's signed ranks test and MannWhitney U-test were used for assessing ‘within’ and ‘between’ groups differences, respectively.
Tables and show the interventions of both study and control groups. shows the baseline characteristics which were similar between groups on all variables (P > 0.05, Mann–Whitney test for pre values).