Professional Documents
Culture Documents
Acm 2019 0140
Acm 2019 0140
Abstract
Objective: To determine whether the effectiveness of Hatha yoga therapy is comparable to conventional
therapeutic exercises (CTEs) for reducing back pain intensity and back-related dysfunction in patients with
chronic nonspecific low-back pain (CNLBP).
Design: The study was a prospective randomized comparative trial, divided into two phases: an initial
6-weekly supervised intervention period followed by a 6-week follow-up period.
Settings: This study was conducted at Department of Physical Medicine and Rehabilitation and Centre for
Integrative Medicine and Research of a tertiary care hospital.
Subjects: Patients between 18 and 55 years of age with complaint of CNLBP persisting ‡12 weeks with pain
rating ‡4 on a numerical rating scale (0–10).
Intervention: A total of six standardized 35-min weekly Hatha yoga sessions (yoga group) and similarly 35-
min weekly sessions of CTEs (CTE group), designed for people with CNLBP unaccustomed to structured yoga
or CTE program. Participants were asked to practice on nonclass days at home.
Outcome measures: The primary outcome measures were Defense and Veterans Pain Rating Scale (DVPRS)
(0–10) and 24-point Roland Morris Disability Questionnaire (RDQ). Secondary outcomes were pain medication
usage per week and a postintervention Perceived recovery (Likert seven-point scale) of back-related dys-
function. Outcomes were recorded at the baseline, 6-week follow-up, and 12-week follow-up.
Results: Seventy subjects were randomized to either yoga (n = 35) or CTE group (n = 35). Data were analyzed
using intention-to-treat, with last observation carried forward. Both yoga and the CTE group have shown sig-
nificant improvement in back pain intensity and back-related dysfunction within both the groups at 6- and 12-week
follow-ups compared to baseline. No statistically significant differences in the pain intensity (DVPRS; at 6 weeks:
n = 35, difference of medians 1.0, 95% confidence interval [-5.3 to 3.0], p = 0.5; at 12 weeks: n = 35, 0.0 [-4.2 to
5.0], 0.7) and back-related dysfunction (RDQ; at 6 weeks: n = 35, 1.0 [-9.6 to 10.6], 0.4; at 12 weeks: n = 35, 0.0
[-8.8 to 10.6], 0.3) were noted between two groups. Improvements in pill consumption and perceived recovery
were also comparable between the groups.
Conclusion: Yoga provided similar improvement compared with CTEs, in patients with CNLBP.
Departments of 1Physical Medicine and Rehabilitation and 2Physiology, All India Institute of Medical Sciences, New Delhi,
India.
*Current affiliation: Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Rishikesh,
India.
1
2 NEYAZ ET AL.
and socioeconomic problem in present society. Prevalence The authors excluded individuals whose back pain was
of low-back pain ranges from 40.7% to 42.4% in Indian due to severe scoliosis, sciatica, previous back surgery, or
population.2,3 diagnosed spinal stenosis, potentially attributable to specific
Conventional therapeutic exercises (CTEs) are the most underlying diseases or conditions (e.g., pregnancy, meta-
widely used evidence-based nonpharmacologic treatment static cancer, spondylolisthesis, fractured bones or dislocated
and already proven to be an effective component in treat- joints, large herniated disk, sciatica pain equal to or greater
ment of CNLBP.4,5 Yoga-based treatment has also shown than back pain) or minimal pain (rating of £4 on a 0–10
promising results in reducing pain intensity and pain-related numerical rating scale). The authors also excluded conditions
disability in chronic low-back patients and may be an effi- overlapping with symptoms of back pain or confound
cacious treatment for CNLBP.6,7 treatment effects (rheumatoid arthritis, spondyloarthropathy,
A recent meta-analysis pointed out that the comparison of and severe fibromyalgia). The authors excluded individuals
yoga with therapeutic exercises for back-related dysfunction who were currently receiving other back pain treatments or
and pain is still limited by the number of studies.8 In ad- had participated in Yoga or CTE training for back pain and
dition, even though Yoga is an ancient practice originating those with unstable medical or severe psychiatric conditions
out of the Indian subcontinent, it was surprising to note that or dementia. Patients who had contraindications (e.g., pro-
only a few published studies have evaluated Yoga for pa- gressive neurologic deficits) or schedules that precluded
tients with CNLBP in Indian population. Therefore, a clin- class participation, those with history of active substance or
Downloaded by Imperial College School Of Med from www.liebertpub.com at 08/06/19. For personal use only.
ical trial was designed to compare the efficacy of Yoga with alcohol abuse, those who were unwilling to practice at home,
therapeutic exercises for CNLBP population. This com- or those who have plans to move out of the area in the next 1
prised a structured, 35-min weekly series of Yoga therapy, month were also excluded.
with CTEs, for 6 weeks, supplemented with home practice,
in decreasing pain intensity and improving back-related Interventions
dysfunction for patients with CNLBP. It was hypothesized
A total of six standardized 35-min weekly Yoga sessions
that Yoga therapy is as effective as CTEs in decreasing pain
were given on individual basis at CIMR and similarly 35-
intensity and improving back-related dysfunction in patients
min weekly CTE sessions at PMR Department. The CTE
with CNLBP. Alternatively, if Yoga is less effective, this
intervention was kept identical to the Yoga sessions, in
information will help guide better treatment decisions and
terms of length of sessions (35 min) and number of sessions
reduce unnecessary expenditure of time and other resources
(six sessions). Education regarding postural care for CNLBP
on less effective treatment.
was given in both groups. Participants from both the groups
Methods were asked to practice 30 min on nonclass days at home, and
handouts were given to illustrate technique at home.
Study design
The study was designed as a prospective randomized Yoga group
comparative trial comparing the effect of 35-min supervised An integrated Yoga therapy module for CNLBP was de-
weekly Yoga sessions and 35-min supervised weekly CTE veloped from traditional Hatha yoga practices, in collabora-
sessions, both designed for CNLBP. The trial was divided tion with CIMR. Due to the convenience and lower cost, a
into two phases: an initial 6-week intervention period of 35- once weekly 35-min Yoga session was chosen for the current
min weekly supervised session at institute and practice on study. Each session included introduction to Hatha yoga,
nonclass days at home followed by a 6-week follow-up flexibility practices, four different Yogasanas, quick relaxa-
period. During the 6-week follow-up period, all participants tion technique, pranayamas, and deep relaxation technique
were encouraged to practice at home. The study protocol (Table 1). Yoga sessions were administered by a trained yoga
was approved by institute ethics committee, and all study therapist. Yoga participants were encouraged to practice at
participants provided oral informed consent before the eli- home for 30 min on days when they did not have session.
gibility screening and written consent before the baseline
assessment and randomization. CTE group
Settings and participants Weekly sessions were held by trained physiotherapists,
which began with short educational talk that provided in-
This study was conducted from February 2017 to April
formation on proper body mechanics, benefits of exercise,
2018, at Department of Physical Medicine and Rehabilitation
followed by simple warm-up and three different stretching
(PMR) and Centre for Integrative Medicine and Research
and five different strengthening exercises that emphasize
(CIMR) at tertiary care hospital. Patients aged between 18
hip, abdominal, and back muscles (Table 2). Frequency of
and 55 years who were attending outpatient at PMR depart-
repetitions of each stretching and strength exercises was 10
ment with complaint of CNLBP persisting ‡12 weeks and
with holding time of 10 sec. Each set of strengthening ex-
pain rating ‡4 on a 0–10 numerical rating scale (0 = no pain to
ercises was followed by a different set of stretching exer-
10 = worst possible pain) were screened for eligibility. A de-
cise. Sessions ended with a short unguided period of deep
tailed history was taken, and clinical examination findings
slow breathing.
were recorded. Complete blood picture (hemoglobin, total
leukocyte count, differential leukocyte count, erythrocyte
Outcome measures
sedimentation rate) and radiograph of lumbar spine (ante-
roposterior and lateral view) were obtained in every patient. The primary outcome measures were back pain intensity
Other investigations were conducted if indicated. and back-related dysfunction. Secondary outcomes were
YOGA VERSUS EXERCISE FOR CHRONIC LOW-BACK PAIN 3
Table 1. Components of Hatha Yoga Session and sensitive to changes.10,11 These primary outcomes were
recorded at baseline, 6-week postintervention, and 12-week
Time follow-up. Those who were more comfortable with local
S. No. Components of each yoga session (min) (Hindi) language were provided with a translated version of
A Introduction of Yoga philosophy 5 the RDQ.
Questions were asked to determine the weekly con-
B Sithilikaran Vyayama (Flexibility practice)
01 Supta Udarakarshanasana (folded 3 sumption of pain medication12 for CNLBP management
leg lumbar stretch) before the intervention. Changes in weekly drug consump-
02 Shavaudarakarshanasana (Crossed 3 tion were recorded in both the groups at 6-week post-
leg lumbar stretch) intervention and 12-week follow-up compared to baseline.
03 Supta Pawanmuktasana (leg lock pose) 2 Perceived recovery of back-related pain and dysfunction
C Yogasanas was rated by patient on a seven-point Likert scale indicating
01 Ustrasana (Camel Pose) 2 ‘‘very large improvement’’ (including complete recovery),
02 Bhujangasana (Cobra Pose) 2 ‘‘much improved’’, ‘‘little improved’’, ‘‘unchanged’’, ‘‘little
03 Salabhasana (Grasshopper Pose) 2 worse’’, ‘‘much worse’’, and ‘‘very much worse’’.13 Scores
04 Setubandasana (Bridge Pose) 2 were evaluated as change from last time point.
D Quick relaxation technique
Downloaded by Imperial College School Of Med from www.liebertpub.com at 08/06/19. For personal use only.
Table 4. Comparison of Low-Back Pain Intensity Score (Defense and Veterans Pain Rating Scale)
p-Value (between
n Yoga n CTEs the groups)
Downloaded by Imperial College School Of Med from www.liebertpub.com at 08/06/19. For personal use only.
5
6 NEYAZ ET AL.
baseline. However, no statistically significant difference in The subjects attended an average of 4.3 – 2.2 classes, with
the improvement was observed when a comparison was 47 subjects (23 in yoga group and 24 in CTE group) having
Downloaded by Imperial College School Of Med from www.liebertpub.com at 08/06/19. For personal use only.
made between the Yoga group and the CTE group at 6- and attended ‡4 classes, making them ‘‘good adherers’’. Despite
12-week follow-up (Table 4). good adherence, eight subjects dropped out (three from
A univariate analysis of back-related dysfunction showed Yoga group, five from CTE group) and four subjects were
significant improvement in RDQ scores within the Yoga lost to follow-up (three from Yoga group, one from CTE
group and the CTE group at 6- and 12-week follow-up group). Three out of 70 recruited subjects (two from Yoga
compared to baseline. There was no statistically significant and one from CTE group) did not attend any class, that is,
difference observed between the Yoga group and the CTE they did not receive the allocated intervention. Twenty
group at 6- and 12-week follow-up (Table 5). subjects attended £3 classes, that is, they discontinued the
At baseline, about 46 (65%) participants were using pain allocated intervention. Interestingly, those who discontinued
medication (21 [60%] Yoga group, 25 [71%] CTE group). the intervention did not report at 6-week time point. The
The weekly consumption of pain relieving medication was authors attempted to assess if any baseline characteristics
comparable between the groups at randomization, 6-, and could have played a role in the adherence or compliance of
12-week time point. Both Yoga and CTEs significantly re- the participants. Comparison of the baseline variables for
duced the number of pills consumed as per the per-protocol adherence (good adherers vs. poor adherers) and compliance
analysis, but not according to intention-to-treat analysis (completers vs. noncompleters) showed no statistical dif-
(Table 6). ferences (Tables 8 and 9).
All the participants reported some degree of improvement
from the baseline after the 6-week intervention period, as Adverse events
well as at 12-week follow-up period, barring one subject in
yoga group who reported no change after the 6-week in- No serious adverse event was observed in any group.
tervention. At the end of 12-week Yoga protocol, 5 (26%) Nonserious side effects were observed in three patients and
participants reported ‘‘very much improvement,’’ and 8 these related to slight increased pain.
(42%) participants reported ‘‘much improved’’. The num-
Discussion
bers were 9 (50%) and 7 (38%) for the CTE group in their
respective categories. No statistical differences were found This study investigated the effect of Yoga compared to
between the Yoga and CTE group at 6- and 12-week follow- CTEs in terms of change in pain intensity, back-related
up (Table 7). dysfunction, pain medication usage, and perceived recovery.
There was significant and comparable improvement in back not have been possible in such a study. Future studies may
pain and back-related dysfunction in the Yoga group and the investigate the reasons and motivations behind the compli-
CTE group by the end of the 6-week intervention, and im- ance of the subjects that could inform the development
provements were maintained at the 12-week follow-up. The of patient retention strategies, at least in clinical settings.
results support the hypothesis that the yoga therapy provides On that note, the present protocol neither attempted to im-
similar improvement in back pain and back-related dys- prove compliance nor did it use any strategy to motivate the
function to CNLBP patients compared to CTEs. These adherence to the protocol. Such attributes were designed
findings are in agreement with previous studies and indicate bearing in mind the general applicability of the results. 19
that both interventions are effective.15–17 Nevertheless, investigations in either direction would be in-
Another outcome of the study was the number of pills teresting to note given that yoga is a deeply rooted practice in
consumed per week. No statistical significance was seen for the Indian culture, thus posing its unique set of challenges
Yoga and CTE groups as per intention-to-treat analysis. and strengths in conducting such studies.20
While the results are contrary to their expectations, some
caution is advised in this case. On reanalyzing the data as Conclusion
per protocol, both Yoga and CTE groups were found to be
significant. It may be reasonable to assume that the null Yoga provided comparable improvement in terms of pain
results could be attributed to the dropouts. Indeed, the re- intensity and back-related dysfunction in patients with
duction of pill consumption can be ascertained by looking at CNLBP compared to CTEs.
the proportions, out of the initial 46 participants who were
consuming pills; in the end only 3 participants continued Acknowledgments
with pill consumption, while rest of the participants did not
feel the need to consume pills. Bearing these points in mind, The authors thank the study yoga instructor Mr. Niranjan
the authors deemed the effect of Yoga and CTEs on pill Parajuli and Nursing research office, Mr. Mansingh Jat at
consumption to be clinically significant. Williams et al.6 Centre for Integrative Medicine and Research, and senior
have reported a similar reduction in pain medications by physiotherapist at Department of PMR (Mrs. Ng Dhan-
Yoga participants at 12 weeks’ time point in their study, but manjari Devi).
this evidence needs to be tested as the comparator group was
a nonactive standard care. Author Disclosure Statement
Another outcome was the perceived improvement in
back-related pain and dysfunction. No statistical difference No competing financial interests exist.
was found between the Yoga and CTE group. The propor-
tion of subjects reporting improvement since the start of the References
therapy makes the results clinically important even though it
1. Chou R. Low back pain (chronic). BMJ Clin Evid 2010;10:
did not achieve statistical significance.
1116.
Both Yoga and the CTE therapy were found to be safe
2. Ganesan S, Acharya AS, Chauhan, R, Acharya S. Pre-
during the present study with few nonserious side effects valence and risk factors for low back pain in 1,355 young
mostly related to increase in low-back pain. Few previous adults: A cross-sectional study. Asian Spine J 2017;11:610–
studies have reported that side effects were mostly related to 617.
mild self-limited joint and back pain and did not differ sig- 3. Mathew AC, Safar RS, Anithadevi TS, et al. The preva-
nificantly in frequency or severity between the groups.17,18 lence and correlates of low back pain in adults: A cross
Among strengths of their study it can be stated that it was sectional study from Southern India. Int J Med Public
methodologically sound owing to the use of appropriate Health 2013;3:342–346.
outcome variables, computerized randomization ensuring no 4. van Middelkoop M, Rubinstein SM, Verhagen AP, et al.
selection bias, and blinding of the principal investigator, Exercise therapy for chronic nonspecific low-back pain.
outcome assessor, and statistician. Participant blinding could Best Pract Res Clin Rheumatol 2010;24:193–204.
8 NEYAZ ET AL.
5. Searle A, Spink M, Ho A, Chuter V. Exercise interventions yoga in nonspecific chronic low back pain: A randomized
for the treatment of chronic low back pain: A systematic controlled study. Int J Yoga 2014;7:48–53.
review and meta-analysis of randomised controlled trials. 15. Sherman KJ, Cherkin DC, Wellman RD, et al. A random-
Clin Rehabil 2015;29:1155–1167. ized trial comparing yoga, stretching, and a self-care book
6. Williams K, Abildso C, Steinberg L, et al. Evaluation of the for chronic low back pain. Arch Intern Med 2011;171:
effectiveness and efficacy of Iyengar yoga therapy on 2019–2026.
chronic low back pain. Spine 2009;34:2066–2076. 16. Highland KB, Schoomaker A, Rojas W, et al. Benefits of
7. Tekur P, Singphow C, Nagendra HR, Raghuram N. Effect the restorative exercise and strength training for operational
of short-term intensive yoga program on pain, functional resilience and excellence yoga program for chronic low
disability and spinal flexibility in chronic low back pain: A back pain in service members: A pilot randomized con-
randomized control study. J Altern Complement Med 2008; trolled trial. Arch Phys Med Rehabil 2018;99:91–98.
14:637–644. 17. Saper RB, Lemaster C, Delitto A, et al. Yoga, physical ther-
8. Wieland LS, Skoetz N, Manheimer E, et al. Yoga treatment apy, or education for chronic low back pain: A randomized
for chronic non-specific low-back pain. Cochrane Database noninferiority trial. Ann Intern Med 2017;167:85–94.
Syst Rev 2017;1:CD10671. 18. Tilbrook HE, Cox H, Hewitt CE, et al. Yoga for chronic
9. Nassif TH, Hull A, Holliday SB, et al. Concurrent validity low back pain: A randomized trial. Ann Intern Med 2011;
of the Defense and Veterans Pain Rating Scale in VA 155:569–578.
outpatients. Pain Med 2015;16:2152–2161. 19. Sedgwick P. Explanatory trials versus pragmatic trials.
Downloaded by Imperial College School Of Med from www.liebertpub.com at 08/06/19. For personal use only.
10. Roland M, Morris R. A study of the natural history of back BMJ 2014;349:g6694.
pain: Part I: Development of a reliable and sensitive mea- 20. Cramer H, Lauche R, Langhorst J, Dobos G. Are Indian
sure of disability in low-back pain. Spine 1983;8:141–144. yoga trials more likely to be positive than those from other
11. Roland M, Fairbank J. The Roland-Morris disability countries? A systematic review of randomized controlled
questionnaire and the Oswestry disability questionnaire. trials. Contemp Clin Trials 2015;41:269–272.
Spine 2000;25:3115–3124.
12. Williams KA, Petronis J, Smith D, et al. Effect of Iyengar Address correspondence to:
yoga therapy for chronic low back pain. Pain 2005;115: Lukram Sumila, MBBS
107–117. Department of Physical Medicine and Rehabilitation
13. Jellema P, Van der Roer N, van der Windt DA, et al. Low All India Institute of Medical Sciences
back pain in general practice: Cost-effectiveness of a Ansari Nagar
minimal psychosocial intervention versus usual care. Eur New Delhi 110029
Spine J 2007;16:1812–1821. India
14. Nambi GS, Inbasekaran D, Khuman R, Devi S. Changes in
pain intensity and health related quality of life with Iyengar E-mail: sumilalukram124@rediffmail.com