Abstract
Objectives:
The objective was to study the effect of the add-on yogic prana energization technique (YPET) on healing of fresh fractures.
Materials and methods:
Thirty (30) patients (22 men and 8 women) between 18 and 55 years with simple extra-articular fractures of long and short bones were selected from the outpatient department of Ebnezar Orthopaedic Centre and Parimala Speciality Hospital, Bengaluru. They were randomized into yoga (n = 15) and control (n = 15) groups. Compound, complicated, pathologic fractures, old fractures, and those associated with dislocations were excluded. Both groups received the conventional plaster of paris immobilization of the fracture site as the primary treatment. The yoga group, in addition, practiced YPET twice a day (30 minutes/session) for 2 weeks using taped audio instructions after learning under supervision for 1 week. YPET is an advanced yoga relaxation practice that involves breath regulation, chanting, and visualization, which according to yogic science revitalizes the tissues by activating the subtle energies (prana) within the body. Both the groups were assessed on the 1st and 21st day by the Numerical Pain Rating Scale for pain (NRS), tenderness (0–4), swelling (0–4), fracture line density (1–4), and the bridging of cortices (1–4).
Results:
Two (2) groups were matched on all variables. The Wilcoxon test showed significant improvement in both groups on all variables. Pain reduction (NRS) was better (p = 0.001 Mann–Whitney test) in the YPET group (94.5%) than in the control group (58.6%); Tenderness reduced (p = 0.001) better in the YPET group (94.4 %) than in the control group (69.12%); Swelling reduced by 93% in the YPET group and by 69.4% in controls (between-groups p = 0.093, i.e., nonsignificant); increase in fracture line density was better (p = 0.001) in the YPET group (48%) than in the control group (18.25%). The number of cortices united was significantly better (p = 0.001) in the YPET group (81.4%) than in controls (39.7 %).
Conclusions:
Add-on yoga-based YPET accelerates fracture healing.
Introduction
It is estimated that on an average day, any large hospital in India treats 75 fresh fractures cases, out of which at least 5–8 require operative intervention. 2 About 500–700 cases of nonunions and infected nonunions are treated per year. 2 Each metropolitan city has a number of such hospitals; thus, India has to deal with an enormous burden of fresh fractures and complicated trauma. 2 Due to significant repercussions of untimely fracture healing, substantial research has sought to elucidate the effectiveness of adjunctive therapies for accelerating fresh fracture healing. 1
Several adjunctive therapies have been tried in cases of delayed fracture healing, of which very few have been studied scientifically. Biophysical stimulations of the immobilized fracture site using pulsed electromagnetic fields (PEMFs), 3 low-intensity pulsed ultrasound stimulation (LIPUS), 4 and extracorporeal shock wave therapy (ESWT) 5 have been found effective. Delima and Tanna 3 found an 82.5% success rate with PEMFs for recalcitrant nonunion of long bones. In a study by Dijkman et al. 4 on low-intensity pulsed ultrasound for nonunions, healing rates averaged 87% (range 65.6%–100%) among eight trials wherein the mean time to healing was 146.5 days (range 56–219 days). In their review on ESWT, Petrisor et al. 5 found a 72% union rate overall for nonunions or delayed unions, and a 46% relative risk reduction in nonunions when it is used for acute high-energy fractures.
Yoga, an ancient science that provides a holistic approach, has been investigated by researchers for its application in therapy over the last 5 decades with several publications on its efficacy in management of chronic pain 6 and wound healing. 7 A randomized control trial in an intensive residential weeklong integrated yoga program 6 showed a reduction in chronic low-back pain in the yoga group by 48.76% compared to 8.09% in the control group. Yoga was found to be effective for patients undergoing surgery for early operable breast cancer 7 as there was a rapid healing of the surgical wounds, as evidenced by shorter intervals for suture removal (95% confidence interval [CI] = 0.23–4.6) and a decrease in the duration of hospital stay (95% CI = 0.44–2.1) following surgery in the yoga group as compared to controls.
Yoga-based yogic prana energization technique (YPET) is an advanced yoga relaxation practice that involves breath regulation, chanting, and visualization. According to the traditional yoga texts, 8 all these practices are meant to revitalize the tissues and restore their healthy functioning. Prana, the term used by yoga masters of India, seems to be synonymous to qi referred to by the Chinese masters of qigong therapy. Zin and Jinding 9 demonstrated that the amount and density of callus formation was significantly higher in the emitted qi group compared to the control group in experimentally induced fractures in rabbits. 9 There are no studies that have explored the role of add-on yoga to conventional management in acute traumatic conditions such as fracture.
Materials and Methods
Subjects
Thirty (30) subjects of both sexes ages 18–55 years who satisfied the selection criteria were allotted to experimental YPET and control groups, using a random-number table generated on
Source of subjects
All patients were selected from the outpatient department of Ebnezar Orthopaedic Centre and Parimala Speciality Hospital, Bengaluru.
Ethical clearance
The study was approved by the institutional review board (IRB) that consisted of unaffiliated, impartial members as per the criteria for an IRB as specified by the Indian Council of Medical Research, and the ethical clearance for the project was obtained from the ethical committee of Swami Vivekananda Yoga Anusandhana Samsthana. Signed informed consent was obtained from all of the patients.
Design
This was a prospective, randomized control two-group study to assess the efficacy of add-on YPET on healing of simple fractures. Thirty (30) subjects who satisfied the selection criteria and signed informed consent were randomized into yoga and control groups. Both groups were treated by the same orthopedic surgeon by the conventional immobilization procedure using plaster of paris cast with advice on the necessary precautions such as general exercise, care of the immobilization material, etc. All were prescribed nonsteroidal anti-inflammatory agents twice a day for 3–5 days and were advised to report to the center if there were any unusual swelling or complications.
The yoga group was asked to come to the center for 30 minutes daily for 7 days for training in YPET. Following this, they were advised to practice YPET twice a day for 3 weeks by using prerecorded instructions on an audio CD. The compliance was monitored with the help of a booklet provided to the subjects in which they checked off the box immediately after their practice of YPET twice a day. Phone calls by the therapist to the patient once in 3 days ensured the regularity. This was further checked when they came for a follow-up check at the end of the second and the third week for follow-up.
Blinding and masking
The coded data sheets of all measures were withheld for assessments at the end of the study to prevent assessment bias. The radiologist and the statistician were blind to the group.
Intervention
YPET 1
This technique involves six steps that progressively deepen the internal awareness and helps in developing voluntary mastery over the subtle energy (prana) system of the body. According to the science of ashtanga yoga of patanjali, pranayama (voluntary slowing of breath rate) is one of the eight techniques that help in achieving mastery over the mind–body complex (Swasa praswasayoh gatir vichedah pranayamah). Through this, one develops the ability to perceive and master the subtle energy system (pranamaya kosha) that is responsible for all the physiologic activities (that makes us live) of the material body (annamaya kosha). Yoga therapy works on the principle that the mind (chitta) can manipulate the body functions through changing the quantity of prana that flows to an organ. This is possible only by developing an introspective ability to first channelize the mind through intense focusing on a single thought that is fixed on the zone to be healed (desa bandha chittasya dharanam). The next step is to let go the effort and maintain the flow of the same thought (pratyaya ekatanata) and then move on to samadhi (i.e., become the object by dropping the observer, the “I”) (tadeva artha matra nirbhasam swarupa shunyamiva samadhi). This is said to bring about the necessary mastery and intended healing. This concept was used in designing YPET wherein the patient directs their prana in the form of healing white light to the fracture site and gets lost into samadhi. Table 1 gives the steps of instructions for the practice of YPET.
Assessments
Clinical parameters
Pain
Pain was measured using a Numerical Pain Rating Scale 10 (NRS). NRS, the most widely used tool for assessing pain, requires patients to rate their pain from 0 to 10, with 10 being the most severe.
Tenderness
Tenderness was assessed clinically and marked according to the standard tenderness grades: 11 0—nil, 1—just a suspect, 2—winces, 3—winces and withdraws, 4—doesn't allow to touch.
Swelling
Swelling was assessed clinically according to these grades: 0—none, 1— mild, 2— moderate, 3—severe.
Radiologic parameters
Fracture line density
Following Sinha and Goel's 12 example, radiologic evaluation was carried out by the assessment of a standard x-ray film, assigning a score based on the following criteria: 1— fracture line clearly visible, 2—hazy, 3—dense, 4—bony dense.
Cortices. 2
The radiologist looked for the number of broken cortices (1–4) visible on the first and the 21st day.
Data Analysis
The data were analyzed using SPSS 10.00. The data were tested for normalcy using Kolmogorov and Smirnov test. As the data were not normally distributed, Wilcoxon signed-ranks test and Mann–Whitney test were used for within- and between-groups comparison, respectively.
Results
Table 2 shows the demographic and baseline details of subjects in the 2 groups. There were 22 men and 8 women. One (1) case was dropped as he would not practice YPET regularly. The mean age of the control group was 34.73 ± 8.39 years and for the YPET group was 34.35 ± 13.88 years. The baseline characteristics of the 2 groups were matched (p > 0.05 Mann–Whitney test) on all five outcome measures.
YPET, yogic prana energization technique.
Table 3 shows the results after the intervention.
SD, standard deviation; CI (LB–UB), confidence interval (lower bound–upper bound).
NRS was reduced from 9 ± 1.30 to 3.73 ± 1.48 (58.55%) in controls and 9.07 ± 1.32 to 0.5 ± 0.75 (94.48%) in YPET groups, with a faster reduction in the YPET group (p < 0.001).
Tenderness was reduced from 3.66 ± 0.48 to 1.13 ± 0.35 (69.12%) in controls and from 3.78 ± 0.57 to 0.21 ± 0.42 (94.44%) in YPET groups, with a more significant reduction in the YPET group (p < 0.001).
Swelling reduced from 1.73 ± 0.70 to 0.53 ± 0.63 in controls (69.36%) and from 2.00 ± 0.67 to 0.14 ± 0.53 (93%) in the YPET group. There was no significant difference between groups (p = 0.093).
Fracture line density increased from grade 1 (clearly visible) to 1.73 ± 0.45 (18.25%) in the control group and from 1 to 2.92 ± 0.26 (48%) in YPET groups, with better healing in the YPET group (p < 0.001).
Number of cortices broken in the control group reduced from 3.53 ± 0.63 to 2.13 ± 0.92 (39.88%, p = 0.001); in the YPET group it reduced from 3.5 ± 0.65 to 0.64 ± 0.84 (81.4%, p < 0.001), with significant difference between groups (p = 0.001).
Discussion
This two-armed prospective randomized control study on 30 patients explored the effect of the YPET as an add-on to conventional nonsurgical immobilization of simple fresh fractures. The experimental group practiced YPET 30 minutes, twice daily for 3 weeks. The results showed significantly better healing (p = 0.001 Mann–Whitney U test) in the YPET group than in the control group.
Pain
The pain reduced in both of the groups, with better reduction in the YPET group (94.5%) than in the control group (58.6%), pointing to better pain reduction after YPET. As this is the first study on YPET and there are no earlier studies using similar interventions in fracture management, an attempt is made to compare the current results with other published add-on therapies such as ESWT. In a two-armed randomized control study 6 on 59 patients, the add-on ESWT intervention showed lesser pain scores and weight-bearing status than the control group (p < 0.01) at all time points.
Tenderness
Both YPET and control groups improved with better reduction in tenderness in the YPET group (p < 0.001 Mann–Whitney U test) by 3 weeks. In a randomized placebo-controlled trial, 13 patients with tibial nonunions were included for assessment of pain and tenderness. An electrical stimulation device was used for 24 weeks; no treatment other than the device and a cast was given. No difference in union rates, pain, or tenderness was found between the active and dummy device groups.
Swelling
Both YPET and control groups improved (p < 0.001) with nonsignificant difference between groups. This was probably because the swelling had disappeared completely in most of the cases in both groups by 3 weeks. There are no similar studies that had included assessment of swelling as an outcome variable.
Fracture line density and breaks in cortices
Both YPET and the control groups showed increase in density and reduction in number of broken cortices (p < 0.001), with significant difference between groups indicating a better radiological healing after YPET.
Data are available on the efficacy of LIPUS therapy in decreasing the healing time. In a study of 67 closed or grade 1 open diaphyseal fractures of the tibia, treated by closed reduction and cast immobilization, the time taken for bridging of all four cortices was significantly less for the 33 fractures treated with LIPUS than for the 34 treated with placebo (114 ± 7.5 days LIPUS versus 182 ± 15.8 days placebo, p = 0.0002). 14
One (1) published study on qigong therapy by Zin and Jinding 9 demonstrated that the amount and density of callus formation was significantly higher in the experimental (emitted qi) group compared to the control group in experimentally induced fractures in rabbits. 9 It may be hypothesized, based on the available literature, that there are three mechanisms to explain the processes involved in rapid healing observed in this study: (1) YPET may have similar effects to qigong therapy, where the concept of projecting the qi energy to the fracture site by an external healer is practiced widely in China. (2) Research indicates that the techniques included in the YPET program, such as progressive relaxation, guided visualization (white light projected to the affected area), suggestion, and meditation, could affect the hypothalamic–pituitary–adrenal (HPA) axis, 15 sympathovagal balance, and probably oxytocin release. 16 All of these could affect wound 17 and bone healing, 16,18 pain perception, 19 and stress. 17 Guided imagery has also been associated with reduced stress, reduced cortisol, and enhanced wound healing. 17 There are various studies on the effect of meditation on the HPA axis. 15 It has been suggested that oxytocin (OT) can become conditioned to psychologic state or imagery, and therefore it may also mediate the benefits attributed to therapies such as hypnosis or meditation. 16 Stripolli et al. report that OT, a primitive neurohypophyseal hormone, hitherto thought solely to modulate lactation and social bonding, is a direct regulator of bone mass. 18 The techniques included in YPET probably enhance parasympathetic tone and may release OT which could enhance bone healing. (3) Hypnotic suggestion has been shown to induce forearm vasodilation and blood flow while decreasing vascular resistance. 20 Hypnosis is a form of focused attention. It may be hypothesized that the suggestion of white light projected to the affected area in YPET has a similar effect and culminates in enhanced blood flow at the fracture site.
Several confounding variables such as site of the fracture, type of fracture, time lapsed before seeking help, diet, activity level, and the basic nutritional status may all have influenced the rate of healing. Many more randomized control studies controlling for all variables may be necessary before recommending this practice routinely in clinical practice.
Limitations
Small sample size, short duration of study, lack of an active control intervention, and assessments done using a simple roentgenographic image repeated at two points could be considered limitations of this study.
Strength and suggestions
The strength of this study was its randomized design with well-matched groups with simple fractures recruited from one orthopedic center with the same surgeon's protocol of management for both groups. Results showing significant difference between groups even with a small sample size is another useful contribution. Future studies on cases of nonunion in different ethnic groups are recommended.
Conclusions
In a randomized controlled study of simple fractures, patients given add-on YPET showed significant improvements in ratings of pain, tenderness, fracture line density, and bridging of cortices compared with those given standard treatment alone.
Footnotes
Acknowledgments
We thank the hospital administration of Ebnezar Orthopedic Centre, Parimala Speciality Hospital, Bengaluru for funding the study. We are grateful to the biostatistician Dr. R. Kulkarni for his help.
Disclosure Statement
No competing financial interests exist.
