Extension Trial of Qigong for Fibromyalgia: A Quantitative and Qualitative Study

This extension trial is an open-label observational trial of 20 subjects with fibromyalgia who undertook level 2 Chaoyi Fanhuan Qigong (CFQ) training following an earlier controlled trial of level 1 CFQ. Subjects practiced 60 min/day for 8 weeks and continued some daily practice for 6 months. Quantitative measures, assessed at baseline, 8 weeks, 4 and 6 months, were of pain, impact, sleep, physical and mental functions, and practice time. Qualitative comments also were recorded. Compared to baselines, CFQ practice led to significant improvements in pain, impact, sleep, and physical function in the 13 subjects (65%) who completed the trial; changes were present at 8 weeks and were maintained for the 6-month trial duration. A highly motivated subgroup of N = 5, who practiced the most, had the best outcomes in terms of end symptomology, and qualitative comments indicated health benefits in other domains as well. Qualitative comments by the remaining N = 8 trial completers and N = 7 withdrawals indicate different experiences with the practice. This extension trial indicates that diligent CFQ practice over time produces significant health gains in fibromyalgia in a subset of individuals. Future studies will need to address factors that might predispose to favourable outcomes.


Introduction
Qigong, which means the cultivation of qi or the energetic essence of the human being, has a long history extending thousands of years, is part of contemporary Traditional Chinese Medicine and constitutes a distinct approach to healing [1,2]. Qigong practice (internal qigong) involves physical movements and postures, breathing practices, and meditative techniques, and there are many forms [1,2]. Multiple forms of qigong are now practiced in many countries, and there is an emerging literature reporting health benefits in several chronic health conditions [3,4]. More recently, qigong has been characterized as "mindful exercise" [5] or "meditative movement" [6] and this provides domains in which components of the practice can be considered.
Fibromyalgia is a chronic pain condition associated with sleep and mood disturbances and diminished quality of life [7,8]. In 2008, a Swedish study reported long-term benefits in pain, sleep, and psychological function in fibromyalgia in a controlled study involving daily practice of qigong for 7 weeks [9]. In Nova Scotia, following completion of a pilot trial involving a similar regimen [10], we conducted a controlled trial of Chaoyi Fanhuan Qigong (CFQ) [11] for fibromyalgia in which subjects were trained in level 1 CFQ movements, practiced daily for 8 weeks, and were encouraged to continue practice for 6 months [12]. Wait list subjects served as a control group and underwent instruction and practice at the end of the wait time. In both cohorts (immediate, delayed), there were significant improvements in pain, impact, sleep, physical function, and mental function, and benefits were maintained to 6 months [12]. Following that trial, some subjects ( = 10) voluntarily undertook level 2 CFQ training (meditation) in the community, continued their practice, and were known, anecdotally, to be experiencing further health improvements. Furthermore, cases of marked benefits in fibromyalgia in those undertaking community-based training and engaging in extensive CFQ practice were documented [13]. In view of this, we undertook an extension trial in which participants 2 Evidence-Based Complementary and Alternative Medicine who completed the controlled trial were invited to participate in a further trial in which level 2 CFQ (meditation) was added to the level 1 CFQ (movement) instruction. The goals of the extension trial were (a) to determine whether level 2 CFQ instruction and further practice would produce additional benefits in fibromyalgia and (b) to document health effects of extensive practice of CFQ. Fibromyalgia is a complex and difficult condition to treat [14] and is a challenge for both patients and clinicians [15]. While drugs are approved for treating fibromyalgia, these have limited efficacy [7,14,16]. Furthermore, multimodal treatments show limited effectiveness in the long-term [17], and longitudinal benefits of treatments are generally modest [18]. It is therefore important to explore all possible modalities for this condition, including practices considered as complementary and alternative medicine or CAM [19,20].

Participants.
The controlled trial of level 1 CFQ was conducted between September 2009 and July 2011 [12]. The current extension trial took place between March and September 2012 and was conducted at the Pain Management Unit, Queen Elizabeth II Health Sciences Centre, Halifax, with Ethics Review Committee approval. Original participants were invited to a review session of trial results (25 attended) and invited to join the extension trial.
= 20 entered the 6-month open-label extension phase. Participants were assigned the same study number as in the original trial for longitudinal tracking. During the initial trial, there were several training cohorts, so the amount of time between level 1 and level 2 CFQ instruction was variable.

Training and Practice.
Extension trial participants received training in level 2 CFQ by a certified instructor (DM) at two half-day (4 hours each) training sessions. This was followed by weekly group practice sessions (60 mins) for 8 weeks. Participants were required to practice daily for 60 mins during these 8 weeks; following that, continued daily practice was encouraged to the end of the trial.
CFQ was developed in the 1990s [11] and is available locally in Nova Scotia. Level 1 instruction consists of a set of 7 movements which are slow and rhythmical and are accompanied by a relaxed mental state and connection-tobody feeling. In a set, there are 10 repetitions of movements 1-5, and 5 repetitions of movements 6-7; each set takes 10-12 mins to complete. Level 2 consists of instruction in meditation techniques, primarily sitting meditation, but standing and lying meditation also were presented as practice options. Sitting meditation involves bringing attention to the interface with the chair, feeling the chair, disengaging thought, and switching into open awareness. With standing meditation, attention is brought to the lower abdomen and into the feet, with lying meditation, to the lower abdomen and contact with the floor, with similar feeling-of-contact and mental instructions. Meditation is practiced for 30 min intervals. Participants were required to practice for a total of 60 mins per day, with a recommendation of level 1 CFQ (movements) and level 2 CFQ (meditation) for 30 mins each.

Outcome Measures.
Quantitative measures were the same as in the level 1 CFQ controlled trial [12] and comply with recommendations for core domain assessments in chronic pain and fibromyalgia trials [21,22]. Measures included (1) pain (NRS-PI, 11-point numerical rating scale pain intensity, with anchors of "no pain" and "pain as bad as you can imagine"), (2) Fibromyalgia Impact Questionnaire (FIQ), (3) Pittsburgh Sleep Quality Index (PSQI), and (4) SF-36 Health Survey (physical and mental scores analysed separately). Participants also completed the following: (5) Patient Satisfaction Scale (How satisfied are you with the qigong treatment? with −3 = very unsatisfied, 0 = neither satisfied nor dissatisfied, +3 = completely satisfied) and (6) Patient Global Impression of Change Scale (How would you grade your overall fibromyalgia condition since using qigong? with −3 = very much worse, 0 = no change, +3 = very much improved). They were also asked to indicate the following: (7) daily practice time (categories of 60, 45, 30, 15, 0 min) and (8) side effects from their practice. A qualitative questionnaire, which invited open-ended comments on experiences, also was included. (At Baseline: briefly describe changes to your health with completion of the first phase of the trial. At 8 weeks: describe changes in your health that you attribute to CFQ practice over the past 8 weeks. At 4 and 6 months: describe changes in your health since entering the study that you attribute to CFQ practice.) Those that had previously voluntarily undertaken level 2 CFQ training were identified in this questionnaire. Assessments were completed on the day of training (baseline) and at the last weekly group session (8 weeks); 4-6 months reports were returned by mail.

Statistical Analysis.
Statistical analysis was conducted on the group that completed the trial to 6 months, the per protocol group. Baselines were compared with 8-week, 4-and 6-month values. Pain, sleep, and SF-physical comparisons were performed using one-way repeated measures analysis of variance (ANOVA), with the Holm-Sidak method for multiple comparisons versus baseline. FIQ scores failed the equal variance test using this method and were analysed using one-way ANOVA with the Student-Newman-Keuls test for pairwise comparisons. SF-mental scores failed variance (oneway repeated measures ANOVA) and normality (one-way ANOVA) and could not be further analysed.

Quantitative Assessments.
The results for pain, impact, sleep, and physical and mental functions for the entire group are presented in Figure 2. Improvements in quantitative scores were generally manifested by 8 weeks and maintained at 4-6 months. There were significant pre-versus postpractice effects for pain, impact, sleep, and physical function. Mental function showed directional trends towards improvement (see also qualitative comments). Data was also analysed as subgroups: (1) those who voluntarily undertook level 2 training prior to the extension trial and were highly motivated ( = 5), (2) other participants who completed the trial ( = 8), and (3) those that withdrew from the trial ( = 7). These results are presented in Figure 3. Both subgroups completing the trial showed improvements in pain, impact, sleep, and physical and mental functions, with similar prepost practice differences. Baseline values appeared different between subgroups, with the highly motivated subgroup showing less severe symptoms, but only physical function was significantly different ( = 0.04, Student's -test).
Self-reported practice times from the categorical checklist are indicated in Table 2. On average, the group completing the trial practiced 35-44 min/day throughout. The = 5 highly motivated subgroup complied with 60 mins/day practice over 8 weeks and maintained this over time (66, 57, and 60 mins/day); the remaining subgroup completing the trial had lower practice times at 8 weeks and these declined over time (38,24, and 20 mins/day). Those that withdrew from the trial had the lowest practice times at 8 weeks.
Patient satisfaction scores (mean ± SD) for those completing the trial were uniformly high at all intervals (7 indicates "completely satisfied"): 5.9 ± 1.8 at 8 weeks, 5.8 ± 1.9 at 4  months, and 6.3 ± 1.0 at 6 months. Patient global impression of change scores (mean ± SD) also were uniformly high (7 indicates "very much improved"): 5.6 ± 1.6 at 8 weeks, 5.7 ± 1.4 at 4 months, and 5.6 ± 1.0 at 6 months. No subgroup analysis of these scores was undertaken. For those who completed the trial ( = 13), the number of pain medications (mean ± SD) at entry was 3.2 ± 1.3; at the end of the trial, this was 1.1 ± 1.3. Six participants (46%) reported no longer taking any pain medications at the end of the trial; all had been taking pain medications at the beginning of the trial. Table 3 presents qualitative comments by the = 5 who voluntarily undertook level 2 CFQ training prior to entering the extension trial. Baseline comments reflect experiences following the previous trial, as well as subsequent voluntary practice. Improvements in many areas were identified after 8 weeks and consolidated at 4 and 6 months. Comments indicate further health benefits beyond those documented by quantitative results. Thus, there are reports of improvements in asthma (006, 007), food allergies (006, 007), allergies and sinus headaches (098), chemical sensitivities (006, 007), carpel tunnel symptoms,  Evidence-Based Complementary and Alternative Medicine   Table 4 summarizes qualitative comments offered by remaining participants who completed the extension trial ( = 8). Several comments are positive and, in addition to mentioning symptoms evaluated in quantitative results, there is mention of improvements in blood pressure (029) and muscular dystrophy symptoms (048). There are also comments indicating pain as a result of practice (019, 029, 044, 075) (see also side effects) and difficulties with meditation (019, 029, 042). Self-reported practice times in the open format for this group are lower than those in the highly motivated group. Table 5 summarizes qualitative comments by those who withdrew from the trial. There are several positive comments as a result of earlier qigong experiences (004, 005), including reduced blood pressure (004, 087), stopping medications (025, 082), and quality of life improvements (089). There are also challenges with the meditation instruction (060). Two who withdrew had low baseline levels of pain (2-3) (004, 005) and would not have been included in the trial if a minimum symptom severity (≥4) was required.

Discussion
This was an extension to a previous randomized controlled trial in which level 2 CFQ (meditation) was added to level 1 CFQ (movement) for subjects with fibromyalgia. Qigong was recently characterized as meditative movement [6], and we were interested in determining whether components of the practice could be examined sequentially. We also wished to document health effects in those who engaged in extensive qigong practice. The trial is best characterized as an open-label observational trial; it is also a long-term trial (2-3 years) and provides valuable longitudinal information on the effects of diligent practice. Quantitative results in those who completed the extension trial indicate significant improvements in core domains of fibromyalgia as a result of qigong practice. Subgroup analysis indicates that the highly motivated group and others who completed the trial attained similar reductions in pain, impact, and sleep impairment, and improvements in function. Of note in the highly motivated subgroup is the observation that postpractice absolute values for pain (scores of 2-3) and impact (scores of 15-25) suggest mild symptomology. Qualitative comments by the highly motivated subgroup recapitulate benefits in core domains, as well as indicating diverse further health benefits (improvements in allergies/sensitivities, migraines, asthma, blood pressure, and vision). Benefits include resumption of exercise and weight loss, which further contribute to improved health. Qualitative comments for others who completed the trial also contain positive health comments but are more moderate in tone. Subgroups were distinguished in terms of self-reported  Week 8: for the first 2 weeks felt worse, or not improved; had a lot of movements during meditation which I found exhausting, woke stiff and sore. By week 3/4 was feeling a bit more energetic and woke feeling better, but tired. By week 6, was feeling good upon waking. By week 7/8, am feeling good most of the day. Back gets sore by late afternoon. Burning and stiffness due to fibromyalgia are mostly gone. Have more energy, less pain. Month 4-6: had to stop sitting meditation as it caused lower back pain, so do lying meditation; very relaxing, fall asleep within minutes. Sleep more soundly and have more energy. Less fibromyalgia pain (still have arthritis aches-spine and hand) (4 mo). Am more relaxed, fall asleep more easily.   Collectively, these quantitative and qualitative results indicate that dedicated CFQ practice over time produces marked and sustained benefits in core domains relevant to fibromyalgia, as well as additional health benefits. These outcomes are generally supported by other trials of fibromyalgia and related conditions, where sustained qigong practice (daily for 6-12 weeks) is involved [9,23,24]. Other trials of qigong for fibromyalgia used qigong as part of a weekly regimen over 8-12 weeks and reported more equivocal results [25][26][27]. Improvements in some conditions in the present trial noted in qualitative comments (e.g., blood pressure) are supported by an emerging literature [28]. Of particular note is the magnitude of change in several conditions (asthma resolving, improved mobility, weight loss, improved eyesight, resolution of carpel tunnel symptoms, and resolution of allergies/sensitivities). Beneficial effects were most prominent in the group that engaged in the most qigong practice. Similar marked improvements in diverse conditions were observed after extended CFQ practice in case reports [13]. Based on these results, and recognizing that these benefits occur in those who have been compromised for an extended period of time (fibromyalgia mean duration 11.8 years, = 13), further studies on the health benefits of qigong practice, and especially extended practice, in fibromyalgia as well as other chronic health conditions, are encouraged. In some frameworks, fibromyalgia is considered a central sensitization syndrome along with other disorders (e.g., chronic fatigue syndrome, regional pain disorders, irritable bowel syndrome, and headache disorders) [29,30], and it would be interesting to ascertain effects of qigong in these conditions. Thus, it was recently reported that qigong is of benefit in chronic fatigue syndrome [24].
There are several methodological issues to consider in relation to this extension trial. (1) Qigong, a Complex Practice. Qigong, along with tai chi, is characterized as meditative movement [6] and is a complex intervention with many components potentially contributing to efficacy [3,5,31]. It is impossible to blind qigong practice, and trial designs such as randomized controlled trials of fixed protocols, communitybased observational trials, cross-sectional studies of longterm practitioners, and studies that integrate qualitative methods to capture the richness of participant experiences have been encouraged [32]. The current extension trial incorporates several of these recommended trial design elements.
(2) Plurality of Forms, Components. There are many forms of qigong [1,2], and the contribution of a particular component of activity to the outcome is not clear. Considering qigong as meditative movement [6] is useful as it provides domains for comparison, and future trials can compare qigong with exercise regimens or with meditation groups. However, there are various forms (aerobic, strength, and flexibility) and intensities (mild, moderate) of exercise, and this area has its own research challenges [33,34]. Additionally, there is a multiplicity of mind-body interventions (mindfulness, meditation) and this field also contends with methodological challenges [35]. The current trial did not have a comparison group and assessed pre-versus post-intervention outcomes in a quantitative and qualitative manner; it is pragmatic and akin to clinical practice. (3) Extent of Practice, Effectiveness of Practice. How much qigong practice is needed for clinically meaningful effects ("minimal dose"), and whether further practice leads to better outcomes ("dose-response relationship"), are important issues. Furthermore, there is the issue of effectiveness ("bioavailability"), of whether all time spent seemingly engaged in an activity is equivalent [32]. Post hoc analysis of outcomes in relation to extent of practice indicated differences between those who practiced per protocol or minimally in the earlier controlled trial [12]. In the present trial, we also observed a practice-response relationship, as those who practiced the most had the best outcomes. Systematic assessment of practice time is feasible using standard protocols in controlled trials, as well as with observational trials, and is encouraged for all qigong trials. Furthermore, meta-analysis of qigong trials for fibromyalgia will need to consider this factor in clustering studies for analysis [19,36]. Finally, motivation for or barriers to continued/extensive practice (e.g., use of booster sessions, group versus individual sessions, nature of instruction, and effectiveness of different instructors) will need to be considered in future studies. (4) Identifying Those Who Benefit from Qigong. In this trial, 13/20 (65%) undertook additional instruction, completed 6 months, and experienced significant pre-versus postpractice benefits. This subgroup represents 18% of original trial completers (13/73). Extensive qigong practice requires a considerable commitment and will not be suitable for everyone for many reasons. However, because multiple health benefits can result from diligent practice, as documented here and in case studies of CFQ [13], there will be some willing to engage in such practice if it means relief from a long-standing condition which has not been amenable to other approaches. Future studies on qigong could include additional assessments of participant factors (e.g., psychosocial profile, locus of control, and attitudes towards CAM), to determine those that might predispose to favourable outcomes. Thus, those with fibromyalgia exhibit differences in health related locus of control, cognitive attributes, and perceived social support compared to other chronic pain populations and/or controls, for example, [37,38]. This approach fits within the conceptual frameworks of attribute-treatment interactions [39], preference trials [40], and personalized medicine.

Conclusion
This open-label extension trial indicates that diligent practice of CFQ, a particular form of qigong, produces sustained benefits in fibromyalgia as indicated by quantitative assessments in core domains for fibromyalgia. Qualitative comments indicate health benefits in other areas as well. Benefit is related to extent of practice.