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| Name | Class |
|---|---|
| The Swedish Institute for Health Sciences | UNKNOWN |
| Ekhaga foundation | UNKNOWN |
| Greta and Johan Kock Foundation | UNKNOWN |
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The purpose of this study is to evaluate a Zhineng Qigong intervention for patients with chronic low back pain and/or leg pain, and to test feasibility aspects.
Zhineng Qigong is a self-training method which enables the participant to take an active part in a possible recovery process.
The aims of this study are: 1) evaluate a Zhineng Qigong intervention regarding health aspects (both subjective and objective outcomes) in patients with chronic low back pain and/or leg pain; 2) test different aspects of feasibility including recruiting from different patient populations and testing outcome measurements; and, 3) get a basis for power calculation for a future Randomised Controlled Trial.
Based on previous experiences after Zhineng Qigong training with European Zhineng Qigong, this study is based on the following hypotheses:
The investigators´ idea was to give patients with chronic low back pain and/or leg pain the opportunity to practise Zhineng Qigong in an intervention arranged by European Zhineng Qigong. To this prospective interventional study without control group, patients were recruited from the Swedish spine surgery register (SweSpine), Orthopaedic clinic, and Primary Healthcare. The intervention period was 12 weeks, with measurements once before and once after intervention. However, because of difficulties in recruiting, 15 of the respondents were enrolled to 3 weeks shorter intervention, joining respondents who already started the 12 weeks intervention. Totally, 55 respondents were enrolled.
Background data:
The same physiotherapist examined the respondents once before and once after the intervention period. Two weeks before and two weeks after the intervention period, a "pain diary" was filled in by the respondents. Also, they filled in questionnaires once before and once after the intervention.
During the intervention period participation in the group activities was registered on an attendance list. Every day during the intervention period and two weeks after, the respondents filled in a "training diary" with information about how much Zhineng Qigong was practised besides the group activities.
The respondents that were on waiting list for lumbar spine surgery were asked by telephone if lumbar spine surgery was performed or not. This was done six months after the intervention was completed.
Descriptive and analytical statistics are used to present the results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zhineng Qigong | Other | Zhineng Qigong intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zhineng Qigong intervention | Other | The intervention consisted of group activities which were performed in one group, as lectures, demonstrations, and Zhineng Qigong training, all planned and led by European Zhineng Qigong. The group activities were performed during four weekends (12 hours each) and weekly training two times per week (each for two hours). Introductory lecture (two hours) was given at the evening before the first weekend. The respondents were recommended daily Zhineng Qigong training with help of an instructional training CD. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | "Pain diary" (designed for this study) measured most usual pain intensity (NRS; 0-10) in lumbar spine and/or leg (caused by lumbar spine disorder). | Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain symptoms | Question (designed for this study) with checkboxes for selecting common lumbar spine-related pain symptoms. | Before intervention and as soon as possible after |
| Non-pain symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Concomitant disorders | Concomitant disorders/major health complaints/symptoms other than related to the lumbar spine. Question designed for this study, with checkboxes for common disorders. | Before intervention and as soon as possible after |
| Physical activities |
General inclusion criteria:
Specific inclusion criteria, clinical pathway:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriella Pozarek, MD | Faculty of Medicine, Department of Health Sciences, Lund University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Healthcare Centre Dalby | Dalby | Sweden | ||||
| Primary Healthcare Centre Löddeköpinge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37312140 | Derived | Pozarek G, Stromqvist B, Ekvall Hansson E, Ahlstrom G. Pain and function in patients with chronic low back pain and leg pain after Zhineng Qigong - a quasi-experimental feasibility study. BMC Musculoskelet Disord. 2023 Jun 13;24(1):480. doi: 10.1186/s12891-023-06581-w. |
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|
Question (designed for this study) with checkboxes for selecting common lumbar spine-related non-pain symptoms.
| Before intervention and as soon as possible after |
| How often "free from pain" | Question (designed for this study) with options "Almost never" to "Completely free". | Before intervention and as soon as possible after |
| How often "free from non-pain symptoms" | Question (designed for this study) with options "Almost never" to "Completely free". | Before intervention and as soon as possible after |
| Change in intake of analgesics | Question (designed for this study) with options. | At baseline concerning past 3 months, after intervention since intervention start |
| Change in intake of other medications | Question (designed for this study) with options. | At baseline concerning past 3 months, after intervention since intervention start |
| Healthcare utilisation | Number of visits to physicians, nurses, physiotherapists, occupational therapists, and others. Question designed for this study. | At baseline concerning past 3 months, after intervention since intervention start |
| Performed lumbar spine surgery | Follow-up if planned surgery was performed, for respondents on waiting list for lumbar spine surgery. | 6 months after intervention |
| Walking ability | The respondent walked 10 meters and back, gait performance was noted ("normal gait", "slight limping", or "severe limping"). | Before and after the intervention period |
| Active cervical range of motion | Flexion, extension, rotation, and lateral flexion measured using Myrin inclinometer. | Before and after the intervention period |
| Active maximal functional shoulder mobility | Active shoulder flexion and "hand on neck" were measured using goniometer. "Hand on back" position was noted ("buttocks"; "lumbosacral"; "thoracolumbar"; and, "between scapulae"). | Before and after the intervention period |
| Passive hip mobility | Hip flexion, and external and internal rotation were measured using goniometer. Extension was assessed as normal or reduced. | Before and after the intervention period |
| Finger tip-floor distance | Flexion of lumbar spine with straight knees, with direction of fingers towards the floor in front of the feet. The distance between the middle finger tips and the floor was measured using tape measure. | Before and after the intervention period |
| Schober test | The respondent was asked to do a lumbar flexion with straight knees to a self-chosen range and the increased distance between two skin marks (made at level S1 and 10 centimetres cranially) was registered using tape measure. | Before and after the intervention period |
| Single leg stance | A functional test for balance. The respondent lifted each foot to a standard height of 20 centimetres and tried to maintain the position for 30 seconds. Timed scores were recorded with a digital stop watch. | Before and after the intervention period |
| Timed get-up-and-go | A test for functional mobility. The respondent sat in a chair and at a verbal signal, the respondent stood up without using hands and walked to a point 3 meters in front, then turned around, walked back and sat down again without using hands. Timed scores were recorded with a digital stop watch. | Before and after the intervention period |
| Straight leg raising test | The flexion angle of each hip was measured using Myrin inclinometer placed on the ankle joint. Also, eventual pain radiating to the leg and/or low back pain was registered. | Before and after the intervention period |
| Oswestry Disability Index version 2.1a | Questionnaire assessing spine-related disability "for today". | Before intervention and as soon as possible after |
| Short Form 36 version 2 | Questionnaire assessing generic Health-Related Qualify of Life (standard 4-week recall). | Before intervention and as soon as possible after |
| EQ-5D-5L (including EQ VAS) | Questionnaire assessing generic Health-Related Qualify of Life "for the day". | Before intervention and as soon as possible after |
| Additional aspects concerning Health-Related Qualify of Life | Questions (designed for this study) evaluating perceived concentration ability, distress, sleeping quality, energy level, sadness/depression, irritability, and tension/anxiety, respectively, "the past week" (NRS; 0-10). | Before intervention and as soon as possible after |
| Recruitment rate | The percentage of enrolled patients among those who early were estimated to be eligible. | Before intervention |
| Retention rate | The percentage of patients who completed the study among those who were enrolled. | After intervention |
| Attendance in group activities | Attended hours in group activities were registered. | During intervention |
| Individual Zhineng Qigong training time | Training diary (designed for this study) with individual daily Zhineng Qigong training time (minutes), besides group activities. | During intervention and 2 weeks after intervention |
| Ability to collect outcome measures | The percentage of completed outcome measures. | At baseline and after intervention |
Type and amount of performed physical activities, question designed for this study. |
| At baseline concerning past 3 months, after intervention since intervention start |
| Treatments | Type and amount of received treatments, question designed for this study. | At baseline concerning past 3 months, after intervention since intervention start |
| Work status | Work status (Full-time, Part-time, Not working), and the reason not to work full-time. Question designed for this study. | Before intervention and as soon as possible after |
| Löddeköpinge |
| Sweden |
| Primary Healthcare Centre Capio Citykliniken Clemenstorget | Lund | Sweden |
| Primary Healthcare Centre Laurentiikliniken | Lund | Sweden |
| Primary Healthcare Centre Linero/Östra Torn | Lund | Sweden |
| Primary Healthcare Centre Måsen | Lund | Sweden |
| Primary Healthcare Centre Nöbbelöv | Lund | Sweden |
| Orthopaedic clinic, Skåne University Hospital | Malmö | Sweden |
| Primary Healthcare Centre Södra Sandby | Södra Sandby | Sweden |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| D013168 | Spondylolisthesis |
| D017116 | Low Back Pain |
| D055959 | Intervertebral Disc Degeneration |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
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