A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
- Conditions
- LumbagoChronic SciaticaLumbar SpondylolisthesisLumbar Spinal StenosisPersistent Postoperative PainLumbar Disc DegenerationChronic Low Back PainLumbar Disc Herniation
- Interventions
- Other: Zhineng Qigong intervention
- Registration Number
- NCT04520334
- Lead Sponsor
- Lund University
- Brief Summary
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.
- Detailed Description
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:
1. Zhineng Qigong training gives pain reduction and reduced consumption of analgesics.
2. Zhineng Qigong training reduces lumbar spine-related symptoms (other than pain).
3. Zhineng Qigong training reduces healthcare utilisation, including lumbar spine surgery.
4. Zhineng Qigong training improves walking ability, mobility, and functional capacity.
5. Zhineng Qigong training improves Health-Related Quality of Life, including perceived concentration ability, distress, sleeping quality, vitality, depression, mood, and anxiety.
The investigatorsĀ“ 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:
* Age
* Gender
* Marital status
* Children at home (number and age)
* Duration of symptoms in the lumbar spine and/or leg (year-month when the symptoms started)
* Lumbar spine diagnosis (name and year-month of the diagnosis)
* History of lumbar spine surgery (number of times and which years)
* Type of surgery and surgery level(s) (for postoperative patients)
* Sick- or disability pension (since which year-month and main reason)
* Treatments and/or training methods already tried (also for how long time)
* Educational level
* Occupation or living situation
* Smoking habits
* Financial difficulties
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zhineng Qigong Zhineng Qigong intervention Zhineng Qigong intervention
- Primary Outcome Measures
Name Time Method Pain intensity Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively "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).
- Secondary Outcome Measures
Name Time Method Timed get-up-and-go Before and after the intervention period 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.
Additional aspects concerning Health-Related Qualify of Life Before intervention and as soon as possible after 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).
Retention rate After intervention The percentage of patients who completed the study among those who were enrolled.
Pain symptoms Before intervention and as soon as possible after Question (designed for this study) with checkboxes for selecting common lumbar spine-related pain symptoms.
Non-pain symptoms Before intervention and as soon as possible after Question (designed for this study) with checkboxes for selecting common lumbar spine-related non-pain symptoms.
How often "free from pain" Before intervention and as soon as possible after Question (designed for this study) with options "Almost never" to "Completely free".
Change in intake of analgesics At baseline concerning past 3 months, after intervention since intervention start Question (designed for this study) with options.
Change in intake of other medications At baseline concerning past 3 months, after intervention since intervention start Question (designed for this study) with options.
How often "free from non-pain symptoms" Before intervention and as soon as possible after Question (designed for this study) with options "Almost never" to "Completely free".
Active maximal functional shoulder mobility Before and after the intervention period Active shoulder flexion and "hand on neck" were measured using goniometer. "Hand on back" position was noted ("buttocks"; "lumbosacral"; "thoracolumbar"; and, "between scapulae").
Oswestry Disability Index version 2.1a Before intervention and as soon as possible after Questionnaire assessing spine-related disability "for today".
Healthcare utilisation At baseline concerning past 3 months, after intervention since intervention start Number of visits to physicians, nurses, physiotherapists, occupational therapists, and others. Question designed for this study.
Performed lumbar spine surgery 6 months after intervention Follow-up if planned surgery was performed, for respondents on waiting list for lumbar spine surgery.
Walking ability Before and after the intervention period The respondent walked 10 meters and back, gait performance was noted ("normal gait", "slight limping", or "severe limping").
Active cervical range of motion Before and after the intervention period Flexion, extension, rotation, and lateral flexion measured using Myrin inclinometer.
Passive hip mobility Before and after the intervention period Hip flexion, and external and internal rotation were measured using goniometer. Extension was assessed as normal or reduced.
Finger tip-floor distance Before and after the intervention period 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.
Schober test Before and after the intervention period 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.
Single leg stance Before and after the intervention period 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.
Straight leg raising test Before and after the intervention period 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.
Short Form 36 version 2 Before intervention and as soon as possible after Questionnaire assessing generic Health-Related Qualify of Life (standard 4-week recall).
Recruitment rate Before intervention The percentage of enrolled patients among those who early were estimated to be eligible.
Attendance in group activities During intervention Attended hours in group activities were registered.
EQ-5D-5L (including EQ VAS) Before intervention and as soon as possible after Questionnaire assessing generic Health-Related Qualify of Life "for the day".
Individual Zhineng Qigong training time During intervention and 2 weeks after intervention Training diary (designed for this study) with individual daily Zhineng Qigong training time (minutes), besides group activities.
Ability to collect outcome measures At baseline and after intervention The percentage of completed outcome measures.
Trial Locations
- Locations (9)
Primary Healthcare Centre Dalby
šøšŖDalby, Sweden
Primary Healthcare Centre Laurentiikliniken
šøšŖLund, Sweden
Primary Healthcare Centre Linero/Ćstra Torn
šøšŖLund, Sweden
Primary Healthcare Centre MĆ„sen
šøšŖLund, Sweden
Primary Healthcare Centre Nƶbbelƶv
šøšŖLund, Sweden
Primary Healthcare Centre Lƶddekƶpinge
šøšŖLƶddekƶpinge, Sweden
Orthopaedic clinic, SkƄne University Hospital
šøšŖMalmƶ, Sweden
Primary Healthcare Centre Sƶdra Sandby
šøšŖSƶdra Sandby, Sweden
Primary Healthcare Centre Capio Citykliniken Clemenstorget
šøšŖLund, Sweden