A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
Primary Purpose
Chronic Low Back Pain, Chronic Sciatica, Lumbar Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Zhineng Qigong intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Exercise, Training, Qigong, Clinical Trial
Eligibility Criteria
General inclusion criteria:
- Low back pain and/or leg pain (caused by lumbar disorder) with at least 3 months duration.
- Pain intensity in lumbar spine and/or leg (caused by lumbar disorder) at least 30 on a 0-100 Visual Analogue Scale (VAS), being "the best description of pain the past 2 weeks". (As enrolment initially went slow, also patients scoring VAS pain intensity 25 to 30 became eligible if their pain situations were qualitatively assessed severe, resulting in enrolment of 5 such patients).
- Resident in the county of Skåne (southern part of Sweden).
- Comfortable with the Swedish language.
- Acceptance not to practise Yoga, Meditation, or any other Qigong exercises during or 1 month after the intervention.
Specific inclusion criteria, clinical pathway:
- Postoperative after lumbar spine surgery: one lumbar spine surgery 1-6 years earlier, for either spinal stenosis, spondylolisthesis, or segmental pain. Pain intensity (back and/or leg) at least 30 on 0-100 mm VAS in latest SweSpine follow-up protocol.
- Patients from Primary Healthcare Centres: chronic low back pain (at least 3 months duration) with or without leg pain.
- Patients on waiting list for lumbar spine surgery: Planned first surgery for either spinal stenosis, spondylolisthesis, or segmental pain.
Exclusion criteria:
- Lumbar spine or other major surgery planned before, during, or within 1 month after the intervention period.
- History of serious mental disease, epilepsy, or narcolepsy.
- Current abuse of medicament, drug, or alcohol.
- Pregnancy (due to practical reasons only).
Sites / Locations
- Primary Healthcare Centre Dalby
- Primary Healthcare Centre Capio Citykliniken Clemenstorget
- Primary Healthcare Centre Laurentiikliniken
- Primary Healthcare Centre Linero/Östra Torn
- Primary Healthcare Centre Måsen
- Primary Healthcare Centre Nöbbelöv
- Primary Healthcare Centre Löddeköpinge
- Orthopaedic clinic, Skåne University Hospital
- Primary Healthcare Centre Södra Sandby
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Zhineng Qigong
Arm Description
Zhineng Qigong intervention
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Pain symptoms
Question (designed for this study) with checkboxes for selecting common lumbar spine-related pain symptoms.
Non-pain symptoms
Question (designed for this study) with checkboxes for selecting common lumbar spine-related non-pain symptoms.
How often "free from pain"
Question (designed for this study) with options "Almost never" to "Completely free".
How often "free from non-pain symptoms"
Question (designed for this study) with options "Almost never" to "Completely free".
Change in intake of analgesics
Question (designed for this study) with options.
Change in intake of other medications
Question (designed for this study) with options.
Healthcare utilisation
Number of visits to physicians, nurses, physiotherapists, occupational therapists, and others. Question designed for this study.
Performed lumbar spine surgery
Follow-up if planned surgery was performed, for respondents on waiting list for lumbar spine surgery.
Walking ability
The respondent walked 10 meters and back, gait performance was noted ("normal gait", "slight limping", or "severe limping").
Active cervical range of motion
Flexion, extension, rotation, and lateral flexion measured using Myrin inclinometer.
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").
Passive hip mobility
Hip flexion, and external and internal rotation were measured using goniometer. Extension was assessed as normal or reduced.
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.
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.
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.
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.
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.
Oswestry Disability Index version 2.1a
Questionnaire assessing spine-related disability "for today".
Short Form 36 version 2
Questionnaire assessing generic Health-Related Qualify of Life (standard 4-week recall).
EQ-5D-5L (including EQ VAS)
Questionnaire assessing generic Health-Related Qualify of Life "for the day".
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).
Recruitment rate
The percentage of enrolled patients among those who early were estimated to be eligible.
Retention rate
The percentage of patients who completed the study among those who were enrolled.
Attendance in group activities
Attended hours in group activities were registered.
Individual Zhineng Qigong training time
Training diary (designed for this study) with individual daily Zhineng Qigong training time (minutes), besides group activities.
Ability to collect outcome measures
The percentage of completed outcome measures.
Full Information
NCT ID
NCT04520334
First Posted
March 3, 2014
Last Updated
August 18, 2020
Sponsor
Lund University
Collaborators
The Swedish Institute for Health Sciences, Ekhaga foundation, Greta and Johan Kock Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04520334
Brief Title
A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
Official Title
A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
The Swedish Institute for Health Sciences, Ekhaga foundation, Greta and Johan Kock Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Zhineng Qigong training gives pain reduction and reduced consumption of analgesics.
Zhineng Qigong training reduces lumbar spine-related symptoms (other than pain).
Zhineng Qigong training reduces healthcare utilisation, including lumbar spine surgery.
Zhineng Qigong training improves walking ability, mobility, and functional capacity.
Zhineng Qigong training improves Health-Related Quality of Life, including perceived concentration ability, distress, sleeping quality, vitality, depression, mood, and anxiety.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Chronic Sciatica, Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbago, Lumbar Disc Degeneration, Persistent Postoperative Pain
Keywords
Exercise, Training, Qigong, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zhineng Qigong
Arm Type
Other
Arm Description
Zhineng Qigong intervention
Intervention Type
Other
Intervention Name(s)
Zhineng Qigong intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
"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).
Time Frame
Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively
Secondary Outcome Measure Information:
Title
Pain symptoms
Description
Question (designed for this study) with checkboxes for selecting common lumbar spine-related pain symptoms.
Time Frame
Before intervention and as soon as possible after
Title
Non-pain symptoms
Description
Question (designed for this study) with checkboxes for selecting common lumbar spine-related non-pain symptoms.
Time Frame
Before intervention and as soon as possible after
Title
How often "free from pain"
Description
Question (designed for this study) with options "Almost never" to "Completely free".
Time Frame
Before intervention and as soon as possible after
Title
How often "free from non-pain symptoms"
Description
Question (designed for this study) with options "Almost never" to "Completely free".
Time Frame
Before intervention and as soon as possible after
Title
Change in intake of analgesics
Description
Question (designed for this study) with options.
Time Frame
At baseline concerning past 3 months, after intervention since intervention start
Title
Change in intake of other medications
Description
Question (designed for this study) with options.
Time Frame
At baseline concerning past 3 months, after intervention since intervention start
Title
Healthcare utilisation
Description
Number of visits to physicians, nurses, physiotherapists, occupational therapists, and others. Question designed for this study.
Time Frame
At baseline concerning past 3 months, after intervention since intervention start
Title
Performed lumbar spine surgery
Description
Follow-up if planned surgery was performed, for respondents on waiting list for lumbar spine surgery.
Time Frame
6 months after intervention
Title
Walking ability
Description
The respondent walked 10 meters and back, gait performance was noted ("normal gait", "slight limping", or "severe limping").
Time Frame
Before and after the intervention period
Title
Active cervical range of motion
Description
Flexion, extension, rotation, and lateral flexion measured using Myrin inclinometer.
Time Frame
Before and after the intervention period
Title
Active maximal functional shoulder mobility
Description
Active shoulder flexion and "hand on neck" were measured using goniometer. "Hand on back" position was noted ("buttocks"; "lumbosacral"; "thoracolumbar"; and, "between scapulae").
Time Frame
Before and after the intervention period
Title
Passive hip mobility
Description
Hip flexion, and external and internal rotation were measured using goniometer. Extension was assessed as normal or reduced.
Time Frame
Before and after the intervention period
Title
Finger tip-floor distance
Description
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.
Time Frame
Before and after the intervention period
Title
Schober test
Description
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.
Time Frame
Before and after the intervention period
Title
Single leg stance
Description
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.
Time Frame
Before and after the intervention period
Title
Timed get-up-and-go
Description
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.
Time Frame
Before and after the intervention period
Title
Straight leg raising test
Description
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.
Time Frame
Before and after the intervention period
Title
Oswestry Disability Index version 2.1a
Description
Questionnaire assessing spine-related disability "for today".
Time Frame
Before intervention and as soon as possible after
Title
Short Form 36 version 2
Description
Questionnaire assessing generic Health-Related Qualify of Life (standard 4-week recall).
Time Frame
Before intervention and as soon as possible after
Title
EQ-5D-5L (including EQ VAS)
Description
Questionnaire assessing generic Health-Related Qualify of Life "for the day".
Time Frame
Before intervention and as soon as possible after
Title
Additional aspects concerning Health-Related Qualify of Life
Description
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).
Time Frame
Before intervention and as soon as possible after
Title
Recruitment rate
Description
The percentage of enrolled patients among those who early were estimated to be eligible.
Time Frame
Before intervention
Title
Retention rate
Description
The percentage of patients who completed the study among those who were enrolled.
Time Frame
After intervention
Title
Attendance in group activities
Description
Attended hours in group activities were registered.
Time Frame
During intervention
Title
Individual Zhineng Qigong training time
Description
Training diary (designed for this study) with individual daily Zhineng Qigong training time (minutes), besides group activities.
Time Frame
During intervention and 2 weeks after intervention
Title
Ability to collect outcome measures
Description
The percentage of completed outcome measures.
Time Frame
At baseline and after intervention
Other Pre-specified Outcome Measures:
Title
Concomitant disorders
Description
Concomitant disorders/major health complaints/symptoms other than related to the lumbar spine. Question designed for this study, with checkboxes for common disorders.
Time Frame
Before intervention and as soon as possible after
Title
Physical activities
Description
Type and amount of performed physical activities, question designed for this study.
Time Frame
At baseline concerning past 3 months, after intervention since intervention start
Title
Treatments
Description
Type and amount of received treatments, question designed for this study.
Time Frame
At baseline concerning past 3 months, after intervention since intervention start
Title
Work status
Description
Work status (Full-time, Part-time, Not working), and the reason not to work full-time. Question designed for this study.
Time Frame
Before intervention and as soon as possible after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General inclusion criteria:
Low back pain and/or leg pain (caused by lumbar disorder) with at least 3 months duration.
Pain intensity in lumbar spine and/or leg (caused by lumbar disorder) at least 30 on a 0-100 Visual Analogue Scale (VAS), being "the best description of pain the past 2 weeks". (As enrolment initially went slow, also patients scoring VAS pain intensity 25 to 30 became eligible if their pain situations were qualitatively assessed severe, resulting in enrolment of 5 such patients).
Resident in the county of Skåne (southern part of Sweden).
Comfortable with the Swedish language.
Acceptance not to practise Yoga, Meditation, or any other Qigong exercises during or 1 month after the intervention.
Specific inclusion criteria, clinical pathway:
Postoperative after lumbar spine surgery: one lumbar spine surgery 1-6 years earlier, for either spinal stenosis, spondylolisthesis, or segmental pain. Pain intensity (back and/or leg) at least 30 on 0-100 mm VAS in latest SweSpine follow-up protocol.
Patients from Primary Healthcare Centres: chronic low back pain (at least 3 months duration) with or without leg pain.
Patients on waiting list for lumbar spine surgery: Planned first surgery for either spinal stenosis, spondylolisthesis, or segmental pain.
Exclusion criteria:
Lumbar spine or other major surgery planned before, during, or within 1 month after the intervention period.
History of serious mental disease, epilepsy, or narcolepsy.
Current abuse of medicament, drug, or alcohol.
Pregnancy (due to practical reasons only).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriella Pozarek, MD
Organizational Affiliation
Faculty of Medicine, Department of Health Sciences, Lund University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Healthcare Centre Dalby
City
Dalby
Country
Sweden
Facility Name
Primary Healthcare Centre Capio Citykliniken Clemenstorget
City
Lund
Country
Sweden
Facility Name
Primary Healthcare Centre Laurentiikliniken
City
Lund
Country
Sweden
Facility Name
Primary Healthcare Centre Linero/Östra Torn
City
Lund
Country
Sweden
Facility Name
Primary Healthcare Centre Måsen
City
Lund
Country
Sweden
Facility Name
Primary Healthcare Centre Nöbbelöv
City
Lund
Country
Sweden
Facility Name
Primary Healthcare Centre Löddeköpinge
City
Löddeköpinge
Country
Sweden
Facility Name
Orthopaedic clinic, Skåne University Hospital
City
Malmö
Country
Sweden
Facility Name
Primary Healthcare Centre Södra Sandby
City
Södra Sandby
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
We'll reach out to this number within 24 hrs