Chronic Low Back PainNCT04520334
A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
A study testing Zhineng Qigong intervention in people with Chronic Low Back Pain and Chronic Sciatica, run by Lund University at 9 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain, Chronic Sciatica, Lumbar Spinal Stenosis
- What is being tested?
- Zhineng Qigong intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 9 sitesSweden
- Study dates
- Nov 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Sweden9 sites
Primary Healthcare Centre Dalby
Dalby
Primary Healthcare Centre Löddeköpinge
Löddeköpinge
Primary Healthcare Centre Capio Citykliniken Clemenstorget
Lund
Primary Healthcare Centre Laurentiikliniken
Lund
Primary Healthcare Centre Linero/Östra Torn
Lund
Primary Healthcare Centre Måsen
Lund
Primary Healthcare Centre Nöbbelöv
Lund
Orthopaedic clinic, Skåne University Hospital
Malmö
Primary Healthcare Centre Södra Sandby
Södra Sandby
About this study
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.
Read the 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.
- Conditions
- Chronic Low Back Pain, Chronic Sciatica, Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbago
- Being tested
- Zhineng Qigong intervention
- Keywords
- Exercise, Training, Qigong, Clinical Trial
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Spondylolisthesis, Low Back Pain, Intervertebral Disc Degeneration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zhineng Qigong interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Zhineng Qigong | Other | Zhineng Qigong intervention Receives: Other: Zhineng Qigong intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively
Secondary outcomes (26)
Pain symptoms
Question (designed for this study) with checkboxes for selecting common lumbar spine-related pain symptoms.
Measured: Before intervention and as soon as possible after
Non-pain symptoms
Question (designed for this study) with checkboxes for selecting common lumbar spine-related non-pain symptoms.
Measured: 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".
Measured: 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".
Measured: Before intervention and as soon as possible after
Change in intake of analgesics
Question (designed for this study) with options.
Measured: At baseline concerning past 3 months, after intervention since intervention start
Change in intake of other medications
Question (designed for this study) with options.
Measured: 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.
Measured: 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.
Measured: 6 months after intervention
Walking ability
The respondent walked 10 meters and back, gait performance was noted ("normal gait", "slight limping", or "severe limping").
Measured: Before and after the intervention period
Active cervical range of motion
Flexion, extension, rotation, and lateral flexion measured using Myrin inclinometer.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after the intervention period
Oswestry Disability Index version 2.1a
Questionnaire assessing spine-related disability "for today".
Measured: 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).
Measured: 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".
Measured: 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).
Measured: Before intervention and as soon as possible after
Recruitment rate
The percentage of enrolled patients among those who early were estimated to be eligible.
Measured: Before intervention
Retention rate
The percentage of patients who completed the study among those who were enrolled.
Measured: After intervention
Attendance in group activities
Attended hours in group activities were registered.
Measured: During intervention
Individual Zhineng Qigong training time
Training diary (designed for this study) with individual daily Zhineng Qigong training time (minutes), besides group activities.
Measured: During intervention and 2 weeks after intervention
Ability to collect outcome measures
The percentage of completed outcome measures.
Measured: At baseline and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study startNov 2013
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Institute for Health Sciences, Ekhaga foundation, Greta and Johan Kock Foundation
- Responsible party
- Sponsor
- Investigators
- Gabriella Pozarek, MD, Principal investigator, Faculty of Medicine, Department of Health Sciences, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520334
- Sponsor's protocol ID
- Project Zhineng Qigong
- Status last verified
- Aug 2020
- First submitted
- 3 Mar 2014
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37312140
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
- ClinicalTrials.gov ID
- NCT04520334
- Acronym / sponsor ID
- Project Zhineng Qigong
- Conditions
- Chronic Low Back Pain, Chronic Sciatica, Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbago
- Keywords
- Exercise, Training, Qigong, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- The Swedish Institute for Health Sciences, Ekhaga foundation, Greta and Johan Kock Foundation
- Study start
- Nov 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zhineng Qigong | Other | Other: Zhineng Qigong interventionZhineng Qigong intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zhineng Qigong interventionThe 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. | Other | Zhineng Qigong |
Primary outcome
Pain intensity
Time frame: 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).
26 secondary outcomes
Pain symptoms
Time frame: Before intervention and as soon as possible after
Non-pain symptoms
Time frame: Before intervention and as soon as possible after
How often "free from pain"
Time frame: Before intervention and as soon as possible after
How often "free from non-pain symptoms"
Time frame: Before intervention and as soon as possible after
Change in intake of analgesics
Time frame: At baseline concerning past 3 months, after intervention since intervention start
Change in intake of other medications
Time frame: At baseline concerning past 3 months, after intervention since intervention start
Healthcare utilisation
Time frame: At baseline concerning past 3 months, after intervention since intervention start
Performed lumbar spine surgery
Time frame: 6 months after intervention
Walking ability
Time frame: Before and after the intervention period
Active cervical range of motion
Time frame: Before and after the intervention period
Active maximal functional shoulder mobility
Time frame: Before and after the intervention period
Passive hip mobility
Time frame: Before and after the intervention period
Finger tip-floor distance
Time frame: Before and after the intervention period
Schober test
Time frame: Before and after the intervention period
Single leg stance
Time frame: Before and after the intervention period
Timed get-up-and-go
Time frame: Before and after the intervention period
Straight leg raising test
Time frame: Before and after the intervention period
Oswestry Disability Index version 2.1a
Time frame: Before intervention and as soon as possible after
Short Form 36 version 2
Time frame: Before intervention and as soon as possible after
EQ-5D-5L (including EQ VAS)
Time frame: Before intervention and as soon as possible after
Additional aspects concerning Health-Related Qualify of Life
Time frame: Before intervention and as soon as possible after
Recruitment rate
Time frame: Before intervention
Retention rate
Time frame: After intervention
Attendance in group activities
Time frame: During intervention
Individual Zhineng Qigong training time
Time frame: During intervention and 2 weeks after intervention
Ability to collect outcome measures
Time frame: At baseline and after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Derived from this study: PubMed 37312140Pozarek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella Pozarek, MD principal investigator
Faculty of Medicine, Department of Health Sciences, Lund University, Sweden
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zhineng Qigong intervention in people with Chronic Low Back Pain and Chronic Sciatica, run by Lund University at 9 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04520334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.