Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-04-19 @ 6:52 AM
Study NCT ID:
NCT04520334
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
Sponsor:
Lund University
Organization:
Study Overview
Official Title:
A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: