A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain

Chronic Low Back Pain Clinical Trial

Official title:

A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520334
• Other study ID #: Project Zhineng Qigong
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Sciatica
• Intervertebral Disc Degeneration
• Low Back Pain
• Lumbago
• Lumbar Disc Degeneration
• Lumbar Disc Herniation
• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Persistent Postoperative Pain
• Sciatica
• Spinal Stenosis
• Spondylolisthesis

Intervention

Other:
• Zhineng Qigong intervention
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.

Locations

Country	Name	City	State
Sweden	Primary Healthcare Centre Dalby	Dalby
Sweden	Primary Healthcare Centre Löddeköpinge	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

Sponsors (4)

Lead Sponsor	Collaborator
Lund University	Ekhaga foundation, Greta and Johan Kock Foundation, The Swedish Institute for Health Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Physical activities	Type and amount of performed physical activities, question designed for this study.	At baseline concerning past 3 months, after intervention since intervention start
Other	Treatments	Type and amount of received treatments, question designed for this study.	At baseline concerning past 3 months, after intervention since intervention start
Other	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
Primary	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
Secondary	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
Secondary	Non-pain symptoms	Question (designed for this study) with checkboxes for selecting common lumbar spine-related non-pain symptoms.	Before intervention and as soon as possible after
Secondary	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
Secondary	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
Secondary	Change in intake of analgesics	Question (designed for this study) with options.	At baseline concerning past 3 months, after intervention since intervention start
Secondary	Change in intake of other medications	Question (designed for this study) with options.	At baseline concerning past 3 months, after intervention since intervention start
Secondary	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
Secondary	Performed lumbar spine surgery	Follow-up if planned surgery was performed, for respondents on waiting list for lumbar spine surgery.	6 months after intervention
Secondary	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
Secondary	Active cervical range of motion	Flexion, extension, rotation, and lateral flexion measured using Myrin inclinometer.	Before and after the intervention period
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Oswestry Disability Index version 2.1a	Questionnaire assessing spine-related disability "for today".	Before intervention and as soon as possible after
Secondary	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
Secondary	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
Secondary	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
Secondary	Recruitment rate	The percentage of enrolled patients among those who early were estimated to be eligible.	Before intervention
Secondary	Retention rate	The percentage of patients who completed the study among those who were enrolled.	After intervention
Secondary	Attendance in group activities	Attended hours in group activities were registered.	During intervention
Secondary	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
Secondary	Ability to collect outcome measures	The percentage of completed outcome measures.	At baseline and after intervention