Clinical trial NCT04520334: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: The Swedish Institute for Health Sciences
name: Ekhaga foundation
name: Greta and Johan Kock Foundation
First posted: 2020-08-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Pain intensity
timeFrame: Filled in once daily during 2 weeks, directly before and directly after the intervention period, respectively
Secondary outcomes:
measure: Pain symptoms
timeFrame: Before intervention and as soon as possible after
measure: Non-pain symptoms
timeFrame: Before intervention and as soon as possible after
measure: How often "free from pain"
timeFrame: Before intervention and as soon as possible after
measure: How often "free from non-pain symptoms"
timeFrame: Before intervention and as soon as possible after
measure: Change in intake of analgesics
timeFrame: At baseline concerning past 3 months, after intervention since intervention start
measure: Change in intake of other medications
timeFrame: At baseline concerning past 3 months, after intervention since intervention start
measure: Healthcare utilisation
timeFrame: At baseline concerning past 3 months, after intervention since intervention start
measure: Performed lumbar spine surgery
timeFrame: 6 months after intervention
measure: Walking ability
timeFrame: Before and after the intervention period
measure: Active cervical range of motion
timeFrame: Before and after the intervention period
measure: Active maximal functional shoulder mobility
timeFrame: Before and after the intervention period
measure: Passive hip mobility
timeFrame: Before and after the intervention period
measure: Finger tip-floor distance
timeFrame: Before and after the intervention period
measure: Schober test
timeFrame: Before and after the intervention period
measure: Single leg stance
timeFrame: Before and after the intervention period
measure: Timed get-up-and-go
timeFrame: Before and after the intervention period
measure: Straight leg raising test
timeFrame: Before and after the intervention period
measure: Oswestry Disability Index version 2.1a
timeFrame: Before intervention and as soon as possible after
measure: Short Form 36 version 2
timeFrame: Before intervention and as soon as possible after
measure: EQ-5D-5L (including EQ VAS)
timeFrame: Before intervention and as soon as possible after
measure: Additional aspects concerning Health-Related Qualify of Life
timeFrame: Before intervention and as soon as possible after
measure: Recruitment rate
timeFrame: Before intervention
measure: Retention rate
timeFrame: After intervention
measure: Attendance in group activities
timeFrame: During intervention
measure: Individual Zhineng Qigong training time
timeFrame: During intervention and 2 weeks after intervention
measure: Ability to collect outcome measures
timeFrame: At baseline and after intervention
Other outcomes:
measure: Concomitant disorders
timeFrame: Before intervention and as soon as possible after
measure: Physical activities
timeFrame: At baseline concerning past 3 months, after intervention since intervention start
measure: Treatments
timeFrame: At baseline concerning past 3 months, after intervention since intervention start
measure: Work status
timeFrame: Before intervention and as soon as possible after
Locations:
city: Dalby
country: Sweden
facility: Primary Healthcare Centre Dalby
city: Lund
country: Sweden
facility: Primary Healthcare Centre Capio Citykliniken Clemenstorget
city: Lund
country: Sweden
facility: Primary Healthcare Centre Laurentiikliniken
city: Lund
country: Sweden
facility: Primary Healthcare Centre Linero/Östra Torn
city: Lund
country: Sweden
facility: Primary Healthcare Centre Måsen
city: Lund
country: Sweden
facility: Primary Healthcare Centre Nöbbelöv
city: Löddeköpinge
country: Sweden
facility: Primary Healthcare Centre Löddeköpinge
city: Malmö
country: Sweden
facility: Orthopaedic clinic, Skåne University Hospital
city: Södra Sandby
country: Sweden
facility: Primary Healthcare Centre Södra Sandby
Study officials:
affiliation: Faculty of Medicine, Department of Health Sciences, Lund University, Sweden
name: Gabriella Pozarek, MD
role: PRINCIPAL_INVESTIGATOR
References: