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

Lund University

Status

Completed

Conditions

Chronic Low Back Pain

Lumbar Spondylolisthesis

Lumbar Spinal Stenosis

Persistent Postoperative Pain

Lumbar Disc Herniation

Lumbago

Lumbar Disc Degeneration

Chronic Sciatica

Treatments

Other: Zhineng Qigong intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04520334

Project Zhineng Qigong

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).