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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zhineng Qigong

Zhineng Qigong intervention

Group Type OTHER

Zhineng Qigong intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No