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

NCT04520334 | Completed

• 1 other identifier: Project Zhineng Qigong
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Pain symptoms

  Before intervention and as soon as possible after

• Non-pain symptoms

  Before intervention and as soon as possible after

• How often "free from pain"

  Before intervention and as soon as possible after

• How often "free from non-pain symptoms"

  Before intervention and as soon as possible after

• Change in intake of analgesics

  At baseline concerning past 3 months, after intervention since intervention start

Other Outcomes (4)

• Concomitant disorders

  Before intervention and as soon as possible after

• Physical activities

  At baseline concerning past 3 months, after intervention since intervention start

• Treatments

  At baseline concerning past 3 months, after intervention since intervention start

Study Arms (1)

Zhineng Qigong

OTHER

Zhineng Qigong intervention

Other: Zhineng Qigong intervention

Interventions

Zhineng Qigong intervention 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.

Zhineng Qigong

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lund University: lead
• The Swedish Institute for Health Sciences: collaborator
• Ekhaga foundation: collaborator
• Greta and Johan Kock Foundation: collaborator

Study Sites (9)

Primary Healthcare Centre Dalby

Dalby, Sweden

Location

Primary Healthcare Centre Löddeköpinge

Löddeköpinge, Sweden

Location

Primary Healthcare Centre Capio Citykliniken Clemenstorget

Lund, Sweden

Location

Primary Healthcare Centre Laurentiikliniken

Lund, Sweden

Location

Primary Healthcare Centre Linero/Östra Torn

Lund, Sweden

Location

Primary Healthcare Centre Måsen

Lund, Sweden

Location

Primary Healthcare Centre Nöbbelöv

Lund, Sweden

Location

Orthopaedic clinic, Skåne University Hospital

Malmo, Sweden

Location

Primary Healthcare Centre Södra Sandby

Södra Sandby, Sweden

Location

Related Publications (1)

• Pozarek G, Stromqvist B, Ekvall Hansson E, Ahlstrom G. Pain and function in patients with chronic low back pain and leg pain after Zhineng Qigong - a quasi-experimental feasibility study. BMC Musculoskelet Disord. 2023 Jun 13;24(1):480. doi: 10.1186/s12891-023-06581-w.

  PMID: 37312140 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement; Spondylolisthesis; Low Back Pain; Intervertebral Disc Degeneration; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Gabriella Pozarek, MD

  Faculty of Medicine, Department of Health Sciences, Lund University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: August 20, 2020
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (9)