NCT02724826

Brief Summary

A randomized controlled, multicenter trial comparing qigong and exercise therapy concerning pain intensity, treatment expectations, disability, neck movements and quality of life in subjects with non-specific, long-term NP after three and twelve months.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
11 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

March 7, 2016

Last Update Submit

March 24, 2016

Conditions

Neck Pain

Keywords

ExpectationsOutcomesQigongExercise therapyDisabilityNeck movements,

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    measured with a visual analogue scale (VAS - measured in millimeters with the end points 0 = no pain and 100 = unbearable pain)

    3 months and after 1 year

Secondary Outcomes (4)

  • Expectation

    3 months

  • Disability, measured with the Neck Disability Index (NDI)

    3 months and after 1 year

  • Quality of Life (SF36)

    3 months and after 1 year

  • Segmental flexion and mobility in the cervico-thoracic spine

    3 months and after 1 year

Study Arms (2)

Qigong therapy

EXPERIMENTAL

The qigong treatment was done according to medical qigong, and is a way of affecting and directing qi (energy) for medical benefit. Each qigong practice included body posture adjustment, gentle movement, meditation, relaxation, breathing regulation practices and massage. The qigong was practiced in groups of ten to 15 participants. Each qigong session started with information about the philosophy and a general warm-up with soft movements and 14 selected qigong exercises according to the Biyun method.

Behavioral: Exercise therapy

Exercise therapy

ACTIVE COMPARATOR

Exercise therapy was carried out individually, adjusted for each participant. A physiotherapist instructed the participant with focused on the cervical and shoulder/thoracic regions. Each training session included stationary bicycle for ten minutes, 40 minutes of dynamic exercises. These exercises consisted of active movements in all neck directions and muscle exercises aimed to maintain/increase circulation, endurance and strength. The load at the muscle exercises was to achieve between 30 and 70% of maximum muscle capacity and was gradually increased as endurance and strength were gained.

Behavioral: Qigong therapy

Interventions

Qigong therapyBEHAVIORAL

Medical qigong

Exercise therapy
Exercise therapyBEHAVIORAL

Regular exercise

Qigong therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 18-65 years of age
  • nonspecific, long term neck pain (\<3 months).

You may not qualify if:

  • chronic tension-type headache,
  • migraine,
  • traumatic neck injuries,
  • neurologic signs or symptoms,
  • rheumatic diseases,
  • fibromyalgia or other severe physiologic or physical diseases
  • difficulty in understand the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Persson LCG, Lansinger B, Carlsson J, Gard G. Expectations of Qigong and Exercise Therapy in Patients With Long-term Neck Pain: An Analysis of a Prospective Randomized Study. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):676-684. doi: 10.1016/j.jmpt.2017.07.009.

    PMID: 29229058DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Lena-Karin Erlandsson, PhD

    Head of Health Sciences Lund

    STUDY CHAIR

  • Jane Y Carlsson, professor

    Head of Health Sciences Gothenburg, jane.carlsson@neuro.gu.se

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RPT. PhD

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 31, 2016

Study Start

August 1, 2000

Primary Completion

August 1, 2004

Study Completion

August 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report Access