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Neck PainQIINCT02724826

Effects of Qigong and Exercise Therapy Among Patients With Chronic Neck Pain

A study testing Qigong therapy and Exercise therapy in people with Neck Pain, run by Lund University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neck Pain
What is being tested?
Qigong therapy and Exercise therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
No sites listed yet
Study dates
Aug 2000to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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.

Read the detailed description

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. A comparison will be performed between the two randomized treatment groups in these variables before and after three and 12 months.

Participants were recruited via an advertisement in a local newspaper. Inclusion: Men and women between 18-65 years of age with nonspecific, long term neck pain (<3 months).Exclusion criteria were chronic tension-type headache, migrain, traumatic neck injuries, neurologic signs or symptoms. rheumatic diseases, fibromyalgia or other severe physiologic or physical diserases and difficulties in understand the Swedish language.

The enrollment of participants, the randomization procedure and the performance of measurements were conducted by four independent physiotherapists. Randomization was done in blocks of 30 according to a sealed envelope technique. Assessments were made before treatment (baseline), immediately after treatment and at six and 12-month follow-ups. All participants answered questionnaires about demographic data, pain (duration and intensity) and disability. Pain intensity was rated as current NP and average NP during the week before the assessment, measured with a visual analogue scale (VAS - measured in millimeters with the end points 0 = no pain and 100 = unbearable pain) (Carlsson, 1983). Neck Movements was measured with cervico Thorac Ratio (CTR) (Norlander 2995), Disability was measured with the Neck Disability Index (NDI) (Vernon, 1991), which consists of a ten-item, scaled questionnaire where the total scores are recalculated into percent (0%, no disability; 100%, maximum disability). The items assess NP according to intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation. Quality of Life was measured with the SF-36 questionnaire (Sullivan1995).

Study participants One hundred and twenty-two subjects with long-term, non-specific NP were randomized to the interventions of qigong (n=60) and exercise therapy (n=62). Eighty-six (70%) were women and 36 (30%) men, with a mean age of 44 years

The participants were allocated randomly to receive qigong or exercise therapy. In each group, the participants received ten to 12 treatments over a period of three months, and each treatment session lasted one hour. A treatment-specific guideline was developed for each treatment. Treatments were provided by experienced physiotherapists; the physiotherapist responsible for qigong had nothing to do with exercise therapy and vice versa. An attendance list was kept during the intervention period, and all participants were informed that they had to attend at least eight of the 12 sessions to be included for analysis in the study.

Qigong was done according to medical qigong, which is a modality of traditional Chinese medicine and is a way of affecting and directing qi (energy) for medical benefit. There are several medical qigong techniques, one being the Biyun method . Each qigong practice included body posture adjustment and gentle movement, meditation (concentration) and purposeful relaxation, breathing regulation practices and self-administered massage. In this study, qigong was practiced in groups of ten to 15 participants. Each qigong session started with information about the philosophy of medical qigong, which was followed by a general warm-up with soft movements for the whole body and then 14 selected qigong exercises according to the Biyun method. The participants were recommended to practice different qigong exercises at home every day.

Exercise therapy was carried out individually, and the training program was adjusted for each participant. A physiotherapist instructed the participant throughout the training program, which focused mainly on the cervical and shoulder/thoracic regions. Each training session started with a warm-up on a stationary bicycle for about ten minutes, followed by 40 minutes of dynamic exercises. These exercises consisted of active movements aimed to cover the full range of motion in all neck directions and muscle exercises aimed to maintain/increase circulation, endurance and strength. The muscle exercises were carried out against gravity or with added resistance (for example with weights, rubber expander, dumbbells and pulley apparatus) and ended with stretching the muscles in the neck, shoulders and upper limbs. The amount of load was individualized and kept within pain tolerance (aimed not to increase pain). 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.

Conditions
Neck Pain
Being tested
Qigong therapy, Exercise therapy
Keywords
Expectations, Outcomes, Qigong, Exercise therapy, Disability, Neck movements,
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qigong therapyBehavioural

    Medical qigong

  • Exercise therapyBehavioural

    Regular exercise

Study groups in NCT02724826
Study groupRoleWhat they receive
Qigong therapyExperimentalThe 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.
Receives: Behavioral: Exercise therapy
Exercise therapyActive comparatorExercise 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.
Receives: Behavioral: Qigong therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity

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

    Measured: 3 months and after 1 year

Secondary outcomes (4)
  1. Expectation

    questionnaires

    Measured: 3 months

  2. Disability, measured with the Neck Disability Index (NDI)

    the Neck Disability Index (NDI) which consists of a ten-item, scaled questionnaire where the total scores are recalculated into percent (0%, no disability; 100%, maximum disability). The items assess NP according to intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and recreation.

    Measured: 3 months and after 1 year

  3. Quality of Life (SF36)

    SF36 questionnaires consists of 36 statements subdivided into eight health-related dimensions: (1) physical functioning, (2) role physical: role limitations due to physical health problems, (3) bodily pain, (4) general health, (5) vitality: energy levels/fatigue, (6) social functioning, (7) role emotional: role limitations due to emotional problems, and (8) mental health: psychological distress Each scale has a maximum score of 100 and higher scores indicate higher subjective health.

    Measured: 3 months and after 1 year

  4. Segmental flexion and mobility in the cervico-thoracic spine

    assesssment with Myrin and Cervical Thoracal Ratio (CTR)

    Measured: 3 months and after 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2016 (estimated)
  2. Study startAug 2000
  3. Primary completionAug 2004
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02724826
Sponsor's protocol ID
516/99
Acronym
QII
Status last verified
Mar 2016
First submitted
7 Mar 2016
Last updated
31 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29229058

Questions about this trial

What is this clinical trial studying?

A study testing Qigong therapy and Exercise therapy in people with Neck Pain, run by Lund University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: 3 months and after 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02724826, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.

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