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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Qigong therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Expectation
questionnaires
Measured: 3 months
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
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
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.
- First posted31 Mar 2016 (estimated)
- Study startAug 2000
- Primary completionAug 2004
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Liselott Persson, Lund University
- Investigators
- Lena-Karin Erlandsson, PhD, Study chair, Head of Health Sciences LundJane Y Carlsson, professor, Study chair, Head of Health Sciences Gothenburg, jane.carlsson@neuro.gu.se
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Qigong and Exercise Therapy Among Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02724826
- Acronym / sponsor ID
- QII / 516/99
- Conditions
- Neck Pain
- Keywords
- Expectations, Outcomes, Qigong, Exercise therapy, Disability, Neck movements,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Aug 2000
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong therapy | Experimental | Behavioral: Exercise therapyThe 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. |
| Exercise therapy | Active comparator | Behavioral: Qigong therapyExercise 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women between 18-65 years of age
- nonspecific, long term neck pain (<3 months).
Key exclusion criteria (7 listed)
- chronic tension-type headache,
- migraine,
- traumatic neck injuries,
- neurologic signs or symptoms,
- rheumatic diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong therapyMedical qigong | Behavioural | Exercise therapy |
| Exercise therapyRegular exercise | Behavioural | Qigong therapy |
Primary outcome
Pain Intensity
Time frame: 3 months and after 1 year
measured with a visual analogue scale (VAS - measured in millimeters with the end points 0 = no pain and 100 = unbearable pain)
4 secondary outcomes
Expectation
Time frame: 3 months
Disability, measured with the Neck Disability Index (NDI)
Time frame: 3 months and after 1 year
Quality of Life (SF36)
Time frame: 3 months and after 1 year
Segmental flexion and mobility in the cervico-thoracic spine
Time frame: 3 months and after 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 29229058Persson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena-Karin Erlandsson, PhD study chair
Head of Health Sciences Lund
Jane Y Carlsson, professor study chair
Head of Health Sciences Gothenburg, jane.carlsson@neuro.gu.se
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.