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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qigong therapy
Exercise therapy
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Expectations, Outcomes, Qigong, Exercise therapy, Disability, Neck movements,

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Qigong therapy

    Exercise therapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Expectation
    questionnaires
    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.
    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.
    Segmental flexion and mobility in the cervico-thoracic spine
    assesssment with Myrin and Cervical Thoracal Ratio (CTR)

    Full Information

    First Posted
    March 7, 2016
    Last Updated
    March 24, 2016
    Sponsor
    Lund University
    Collaborators
    Göteborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02724826
    Brief Title
    Effects of Qigong and Exercise Therapy Among Patients With Chronic Neck Pain
    Acronym
    QII
    Official Title
    Effects of Qigong and Exercise Therapy Among Patients With Chronic Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lund University
    Collaborators
    Göteborg University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain
    Keywords
    Expectations, Outcomes, Qigong, Exercise therapy, Disability, Neck movements,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    122 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Qigong therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Exercise therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Qigong therapy
    Intervention Description
    Medical qigong
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise therapy
    Intervention Description
    Regular exercise
    Primary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    measured with a visual analogue scale (VAS - measured in millimeters with the end points 0 = no pain and 100 = unbearable pain)
    Time Frame
    3 months and after 1 year
    Secondary Outcome Measure Information:
    Title
    Expectation
    Description
    questionnaires
    Time Frame
    3 months
    Title
    Disability, measured with the Neck Disability Index (NDI)
    Description
    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.
    Time Frame
    3 months and after 1 year
    Title
    Quality of Life (SF36)
    Description
    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.
    Time Frame
    3 months and after 1 year
    Title
    Segmental flexion and mobility in the cervico-thoracic spine
    Description
    assesssment with Myrin and Cervical Thoracal Ratio (CTR)
    Time Frame
    3 months and after 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Men and women between 18-65 years of age nonspecific, long term neck pain (<3 months). Exclusion criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lena-Karin Erlandsson, PhD
    Organizational Affiliation
    Head of Health Sciences Lund
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Jane Y Carlsson, professor
    Organizational Affiliation
    Head of Health Sciences Gothenburg, jane.carlsson@neuro.gu.se
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29229058
    Citation
    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.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Clinical Study Report
    Available IPD/Information URL
    http://resolver.ebscohost.com/openurl?sid=Entrez%3aPubMed&id=pmid%3a18090079&site=ftf-live

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

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