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NCT Number: NCT01869712

PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies

To assess the application of partially randomized patient preference (PRPP) trial model which concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies (acupuncture and cupping therapy) for fibromyalgia.

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Key information

Conditions

Fibromyalgia Behavior Health Behavior Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Patient Preference Patient Satisfaction Rheumatic Diseases Treatment Adherence and Compliance

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing University of Chinese Medicine Affiliated Dongfang Hospital

Beijing, Beijing Municipality, 100078, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with fibromyalgia diagnosed according to criteria formulated by American College Rheumatology 2002;
  • Patients whose scores for pain intensity is more than 30mm;
  • Patients who are 20 to 60 years old;
  • Patients who fully understand the process of this research and who are willing to provide informed consent.

Exclusion criteria

  • The widespread muscular-skeletal pain is caused by some kind of disease, surgery, or other external interference factors (except fibromyalgia);
  • Patients with mental disorders, or other serious organic diseases, such as organ failure;
  • Patients who take oral anodyne medications or accept other interventions for pain relief during the treatment;
  • Pregnant or lactating women;
  • Patients currently participating in another clinical trial.

Treatment and study plan

cupping therapy

Other

Acupuncture

Other

Primary outcomes

  1. Patients' compliance

    Time frame: Record the number of drop out or lost during the 5 weeks' treatment and 3 months' follow up duration (for an expected totally 17 weeks) and note the reason for missing data

  2. Patients satisfactory for the treatment

    Time frame: The satisfactory for the treatment is investigated at week 5 (as the end of the treatment).

    Satisfactory for the treatment is measured by a seven-score scale, with 1 for "very satisfied" and 7 for "very unsatisfied".

  3. Practitioners' attitude for the research model

    Time frame: Practitioners' attitude for the research model is investigated at week 5 (as the end of the treatment).

    Individual interview or the focus group interview will be applied after the treatment, all the practitioners in the study (including acupuncturists and cupping therapy practitioners) will be interviewed to know their attitude for conducting the partially randomized patient preference trial model and their thoughts of this model compare to general randomized controlled trial.

Secondary outcomes

  1. Adverse events

    Time frame: Adverse events will be observed for the duration of 5 weeks' treatment and 3 months' follow-up, with an expected average of totally 17 weeks.

    Researchers should note any minor or serious adverse event occurs during treatment and follow up duration, including cases and symptoms of patients with adverse events.

  2. Patients' expectation for the treatment

    Time frame: Patients' expectation is investigated at week 0

    Patients' expectation is measured by a four-score scale, with 1 for "symptoms are totally disappear" and 4 for "no change for symptoms".

  3. Visual Analogue Scale (VAS) for pain intensity

    Time frame: VAS should be measured seven times at week 0, the end of each five times treatment (totally fifteen times treatment in 5 weeks), week 9, week 13, and week 17, respectively.

    The length of scale of VAS is 100mm, 0 is representing for no pain, and 100 is representing unbearable pain which may affect appetite and quality of sleep. Researchers should show the scale to patients, and note the scores of pain degree given by patients according to the scale.

Other outcomes

  1. Widespread Pain Index (WPI）for pain intensity

    Time frame: WPI should be measured seven times at week 0, the end of each five times treatment (totally fifteen times treatment in 5 weeks), week 9, week 13, and week 17, respectively.

    WPI is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia.

  2. Symptom Severity (SS) for pain intensity

    Time frame: SS should be measured seven times at week 0, the end of each five times treatment (totally fifteen times treatment in 5 weeks), week 9, week 13, and week 17, respectively.

    SS is defined according to the American College of Rheumatology diagnostic criteria （2002）for fibromyalgia

  3. Hamilton Depression Scale (HAMD)

    Time frame: HAMD is measured totally 3 times at week 0, week 5 and week 17, respectively.

  4. Quality of life measured by The Medical Outcome Study 36-item short-form health survey (SF36)

    Time frame: SF36 is measured totally 3 times at week 0, week 5 and week 17, respectively.

  5. Fibromyalgia Intensive Questionnaire (FIQ)

    Time frame: FIQ is measured totally 3 times at week 0, week 5 and week 17, respectively.

Sponsors and collaborators

Lead sponsor

Beijing University of Chinese Medicine

Other

Registry information

Official study title

Using Partially Randomized Patient Preference Research Model for Evaluation the Therapeutic Effect of Non-pharmaceutical Therapies: Protocol for a Feasibility Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2013
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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