Effect of Electroacupuncture in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Irritable bowel syndrome (IBS) is the most common digestive disorder that affects more than
      5% of population in Hong Kong. However, there is no effective treatment of IBS using Western
      Medicine. Acupuncture, a traditional therapeutic modality, has been used in China for
      thousands of years for various pain disorders. In addition to analgesia, acupuncture has also
      been shown to influence physiology of gastrointestinal tract. The investigators set out to
      evaluate the therapeutic value of acupuncture in IBS. The investigators will study its
      effects on rectal sensation and brain activity in patients with IBS.

      All patients will be evaluated for study eligibility at visit 1 (baseline). Baseline
      assessment includes individual IBS symptoms (pain/discomfort, bloating, constipation, and
      diarrhea) as perceived by patients will be scored. The syndrome of IBS patients will also be
      recorded and analyzed based on the Chinese medicine theories. All patients will then undergo
      baseline rectal barostat for thresholds of rectal sensation. At visit 2, eligible patients
      will be randomly assigned to either (1) electroacupuncture or (2) sham electroacupuncture
      treatment groups. Functional Magnetic Resonance Imaging (fMRI) scanning will be performed
      before, during and after the electroacupuncture or sham electroacupuncture treatment.
    

Detailed description: 
      All patients will be evaluated for study eligibility at visit 1 (baseline). Baseline
      assessment includes the following items:

        1. Global symptom assessment: Based on Rome III Working Group recommendation, a clinical
           outcome response measure is used in which patients are required to report "improved",
           "the same" or "worsened" to the question "Do you have adequate symptom relief in the
           past 7 days?"

        2. Individual IBS symptoms: The individual IBS symptom (pain/discomfort, bloating,
           constipation, and diarrhea) as perceived by patients will be scored in a 5-point scale
           (0=none or asymptomatic; 1=mild with no limitation of normal activities; 2=moderate with
           limitation of some normal activities; 3=intense and unable to carry out most normal
           activities; 4=incapacitating symptom that are intolerable and unable to carry out all
           normal activities).

        3. Syndrome of Chinese medicine: The syndrome of IBS patients will be recorded and analyzed
           based on the Chinese medicine theories. These symptoms involving: fatigue, appetite,
           sense of mouth, quality of sleep, the coating of tongue, pulse, etc.

        4. Quality of life (QOL) assessment: A disease-specific questionnaire- IBS Quality of Life
           Scale (Chinese) will be used for assessment of QOL in response to treatment. The
           questionnaire was locally validated, and was recently developed by our group.

        5. Rectal barostat: The patients will be evaluated for the sensory threshold and maximum
           tolerable threshold of rectum in response to balloon distension of rectum before the
           acupuncture treatment.

      At visit 2, eligible patients will be randomly assigned to either (1) electroacupuncture or
      (2) sham electroacupuncture. During the treatment, the patient will receive fMRI to evaluate
      the cerebral cortical activity in response to balloon distension of rectum. Three sets of
      real-time functional brain mapping using fMRI will be performed during rectal balloon
      distensions at maximum tolerable pressure at the following time points:

        1. 10 minutes after acupuncture needle insertion before delivery of electrical stimulation

        2. 15 minutes after electrical stimulation begins (electrical stimulation continues during
           MRI)

        3. Immediately after electrical stimulation stops before removal of acupuncture needle

      Rectal barostat:

      The barostat device contains a built-in computer system that can be programmed to
      automatically perform distensions of balloon with fixed time lags and bag pressure
      increments. Variation in balloon volume in a constant pressure reflects the change in tone
      and compliance of the visceral wall. Furthermore, through a programmed variation in
      intraballoon pressure, the sensory threshold of subject can be evaluated.

      The patient is instructed to take low residue diet 2 days prior to barostat. On the day
      before barostat, bowel preparation is performed by ingestion of 4 liters of polyethylene
      glycol solution in 2 divided doses. After a 12-hour fast, the participant is positioned in
      supine position on MRI table. A barostat bag is inserted into the rectum. The barostat device
      is connected to the barostat catheter using a low compliance PVC tubing. The participant will
      remain alone in MRI cubicle during the whole experiment but a speaker and microphone system
      allows communication with the investigator. He/she is also provided a squeeze bulb to signify
      pain. Repeated squeezing of the bulb signifies request for termination of procedure.

      Phasic isobaric rectal distensions are performed automatically using ascending method of
      limits (AML) protocol with successive increments of 4 mm Hg (40-second duration) alternating
      with intermittent periods of bag deflation (40 seconds). During each distension phase, the
      participant is requested to report the perception ratings by pressing on the perception panel
      of barostat device with the following scale: (1) no sensation (2) the first sensation of
      balloon distension, (3) desire for defecation, (4) maximum tolerable sensation. The procedure
      will be stopped when pain or maximum tolerable sensation is reported. The sensory threshold
      is defined as lower limit of the bag pressure that evokes the first sensation of balloon
      distension. The pain threshold is defined as pressure that elicits a "pain" response or
      maximum tolerable sensation.

      Electroacupuncture Treatment:

      Treatment will be performed by a single licensed acupuncturist. Both the patient and the
      investigator are unaware of the treatment assigned. A specially designed copper needle
      (0.22x4mm), which can be used safely in MRI suite, will be inserted through a plaster over
      the respective acupoints, under which a plastic ring will be positioned, connected with
      electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair) through wires with
      stimulation frequency of 150Hz, lasting for 30 minutes. For sham acupuncture, the needle will
      be positioned at 2cm away from the true respective acupoints., the same electric stimulation
      will be the same as real acupuncture treatment. The treatment will be given by an independent
      acupuncturist who is not involved in the data acquisition and analysis. Points for
      acupuncture treatment are chosen to regain the balance of liver qi stagnation and strengthen
      the spleen:

      Anatomical location (Function according to TCM)

        1. SP06:3cm above the medial malleolus dorsal tibial rim (Strengthens spleen and stomach)

        2. ST25:2cm lateral to the umbilicus (Strengthens spleen and stop diarrhea)

        3. ST36:5cm below patella, 2 cm lateral of the tibial rim (Strengthens spleen and stomach)

        4. ST37:3cm below ST36 (Strengthens spleen and stop diarrhea)

      Functional MRI:

      BOLD imaging is performed with a 3-T MRI scanner (Philips Achieva 3.0T, X series, Quasar Dual
      MRI system). Each study consists of axial T1-weighted spin echo images (matrix of at least
      192 × 256) covering the whole brain for anatomical correlation. Functional scan is performed
      using a single-shot echo planar pulse sequence in an interleaved multislice format with a
      field of view of 24 cm and a matrix size of at least 64 × 64, resulting in a in-plane
      resolution of 3.75 × 3.75. The pulse sequence parameters include a 90° flip-angle with a TE
      (time to echo)/TR (repetition time) of 60 ms/4000 ms. Each paradigm consists of 5 periods.
      Each period will consist of rest and stimulation (tube inflation causing rectal distension).
      In each period, 50 dynamics are performed. Each dynamic will last for 2 seconds. The scans
      will be performed with the rectal tube inflated to render:

        1. Desire for defecation, and

        2. Painful sensation, as determined by the barostat study at baseline visit within one week
           before MRI scanning.
    

Intervention name(s): Electroacupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair)); Sham acupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair))
Intervention type(s): Device; Device
Intervention description(s): A specially designed copper needle (0.22 x 4 mm), which can be used safely in MRI suite, will be inserted through a plaster over the respective acupoints, under which a plastic ring will be positioned, connected with electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair) through wires with stimulation frequency of 150 Hz, lasting for 30 minutes.; Needle will be positioned at 2 cm away from the true respective acupoints, with a blunted, telescopic placebo needle. The same electric stimulation will be the same as real acupuncture treatment.
Other intervention name(s): electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: irritable bowel syndrome; IBS; fMRI; acupuncture; functional; brain