Connective Tissue Manipulation Improves Symptoms and Quality of Life in Patients With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Connective tissue manipulation (CTM) is a manual reflex therapy, which increases intestinal
      motility by stimulating autonomic nervous system to re-balance the parasympathetic and
      sympathetic functions. However, there is no randomized controlled trial (RCT) regarding the
      efficacy of CTM on constipation. This study was planned to investigate the effects of CTM in
      patients with chronic constipation.

      Patients who have diagnosis of chronic constipation according to Rome III criteria were
      recruited and randomized to intervention and control group. The intervention group received
      CTM in addition to the lifestyle advice, while the control group was given only lifestyle
      advice for constipation. All assessments were performed at baseline and at the end of 4
      weeks. The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary
      outcomes included Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL),
      Bristol Stool Scale (BSS) and 7-day bowel diary. Differences between groups were analyzed
      with t-tests, Mann-Whitney U test and Chi-square test.
    

Detailed description: 
      In this prospective randomized controlled trial, informed consent forms were obtained from
      all participants and they were informed about the study based on the Declaration of Helsinki.
      The study was approved by local ethics committee of Hacettepe University (LUT 12/35-48).
      After comprehensive clinical evaluation, subjects were randomly assigned to the intervention
      group or the control group, using stratified block randomization procedure with blocks of
      four, using opeque and sealed envelopes, containing group allocation number from a computer
      generated random number table The intervention group received CTM in addition to the
      lifestyle advice, while the control group was given only lifestyle advice for constipation.

      Patients diagnosed with chronic constipation by a based on Rome III Criteria were recruited
      by a gastroenterologist from Hacettepe University, Adult Hospital, Gastroenterology Unit and
      the patients were evaluated and treated at Hacettepe University, Faculty of Health Sciences,
      Physiotherapy and Rehabilitation Department, Women's Health Unit.

      Participants were recruited if they were over 18 years of age and had a diagnosis of chronic
      constipation according to Rome III criteria. Exclusion criteria were comorbid neurological,
      anatomical, or metabolic condition, pregnancy, mental problems preventing cooperation,
      history of colostomy surgery, history of gastrointestinal, spinal, or pelvic surgery except
      cholecystectomy, appendectomy, or hysterectomy, comorbid various colonic conditions
      (intestinal obstruction, peritonitis, bowel perforation, peptic ulcer, gastrointestinal
      bleeding, or acute inflammation of abdominal organs), history of intestinal cancer, existence
      of open sore or tumor at the massage region, and abdominal hernia. Patients taking laxatives
      were excluded or were asked to discontinue the drug two weeks before enrollment.

      Intervention CTM was applied five days per week, a total of 20 sessions for 4 weeks. Each
      session lasted around 15-20 minutes. While patients were in a sitting position, starting from
      the lumbosacral region, lower thoracic, scapular, inter-scapular and cervical regions were
      included in the treatment, respectively. All patients were also advised to increase their
      physical activity levels, fluid and fibre intake, and to take the ideal posture for
      defecation (squatting position) with a two-pages document.

      Evaluations Physical (age, gender, Body Mass Index (BMI)(kg/m²) and demographic (educational
      status, duration of constipation, marital status, employment status) data of the participants
      were recorded. In addition, the number of meals per day, daily amount of liquid consumption,
      and physical activity levels were recorded. The participants' physical activity levels were
      measured using the Turkish version of the International Physical Activity Questionnaire-Short
      Form (IPAQ-SF). Measurements were performed at baseline and immediately after the treatment.
      All patients were evaluated by the same experienced therapist, who was blinded to the results
      of the pre-treatment measurements (CG).

      The primary outcome measure

      *Constipation Severity Instrument (CSI) To evaluate the severity of the participants'
      constipation, Constipation Severity Instrument (CSI) was used. CSI was designed to evaluate
      individuals' defecation frequency and consistency as well as the level of straining
      experienced by individuals during bowel movement. There are three subscales of CSI,
      obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate
      more severe constipation. Kaya et al. showed that the Turkish version of CSI is reliable and
      valid in determining constipation and grading of its severity.

      Secondary outcome measures

        -  Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Patient
           Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) includes a total of
           28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items),
           psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL
           indicate more negative effects of constipation on the quality of life. Turkish version
           of PAC-QOL was demonstrated to be reliable and valid.

        -  Bristol Stool Scale (BSS) The stool consistency was evaluated using the Bristol Stool
           Scale (BSS), a seven-point scale (from 1 to 7), where 1 =separate hard lumps, like nuts;
           2=sausage shaped but lumpy; 3 = like a sausage or snake, but with cracks on its surface;
           4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear cut edges;
           6=ﬂuffy pieces with ragged edges, a mushy stool; 7=water, no solid pieces.

        -  7-Day Bowel Diary In order to gather information regarding the participants' symptoms of
           constipation, they were asked to complete a 7-day bowel diary before and after the
           treatment. This diary included items regarding the frequency of bowel movement, stool
           consistency, defecation time, feeling of incomplete evacuation, and changes in food and
           liquid consumption.

        -  Perception of Subjective Change Individuals' perception of subjective change after the
           treatment was evaluated using a 5-point Likert-type scale: 0: No change, 1: Minimal
           change, 2: Moderate change, 3: Important change, 4: Very important change.

        -  Compliance to the Advices Compliance of the participants to lifestyle advices was
           evaluated using a 4-point Likert-type scale: 0: No compliance, 1: minimal compliance, 2:
           moderate compliance, and 3: Full compliance.
    

Intervention name(s): connective tissue manipulation; life style advice
Intervention type(s): Other; Behavioral
Intervention description(s): We will apply connective tissue manipulation 5 days a week for four weeks.; We will apply life style advice for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation; connective tissue manipulation; conservative therapy; massage; randomized controlled trial