x

We are happy to announce that all trial registrations will now be issued DOIs (digital object identifiers). For more information, see here.
Dry cupping in children with functional constipation, a randomized open label clinical trial
Last registered on October 04, 2015

Pre-Trial

Trial Information
General Information
Title
Dry cupping in children with functional constipation, a randomized open label clinical trial
RCT ID
AEARCTR-0000896
Initial registration date
October 04, 2015
Last updated
October 04, 2015 5:55 AM EDT
Location(s)
Primary Investigator
Affiliation
Shiraz University of Medical Sciences
Other Primary Investigator(s)
PI Affiliation
Shiraz University of Medical Sciences
PI Affiliation
Shiraz University of Medical Sciences
Additional Trial Information
Status
Completed
Start date
2013-09-01
End date
2013-12-30
Secondary IDs
ec-p-92-4944
Abstract
Aim: To investigate the efficacy of dry cupping therapy in children (an eastern traditional manipulative therapy) with functional constipation.
Methods and materials: One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on abdominal wall for 8 minutes every other day or standard laxative therapy (Poly ethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation.
Results: There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of items of ROME III criteria of patients in PEG group. By contrast after four weeks of the intervention the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of follow up period.
Conclusion: This study showed that dry cupping of abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.
Keywords: Functional constipation, cupping, children, musculoskeletal manipulations

External Link(s)
Registration Citation
Citation
Heydari, Mojtaba, Khadijehsadat Najib and Mahmmod Shahamat. 2015. "Dry cupping in children with functional constipation, a randomized open label clinical trial." AEA RCT Registry. October 04. https://doi.org/10.1257/rct.896-1.0.
Former Citation
Heydari, Mojtaba, Khadijehsadat Najib and Mahmmod Shahamat. 2015. "Dry cupping in children with functional constipation, a randomized open label clinical trial." AEA RCT Registry. October 04. https://www.socialscienceregistry.org/trials/896/history/5484.
Sponsors & Partners

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information
Experimental Details
Interventions
Intervention(s)
2. Patients
Patients were selected from 224 children attending imam Reza pediatric gastroenterology clinic. The children with diagnosis of functional constipation based on Rome III criteria , for at least 3 months before diagnosis and age between 4-18 years old were considered for inclusion study. Children having the Rome III criteria for Inflammatory bowel disease or organic causes of defecation disorders such as Hirschsprung's disease, spina bifida occulta, hypothyroidism, cystic fibrosis, neurologic abnormalities, intestinal pseudo-obstruction, and diabetes mellitus were excluded from the study.

3. Study procedure
A three months, prospective, randomized clinical trial was performed. Through a block randomization, patients were divided into two parallel therapeutic groups (60 patients in each group). The sample size was determined based on a previous study . Totally, 120 children were allocated into cupping therapy and PEG groups. The methodologist and the statistician who assessed and analyzed the data were blind to the protocol.

At enrollment, a complete history was taken and physical examination done by a pediatrist involved in the study. Baseline frequency of defecation, presence of fecal soiling (encopresis), hard stool consistency, retention posturing and abdominal pain was recorded.

4, Intervention
In both groups, an expert person instructed routine nutritional and behavioral recommendations for children's constipation. Patients with fecal impaction in both groups were also disimpacted with bisacodil suppositories at the first visit before enrolment. The parents were instructed to call the researcher if they observed any adverse effect or had any question.
In a cupping group, a registered operator of cupping therapy explained the method, duration, sites and frequency of cupping therapy to participants' parents and cupped the patients under their parents view. In a second session, the parents cupped their children under supervision of the instructor to adopt and correct the procedure. The remained 12 session of cupping were done by the parents at home every other day (totally 28 days of cupping therapy). Patients were excluded from the study if they had no bowel movement for seven days or developed fecal impaction, at any stage.
Medication was oral administration of PEG (40% solution without electrolyte), 0.4 g/kg once daily for 4 weeks. Parents were requested to refer to call the pediatrist in confronting with any complication. Weekly reports were taken from by the interviewer. Patients were followed after 2, 4 , 8 and 12 weeks of intervention.

5. Procedure
Various sterile disposable cups (manufactured in ABC ®, a chinese company) from 1.5 cm to 5 cm in diameter (10 – 100 cc) were used (regard to patient age). ّour to six cups (regard to patient skin surface) were applied on the abdominal skin (not on umbelicus) in each session. Duration of cupping therapy was 8 minutes. The negative pressure was applied until skin became congested. After that, the cup was remained on the skin until 7 minutes. Then the regulating button on back of the cup was pulled to release the cup from the skin. The potential changes of skin color until a few days after cupping therapy were explained to the parents.
Intervention Start Date
2013-09-01
Intervention End Date
2013-12-30
Primary Outcomes
Primary Outcomes (end points)
6. Outcome measures
The primary outcome was number of patients who had responded to the treatment. Response to the treatment was defined as improvement of constipation for at least to three bowel movements, soft stool and convenient defecation, no soiling and bloody stool per week as well as not full filling the Rome III criteria for constipation after the 2nd, 4th, 8th and 12th weeks of intervention. Secondary outcomes were frequency of defecation, presence of fecal soiling (encopresis), hard stool consistency, retention posturing and abdominal pain, at the mentioned time periods.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The study was conducted from September to December 2013 at Imam Reza pediatric gastroenterology clinic affiliated by Shiraz University of Medical Sciences (Shiraz, Iran). The study was approved by ethics committee of Shiraz University of Medical Sciences (Ethics committee ID: ). The trial enrollment started at September 2013. Before enrollment, informed consent was obtained from the parents after complete explanation about the study and its therapeutical methods (cupping therapy and PEG). In this trial, patients were examined by a pediatrist and their diagnosis (chronic functional constipation) was confirmed by him.
Experimental Design Details
Randomization Method
Block randomization
Randomization Unit
individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
0
Sample size: planned number of observations
120
Sample size (or number of clusters) by treatment arms
60
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
30
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
IRB Approval Date
IRB Approval Number
Analysis Plan

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers