Efficacy of Osteopathic Treatment in Function Abdominal Pain in Children and Adolescents

NCT02594774 | Unknown

• 1 other identifier: 2015/6312/I
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to evaluate the efficacy of osteopathic treatment as an adjunct to standard medical treatment in reducing child functional abdominal pain. A convenience sample that includes no more than 30 patients per study group (n = 60) are being recruited. As an exploratory study the investigators did not proceed to make any sample size calculation. This is a comparative study of two quasi-experimental interventions (standard treatment vs. standard treatment + Osteopathy). This will be a single-blind trial where only the evaluator will be blinded. The principal outcome will be pain measured by a visual analog scale. A version with more appropriate pictograms for pediatric patients is used. Measurements will be taken at baseline (baseline measurements) at 4, 8 weeks (the duration of interventions) and 6 months post-study.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain (visual analog scale)

  Pain measurement through visual analog scale

  Baseline, 4 weeks, 8 weeks, 6 months

Study Arms (2)

Osteopathic treatment

EXPERIMENTAL

Manipulative osteopathy (and standard medical treatment)

Other: Manipulative osteopathy

Standard medical treatment

NO INTERVENTION

Standard medical treatment

Interventions

Manipulative osteopathy OTHER

Osteopathic treatment (BMT) which works on the influence on the pressure distribution in the (especially abdominal) body cavities and consequently on the viscera contained therein, proper arterial supply and venous and limphatic drainage.

Osteopathic treatment

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients of school age (6-16 years old)
• Diagnosed with functional abdominal pain (Functional Abdominal Pain-Related Disorders) according to the diagnostic criteria for functional gastrointestinal disorders ROME guide III
• Signed informed consent

You may not qualify if:

• Patients diagnosed with digestive disease
• Patients who have or are receiving medical aids
• Patients who are not studying physical treatments
• Refusal to participate

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Parc de Salut Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (7)

• Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

  PMID: 16678553 BACKGROUND

• Saps M, Biring HS, Pusatcioglu CK, Mintjens S, Rzeznikiewiz D. A comprehensive review of randomized placebo-controlled pharmacological clinical trials in children with functional abdominal pain disorders. J Pediatr Gastroenterol Nutr. 2015 May;60(5):645-53. doi: 10.1097/MPG.0000000000000718.

  PMID: 25906454 BACKGROUND

• van Tilburg MA, Palsson OS, Levy RL, Feld AD, Turner MJ, Drossman DA, Whitehead WE. Complementary and alternative medicine use and cost in functional bowel disorders: a six month prospective study in a large HMO. BMC Complement Altern Med. 2008 Jul 24;8:46. doi: 10.1186/1472-6882-8-46.

  PMID: 18652682 BACKGROUND

• Hussain Z, Quigley EM. Systematic review: Complementary and alternative medicine in the irritable bowel syndrome. Aliment Pharmacol Ther. 2006 Feb 15;23(4):465-71. doi: 10.1111/j.1365-2036.2006.02776.x.

  PMID: 16441466 BACKGROUND

• Attali TV, Bouchoucha M, Benamouzig R. Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial. J Dig Dis. 2013 Dec;14(12):654-61. doi: 10.1111/1751-2980.12098.

  PMID: 23981319 BACKGROUND

• Muller A, Franke H, Resch KL, Fryer G. Effectiveness of osteopathic manipulative therapy for managing symptoms of irritable bowel syndrome: a systematic review. J Am Osteopath Assoc. 2014 Jun;114(6):470-9. doi: 10.7556/jaoa.2014.098.

  PMID: 24917634 BACKGROUND

• Dobson D, Lucassen PL, Miller JJ, Vlieger AM, Prescott P, Lewith G. Manipulative therapies for infantile colic. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004796. doi: 10.1002/14651858.CD004796.pub2.

  PMID: 23235617 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• CRISTINA MOLERA-BUSOMS

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OSCAR GARCIA-ALGAR, PhD

CONTACT

+34932483551; 90458@parcdesalutmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

ES (1)