NCT01908920

Brief Summary

The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

July 19, 2013

Last Update Submit

September 8, 2013

Conditions

Healthy SubjectHeart Rate Variability

Outcome Measures

Primary Outcomes (1)

  • Change from baseline high frequency (HF) value at 1 week

    baseline and 1 week

Secondary Outcomes (18)

  • Change from baseline in low frequency (LF) value at 1 week

    baseline and 1 week

  • Change from baseline LF/HF ratio value at 1 week

    baseline and 1 week

  • Change from baseline very low frequency (VLF) value at 1 week

    baseline and 1 week

  • Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week

    baseline and 1 week

  • Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week

    baseline and 1 week

  • +13 more secondary outcomes

Study Arms (3)

OMT

OTHER

Each osteopathic session is based on structural evaluation and treatment using indirect techniques.

Other: Osteopathic manipulative treatment

SHAM

OTHER

Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to "treat" the subject. A pre-determined protocol has been used. The practitioner's attention was distracted by subtracting calculation in silence.

Other: SHAM

CONTROL

OTHER

No intervention

Other: CONTROL

Interventions

Osteopathic manipulative treatmentOTHER
OMT
SHAMOTHER
SHAM
CONTROLOTHER
CONTROL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45;
  • No chronic symptomatology;
  • No acute symptomatology during the last 72 hours before intervention;
  • No pathologies

You may not qualify if:

  • Age below 18 or over 45;
  • Pregnancy;
  • Menopause;
  • Abuse of alcool during the last 48 hours;
  • Chronic pain;
  • Acute pain during the last 72 hours;
  • Conclamate pathologies;
  • Use of drugs during the last 72 hours ;
  • Use of ortothic devices during the last 3 months;
  • Any type of surgery;
  • Osteopathic treatment during the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accademia Italiana Osteopatia Tradizionale

Pescara, Italy

Location

Related Publications (1)

  • Ruffini N, D'Alessandro G, Mariani N, Pollastrelli A, Cardinali L, Cerritelli F. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial. Front Neurosci. 2015 Aug 4;9:272. doi: 10.3389/fnins.2015.00272. eCollection 2015.

    PMID: 26300719DERIVED

MeSH Terms

Interventions

Manipulation, Osteopathicsalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Francesco Cerritelli, MS, DO

    Italian Academy of Traditional Osteopathy - AIOT

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS, DO

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 26, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

IT(1)