NCT04822428

Brief Summary

Forty female patients with age ranging from 30-40 years old were suffering from low back pain due to visceral dysfunctions participated in this study. They were recruited from a private clinic. They were assigned into two groups equal in number; Group (A): included twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks, and Group (B): included twenty patients who received only analgesic drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 26, 2021

Last Update Submit

March 26, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • The visual analog scale (VAS)

    The patient determined the pain intensity on a 10 cm scale marked with points ranging from predetermined no pain and excruciating pain

    change from baseline to after 3 weeks

  • The Oswestry Disability Index (ODI)

    (ODI) consists of 10 items on the degree of severity to which back (or leg) trouble has affected the ability to manage in everyday life.

    change from baseline to after 3 weeks

  • Modified Schober's test (MST)

    the participant stood erect while the lumbosacral junction was marked as indicated by the dimples of Venus. For measuring the MST, we put a mark 5 cm below and 10 cm above the junction. The participant was asked to bend forward as far as possible and the stretched distance of these two points was measured as the MST value.

    change from baseline to after 3 weeks

Study Arms (2)

study group(A)

EXPERIMENTAL

Group (A): included Twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks.

Other: Osteopathic manipulation

Control group(B)

NO INTERVENTION

Group (B): included twenty patients who received analgesic drugs only.

Interventions

Osteopathic manipulative techniques including; suboccipital release technique,sacral release technique, diaphragmatic release, mesentery release, and Colonic manipulation

study group(A)

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-specific low back pain for more than 12 weeks

You may not qualify if:

  • Malignant tumor
  • Pregnancy
  • Acute ischemic bowel disease,
  • Intestinal obstruction,
  • surgery in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12316, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized, controlled, parallel study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 30, 2021

Study Start

August 20, 2020

Primary Completion

March 12, 2021

Study Completion

March 12, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations