Completed

Duration of Spinal Manipulation Effects as Influenced by Orthotics

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

foot orthotics

+ Sham foot orthotic

Device
Who is being recruted

Organizing Pneumonia+14

+ Back Pain

+ Bronchial Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: September 2011
See protocol details

Summary

Principal SponsorLogan College of Chiropractic
Last updated: October 11, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.

NCT01704807
Principal SponsorLogan College of Chiropractic
Last updated: October 11, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

41 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Organizing PneumoniaBack PainBronchial DiseasesBronchiolitisBronchiolitis ObliteransBronchitisGraft vs Host DiseaseImmune System DiseasesLung DiseasesLung Diseases, ObstructiveNeurologic ManifestationsPainRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBronchiolitis Obliterans SyndromeLow Back Pain

Criteria

5 inclusion criteria required to participate
Able to speak and understand English adequately to complete study forms
Average score on Chiropractic pain Index (Now, Average, and Worst scales from the Quadruple VAS pain scale) of 4 or higher
Current low back pain episode present for one month or more
No change in the past month in prescription medications affecting musculoskeletal pain
Show More Criteria
13 exclusion criteria prevent from participating
Clinically significant chronic inflammatory spinal arthritis
Current pregnancy
Does not speak , read or understand English to an extent which would affect the subject's capacity to participate in informed consent
History of bleeding disorder
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Wearing custom foot orthotics

Group II

Sham
Wearing sham or flat shoe insoles

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Logan College of Chiropractic/University Programs

Chesterfield, United StatesOpen Logan College of Chiropractic/University Programs in Google Maps
CompletedOne Study Center