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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02276794
Other study ID # 19051513.5.0000.5345
Secondary ID
Status Terminated
Phase N/A
First received October 22, 2014
Last updated February 14, 2017
Start date October 2014
Est. completion date November 2015

Study information

Verified date February 2017
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.


Description:

Forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: Thrust manipulation (side-lying rotational manipulation standardized to the L4-L5 level) or non-thrust manipulation (side-lying grade III rotational non-thrust manipulation). A single treatment session will be provided.

Outcome measurement will be conducted immediately after the treatment session. Data will be collected by a blinded assessor. Between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date November 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age greater than 18 years

- Chronic Low back pain (pain lasting for at least 12 weeks)

- NPRS = 3

Exclusion Criteria:

- Previous surgery or fracture at the lumbar spine

- Pregnancy

- Inflammatory disorders

- Symptoms distal to the gluteal line

- Having received manipulative treatment in the past four weeks

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Thrust Manipulation
After positioning patients in right side-lying, a rotational TM technique will be addressed at the L4-L5 lumbar segments. The treating therapist will have up to two attempts to apply the TM.
Non-thrust manipulation (NTM)
A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.

Locations

Country Name City State
Brazil Federal University of Health Sciences of Porto Alegre Porto Alegre Rio Grande do sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Foot contact area Foot contact area will be measured by a digital baropodometer (FootWork Pro) Up to 10 minutes after intervention
Primary Pain Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS) Up to 10 minutes after intervention
Secondary Global Perceived Effect Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE) Up to 10 minutes after intervention
Secondary Lumbar joint position sense Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY) Up to 10 minutes after intervention
Secondary Peak plantar pressure Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro) Up to 10 minutes after intervention
Secondary Center of Pressure displacement CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry Up to 10 minutes after intervention
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