Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02276794
• Other study ID #: 19051513.5.0000.5345
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Backache
• Low Back Pain
• Mechanical Low Back Pain

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