Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

• ClinicalTrials.gov Identifier: NCT02276794
• Recruitment Status: Terminated
• First Posted: October 28, 2014
• Last Update Posted: February 16, 2017
• Sponsor: Federal University of Health Science of Porto Alegre
• Information provided by (Responsible Party): Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain; Mechanical Low Back Pain; Backache	Other: Thrust Manipulation; Other: Non-thrust manipulation (NTM)	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain
• Study Start Date: October 2014
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Thrust manipulation (TM); The patients allocated to the TM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive a rotational TM technique. The treating therapist will have up to two attempts to perform the TM in each patient. There is no need for cavitation in order to consider the TM successful; the occurence of cavitation, however, will be recorded. A single treatment will be provided.	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.; Other Names: Spinal manipulation; Lumbar manipulation; Lumbar thrust; Manual Therapy; Manipulative therapy
Experimental: Non-thrust manipulation (NTM); The patients allocated to the NTM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive 30 oscilations of a grade III rotational NTM. A single treatment will be provided	Other: 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.; Other Names: Mobilization; Joint mobilization; lumbar mobilization; Manual therapy; Maitland

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: Up to 10 minutes after intervention ]
   Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS)

Secondary Outcome Measures :

1. Global Perceived Effect [ Time Frame: Up to 10 minutes after intervention ]
   Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE)
2. Lumbar joint position sense [ Time Frame: Up to 10 minutes after intervention ]
   Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY)
3. Peak plantar pressure [ Time Frame: Up to 10 minutes after intervention ]
   Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro)
4. Center of Pressure displacement [ Time Frame: Up to 10 minutes after intervention ]
   CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry

Other Outcome Measures:

1. Foot contact area [ Time Frame: Up to 10 minutes after intervention ]
   Foot contact area will be measured by a digital baropodometer (FootWork Pro)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Brazil

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do sul, Brazil, 90050-170

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre

Investigators

• Study Chair: Marcelo F Silva, PhD; Adjunct professor

More Information

• Responsible Party: Giovanni Esteves Ferreira, PT, Federal University of Health Science of Porto Alegre
• ClinicalTrials.gov Identifier: NCT02276794
• Other Study ID Numbers: 19051513.5.0000.5345
• First Posted: October 28, 2014
• Last Update Posted: February 16, 2017
• Last Verified: February 2017

Keywords provided by Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre:

Low back pain; Thrust manipulation; Spinal manipulation; Joint mobilization; Non-thrust manipulation; proprioception; Postural stability; Baropodometry

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations