Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

NCT ID: NCT02276794

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-11-30

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.

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.

Conditions

Low Back Pain; Mechanical Low Back Pain; Backache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Thrust Manipulation

Intervention Type: OTHER

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)

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

Group Type: EXPERIMENTAL

Non-thrust manipulation (NTM)

Intervention Type: OTHER

A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Spinal manipulation; Lumbar manipulation; Lumbar thrust; Manual Therapy; Manipulative therapy; Mobilization; Joint mobilization; lumbar mobilization; Manual therapy; Maitland

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Esteves Ferreira

PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo F Silva, PhD

Role: STUDY_CHAIR

Adjunct professor

Locations

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

19051513.5.0000.5345

Identifier Type: -

Identifier Source: org_study_id