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OpenTrials
Completed

NCT Number: NCT02883634

Specific or Non-Specific Manipulation for Patients With Back Pain

We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Cidade de São Paulo

São Paulo, 03071-000, Brazil

About this study

To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.

148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with low back pain duration from 3 to 24 months.

Exclusion criteria

  • Patients with a pain duration lower than 3 months and higher than 24 months.
  • Patients with nerve root compromise or with serious spinal pathology,
  • Pregnant patients,
  • Previous back surgery
  • Patients with any contra-indication to spinal manipulation.

Treatment and study plan

Specific manipulation

Other

Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.

Non-specific manipulation

Other

Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.

Primary outcomes

  1. Pain Intensity

    Time frame: 4 weeks

    Pain intensity will be measured using a 0-10 numerical rating scale

Secondary outcomes

  1. Pain Intensity

    Time frame: 3 and 6 months after randomization

    Pain intensity will be measured using a 0-10 numerical rating scale

  2. Disability

    Time frame: 4 weeks, 3 and 6 months after randomization

    Disability will be measured by the 0-24 Roland Morris Disability Questionnaire

  3. Global Impression of Recovery

    Time frame: 4 weeks, 3 and 6 months after randomization

    Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale

  4. Pressure Pain Threshold

    Time frame: 4 weeks after randomization

    Pressure Pain Threshold will be measure by a digital pressure algomoter

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Registry information

Official study title

Short, Medium and Long Term Effects of Specific and Nonspecific Spinal Manipulative Therapy in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2016
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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