Evaluation of How Different Dosages of Spinal Manipulation Modulate Spinal Stiffness in Participants With Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-12-22

Brief Summary

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This study evaluate the relationships between spinal manipulative therapy dosage (speed and peak force), the resulting modulation of thoracic spinal stiffness and changes in the clinical status in participants with chronic thoracic pain. Participants will attend four sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of three different spinal manipulative therapy dosages based on their group assignment and preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will include spinal stiffness measurement and clinical status evaluation through questionnaires.

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Detailed Description

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Spinal manipulative therapy (SMT) is based on the premise that clinicians can identify spine mechanical changes and accordingly determine the dosage of its biomechanical parameters: preload force, rate of force application and peak force. In recent years, our research team showed, using an apparatus to deliver specific dosage SMTs, that SMT-related neurophysiological responses depend on the dosage of these parameters. Beside determining the SMT dosage, clinicians have to select the spinal level to be treated which is partly done by applying a light pressure to each spinous process (spinal stiffness assessment). This study consist of a randomized controlled trial including 75 participants with chronic thoracic pain who will be randomized in one of three groups. Based on their group assignment, participants will receive a specific dosage SMT delivered at T7 three times over 2 weeks. These SMT dosages are distinct regarding their speed and/or their peak force in order to generate either a high vertebral displacement or a high muscle reflex response. T6, T7 and T8 spinal stiffness will be measured just before and after treatment and clinical status will be assessed at each session beginning through questionnaires. Session four will include the questionnaires and the spinal stiffness measurement procedure. Both SMT and spinal stiffness measurement will be performed using an apparatus aiming at simulating force-time profiles. Surface electromyography electrodes and accelerometers will be positioned over the upper back skin in order to measure the muscle response and vertebral displacement during SMT and spinal stiffness measurement procedures.

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants won't know the SMT dosage they are assigned to.

Study Groups

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1840Newtons/s(N/s);125ms;250 Newtons(N)

Participants will receive a spinal manipulative therapy of 20 Newtons (N) preload leading to a peak force of 250N over 125ms (rate of force application of 1840N/s).

Group Type EXPERIMENTAL

Spinal manipulative therapy

Intervention Type PROCEDURE

A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.

920N/s;125ms;135N

Participants will receive a spinal manipulative therapy of 20N preload leading to a peak force of 135N over 125ms (rate of force application of 920N/s).

Group Type EXPERIMENTAL

Spinal manipulative therapy

Intervention Type PROCEDURE

A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.

920N/s;250ms;250N

Participants will receive a spinal manipulative therapy of 20N preload leading to a peak force of 250N over 250ms (rate of force application of 920N/s).

Group Type EXPERIMENTAL

Spinal manipulative therapy

Intervention Type PROCEDURE

A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.

control

Spinal stiffness will be assessed at each sesssion, however, participants won't receive any spinal manipulative therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spinal manipulative therapy

A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults aged between 18 and 60 years hold and presenting a constant or recurrent pain in the thoracic area for at least 12 weeks. Thoracic are is defined as the region boarded superiorly by T1 spinous process, inferiorly by T12 spinous process and laterally by the lateral border of the thoracic erector spinae muscles. The pain has to be of non organic origin.

Exclusion Criteria

* Spinal arthritis, aortic aneurysm, collagenosis, advanced osteoporosis, spine surgery, neuromuscular disease, current cancer, uncontrolled hypertension, thoracic radiculopathy, thoracic herniated disc, current infection, thoracic scoliosis, current pregnancy, any contraindication to spinal manipulative therapy of the thoracic spine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No