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

NCT03063177 | Completed

• 1 other identifier: UQTR_2017_dose_stiffness
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain

Keywords

chronic thoracic pain; spine stiffness; spinal manipulation; spinal manipulative therapy

Outcome Measures

Primary Outcomes (1)

• Change in spinal stiffness

  Changes in spinal stiffness between session four and the first session will be assessed at T6, T7 and T8. Spinal stiffness is measured by applying a gradual load of 45 Newtons (N) (5 kg) through our apparatus and by recording the associated indenter displacement. The resulting force-displacement data are used to calculate a spinal stiffness coefficient (N/mm) with lower value indicating more mobility at the spinal level. The change in spinal stiffness will be calculated for each participant by subtracting the value obtained during the fourth session to the one during the first session. A positive value will indicate a decrease in spinal stiffness (increase mobility) while a negative value will indicate an increase in spinal stiffness (decrease mobility) with higher value indicating more important changes.

  2 weeks

Secondary Outcomes (1)

• Change in pain intensity

  2 weeks

Other Outcomes (1)

• Change in disability

  2 weeks

Study Arms (4)

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

EXPERIMENTAL

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).

Procedure: Spinal manipulative therapy

920N/s;125ms;135N

EXPERIMENTAL

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).

Procedure: Spinal manipulative therapy

920N/s;250ms;250N

EXPERIMENTAL

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).

Procedure: Spinal manipulative therapy

control

NO INTERVENTION

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

Interventions

Spinal manipulative therapy 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.

1840Newtons/s(N/s);125ms;250 Newtons(N); 920N/s;125ms;135N; 920N/s;250ms;250N

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

Related Publications (2)

• Descarreaux M, Nougarou F, Dugas C. Standardization of spinal manipulation therapy in humans: development of a novel device designed to measure dose-response. J Manipulative Physiol Ther. 2013 Feb;36(2):78-83. doi: 10.1016/j.jmpt.2012.12.007.

  PMID: 23499142 BACKGROUND

• Page I, Descarreaux M. Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord. 2019 Jan 18;20(1):29. doi: 10.1186/s12891-019-2408-4.

  PMID: 30658622 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Descarreaux, Dc

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants won't know the SMT dosage they are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 24, 2017
• Study Start: May 1, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)