Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain

Back Pain Clinical Trial

Official title:

Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02660801
• Other study ID #: UQTR-2016-STIF
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2017

Study information

• Verified date: June 2019
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the present study is to compare the neuromechanical responses to spinal manipulation and spinal mobilization in participants with chronic nonspecific middle back pain.

Description:

Although evidences suggest a similar effectiveness of spinal manipulation and spinal mobilization, there is no study that compares the neuromechanical effects of these manual therapies in a experimental context and with the standardization of both interventions. Therefore, the objective of the present study is to compare the neuromechanical responses to spinal manipulation (low-amplitude and high-velocity dynamic thrust) and spinal mobilization (repetitions of a low-amplitude and low-velocity nonthrust movement) in participants with and without chronic nonspecific back pain.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: November 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• presenting or not a history of chronic nonspecific back pain

Exclusion Criteria:

• History of back trauma or surgery

• Severe osteoarthritis

• Inflammatory arthritis

• Vascular conditions

• Contraindication to the use of spinal manipulation or spinal mobilization

• Pregnancy

• Scoliosis

Related Conditions & MeSH terms

• Back Pain

Intervention

Procedure:
• Spinal manipulation
A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra
• Spinal mobilization
Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivieres	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Unité de recherche en santé musculosqulettique

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Spinal Stiffness	Global stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N	two-minutes before spinal manipulation delivery up to two-minutes after
Primary	Terminal Spinal Stiffness	Terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N	two-minutes before spinal mobilization delivery up to two-minutes after
Primary	Pressure Provoked Pain	Pressure provoked pain intensity was assessed immediately after each spinal stiffness assessment using a 0 to 100 visual analog pain scale minimum value=0, maximum value=100. 0 is no pain while 100 is the worse outcome	immediately after the therapeutic modality application
Primary	Muscular Response, Superior Level Ratio	To assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.	During the spinal manipulation and mobilization
Primary	Muscular Response, Inferior Level Ratio, Normalized RMS	To assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.	During the spinal manipulation and mobilization