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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02660801
Enrollment
26
Registered
2016-01-21
Start date
2016-03-31
Completion date
2017-11-30
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain

Keywords

spinal manipulation, spinal mobilization, spinal stiffness

Brief 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.

Detailed 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.

Interventions

PROCEDURESpinal manipulation

A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra

Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Global Spinal Stiffnesstwo-minutes before spinal manipulation delivery up to two-minutes afterGlobal stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N
Terminal Spinal Stiffnesstwo-minutes before spinal mobilization delivery up to two-minutes afterTerminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N
Pressure Provoked Painimmediately after the therapeutic modality applicationPressure 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
Muscular Response, Superior Level RatioDuring the spinal manipulation and mobilizationTo 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.
Muscular Response, Inferior Level Ratio, Normalized RMSDuring the spinal manipulation and mobilizationTo 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.

Countries

Canada

Participant flow

Recruitment details

the participants were recruited among the local community

Participants by arm

ArmCount
All Participants
Experimental group 1: spinal manipulation, spinal mobilization Participants first received spinal manipulation. After a washout period of 48h, they then received a spinal mobilization at the same spinal level. Experimental group 2: spinal mobilization, spinal manipulation Participants first received spinal mobilization. After a washout period of 48h, they then received a spinal manipulation at the same spinal level.
26
Total26

Baseline characteristics

CharacteristicAll Participants
Age, Continuous29.9 years
STANDARD_DEVIATION 9.14
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Global spinal stiffness
Spinal Manipulation
7.7 N/mm
STANDARD_DEVIATION 1.4
Global spinal stiffness
Spinal mobilization
7.6 N/mm
STANDARD_DEVIATION 1.8
Pressure provoked pain
Spinal manipulation
47.9 units on a scale
STANDARD_DEVIATION 22.8
Pressure provoked pain
Spinal mobilization
47.2 units on a scale
STANDARD_DEVIATION 23.2
Region of Enrollment
Canada
26 Participants
Sex: Female, Male
Female
15 Participants
Sex: Female, Male
Male
11 Participants
Terminal spinal stiffness
Spinal manipulation
7.9 N/mm
STANDARD_DEVIATION 1.5
Terminal spinal stiffness
Spinal mobilization
7.8 N/mm
STANDARD_DEVIATION 1.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 15
other
Total, other adverse events
0 / 110 / 15
serious
Total, serious adverse events
0 / 110 / 15

Outcome results

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

Time frame: two-minutes before spinal manipulation delivery up to two-minutes after

ArmMeasureValue (MEAN)Dispersion
Spinal ManipulationGlobal Spinal Stiffness7.6 N/mmStandard Deviation 1.8
Spinal MobilizationGlobal Spinal Stiffness7.8 N/mmStandard Deviation 1.7
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.

Time frame: During the spinal manipulation and mobilization

ArmMeasureValue (MEAN)Dispersion
Spinal ManipulationMuscular Response, Inferior Level Ratio, Normalized RMS0.79 ratioStandard Deviation 0.6
Spinal MobilizationMuscular Response, Inferior Level Ratio, Normalized RMS0.16 ratioStandard Deviation 0.1
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.

Time frame: During the spinal manipulation and mobilization

ArmMeasureValue (MEAN)Dispersion
Spinal ManipulationMuscular Response, Superior Level Ratio0.78 ratioStandard Deviation 0.56
Spinal MobilizationMuscular Response, Superior Level Ratio0.16 ratioStandard Deviation 0.09
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

Time frame: immediately after the therapeutic modality application

ArmMeasureValue (MEAN)Dispersion
Spinal ManipulationPressure Provoked Pain36.6 score on a scaleStandard Deviation 23.7
Spinal MobilizationPressure Provoked Pain45.4 score on a scaleStandard Deviation 24.3
Primary

Terminal Spinal Stiffness

Terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N

Time frame: two-minutes before spinal mobilization delivery up to two-minutes after

ArmMeasureValue (MEAN)Dispersion
Spinal ManipulationTerminal Spinal Stiffness7.9 N/mmStandard Deviation 1.5
Spinal MobilizationTerminal Spinal Stiffness7.8 N/mmStandard Deviation 1.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026