Manipulation, PsychologicNCT04869514
Does Spinal Manipulation Therapy Impact Lumbar Proprioception
A study testing spinal manipulation in people with Manipulation, Psychologic and Proprioception, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
Spinal manipulation therapy (SMT) has long been a component of manual therapy and physical rehabilitation programs, especially as a modality for pain relief. However, the underlying physiological mechanisms for manipulation-related pain relief and functional improvement remain largely unexplored. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Manipulation, Psychologic, Proprioception, Vibration; Exposure
- What is being tested?
- spinal manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 50
- History of chronic (>3months) LBP clinically not attributable to "red flags" (i.e., infection, trauma, fractures, inflammatory spondylarthropathies).
- Source of LBP clinically at the L4/5 or L5/S1 segment
- No history of vestibular disorders
- Body mass index (BMI) > 16 kg/m2
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
Show all 12Show fewer
- Aged between 18 and 50
- No episode of musculoskeletal pain in the past 3 months
- No history of chronic pain (longer than 3 months)
- No history of vestibular disorders
- Body mass index (BMI) > 16 kg/m2
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
Who cannot join
- Excessive consumption of alcohol or consumption of other drugs or analgesics within the last 24 h
- Pregnancy or breastfeeding
- Prior foot/ankle or spine surgery
- chiropractic (or other manual) treatment in the last 2 weeks
- facet joint, epidural or periradicular injections in the last 6 months
- any contraindication to spinal manipulative interventions (or are deemed unable to tolerate SMT to both body sides)
Show all 13Show fewer
- Any neuromuscular diseases that might affect gait and posture and injuries of the motor system with permanent deformities
- Body mass index (BMI) > 30 kg/m2
- Excessive consumption of alcohol or consumption of other drugs or analgesics within the last 24 h
- Pregnancy or breastfeeding
- Prior foot/ankle or spine surgery
- chiropractic (or other manual) treatment in the last 2 weeks
- Any neuromuscular diseases that might affect gait and posture and injuries of the motor system with permanent deformities Body mass index (BMI) > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Chiropractic Medicine, University of Zurich
Zurich, 8008
About this study
Official title: Does Spinal Manipulation Therapy Impact Lumbar Proprioception? A Double-blind Randomized Controlled Trial Examining the Influence of Spinal Manipulative Therapy (SMT) Versus a Sham and Non-sham Control Intervention on Proprioceptive Function
Spinal manipulation therapy (SMT) has long been a component of manual therapy and physical rehabilitation programs, especially as a modality for pain relief. However, the underlying physiological mechanisms for manipulation-related pain relief and functional improvement remain largely unexplored. To promote targeted treatments for musculoskeletal conditions and to better identify the indication and scope of SMT, its mechanisms must be better understood.
Read the detailed description
Manual therapy is widely used by patients with back pain with about 75% of patients consulting either a chiropractor, physiotherapist or osteopath. Often used manual therapies include spinal manipulative therapy (SMT), which is recommended in several clinical guidelines for management of back pain, mostly for acute low back pain (LBP) but also for chronic LBP. Despite the clinical benefits of SMT, the mechanisms underlying its effectiveness are poorly understood. Several mechanisms of action have been proposed including biomechanical and neurophysiological effects observed on spinal and supraspinal levels with unclear relationship to potential analgesic effects. Furthermore, non-specific effects such as placebo effects can strongly influence treatment outcomes and are difficult to control as consensus is lacking regarding the "active" agent of SMT, making it challenging to design an adequately controlled and blinded study.
A potential biological mechanism underlying the effectiveness of SMT might be related to sustained changes in lumbar proprioceptive function following repeated mechanical pressure on spinal tissues. In support of this, evidence from animal studies indicates that SMT comparable forces applied to the spine increase the discharge frequency of proprioceptive afferents in anesthetized cats, pointing towards an immediate effect of SMT on the activity of proprioceptive afferents. Proprioception is sub-served by mechanoreceptors on superficial and deep tissues. Located in the muscle belly parallel to the extrafusal muscle fibers, muscle spindles represent the main transmitters of proprioceptive information. Proprioceptive deficits have been suggested to provoke LBP through sensorimotor incongruence, abnormal loading across joint surfaces, and spinal instability due to less finely tuned muscular control, potentially causing sensorimotor dysfunction and degenerative processes in spinal tissues. In humans, there is anecdotal evidence that an SMT-induced repetitive barrage of proprioceptive input results in pain reduction and improves perceived function that might help to prevent LBP. However, a potential sustained and specific effect of SMT on lumbar proprioceptive function has not been systematically tested.
How one can test lumbar proprioceptive function in humans? Impairments in lumbar proprioception have been reported in LBP patients but only in sitting positions and mostly using proxy measures of proprioceptive function such as joint repositioning sense (JRS) and threshold to detect passive motion (TTDPM). The validity of these measures has been questioned as they measure position- and velocity-related proprioceptive sensation and the JRS is additionally influenced by motor skills and memory effects. Proprioceptive function can also be tested by assessing balance control (postural sway). Balance control presupposes a complex interplay involving the precise integration of proprioceptive inputs and motor outputs that can be tracked by analyzing postural sway on a force plate, a methodology that has been often used to assess differences in balance control in many diseases and conditions, including LBP. However, postural sway has been shown to be insensitive to changes of lumbar proprioceptive function, perhaps because postural sway relies on afferent input from various body locations and tissues. This can be overcome with a more direct assessment of proprioceptive function, achieved by using vibrotactile stimulation in combination with balance control measures. Vibration applied at frequencies between 60-80Hz (and amplitudes between 0.5-1mm) to muscles can selectively disturb proprioceptive signaling (mediated through primary (Ia) and secondary (II) muscle spindle afferents), affecting balance control by provoking corrective movements, often assessed through changes of the center of pressure (COP) in anterior-posterior direction. When endogenous or environmental conditions change, as in the instance of vibrotactile stimulation applied to the muscle, the balance control system must identify and selectively focus on sensory inputs providing the most reliable information, a process called sensory reweighting. Under normal conditions and while standing on a stable surface, healthy individuals rely on proprioceptive signals originating from ankle and paraspinal muscles. In contrast, standing on an unstable support surface (e.g. foam pad) forces individuals to rely less on ankle proprioception while up-weighting proprioceptive signals from paraspinal muscles. Differences in proprioceptive reweighting have been observed between healthy subjects and LBP patients by applying paraspinal and ankle muscle vibrotactile stimulation during a balance control task. Namely, during vibrotactile stimulation, individuals with recurrent LBP demonstrated an increased reliance on ankle proprioceptive signals compared to healthy subjects who up-weighted the proprioceptive signals from the paraspinal muscles (while down-weighting those from the ankle muscle to control postural balance). Importantly, a more "ankle-focused" strategy while standing on a stable support surface seems to increase the risk for developing or having recurrences of mild LBP within a time period of two years in young healthy individuals.
To test potential specific and sustained effects of SMT on lumbar proprioceptive function, the investigators aim to 1) assess SMT-induced changes in proprioceptive weighting (PW) over a two-week period and 2) use a rigorously controlled approach to control for non-specific effects. The planned experiments will be performed in healthy subjects and chronic LBP patients. This will allow to draw conclusions w.r.t. an isolated effect of SMT on lumbar proprioceptive function, providing a clear mechanism for SMT-induced changes in sensorimotor function.
- Being tested
- spinal manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal manipulationProcedure or surgery
intervention will consist of either lumbar manipulation, thoracic manipulation or lumbar mobilisation
| Study group | Role | What they receive |
|---|---|---|
| either lumbar manipulation (LMANIP) | Active comparator | LMANIP will consist of high velocity low amplitude (HVLA) SMT at the L4/L5 motion segment. LMANIP consists of two HVLA impulses, applied in side-posture on the right and left side (order pseudorandomized). Receives: Procedure: spinal manipulation |
| thoracic manipulation (TMANIP) | Active comparator | TMANIP will consist of high velocity low amplitude (HVLA) SMT at the T4/5 motion segment. TMANIP consists of supine SMT to the right and left (order pseudorandomized) using a thenar contact at facet joint level T4/5 Receives: Procedure: spinal manipulation |
| lumbar mobilisation (LMOB) | Sham comparator | LMOB will be applied with the same positioning as in the LMANIP procedure, but instead of a thrust, a slow, a slow, passive mobilization without impulse will be applied Receives: Procedure: spinal manipulation |
| No intervention | No intervention | A natural history arm will serve to further control for potential specific and non-specific effects of TMANIP and LMOB. Subject will rest in side-lying position for the same duration as during the active interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway (mm)
Postural sway will be measured using a force plate system
Measured: 15 minutes
Proprioceptive weighting ratio (value between 0 and 1)
The proprioceptive weighting ration will be calculated based on postural sway during vibrotactile stimulation on the ankle and paraspinal muscles
Measured: 15 minutes
Secondary outcomes (4)
Tampa-Scale for Kinesiophobia for the general population (TSK-G) questionnaire score
The original 17-item version of the TSK-G creates scores ranging between 17 and 68 higher scores indicating more fear of movement
Measured: 10 minutes
Belief score influence of manipulation on balance control
Subjects will be asked to rate how much they belief a manual intervention will affect their balance control (0 = no influence, 10 = maximal influence)
Measured: 1 minute
PainDETECT questionnaire
painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain
Measured: 5 minutes
Pain intensity on numeric rating scale (NRS pain, 0-10)
Subjects will be ask to rate their current pain intensity on a scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Mar 2023
- Primary completion1 Apr 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manipulation, PsychologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design consists of a four-arm (1:1:1:1 ratio) randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Meier, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869514
- Sponsor's protocol ID
- Project Nexus
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Spinal Manipulation Therapy Impact Lumbar Proprioception? A Double-blind Randomized Controlled Trial Examining the Influence of Spinal Manipulative Therapy (SMT) Versus a Sham and Non-sham Control Intervention on Proprioceptive Function
- ClinicalTrials.gov ID
- NCT04869514
- Acronym / sponsor ID
- Project Nexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal manipulation therapy (SMT) has long been a component of manual therapy and physical rehabilitation programs, especially as a modality for pain relief. However, the underlying physiological mechanisms for manipulation-related pain relief and functional improvement remain largely unexplored. To promote targeted treatments for musculoskeletal conditions and to better identify the indication and scope of SMT, its mechanisms must be better understood.
Detailed description
Manual therapy is widely used by patients with back pain with about 75% of patients consulting either a chiropractor, physiotherapist or osteopath. Often used manual therapies include spinal manipulative therapy (SMT), which is recommended in several clinical guidelines for management of back pain, mostly for acute low back pain (LBP) but also for chronic LBP. Despite the clinical benefits of SMT, the mechanisms underlying its effectiveness are poorly understood. Several mechanisms of action have been proposed including biomechanical and neurophysiological effects observed on spinal and supraspinal levels with unclear relationship to potential analgesic effects. Furthermore, non-specific effects such as placebo effects can strongly influence treatment outcomes and are difficult to control as consensus is lacking regarding the "active" agent of SMT, making it challenging to design an adequately controlled and blinded study.
A potential biological mechanism underlying the effectiveness of SMT might be related to sustained changes in lumbar proprioceptive function following repeated mechanical pressure on spinal tissues. In support of this, evidence from animal studies indicates that SMT comparable forces applied to the spine increase the discharge frequency of proprioceptive afferents in anesthetized cats, pointing towards an immediate effect of SMT on the activity of proprioceptive afferents. Proprioception is sub-served by mechanoreceptors on superficial and deep tissues. Located in the muscle belly parallel to the extrafusal muscle fibers, muscle spindles represent the main transmitters of proprioceptive information. Proprioceptive deficits have been suggested to provoke LBP through sensorimotor incongruence, abnormal loading across joint surfaces, and spinal instability due to less finely tuned muscular control, potentially causing sensorimotor dysfunction and degenerative processes in spinal tissues. In humans, there is anecdotal evidence that an SMT-induced repetitive barrage of proprioceptive input results in pain reduction and improves perceived function that might help to prevent LBP. However, a potential sustained and specific effect of SMT on lumbar proprioceptive function has not been systematically tested.
How one can test lumbar proprioceptive function in humans? Impairments in lumbar proprioception have been reported in LBP patients but only in sitting positions and mostly using proxy measures of proprioceptive function such as joint repositioning sense (JRS) and threshold to detect passive motion (TTDPM). The validity of these measures has been questioned as they measure position- and velocity-related proprioceptive sensation and the JRS is additionally influenced by motor skills and memory effects. Proprioceptive function can also be tested by assessing balance control (postural sway). Balance control presupposes a complex interplay involving the precise integration of proprioceptive inputs and motor outputs that can be tracked by analyzing postural sway on a force plate, a methodology that has been often used to assess differences in balance control in many diseases and conditions, including LBP. However, postural sway has been shown to be insensitive to changes of lumbar proprioceptive function, perhaps because postural sway relies on afferent input from various body locations and tissues. This can be overcome with a more direct assessment of proprioceptive function, achieved by using vibrotactile stimulation in combination with balance control measures. Vibration applied at frequencies between 60-80Hz (and amplitudes between 0.5-1mm) to muscles can selectively disturb proprioceptive signaling (mediated through primary (Ia) and secondary (II) muscle spindle afferents), affecting balance control by provoking corrective movements, often assessed through changes of the center of pressure (COP) in anterior-posterior direction. When endogenous or environmental conditions change, as in the instance of vibrotactile stimulation applied to the muscle, the balance control system must identify and selectively focus on sensory inputs providing the most reliable information, a process called sensory reweighting. Under normal conditions and while standing on a stable surface, healthy individuals rely on proprioceptive signals originating from ankle and paraspinal muscles. In contrast, standing on an unstable support surface (e.g. foam pad) forces individuals to rely less on ankle proprioception while up-weighting proprioceptive signals from paraspinal muscles. Differences in proprioceptive reweighting have been observed between healthy subjects and LBP patients by applying paraspinal and ankle muscle vibrotactile stimulation during a balance control task. Namely, during vibrotactile stimulation, individuals with recurrent LBP demonstrated an increased reliance on ankle proprioceptive signals compared to healthy subjects who up-weighted the proprioceptive signals from the paraspinal muscles (while down-weighting those from the ankle muscle to control postural balance). Importantly, a more "ankle-focused" strategy while standing on a stable support surface seems to increase the risk for developing or having recurrences of mild LBP within a time period of two years in young healthy individuals.
To test potential specific and sustained effects of SMT on lumbar proprioceptive function, the investigators aim to 1) assess SMT-induced changes in proprioceptive weighting (PW) over a two-week period and 2) use a rigorously controlled approach to control for non-specific effects. The planned experiments will be performed in healthy subjects and chronic LBP patients. This will allow to draw conclusions w.r.t. an isolated effect of SMT on lumbar proprioceptive function, providing a clear mechanism for SMT-induced changes in sensorimotor function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- The study design consists of a four-arm (1:1:1:1 ratio) randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| either lumbar manipulation (LMANIP) | Active comparator | Procedure: spinal manipulationLMANIP will consist of high velocity low amplitude (HVLA) SMT at the L4/L5 motion segment. LMANIP consists of two HVLA impulses, applied in side-posture on the right and left side (order pseudorandomized). |
| thoracic manipulation (TMANIP) | Active comparator | Procedure: spinal manipulationTMANIP will consist of high velocity low amplitude (HVLA) SMT at the T4/5 motion segment. TMANIP consists of supine SMT to the right and left (order pseudorandomized) using a thenar contact at facet joint level T4/5 |
| lumbar mobilisation (LMOB) | Sham comparator | Procedure: spinal manipulationLMOB will be applied with the same positioning as in the LMANIP procedure, but instead of a thrust, a slow, a slow, passive mobilization without impulse will be applied |
| No intervention | No intervention | –A natural history arm will serve to further control for potential specific and non-specific effects of TMANIP and LMOB. Subject will rest in side-lying position for the same duration as during the active interventions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Aged between 18 and 50
- History of chronic (>3months) LBP clinically not attributable to "red flags" (i.e., infection, trauma, fractures, inflammatory spondylarthropathies).
- Source of LBP clinically at the L4/5 or L5/S1 segment
- No history of vestibular disorders
- Body mass index (BMI) > 16 kg/m2
Key exclusion criteria (13 listed)
- Excessive consumption of alcohol or consumption of other drugs or analgesics within the last 24 h
- Pregnancy or breastfeeding
- Prior foot/ankle or spine surgery
- chiropractic (or other manual) treatment in the last 2 weeks
- facet joint, epidural or periradicular injections in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal manipulationintervention will consist of either lumbar manipulation, thoracic manipulation or lumbar mobilisation | Procedure or surgery | either lumbar manipulation (LMANIP), lumbar mobilisation (LMOB), thoracic manipulation (TMANIP) |
Primary outcome
Postural sway (mm)
Time frame: 15 minutes
Postural sway will be measured using a force plate system
Proprioceptive weighting ratio (value between 0 and 1)
Time frame: 15 minutes
The proprioceptive weighting ration will be calculated based on postural sway during vibrotactile stimulation on the ankle and paraspinal muscles
4 secondary outcomes
Tampa-Scale for Kinesiophobia for the general population (TSK-G) questionnaire score
Time frame: 10 minutes
Belief score influence of manipulation on balance control
Time frame: 1 minute
PainDETECT questionnaire
Time frame: 5 minutes
Pain intensity on numeric rating scale (NRS pain, 0-10)
Time frame: 5 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal manipulation in people with Manipulation, Psychologic and Proprioception, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural sway (mm) (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.