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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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:
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  • 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)
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  • 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

Other trials in Switzerland

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 groups in NCT04869514
Study groupRoleWhat they receive
either lumbar manipulation (LMANIP)Active comparatorLMANIP 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 comparatorTMANIP 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 comparatorLMOB 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 interventionNo interventionA 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.

  1. Postural sway (mm)

    Postural sway will be measured using a force plate system

    Measured: 15 minutes

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted3 May 2021
  2. Study start1 Mar 2023
  3. Primary completion1 Apr 2024
  4. Study completion1 Aug 2024

Resources

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)
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

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.

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