Does Spinal Manipulation Therapy Impact Lumbar Proprioception

NCT04869514 | Completed

• 1 other identifier: Project Nexus
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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. To promote targeted treatments for musculoskeletal conditions and to better identify the indication and scope of SMT, its mechanisms must be better understood.

Conditions

Manipulation, Psychologic; Proprioception; Vibration; Exposure

Outcome Measures

Primary Outcomes (2)

• Postural sway (mm)

  Postural sway will be measured using a force plate system

  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

  15 minutes

Secondary Outcomes (4)

• Tampa-Scale for Kinesiophobia for the general population (TSK-G) questionnaire score

  10 minutes

• Belief score influence of manipulation on balance control

  1 minute

• PainDETECT questionnaire

  5 minutes

• Pain intensity on numeric rating scale (NRS pain, 0-10)

  5 seconds

Study Arms (4)

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).

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

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

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.

Interventions

spinal manipulation PROCEDURE

intervention will consist of either lumbar manipulation, thoracic manipulation or lumbar mobilisation

either lumbar manipulation (LMANIP); lumbar mobilisation (LMOB); thoracic manipulation (TMANIP)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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
• Excessive consumption of alcohol or consumption of other drugs or analgesics within the last 24 h
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Department of Chiropractic Medicine, University of Zurich

Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The data collection and analysis will be conducted by a research assistant blind to treatment allocation. The study subjects will be blinded with respect to the hypothesis.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study design consists of a four-arm (1:1:1:1 ratio) randomized controlled trial.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: March 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)