The Immediate Extent of the Hypoalgesic Effect Following Central Mobilisations to L3, L4 and L5

NCT06548633 | Completed

• 1 other identifier: TIEHEFCML345
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to establish the efficacy of spinal mobilisations (a controlled application of a specific amount of force to a targeted spinal level) for reducing pain across different areas of the lower back. Pain was assessed using a pin prick sensation device and recorded in specific locations by the participant using a 10 cm line with one end indicating no pain and the other the worst pain possible.

Conditions

Low Back Pain

Keywords

Vertebral Lumbar Mobilisations; Hypoalgesia; Pinprick sensitivity (PPS); Neuropen®

Outcome Measures

Primary Outcomes (1)

• Pinprick sensitivity (PPS)

  Using a Neuropen® (Owen Mumford, Oxfordshire, UK) a standardised force of 40g was applied to one of the dermatome locations. The participant then received a small piece of card with a vertical 10cm visual analogue scale (VAS) line on it and a pen and was asked to "draw a horizontal line on the scale to indicate how much sensation you feel, 0 being can-not feel anything and 10 being an extremely strong sensation". Following this explanation, the participant was asked if they understood and whether they needed further instruction to complete the VAS card. Once the participant marked the card, the card and pen were collected and stored, this process was repeated with the remaining four locations (these five cards provided the baseline data). A new tip was used for each participant, and a decrease in PPS represents a reduction in pain.

  Up to 15 minutes

Study Arms (1)

Vertebral Lumbar Mobilisations

EXPERIMENTAL

Participants received the intervention.

Other: Lumbar Vertebral Mobilisation

Interventions

Lumbar Vertebral Mobilisation OTHER

The participants received Vertebral Lumbar Mobilisations, these were posterior-anterior central vertebral pressures (PACVPs) for four sets of 30 seconds, with up to 30s between each, at a grade III amplitude.

Vertebral Lumbar Mobilisations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy and consent.

You may not qualify if:

• Yes to any Vertebral Mobilisation Contraindication.
• Consulted a doctor within the last 6 months?
• Presently taking any form of medication?
• Suffered from a bacterial or viral infection in the last 2 weeks?
• Ever suffered from any form of heart complaint?
• Family history of heart disease?
• Ever suffered from: Asthma, Diabetes, Bronchitis, Epilepsy, High blood pressure or Low blood pressure?
• Currently have any form of muscle or joint injury?
• Had to suspend training in the last two weeks for a physical reason?
• Is there anything that may prevent the successful completion of the tests that have been outlined?
• Any "yes" answers to any of the questions above will require further detail, then the answers will be assessed to establish the potential risks to the participant and established if it is safe to participate in the study.

Sponsors & Collaborators

• Darren Cooper: lead

Study Sites (1)

University of Worcester

Worcester, Worcestershire, WR5 3WP, United Kingdom

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Darren Cooper, Dr

  University of Worcester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants were blinded to the intervention they were receiving.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Lecturer in Sports Therapy

Model Details: The design of the study was a randomised, single-blind, repeated measures, cross-over design, performed in a single-centre environment.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 12, 2024
• Study Start: October 4, 2018
• Primary Completion: February 1, 2019
• Study Completion: May 28, 2019
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: December 2024 onwards
• Access Criteria: Emailing the study contact.

Locations

GB (1)