NCT05299268

Brief Summary

The purpose of this study is to investigate how acute pain induced by hypertonic saline prior to exercise influence the magnitude of exercise-induced hypoalgesia after 1x3 min seated isometric knee extension exercise in healthy women. The study is a blinded randomized cross-over trial The results from the study may be of great importance to the understanding of exercise-induced hypoalgesia, and whether the presence of pain affects the effects of exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

March 8, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

February 25, 2022

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in pressure pain threshold will be assessed over the dominant quadriceps muscle

    Between group comparison of the primary outcome, which is change in pressure pain threshold over the dominant quadriceps muscle before and after performing seated isometric knee extension. Pressure pain threshold is measured with a handheld pressure algometer.

    Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)

Secondary Outcomes (2)

  • Pressure pain threshold at the non-dominant quadriceps muscle and non-dominant trapezius muscle

    Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)

  • Pain Intensity in dominant thigh

    Assessed before and immediately after hypertonic and isotonic saline injection as well as 1, 2 and 3 minutes into the Seated Isometric Knee Extension, and immediately after the end of the seated isometric knee extension

Other Outcomes (4)

  • Pressure pain threshold at the dominant and non-dominant thigh as well as non-dominant trapezius muscle

    Before and after determining maximal voluntary contraction on the fist test day and prior to saline injections

  • Rating of perceived exertion (RPE)

    Assessed 1, 2 and 3 minutes into the Seated Isometric Knee Extension

  • Quantifying the individual´s pain experience

    Baseline

  • +1 more other outcomes

Study Arms (2)

Pain (hypertonic saline)

EXPERIMENTAL

Injection (1 ml) of painful hypertonic saline (5.8%) prior to performance of the 1x3 min Seated Isometric Knee Extension

Behavioral: Pain (hypertonic saline)

No pain (isotonic saline)

PLACEBO COMPARATOR

Injection (1 ml) of non-painful isotonic saline (0.9%) prior to performance of the 1x3 min Seated Isometric Knee Extension

Behavioral: No pain (Isotonic saline)

Interventions

A bolus injection (1 ml) of hypertonic saline (5.8%) is injected into the dominant vastus medialis muscle 20 cm proximal from the basis of patella before performance of the 1x3 min Seated Isometric Knee Extension.

Pain (hypertonic saline)

A bolus injection (1 ml) of isotonic saline (0.9%) is injected into the dominant vastus medialis muscle 20 cm proximal from the basis of patella before performance of the 1x3 min Seated Isometric Knee Extension

No pain (isotonic saline)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pain-free
  • Understands and writes Danish

You may not qualify if:

  • Pregnancy
  • Previous addictive behaviour defined as abuse of hash, opioids or other euphoric substances.
  • Previous painful or mental illnesses, neurological or circulatory diseases in the form of heart or lung disease.
  • Surgery in the lower extremities within the last 12 months
  • Chronic or actual pain on the days of testing
  • Under the influence on the days of testing
  • Inability to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Of Health Science and Technology, Aalborg University

Aalborg, 9220, Denmark

Location

Related Publications (1)

  • Mohrsen A, Lund H, Rasmussen SZ, Vaegter HB, Vela J, Hansen S, Christensen SWM. Acute exercise of painful muscles does not reduce the hypoalgesic response in young healthy women - a randomized crossover study. Scand J Pain. 2023 May 4;23(3):599-607. doi: 10.1515/sjpain-2022-0127. Print 2023 Jul 26.

MeSH Terms

Conditions

Pain

Interventions

Saline Solution, HypertonicSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Steffan WM Christensen, PhD

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Assessor and participants will be blinded to the order of injections.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This study is a 2-arm randomized controlled cross-over trial with 1-7 days between arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 28, 2022

Study Start

March 8, 2022

Primary Completion

April 12, 2022

Study Completion

April 12, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations