Influence of Pain on Exercise-induced Hypoalgesia

NCT04354948 | Completed

• 1 other identifier: S-20190081
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 a 3 min isometric wallsquat exercise in healthy subjects. The study is a single blinded (investigator) 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.

Conditions

Pain

Keywords

Exercise-induced hypoalgesia; Pressure pain threshold; hypertonic saline

Outcome Measures

Primary Outcomes (1)

• Pressure pain threshold at the right quadriceps muscle where injection is performed.

  Between group comparison of the primary outcome, which is change in pressure pain threshold at the right quadriceps muscle from before wall squat to after wall squat. Pressure pain threshold is measured with a hand held pressure algometer.

  Before and after the 3 minutes wall squat

Secondary Outcomes (3)

• Pressure pain threshold at the non-dominant trapezius muscle

  Before and after the 3 minutes wall squat

• Pressure pain threshold at the left quadriceps muscle where injection is not performed.

  Before and after the 3 minutes wall squat

• Pain Intensity in thighs

  Assessed before and immediately after hypertonic and isotonic saline injection as well as after 1, 2 and 3 min of wall squat, and immediately after the end of wall squat

Other Outcomes (4)

• Pressure pain threshold

  At baseline on both days before saline injections

• Pressure pain tolerance

  At baseline on both days before saline injections

• Temporal summation of pain

  At baseline on both days before saline injections

Study Arms (2)

Pain (hypertonic saline)

EXPERIMENTAL

Injection (1 ml) of painful hypertonic saline (5.8%) prior to performance of the 3 min wall squat exercise

Behavioral: Pain (hypertonic saline)

No pain (Hypotonic saline)

PLACEBO COMPARATOR

Injection (1 ml) of non-painful isotonic saline (0.9%) prior to performance of the 3 min wall squat exercise

Behavioral: No pain (Hypotonic saline)

Interventions

Pain (hypertonic saline) BEHAVIORAL

A bolus injection (1 ml) of hypertonic saline (5.8%) is injected into the right quadriceps femoris of the quadriceps femoris muscle 1 minute before performance of the 3 min wall squat exercise

Pain (hypertonic saline)

No pain (Hypotonic saline) BEHAVIORAL

A bolus injection (1 ml) of isotonic saline (0.9%) is injected into the right quadriceps femoris of the quadriceps femoris muscle 1 minute before performance of the 3 min wall squat exercise

No pain (Hypotonic saline)

Eligibility Criteria

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

You may qualify if:

• Pain-free
• Understands and writes Danish

You may not qualify if:

• Pregnancy
• Previous addictive behavior 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 within last 3 months
• Pain on the days of testing
• Pain for more than 2 weeks within the last 3 months

Sponsors & Collaborators

• Odense University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Pain Center, University Hospital Odense

Odense, Funen, 5000, Denmark

Location

Related Publications (1)

• Hansen S, Petersen KK, Sloth E, Manum LA, McDonald AK, Andersen PG, Vaegter HB. Hypoalgesia after exercises with painful vs. non-painful muscles in healthy subjects - a randomized cross-over study. Scand J Pain. 2021 Dec 27;22(3):614-621. doi: 10.1515/sjpain-2021-0161. Print 2022 Jul 26.

  PMID: 34958721 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Henrik B Vægter, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researcher responsible for the statistical analyses are blinded to arm allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Physiotherapy

Model Details: This study is a 2-arm randomized controlled cross-over trial with 1 week between arms

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: June 19, 2020
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)