Influence of Pain on Exercise-induced Hypoalgesia

Pain Clinical Trial

Official title:

The Influence of Pain on Exercise-Induced Hypoalgesia in Healthy Subjects: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354948
• Other study ID #: S-20190081
• Status: Completed
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: September 14, 2020

Study information

• Verified date: September 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Exercise is recommended to promote and maintain health and as treatment for more than 25 chronic diseases and pain conditions.

The mechanisms underlying pain relief of exercise are largely unknown but may be related to the modulation of central descending pain inhibitory pathways after acute exercise bouts. Exercise-induced hypoalgesia (EIH) is typically assessed as the temporary change in PPTs after a short acute exercise bout and EIH is seen as a proxy of descending pain inhibitory control. In general, EIH seems hypoalgesic (functional) in asymptomatic subjects. A hyperalgesic (impaired) EIH response has been reported in different chronic pain populations, although a functional EIH response also has been reported in subgroups of knee osteoarthritis patients. This implies differences in the acute response to exercise between healthy (pain-free) subjects and chronic pain patients, but it is still unknown whether the presence of pain itself affects the pain alleviating response (i.e. the EIH response) to acute exercise.

It is hypothesized that acute pain will decrease the EIH response magnitude following hypertonic saline injection compared with the control injection. This study will increase the insight into the EIH mechanisms in healthy subjects in general, and how the presence of pain affects the body's own ability to modulate pain during exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pain-free

• Understands and writes Danish

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Pain (hypertonic saline)
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
• No pain (Hypotonic saline)
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

Locations

Country	Name	City	State
Denmark	Pain Center, University Hospital Odense	Odense	Funen

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pressure pain threshold	Cuff pressure pain threshold (cPPT) is assessed using a computer-controlled cuff pressure algometer (CPAR, NociTech, Denmark,). A 13-cm wide silicone tourniquet cuff is wrapped around the right lower leg with an 8-cm distance to the tibial tuberosity. The cuff pressure is increased with a rate of 1 kPa/s and the maximal pressure limit is 100 kPa. The participants use an electronic visual analog scale (VAS) to rate the pressure-induced pain intensity and a button to release the pressure. Zero- and 10-cm extremes on the VAS were defined as "no pain" and as "maximal pain," respectively. The participants are instructed to rate the pain intensity continuously on the electronic VAS from when the pressure was defined as first sensation of pain and to press the pressure release button when the pain was intolerable. The pressure value when the subject rated the sensation of pain as 1 cm on the VAS was defined as the cPPT.	At baseline on both days before saline injections
Other	Pressure pain tolerance	Cuff pressure pain tolerance (cPTT) is assessed using a computer-controlled cuff pressure algometer (CPAR, NociTech, Denmark,). A 13-cm wide silicone tourniquet cuff is wrapped around the right lower leg with an 8-cm distance to the tibial tuberosity. The cuff pressure is increased with a rate of 1 kPa/s and the maximal pressure limit is 100 kPa. The participants use an electronic visual analog scale (VAS) to rate the pressure-induced pain intensity and a button to release the pressure. Zero- and 10-cm extremes on the VAS were defined as "no pain" and as "maximal pain," respectively. The participants are instructed to rate the pain intensity continuously on the electronic VAS from when the pressure was defined as first sensation of pain and to press the pressure release button when the pain was intolerable. The pressure value when the subject terminates the pressure inflation is defined as the cPTT.	At baseline on both days before saline injections
Other	Temporal summation of pain	Temporal summation of pain (TSP) is assessed at the right lower leg with computer-controlled cuff algometry. Ten repeated cuff pressure stimulations lasting 1 second each (1 sec breaks in between) are induced to assess TSP. Stimulations are delivered by rapid inflation of the cuff with an intensity equivalent to the pressure pain tolerance. Subjects rate the pain intensity on an electronic VAS continuously during the sequential stimulation without returning the VAS to zero between stimulations. VAS scores immediately after each stimulus are extracted, and TSP is calculated as the ratio of the last 3 stimulations to the first four stimulations, with positive values indicating an increase in pain intensity ratings during the repeated stimulation.	At baseline on both days before saline injections
Other	International Physical Activity Questionnaire (IPAQ)	The IPAQ is suitable for adults between 15 and 69 years of age and is used for sample surveillance of physical activity levels.	Baseline of first session
Primary	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	Pressure pain threshold at the non-dominant trapezius muscle	Between group comparison of the secondary outcome, which is change in pressure pain threshold at the left trapezius 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	Pressure pain threshold at the left quadriceps muscle where injection is not performed.	Between group comparison of the secondary outcome, which is change in pressure pain threshold at the left 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	Pain Intensity in thighs	Pain intensity in both thighs are assessed with numerical rating scales with 0 = no pain and 10 = maximal pain.	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