PainNCT04354948
Influence of Pain on Exercise-induced Hypoalgesia
A study testing Pain (hypertonic saline) and No pain (Hypotonic saline) in people with Pain, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Pain (hypertonic saline) and No pain (Hypotonic saline)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jun 2020to 14 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pain-free
- Understands and writes Danish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Pain on Exercise-Induced Hypoalgesia in Healthy Subjects: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Pain
- Being tested
- Pain (hypertonic saline), No pain (Hypotonic saline)
- Keywords
- Exercise-induced hypoalgesia, Pressure pain threshold, hypertonic saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain (hypertonic saline)Behavioural
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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Pain (hypertonic saline) | Experimental | Injection (1 ml) of painful hypertonic saline (5.8%) prior to performance of the 3 min wall squat exercise Receives: 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 Receives: Behavioral: No pain (Hypotonic saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after the 3 minutes wall squat
Secondary outcomes (3)
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.
Measured: Before and after the 3 minutes wall squat
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.
Measured: Before and after the 3 minutes wall squat
Pain Intensity in thighs
Pain intensity in both thighs are assessed with numerical rating scales with 0 = no pain and 10 = maximal pain.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start19 Jun 2020
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a 2-arm randomized controlled cross-over trial with 1 week between arms
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Henrik Bjarke Vægter, Odense University Hospital
- Investigators
- Henrik B Vægter, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354948
- Sponsor's protocol ID
- S-20190081
- Status last verified
- Sep 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34958721
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pain on Exercise-Induced Hypoalgesia in Healthy Subjects: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04354948
- Acronym / sponsor ID
- S-20190081
- Conditions
- Pain
- Keywords
- Exercise-induced hypoalgesia, Pressure pain threshold, hypertonic saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study is a 2-arm randomized controlled cross-over trial with 1 week between arms
| Arm | Type | Receives |
|---|---|---|
| Pain (hypertonic saline) | Experimental | Behavioral: Pain (hypertonic saline)Injection (1 ml) of painful hypertonic saline (5.8%) prior to performance of the 3 min wall squat exercise |
| No pain (Hypotonic saline) | Placebo comparator | Behavioral: No pain (Hypotonic saline)Injection (1 ml) of non-painful isotonic saline (0.9%) prior to performance of the 3 min wall squat exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pain-free
- Understands and writes Danish
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Pain (hypertonic saline) |
| 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 | Behavioural | No pain (Hypotonic saline) |
Primary outcome
Pressure pain threshold at the right quadriceps muscle where injection is performed.
Time frame: Before and after the 3 minutes wall squat
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.
3 secondary outcomes
Pressure pain threshold at the non-dominant trapezius muscle
Time frame: Before and after the 3 minutes wall squat
Pressure pain threshold at the left quadriceps muscle where injection is not performed.
Time frame: Before and after the 3 minutes wall squat
Pain Intensity in thighs
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Derived from this study: PubMed 34958721Hansen 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.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik B Vægter, PhD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain (hypertonic saline) and No pain (Hypotonic saline) in people with Pain, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold at the right quadriceps muscle where injection is performed. (time frame: Before and after the 3 minutes wall squat). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.