Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-01-04 @ 12:26 PM
Study NCT ID:
NCT05299268
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2022-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Pain on Exercise-induced Hypoalgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Assessor and participants will be blinded to the order of injections.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study is a 2-arm randomized controlled cross-over trial with 1-7 days between arms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pressure pain threshold at the dominant and non-dominant thigh as well as non-dominant trapezius muscle', 'timeFrame': 'Before and after determining maximal voluntary contraction on the fist test day and prior to saline injections', 'description': 'Pressure pain threshold is measured with a handheld pressure algometer.'}, {'measure': 'Rating of perceived exertion (RPE)', 'timeFrame': 'Assessed 1, 2 and 3 minutes into the Seated Isometric Knee Extension', 'description': 'Perceived exertion is assessed with Borg RPE scale with 6 = no exertion and 20 = maximal exertion'}, {'measure': 'Quantifying the individual´s pain experience', 'timeFrame': 'Baseline', 'description': 'Quantifying the individual´s pain experience will be assessed using the Pain Catastrophizing Scale (PCS) at the first session. The pain catastrophizing scale have 13 sentences regarding pain-related thoughts. Participants are asked to indicate how well each sentence applies for them: 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree and 4 = all the time. A higher score is worse'}, {'measure': 'Pain experience', 'timeFrame': 'Day 3 (within 2-3 weeks of the initial session)', 'description': 'Participants will be interviewed at the end of the study regarding the experience of pain during the study. The interview will be conducted after all other experimental procedures have been completed.'}], 'primaryOutcomes': [{'measure': 'Change in pressure pain threshold will be assessed over the dominant quadriceps muscle', 'timeFrame': 'Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)', 'description': '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.\n\nPressure pain threshold is measured with a handheld pressure algometer.'}], 'secondaryOutcomes': [{'measure': 'Pressure pain threshold at the non-dominant quadriceps muscle and non-dominant trapezius muscle', 'timeFrame': 'Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)', 'description': 'Between group comparison of the secondary outcome, which is change in pressure pain threshold at the non-dominant quadriceps muscle and non-dominant trapezius muscle from before Seated Isometric Knee Extension to after Seated Isometric Knee Extension.\n\nPressure pain threshold is measured with a handheld pressure algometer.'}, {'measure': 'Pain Intensity in dominant thigh', 'timeFrame': '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', 'description': 'Pain intensity is assessed with numerical rating scales with 0 = no pain and 10 = maximal pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '37137551', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Exercise is recommended to promote and maintain health and as treatment for more than 25 chronic diseases and pain conditions.\n\nThe 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 pressure pain thresholds (PPT) 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.\n\nIt 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain-free\n* Understands and writes Danish\n\nExclusion Criteria:\n\n* Pregnancy\n* Previous addictive behaviour defined as abuse of hash, opioids or other euphoric substances.\n* Previous painful or mental illnesses, neurological or circulatory diseases in the form of heart or lung disease.\n* Surgery in the lower extremities within the last 12 months\n* Chronic or actual pain on the days of testing\n* Under the influence on the days of testing\n* Inability to cooperate'}, 'identificationModule': {'nctId': 'NCT05299268', 'briefTitle': 'Influence of Pain on Exercise-induced Hypoalgesia', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'The Influence of Pain on Exercise-Induced Hypoalgesia in Healthy Women', 'orgStudyIdInfo': {'id': 'S-20210184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain (hypertonic saline)', 'description': 'Injection (1 ml) of painful hypertonic saline (5.8%) prior to performance of the 1x3 min Seated Isometric Knee Extension', 'interventionNames': ['Behavioral: Pain (hypertonic saline)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No pain (isotonic saline)', 'description': 'Injection (1 ml) of non-painful isotonic saline (0.9%) prior to performance of the 1x3 min Seated Isometric Knee Extension', 'interventionNames': ['Behavioral: No pain (Isotonic saline)']}], 'interventions': [{'name': 'Pain (hypertonic saline)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Pain (hypertonic saline)']}, {'name': 'No pain (Isotonic saline)', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['No pain (isotonic saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9220', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Dept. Of Health Science and Technology, Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Steffan WM Christensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Steffan Wittrup Christensen', 'investigatorAffiliation': 'Aalborg University'}}}}