Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT07242235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immediate Effects of TENS on Lumbar Erector Spinae Stiffness in Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessor who performs Myoton and VAS measurements will be blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized (1:1) to active TENS or control/rest; both groups are assessed pre- and immediately post-intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lumbar erector spinae muscle stiffness', 'timeFrame': 'Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)', 'description': 'Muscle stiffness of the lumbar erector spinae will be measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels. The outcome is the change score (post - pre) between TENS and control groups. Lower values indicate reduced stiffness.'}, {'measure': 'Change in pain intensity (VAS)', 'timeFrame': 'Baseline (pre-intervention) and immediately post-intervention (within ~5 minutes of completing the 20-minute session)', 'description': 'Pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst pain). The outcome is the change score (post - pre) to compare TENS and control groups. Lower scores indicate pain reduction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TENS', 'Low Back Pain', 'Muscle Stiffness', 'Randomized Controlled Trial'], 'conditions': ['Low Back Pain', 'Non-specific Low Back Pain', 'Lumbar Muscle Stiffness']}, 'descriptionModule': {'briefSummary': 'Low back pain is frequently associated with increased tone and stiffness of the lumbar erector spinae muscles, which may contribute to pain and functional limitation. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, safe, and widely used modality for pain reduction, but its very short-term (immediate) effects on lumbar muscle stiffness have not been clearly demonstrated. This randomized controlled trial will compare a single 20-minute session of conventional TENS with a control/rest condition in patients with non-specific low back pain. The primary outcomes will be change in lumbar erector spinae muscle stiffness (Myoton) and change in pain intensity (VAS) from baseline to immediately after the intervention. We hypothesize that TENS will produce a greater immediate reduction in muscle stiffness and pain than control.', 'detailedDescription': 'Low back pain (LBP) is one of the most common musculoskeletal problems and often presents with increased paraspinal muscle activity and perceived stiffness around the lumbar region. Increased stiffness of the lumbar erector spinae may perpetuate pain and restrict movement. TENS provides afferent stimulation that can modulate pain through gate-control and descending inhibitory mechanisms and may secondarily reduce muscle tone. However, evidence about its acute influence on objective muscle stiffness parameters in LBP is limited.\n\nThis single-center, parallel-group, randomized controlled trial will recruit adults with chronic or recurrent non-specific low back pain who meet the eligibility criteria. Participants will be randomly assigned (1:1) to (1) an experimental group receiving conventional TENS applied bilaterally over the lumbar paraspinal area for 20 minutes (frequency \\~80-100 Hz, pulse width \\~100-150 μs), or (2) a control group undergoing the same positioning and timing without active TENS. All assessments will be performed immediately before and immediately after the intervention by an outcome assessor blinded to group allocation.\n\nPrimary outcomes are: (a) lumbar erector spinae muscle stiffness measured with a handheld myotonometer (e.g. Myoton) at standardized lumbar levels, and (b) pain intensity measured with a 10-cm visual analog scale (VAS). Secondary observations may include participant-reported comfort/tolerance of TENS and adverse events. The study is designed as a short-term physiological and symptomatic trial; no long-term follow-up is planned. Ethical approval was obtained from the Erzurum Technical University Ethics Committee (Meeting 13, Decision 04, 18.09.2025)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-30 years\n\nNon-specific low back pain persisting or recurring for ≥3 months\n\nReported tenderness/stiffness on palpation of the lumbar erector spinae muscles\n\nAble to understand the study procedures and provide written informed consent\n\nAble to attend on the same day for TENS application and pre-/post-intervention measurements\n\nExclusion Criteria:\n\n* Low back pain with a specific cause (e.g. lumbar disc herniation with radiculopathy, infection, tumor, fracture, severe deformity)\n\nOpen wound, dermatitis, or any skin condition in the lumbar area that prevents electrode placement\n\nPresence of a cardiac pacemaker or other implanted electronic device\n\nElectrotherapy, injection, or manual therapy applied to the lumbar region within the previous 48 hours\n\nPregnancy\n\nSevere neurological deficit or sensory loss\n\nUse of analgesics/NSAIDs at a level that may interfere with pain or stiffness assessment at the time of evaluation\n\nAny other condition deemed unsafe or inappropriate by the investigator'}, 'identificationModule': {'nctId': 'NCT07242235', 'acronym': 'TENS-LUMBAR', 'briefTitle': 'Immediate Effects of TENS on Lumbar Erector Spinae Stiffness in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Erzurum Technical University'}, 'officialTitle': "Immediate Effects of Transcutaneous Electrical Nerve Stimulation on the Lumbar Erector Spinae Muscles' Stiffness and Pain: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'ETU-TENS-LBP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: TENS', 'description': 'Participants receive a single 30-minute session of conventional TENS applied bilaterally over the lumbar paraspinal (erector spinae) region. Pre- and post-intervention Myoton and VAS measurements are taken.', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation (TENS)']}, {'type': 'OTHER', 'label': 'Control: Rest/Positioning', 'description': 'Participants are positioned in the same way and remain at rest for 20 minutes without active TENS. Pre- and post-intervention Myoton and VAS measurements are taken.', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation (TENS)']}], 'interventions': [{'name': 'Transcutaneous Electrical Nerve Stimulation (TENS)', 'type': 'DEVICE', 'otherNames': ['Rest/Observation'], 'description': 'Conventional TENS; frequency 80-100 Hz, pulse width 100-150 μs, intensity adjusted to strong but comfortable sensory level without muscle contraction; total duration 20 minutes; electrodes placed bilaterally at lumbar erector spinae level.', 'armGroupLabels': ['Control: Rest/Positioning', 'Experimental: TENS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Furgani Taş, Mr', 'role': 'CONTACT', 'email': 'furgani.tas@erzurum.edu.tr', 'phone': '445388', 'phoneExt': '2049'}], 'facility': 'Erzurum Technical University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Esedullah AKARAS, Dr.', 'role': 'CONTACT', 'email': 'esedullah.akaras@erzurum.edu.tr', 'phone': '4445388', 'phoneExt': '2772'}], 'overallOfficials': [{'name': 'Gökhan YAĞIZ, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amasya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study is small, single-center, and includes identifiable clinical measurements that could risk participant privacy despite de-identification.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzurum Technical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amasya University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'esedullah akaras', 'investigatorAffiliation': 'Erzurum Technical University'}}}}