Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT06509633
Status:
RECRUITING
Last Update Posted:
2024-07-19
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pain Neuroscience Education and Standard Rehabilitation Regime in Patients of Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Boston Carpal Tunnel Questionnaire (BCTQ)', 'timeFrame': '4th week', 'description': 'BCTQmeasures self reported functional status and severity of symptom. The BCTQ-SSS consists of 11 questions, each question provides 5 response choices, from 1 (no symptoms) to 5 (most severe/often).'}, {'measure': 'Goniometer', 'timeFrame': '4th week', 'description': 'The range of motions like flexion extension radial deviation and ulnar deviation of wrist will be measured by Goniometer.'}], 'primaryOutcomes': [{'measure': 'Numeric pain rate scale (NPRS)', 'timeFrame': '4th week', 'description': 'Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain.'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': '4th week', 'description': 'The Pain Catastrophizing Scale (PCS) was used to measure catastrophic thinking in response to pain through 13 statements with four possible options, from 1 "not at all" to 4 "all the time".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carpal tunnel syndrome', 'Compression', 'Pain neuroscience education', 'Median nerve'], 'conditions': ['Wrist Injuries', 'Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '21922474', 'type': 'BACKGROUND', 'citation': 'Werner RA, Andary M. Electrodiagnostic evaluation of carpal tunnel syndrome. Muscle Nerve. 2011 Oct;44(4):597-607. doi: 10.1002/mus.22208.'}, {'pmid': '32313774', 'type': 'BACKGROUND', 'citation': 'Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.'}, {'pmid': '31010499', 'type': 'BACKGROUND', 'citation': 'Nunez-Cortes R, Espinoza-Ordonez C, Pommer PP, Horment-Lara G, Perez-Alenda S, Cruz-Montecinos C. A single preoperative pain neuroscience education: Is it an effective strategy for patients with carpal tunnel syndrome? Med Hypotheses. 2019 May;126:46-50. doi: 10.1016/j.mehy.2019.03.013. Epub 2019 Mar 22.'}, {'pmid': '37572618', 'type': 'BACKGROUND', 'citation': 'Nunez-Cortes R, Cruz-Montecinos C, Torreblanca-Vargas S, Tapia C, Gutierrez-Jimenez M, Torres-Gangas P, Calatayud J, Perez-Alenda S. Effectiveness of adding pain neuroscience education to telerehabilitation in patients with carpal tunnel syndrome: A randomized controlled trial. Musculoskelet Sci Pract. 2023 Oct;67:102835. doi: 10.1016/j.msksp.2023.102835. Epub 2023 Jul 28.'}, {'pmid': '27842937', 'type': 'BACKGROUND', 'citation': 'Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.'}, {'pmid': '33764394', 'type': 'BACKGROUND', 'citation': 'Bulow K, Lindberg K, Vaegter HB, Juhl CB. Effectiveness of Pain Neurophysiology Education on Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Pain Med. 2021 Apr 20;22(4):891-904. doi: 10.1093/pm/pnaa484.'}, {'pmid': '26928735', 'type': 'BACKGROUND', 'citation': 'Louw A, Puentedura EJ, Zimney K, Schmidt S. Know Pain, Know Gain? A Perspective on Pain Neuroscience Education in Physical Therapy. J Orthop Sports Phys Ther. 2016 Mar;46(3):131-4. doi: 10.2519/jospt.2016.0602.'}, {'pmid': '34579995', 'type': 'BACKGROUND', 'citation': 'Ziegler AM, Minkalis AL, Langdon ER, Vining R. Learning the neurobiology of pain: A scoping review of pain education from an instructional design perspective. Patient Educ Couns. 2022 Jun;105(6):1379-1401. doi: 10.1016/j.pec.2021.09.021. Epub 2021 Sep 14.'}, {'pmid': '37582474', 'type': 'BACKGROUND', 'citation': 'Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Cleland JA, Cook C, de-la-Llave-Rincon AI, Valera-Calero JA, Plaza-Manzano G. Minimal Clinically Important Differences in Hand Pain Intensity (Numerical Pain Rate Scale) and Related-Function (Boston Carpal Tunnel Questionnaire) in Women With Carpal Tunnel Syndrome. Arch Phys Med Rehabil. 2024 Jan;105(1):67-74. doi: 10.1016/j.apmr.2023.07.018. Epub 2023 Aug 13.'}, {'type': 'BACKGROUND', 'citation': 'Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995;7(4):524.'}, {'pmid': '8245050', 'type': 'BACKGROUND', 'citation': 'Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to check the effects of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.', 'detailedDescription': "In 2017 a stud assessed effectiveness of standard conservative protocol of CTS and nerve mobilization along with and without PNE and documented that standard conservative care seems to be the most appropriate option for pain relief, although neuroscience education might be a complementary option to accelerate recovery of function. More high-quality research is still necessary to determine its effectiveness and the subgroups of patients who may respond better to this treatment.\n\nIn 2019 a study was done to assess the effect of PNE and standard rehabilitation exercises on the 41 patients of CTS. The experimenting group was given one session of PNE plus exercises and the control group was given exercise therapy only. Patients were randomly allocated and double blinded. The analysis of study showed better results with experimental group rather than control group.\n\nMany studies have found the effects of standard rehabilitation of Carpal Tunnel syndrome and their results in controlling pain and dysfunction. However as per researchers' knowledge little literature is available on effects of pain neuroscience education and standard rehabilitation regime in carpal tunnel syndrome. Therefore, this study6 is going to determine the effects of effectiveness of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Carpal Tunnel syndrome is prevalent in female housewives and computer users.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 20\\_40 years old.\n* Medical diagnosis of moderate to severe CTS.\n* Symptoms of CTS since 1month\n* Unilateral or bilateral symptoms\n* Availability and access to the hospital.\n\nExclusion Criteria:\n\n* Inability to understand instructions, neurological conditions of the central nervous system (e.g. stroke, spinal cord injury)\n* Patients on treatment with alternative therapies\n* Previous participation in a research program\n* Previous surgery on the affected upper limb'}, 'identificationModule': {'nctId': 'NCT06509633', 'briefTitle': 'Effects of Pain Neuroscience Education and Standard Rehabilitation Regime in Patients of Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Pain Neuroscience Education and Standard Rehabilitation Regime in Patients of Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/01113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Neuroscience education and Standard Rehabilitation regime', 'description': 'Patients will get standard treatment of CTS, which is nerve gliding, stretchings of forearm and wrist muscles and wrist mobilization along with pain neuroscience education.', 'interventionNames': ['Other: Pain Neuroscience education and standard rehabilitation regime']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard Rehabilitation regime', 'description': 'Patient will get only nerve gliding and wrist forearm muscle stretching exercises.', 'interventionNames': ['Other: standard Rehabilitation regime']}], 'interventions': [{'name': 'Pain Neuroscience education and standard rehabilitation regime', 'type': 'OTHER', 'otherNames': ['Standard Rehabilitation regime'], 'description': 'Median nerve gliding exercises, wrist and forearm muscle stretches, wrist mobilizations and finger joint mobilizations', 'armGroupLabels': ['Pain Neuroscience education and Standard Rehabilitation regime']}, {'name': 'standard Rehabilitation regime', 'type': 'OTHER', 'description': 'standard Rehabilitation regime', 'armGroupLabels': ['standard Rehabilitation regime']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56300', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Iqra khan', 'role': 'CONTACT', 'email': 'Iqrakhan485@gmail.com', 'phone': '03354671744'}, {'name': 'Sara Abdulhaq', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Absaar medical center', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Imran Amjad', 'role': 'CONTACT', 'email': 'Imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'Saba khan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}