Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT02560259
Status:
UNKNOWN
Last Update Posted:
2015-09-25
First Post:
2015-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053591', 'term': 'Pain, Referred'}], 'ancestors': [{'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': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Working full time the last week', 'timeFrame': 'At 3months', 'description': 'Response yes or no to question if the participant worked full time last week'}], 'primaryOutcomes': [{'measure': 'Pain on VAS score', 'timeFrame': 'At 3 months', 'description': '0 no pain, 10 worst possible pain'}], 'secondaryOutcomes': [{'measure': 'KOOS score subscales Pain', 'timeFrame': 'At 3 months', 'description': 'Standard scoring on the KOOS subscale of pain'}, {'measure': 'KOOS score subscale Symptoms', 'timeFrame': 'At 3 months', 'description': 'Standard scoring on the KOOS subscale of symptoms'}, {'measure': 'KOOS score subscale Function in daily living', 'timeFrame': 'At 3 months', 'description': 'Standard scoring on the KOOS subscale of Function of daily living'}, {'measure': 'KOOS score subscale Knee-Related Quality of Life', 'timeFrame': 'At 3 months', 'description': 'Standard scoring on the KOOS subscale of Knee-Related Quality of Life'}, {'measure': 'KOOS score subscale Function in Sports and Recreation', 'timeFrame': 'At 3 months', 'description': 'Standard scoring on the KOOS subscale of Function in Sports and Recreation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['knee pain'], 'conditions': ['Referred Pain']}, 'referencesModule': {'references': [{'pmid': '19263036', 'type': 'RESULT', 'citation': 'Meknas K, Kartus J, Letto JI, Flaten M, Johansen O. A 5-year prospective study of non-surgical treatment of retro-trochanteric pain. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):996-1002. doi: 10.1007/s00167-009-0750-z. Epub 2009 Mar 5.'}, {'pmid': '21678093', 'type': 'RESULT', 'citation': 'Meknas K, Johansen O, Kartus J. Retro-trochanteric sciatica-like pain: current concept. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1971-85. doi: 10.1007/s00167-011-1573-2. Epub 2011 Jun 16.'}, {'pmid': '19396428', 'type': 'RESULT', 'citation': 'Meknas K, Kartus J, Letto JI, Christensen A, Johansen O. Surgical release of the internal obturator tendon for the treatment of retro-trochanteric pain syndrome: a prospective randomized study, with long-term follow-up. Knee Surg Sports Traumatol Arthrosc. 2009 Oct;17(10):1249-56. doi: 10.1007/s00167-009-0787-z. Epub 2009 Apr 18.'}, {'pmid': '12855348', 'type': 'RESULT', 'citation': 'Meknas K, Christensen A, Johansen O. The internal obturator muscle may cause sciatic pain. Pain. 2003 Jul;104(1-2):375-80. doi: 10.1016/s0304-3959(03)00045-9.'}]}, 'descriptionModule': {'briefSummary': 'The role of referred pain from the retro trochanteric region, in patients with knee pain. Defining and quantifying this sub group of knee patients in the investigators list of refered knee patients. Evaluating the effect of treatment. A randomized trial.', 'detailedDescription': 'Knee pain is a great problem in the society. Besides obvious and known causes, for which there are increasing understanding and ways to treat, there is still a rather large group of patients in which the symptoms are not easily understood and harder to treat.\n\nThis group is often characterized by having symptoms ranging from months to years, having seen several physicians, gone through several x-rays/mri´s, and various treatment with no help.\n\nThe investigators find ever more suspicion towards specific mechanisms in the hip region as a source of knee pain. It is well known in pediatric medicine that children with serious disease in the hip often debut with knee pain. This relationship is not so well established in adults.\n\nPain in the lower extremity can arise from inflammation or strain of the retro trochanteric muscles, and/or more indirectly if these processes impact the sciatic nerve. The later explanation is commonly known as the piriformis syndrome.\n\nProfessor Oddmund Johansen has studied this type of pain extensively. In the later years he has found interest in patients with knee pain.\n\nThese patients will often have pain with deep palpation to the posterior hip region, when tightening the hip rotators with flexion and adduction, and they will often respond with pain relief, within minutes, when local anesthesia is placed on the distal attachment of the hip rotators on the posterior margin of the greater trochanter. Afterwards, lasting pain relief can be seen with a specified stretching regiment for these muscles.\n\nThe investigators will recruit suiting patients from a knee referral list. Inclusion will be based on clinical examination and whether they respond to the injection. After inclusion they will be scored with pain and quality of life forms, randomised in two groups, one with a stretching regime and one with conservative and symptomatic treatment.\n\nThere is interest in defining and quantifying this sub group of knee patients. They will be followed up after 3 months, with a new examination and scoring to evaluate the effect of the intervention.\n\nThe study will examine how the patients react and comply with the proposed diagnosis and treatment. A cost analysis will also be considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee pain\n* Failure to understand the pain with more conventional diagnosis\n* Symptoms and retrotrochanteric pain with examination\n* Pain relief with retro trochanteric local anaesthetic injection\n\nExclusion Criteria:\n\n* Mental illness\n* Failure to cooperate\n* Not adequate Norwegian language skills\n* Other well known disease explaining symptoms'}, 'identificationModule': {'nctId': 'NCT02560259', 'briefTitle': 'The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain. Prevalence, Interpretation and Management: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2015/157(REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy Group', 'description': 'Physiotherapy', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conservative group', 'description': 'Conservative treatment', 'interventionNames': ['Other: Conservative treatment']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'Physiotherapy', 'armGroupLabels': ['Physiotherapy Group']}, {'name': 'Conservative treatment', 'type': 'OTHER', 'description': 'Conservative treatment', 'armGroupLabels': ['Conservative group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tromsø', 'country': 'Norway', 'contacts': [{'name': 'Anders Hennig, Physician', 'role': 'CONTACT', 'email': 'anders.hennig@unn.no', 'phone': '+4797650807'}, {'name': 'Oddmund Johansen, Professor', 'role': 'CONTACT', 'email': 'oddmund.johansen@unn.no', 'phone': '+4707766'}, {'name': 'Anders Hennig, Physician', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oddmund Johansen, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Northern Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'centralContacts': [{'name': 'Anders Hennig, Physician', 'role': 'CONTACT', 'email': 'anders.hennig@unn.no', 'phone': '+4797650807'}, {'name': 'Oddmund Johansen, Professor', 'role': 'CONTACT', 'email': 'oddmund.johansen@unn.no', 'phone': '+4707766'}], 'overallOfficials': [{'name': 'Oddmund Johansen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital og North Nprway, ortopedic department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Oddmund Johansen', 'investigatorAffiliation': 'University Hospital of North Norway'}}}}