Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT05355220
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2022-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059388', 'term': 'Pelvic Girdle Pain'}], 'ancestors': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Scale (NPRS):', 'timeFrame': '2 weeks', 'description': 'Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI- NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change)'}, {'measure': 'Pelvic Girdle Pain Questionnaire (PGPQ):', 'timeFrame': '2 weeks', 'description': 'The Pelvic Girdle Questionnaire (PGQ) is a condition-specific measure for women with pelvic girdle pain (PGP). The PGQ includes items relating to activity/participation and bodily symptoms and has reliability, validity, and feasibility for use in research and clinical practice'}, {'measure': 'Patient specific Functional Scale (PSFS)', 'timeFrame': '2 weeks', 'description': 'Patient Specific Functional Scale was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. The aim of PSFS is to provide clinicians with a valid, reliable, responsive andefficient outcome measure that would be easy\n\nto use and applicable to a large number of clinical presentations. Patient- Specific Functional Scale is an efficient and valid measure for assessing\n\ndisability and change in disability in persons with musculoskeletal diseases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic girdle pain'], 'conditions': ['Pelvic Girdle Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Abdul Salam K. A Comparative study to Assess the Effectiveness of Combined Tens andExercises over Exercise Alone for Sacroiliac Joint Pain in Pregnancy: College of Physiotherapy,Trinity Mission and Medical Foundation, Madurai; 2011.'}, {'pmid': '26271756', 'type': 'BACKGROUND', 'citation': 'Casagrande D, Gugala Z, Clark SM, Lindsey RW. Low Back Pain and Pelvic Girdle Pain in Pregnancy. J Am Acad Orthop Surg. 2015 Sep;23(9):539-49. doi: 10.5435/JAAOS-D-14-00248. Epub 2015 Aug 13.'}, {'pmid': '18259783', 'type': 'BACKGROUND', 'citation': 'Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.'}, {'pmid': '18582370', 'type': 'BACKGROUND', 'citation': 'Elden H, Ostgaard HC, Fagevik-Olsen M, Ladfors L, Hagberg H. Treatments of pelvic girdle pain in pregnant women: adverse effects of standard treatment, acupuncture and stabilising exercises on the pregnancy, mother, delivery and the fetus/neonate. BMC Complement Altern Med. 2008 Jun 26;8:34. doi: 10.1186/1472-6882-8-34.'}, {'pmid': '15094530', 'type': 'BACKGROUND', 'citation': 'Stuge B, Laerum E, Kirkesola G, Vollestad N. The efficacy of a treatment program focusing on specific stabilizing exercises for pelvic girdle pain after pregnancy: a randomized controlled trial. Spine (Phila Pa 1976). 2004 Feb 15;29(4):351-9. doi: 10.1097/01.brs.0000090827.16926.1d.'}, {'type': 'BACKGROUND', 'citation': 'Lee KS, Kim YH, Min KH, Yoo HK, Hwang YH, Chung CK, et al. Clinical Study of thePostperative Pain Management with Silver Spike Point Electro-therapy. Korean Journal of Anesthesiology. 1985;18(1):63-70.'}, {'pmid': '32903997', 'type': 'BACKGROUND', 'citation': 'Sawada T, Tateyama N, Ikeda T, Ishimaru K. The Effect on Muscle Hardness of Acupuncture Stimulation Using Low-reactive Level Laser Therapy and Silver Spike Point Therapy, along with Stretching. Laser Ther. 2020 Jul 17;29(1):41-46. doi: 10.5978/islsm.20-OR-04.'}, {'type': 'BACKGROUND', 'citation': 'Yi D-H, Kim B-R, Hur Y-J, Kim D-H, Shim S-Y, Yim J-E. Convergence of Acupoint andElectrical Stimulation Therapy for Blood Flow and Pain Threshold. Journal of the Korea Convergence Society. 2019;10(6):79-87.'}, {'pmid': '18604250', 'type': 'BACKGROUND', 'citation': 'Taguchi R. Acupuncture anesthesia and analgesia for clinical acute pain in Japan. Evid Based Complement Alternat Med. 2008 Jun;5(2):153-8. doi: 10.1093/ecam/nem056.'}, {'type': 'BACKGROUND', 'citation': 'Xu H, Ryan J, Li K. Clinical Investigation into the effectiveness of needleless acupuncture inthe management of the symptoms of osteoarthritis of the knee: a preliminary, single-blind and sham- controlled study. Australian Journal of Acupuncture and Chinese Medicine. 2007;2(2):9-15.'}, {'pmid': '8628583', 'type': 'BACKGROUND', 'citation': 'Ishimaru K, Kawakita K, Sakita M. Analgesic effects induced by TENS and electroacupuncture with different types of stimulating electrodes on deep tissues in human subjects. Pain. 1995 Nov;63(2):181-187. doi: 10.1016/0304-3959(95)00030-V.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effects of Silver Spike Point Therapy (SSPT) therapy on pelvic girdle pain and functional activities in pregnancy.The finding of this study will help to establish the role of SSPT therapy to relieve pelvic girdle pain in pregnant females along with exercises. SSP for pelvic girdle pain management can prove to be a useful method. The findings of this study can play a role to establish more rigorous treatment plans for pelvic girdle pain in the pregnant population in the future.', 'detailedDescription': 'This study will be a randomized clinical trial that will investigate the effectiveness of silver spike point therapy and manual therapy in subjects with pregnancy-related pelvic girdle pain. Subjects with pregnancy-related pelvic girdle pain meeting the predetermined inclusion \\& exclusion criteria will be divided into two groups using the lottery method. Pre-assessment will be done using NPRS and PGPQ as subjective measurements and PSFS as objective measurements. Subjects in one group will be treated with silver spike point therapy and manual therapy, the other will be treated with manual therapy only. Each subject will receive 10 treatment sessions, with 05 treatment sessions per week. Post-treatment reading for NPRS, PGPQ, and PSFS will be recorded after the end of the 10th treatment session. Recorded values will be analyzed for any significant difference between pre and post-treatment values SPSS 21.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged between 20 to 40 years of age\n* Healthy pregnancy\n* 14 to 38 weeks gestation\n* Expecting a singleton fetus\n* 2 out of 3 tests positive for PGP according to European guidelines for\n* pelvic girdle pain"(Posterior pelvic pain provocation (P4), Patrick\'s Faber, Modified Trendelenburg\'s test)\n\nExclusion Criteria:\n\n* High-risk pregnancy, Caudaequina Syndrome, Trauma, or spinal surgical history.\n* Inflammatory, infective, metabolic, neoplastic, or degenerative conditions.\n* Sensory symptoms associated with disc herniation or compressive spinal lesion.\n* Any contraindication to exercise.'}, 'identificationModule': {'nctId': 'NCT05355220', 'briefTitle': 'Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Silver Spike Point Therapy on Pelvic Girdle Pain and Functional Activities in Pregnancy', 'orgStudyIdInfo': {'id': 'REC/Lhr/22/0506 Maida'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'silver spike point Therapy Group', 'description': 'One group will receive electrotherapy (silver spike point) for 10 mints along with conservative managment', 'interventionNames': ['Device: Silver Spike Point Therapy (SSPT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative treatment group', 'description': '2nd group will receive strengthening, stretching and stabilization exercises for prlvic girlde', 'interventionNames': ['Other: Conservative Managment']}], 'interventions': [{'name': 'Silver Spike Point Therapy (SSPT)', 'type': 'DEVICE', 'description': 'Silver Spike Point Therapy (SSPT) means passing an electric current through the skin surface with the triangle spike silver coated metal electrode. SSPT was reported by Hyoto and Kitade in Edinburg, Scotland. 3rd World Congress on Pain in 1981; It has a number of advantages over traditional narcotic medication in pelvic girdle pain management. It does not depress the cardiovascular, respiratory, or the metabolic systems and has no apparent effect on the sensorium', 'armGroupLabels': ['silver spike point Therapy Group']}, {'name': 'Conservative Managment', 'type': 'OTHER', 'description': '2 sets of 10 repetitions Bridging, Cat \\& cow exercises, Back press exercises, stretching of hip external rotators and extensors 20 sec / stretch', 'armGroupLabels': ['Conservative treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54700', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Hamza Hospital,', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Ghulam Fatima, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}