Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT06130969
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Cervical Spine Retraction Exercise With and Without Diaphragmatic Breathing in Forward Head Posture.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Photogrammetry for Craniovertebral Angle (CVA) by image j software', 'timeFrame': '6 weeks', 'description': 'CVA, can be measured using the lateral photos exposing C7 and the ear. The participants will maintain the natural head posture through the measurement method of self-balance posture. It is the angle made by the line that connects the seventh cervical spine with the tragus and the horizontal line of the seventh cervical spine in the sitting and standing positions. A CVA of \\<49° is characterized as FHP (3).\n\nImage J is an image processing and analysis program that can read both image file formats and raw formats. It can display, edit, analyze, process, store, and print images, as well as measure distances and angles.'}, {'measure': 'Numeric pain rating scale (NPRS):', 'timeFrame': '6 weeks', 'description': "The NPRS is a subjective pain rating scale using an 11-point scale from 0 to 10, where 0 means 'no pain' and 10 means 'intolerable pain'. Participants select the whole number that best represents their level of pain."}, {'measure': 'Neck disability index (NDI):', 'timeFrame': '6 weeks', 'description': 'that restricts the activities of daily living (ADL); it also helps to determine self- assessed disability. NDI has 10 domains covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Scores range from 0 to 50, with 50 being the greatest levels of dysfunction.'}, {'measure': 'Goniometer for Cervical Range of motion (CROM)', 'timeFrame': '6 weeks', 'description': 'Universal goniometer has fair inter-tester reliability ranging from 0.79-0.92. Validity of this tool is good i.e. 0.97-0.98 This tool is most commonly used in the clinical settings for evaluating joint ROM.'}], 'secondaryOutcomes': [{'measure': 'Global rating of change (GRC)', 'timeFrame': '6 weeks', 'description': 'GRC scale is used as an objective means to test the improvement of patient symptoms, to identify the intervention effect after treatment completion in clinical practice'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Forward Head Posture']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effect of combining diaphragmatic exercises with cervical retraction exercise on pain, disability, active range of motions of cervical spine and craniovertebral angle in individuals with forward head posture.', 'detailedDescription': "Forward head posture altering breathing pattern is one of the most common musculoskeletal deformity. Diaphragmatic exercises can reduce pain and disability levels, and correct forward head posture (FHP) in patients with neck discomfort.\n\nIn this randomized clinical trial, fifty two participants displaying forward head posture (FHP) will be randomly assigned to one of the two intervention groups: the Diaphragmatic Exercises and Cervical Retraction Exercise Combined Group or the Cervical Retraction Exercise Alone Group. Randomization will be performed using a convenient random sampling method via sealed opaque envelopes. Each participant will receive a total of twelve treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session), conclusion (twelfth session), and two weeks after completing the sessions. Outcome measures, including pain intensity, disability levels, cervical range of motion, and craniovertebral angle (CVA), will be evaluated using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), universal goniometer and Image J software, respectively. Data will be analyzed using Statistical Package for the Social Sciences (SPSS) software version 26. Normality of data will be assessed using the Kolmogorov-Smirnov test. For within-group comparisons, either repeated measures ANOVA or the Friedman test will be used. To compare changes between the groups, the independent t-test or Mann-Whitney U test will be applied, depending on the data distribution. The analysis of these outcome measures will provide valuable insights into the impact of the interventions on participants' symptoms and postural alignment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary complaint of neck pain (pain on the posterior part of the cervical spine to the beginning of the thoracic area with or without pain in the shoulder girdle)\n* Age from 20 to 35 years\n* Both gender\n* CVA \\<49° (16)\n\nExclusion Criteria:\n\n* Any serious pathology such as tumor\n* Had history of whiplash injury within 3 months of the examination,\n* Underwent prior surgery to the cervical spine\n* Currently using muscle relaxation medication.\n* Degenerative conditions\n* Exhibited positive neurologic signs consistent with nerve root compression.\n* Patients with a history of respiratory disease, such as repeated bronchitis, pneumonia, asthma, pulmonary lymph nodes, pleurisy, cured tuberculosis and others'}, 'identificationModule': {'nctId': 'NCT06130969', 'briefTitle': 'Effects of Cervical Spine Retraction Exercise With and Without Diaphragmatic Breathing in Forward Head Posture.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Cervical Spine Retraction Exercise With and Without Diaphragmatic Breathing on Pain, Disability and Craniovertebral Angle in Forward Head Posture.', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/23/0155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Cervical Retraction exercise without diaphragmatic breathing along with baseline treatment', 'interventionNames': ['Other: Cervical Retraction Exercise', 'Other: Baseline Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Cervical Retraction exercise with diaphragmatic breathing along with baseline treatment', 'interventionNames': ['Other: Cervical Retraction Exercise', 'Other: Diaphragmatic Breathing', 'Other: Baseline Treatment']}], 'interventions': [{'name': 'Cervical Retraction Exercise', 'type': 'OTHER', 'description': 'Participants will hold cervical retraction for 10 s up to 10 times. A break of 5 s will be provided per one movement and 30 s per one set. A total of three sets will be conducted. Therefore, the total exercise time will be \\<10 mints.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Diaphragmatic Breathing', 'type': 'OTHER', 'description': 'The diaphragmatic exercise will be performed in a supine position with 40° trunk flexion while holding 2.5 kg on the abdomen in the first 5 sessions and then 5 kg in the second 5 sessions. Participants will perform 3 sets with 10 repetitions at a ratio of one second of inspiration to two seconds of expiration, three sets of 15 repetitions at a ratio of two seconds of inspiration to four seconds of expiration, and three sets of 20 repetitions at a ratio of three seconds of inspiration to six seconds of expiration. The rest between rests will be 60 s.', 'armGroupLabels': ['Group B']}, {'name': 'Baseline Treatment', 'type': 'OTHER', 'description': 'Hot fomentation will be given by applying cervical hot pack over the area in prone lying position for 10 mints and Isometric neck strengthening exercises (10 repetitions, each 5-second hold, 1 set) (20). • Nerve Stimulation (TENS) on the painful regions around the neck for 15 minutes with a TENS device. TENS parameters will be 150 μs square pulses with a frequency of 80 Hz.\n\nThe intensity of the current will be adjusted to produce no contraction.\n\n• Posture education to keep upright posture during sitting.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54782', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Mazhar', 'role': 'CONTACT', 'email': 'mehreenmazhar98@gmail.com', 'phone': '+923244936007'}, {'name': 'Aneeqa Manzoor, MS-OMPT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chiropractor & Physio Pain Relief Center', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Imran Amjad, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '+923324390125'}, {'name': 'Imran Amjad', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '051-5481826'}], 'overallOfficials': [{'name': 'Ali Raza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}, {'name': 'Aneeqa Manzoor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}