Disability Physical Clinical Trial
Official title:
Clinical Predictive Effects of Mulligan Treatment in Patients With Chronic Neck Pain: a Machine Learning Approach
Verified date | March 2022 |
Source | Universidad Europea de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is the measurement and comparison of two manual therapy techniques, the Mulligan´s mobilization with movement technique, and de placebo technique, both applicated in patients with subacute neck pain.
Status | Completed |
Enrollment | 42 |
Est. completion date | March 18, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Ages between 18 and 60 years. - Neck pain with/without pain in upper limb/s. - NDI = 10 - Acceptance of the study and completion of the informed consent form. Exclusion Criteria: - Presenting physician-diagnosed "red flag" of non-musculoskeletal origin. - Having had a Whiplash in the last 2 years. - Use of cervical collar in the last year. - Evidence of CNS involvement. - Vestibular Disorders - Inflammatory joint disease - Spinal cord pathology - Bone disease or marked osteoporosis - Intervertebral disc protrusion - Subjects who have received physiotherapeutic treatment of the cervical or thoracic region three months previously. - Fractures, sprain or dislocation of the neck, occurred in a period of less than two months. - Previous shoulder, upper limb and cervical spine surgery, which occurred in the twelve months prior to the investigation. - Pregnancy - Illness - Voluntary abandonment |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Europea de Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Europea de Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) | To evaluate the pain that the patient has, we use the VAS (Appendix 1). This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies. This scale will be used accompanying each CROM measurement as well as in pre-treatment measurements. | Change from base line and immediately after the intervention | |
Primary | Pressure Pain Threshold | The patient supine with algometer perpendicular to the exactly point for evaluation, and the pressure is increasing slowly and linearly. The intervention speed applied will be 1kg/cm2/second until the patient feels pain. Just in that moment, the researcher stops pressure.
Hereby a target response is favored due to fact that patient has more reaction time when he starts to feel pain. In that moment, the researcher interrumps exercised pressure with the algometer. In every anatomical reference, three measures will be performed consecutively in intervals of 30 seconds for measurement to generate an average, neccesary for statical analysis. Pain pressure threshold measure is performed just before therapeutic intervention and 5 minutes later. |
Change from base line and immediately after the intervention | |
Primary | Cervical Range of Movement (CROM) | Measurement of the range of movement by means of an inclinometer. To measure the range of movement the patient will be seated in a chair; feet supported on the floor, triple flexion of lower limbs of 90ยบ (hip, knee and foot), back well supported and straight, head straight and look at the horizon. The inclinometer will be positioned to measure flexion, extension, right and left tilt and right and left rotation. The inclinometer for CROM (cervical range of motion) is approved and validated in different studies. | Change from base line and immediately after the intervention | |
Secondary | Neck Disability Index | It will be used to measure the level of disability perceived by the patient as a result of their neck pain, after performing the technique and to check whether it appears during the control measurements. It is a questionnaire composed of 10 sections on different activities of daily living (ADLs); self-care, reading, lifting weights, driving, sleeping, recreational activities, work, concentration, pain intensity and headache. Each section scores from 0 to 5, with zero being no pain and five being the worst pain imaginable. (Maximum 50 points). Therefore, in order of appearance, of the 6 options, the first option of each item represents 0 and the last one 5. The higher the score obtained, the greater the patient's disability. | Change from base line and immediately after the intervention | |
Secondary | STAI (State-Trait Anxiety) | Questionnaire composed of 20 items with 4 points each that evaluate "state anxiety" (transitory emotional condition influenced by environmental factors that decrease or increase anxiety) and another 20 that evaluate "trait anxiety" (personality factor that predisposes to suffer or not suffer anxiety). The 2-part score ranks patients at a percentile to the general population. The higher the score, the greater the anxiety. It is one of the most widely used tools in research to measure levels of general anxiety. | Change from base line and immediately after the intervention | |
Secondary | Beck II (Depression) | A 21-item scale used to assess the severity of depression. The patient has to select for each item the response alternative that best reflects his/her state during the last week. The total score is obtained by adding up the values of the selected items, which range from 0 to 3. The commonly accepted cut-off points for grading intensity/severity are as follows: 0 to 9, no depression; 10 to 18, mild depression; 19 to 29, moderate depression, and = 30 points, severe depression. | Change from base line and immediately after the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03714256 -
Human Factor Validation of Pediatric Mobility Device
|
N/A | |
Completed |
NCT03680365 -
Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
|
||
Recruiting |
NCT03212391 -
WAVE Study- Walking and Aging in VErona Study
|
N/A | |
Recruiting |
NCT05935982 -
Virtual Reality Exercise in a Community Highschool for Children With Disabilities
|
Phase 1 | |
Completed |
NCT05790798 -
The Effect of Occupational Therapy-Based Instrumental Activities of Daily Living Intervention in People With Disabilities
|
N/A | |
Completed |
NCT05214638 -
Development and Application of Intelligent Assessment System of Longshi Scale
|
||
Not yet recruiting |
NCT05772910 -
Viability of an Educational Program for Lifestyle Changes and an Algorithm for the Derivation of Exercise Programs in Older People at Risk of Dependency at Primary Care.
|
N/A | |
Completed |
NCT04498637 -
Attitudes Towards Disability of Nursing and Physiotherapy Students
|
||
Not yet recruiting |
NCT05568589 -
Effects of Interpectoral-Pectoserratus Plane Block After Breast Cancer Surgery
|
||
Recruiting |
NCT04927377 -
Accessible and Inclusive Diabetes Telecoaching Self-Management Program
|
N/A | |
Completed |
NCT03403920 -
Validity of Profile Fitness Mapping Low Back Questionnaire
|
||
Recruiting |
NCT04889417 -
COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study
|
N/A | |
Completed |
NCT03385694 -
Long Term Clinical and Functional Outcome in Rotationplasty Patients
|
||
Completed |
NCT04131998 -
Albanian Versions and Validation of Visual Analogue Scale, Back Pain and Autonomy Questionnaires
|
||
Completed |
NCT04999085 -
Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma
|
N/A | |
Completed |
NCT04160585 -
Individual and Work-Related Risk Factors for Musculoskeletal Pain: A Cross-Sectional Study Among Turkish Office Workers
|
||
Recruiting |
NCT05600465 -
Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions
|
N/A | |
Completed |
NCT03301428 -
Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability
|
N/A | |
Completed |
NCT05440474 -
Urdu Version of COPENHAGEN Neck Functional Disability Scale: Reliability and Validity Study
|
||
Completed |
NCT06351774 -
Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
|
N/A |