Chronic Pain Clinical Trial
Official title:
Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain
Verified date | November 2022 |
Source | University of Jaén |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.
Status | Completed |
Enrollment | 42 |
Est. completion date | July 9, 2022 |
Est. primary completion date | December 9, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - accept to participate in the study, through informed consent - subjects with chronic nonspecific neck pain lasting equal to or more than 3 months Exclusion Criteria: - Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases. - Cervical pathology of traumatic origin with less than 6 months of evolution. - Rheumatic diseases. - Neck pain with neurological signs such as: radiculopathy and myelopathy. - Previous surgery of the cervical spine. - Pregnancy. - Have received physiotherapeutic treatment in the cervical region during the month prior to the inclusion of the study. - Have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period. - Present serious mental disorders. |
Country | Name | City | State |
---|---|---|---|
Spain | Alexander achalandabaso | Alcalá De Henares | Madrid |
Lead Sponsor | Collaborator |
---|---|
Alexander Achalandabaso |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Neck disability | Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability). | Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement. | |
Secondary | Change in pain perception | Using the Visual Analog Scale (VAS) from 0 to 10 | Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement. | |
Secondary | Change in Range of motion (ROM) | Using a inclinometer | Baseline, 1 month (primary timepoint) and 2 months after intervention commencement. | |
Secondary | Change in craniocervical flexion | Using the craniocervical flexion test (CCFT) we make a evaluation of the strength of the deep cervical flexor muscles. From 22 to 30 mmHg of preasure. | Baseline, 1 month (primary timepoint) and 2 months after intervention commencement. | |
Secondary | Change in kinesophobia | Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia. | Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement. | |
Secondary | Change in Catastrophism | Using the Pain catastrophizing scale from 0 to 56 | Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement. | |
Secondary | Change in Sleep Quality | Using the Pittsburgh Sleep Quality Index | Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement. |
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