Disability Clinical Trial
Official title:
The Influence of Expectations on Post-needling Soreness and Pain Processing After Dry Needling Treatment: an Experimental Study
Verified date | April 2022 |
Source | Universidad Europea de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The general objective of the study is to determine the effectiveness on local mechanical hypoalgesia, pain intensity, disability and psychological variables of the deep dry needling technique on a latent trigger point of the upper trapezius muscle. The specific objective of the study is to observe the interaction between patient expectations and hypoalgesic effects in patients who will receive the same technique but with different explanations about it before punction and which could influence on the modulation of post-punction pain.
Status | Completed |
Enrollment | 42 |
Est. completion date | December 2, 2020 |
Est. primary completion date | November 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 62 Years |
Eligibility | Inclusion Criteria: - Be between 18 and X years of age. - Presence of at least one latent myofascial trigger point in the upper trapezius muscle. - Patients who speak and understand Spanish correctly. - Subjects without previous experience in dry puncture treatment. Exclusion Criteria: - If patients had neurological signs and symptoms. - Subjects with a history of trauma, fracture or previous spinal surgery. - Subjects with a history of musculoskeletal and/or rheumatological diseases. - Unsurpassed fear of needles - Coagulation disorders - Infiltration of corticosteroids or local anesthetics for one year prior to the study. - Taking analgesic or anti-inflammatory medication the week before the study. |
Country | Name | City | State |
---|---|---|---|
Spain | Eleuterio A Sánchez | 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, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling | |
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, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling | |
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, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling | |
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, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling | |
Secondary | PCS (Pain Catastrophizing Scale) | It consists of 14 items valued on a 5-point scale. It evaluates the degree to which they have thoughts and feelings when they experience pain. | Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling | |
Secondary | TSK (Tampa Scale for Kinesiophobia) | 17 items, 4 points each where higher scores indicate higher levels of fear of movement. | Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling | |
Secondary | PASS-20 (Pain Anxiety Symptoms Scale) | It has four 5-item subscales that measure avoidance, fearful thoughts, cognitive and physiological anxiety, and pain responses. Participants rate each item on a 6-point scale ranging from never (0) to always (5). | Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling | |
Secondary | FPQ-III (Fear of Pain Questionnaire) | It consists of 30 items, each with 5 points that measure fear over specific situations that normally produce pain | Change from base line, immediately after the intervention with dry needling; and 24 hours, 48 hours, 72 hours and 1 of week follow-up after the intervention with dry needling |
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