Neck Pain Clinical Trial
— USNPOfficial title:
Effectiveness of Specific Neurodynamic Exercises Compared With Non-specific Exercises on Disability and Neck Pain in Women Older Than 65 Years
Verified date | May 2023 |
Source | University of Salamanca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of multimodal exercise with specific neurodynamic exercises and multimodal exercise with non-specific exercises in disability and neck pain in women older than 65 years. The intervention in both groups will be carried out for 4 weeks, with three weekly sessions. Two evaluations will be carried out, a pre-intervention evaluation and a post-intervention evaluation. We will assess neck pain, disability, upper limb strength, cervical mobility, cervical pressure pain thresholds, kinesiophobia and catastrophism.
Status | Completed |
Enrollment | 56 |
Est. completion date | January 20, 2023 |
Est. primary completion date | December 23, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Women older than 65 years. - Neck pain Exclusion Criteria: - Tumors - Pacemakers - Fibrillations - Cardiac pathology or uncontrolled hypertension - History of severe trauma/recent cervical surgery - Uncontrolled systemic and inflammatory pathologies - Congenital collagen compromise - Presence of difficulties in performing the Initial Evaluation tests - Language barriers - Pending litigation or legal claim |
Country | Name | City | State |
---|---|---|---|
Spain | University of Salamanca | Salamanca |
Lead Sponsor | Collaborator |
---|---|
University of Salamanca |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | Numerical Pain Rating Scale (NPRS) will be used. It is a scale used to quantify the patient's pain level on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain." | four weeks. | |
Primary | Neck disability | The Neck Disability Index (NDI) will be used. It is a modification of the Oswestry Low Back Pain Disability Index. It is a scale used to measure disability associated with cervical pain due to acute or chronic conditions. He has 10 items: 7 related to activities of daily living, 2 related to pain and 1 related to concentration. The test can be interpreted with a maximum score of 50. | four weeks | |
Secondary | Cervical range of motion | The Cervical Range of Motion (CROM) device (Performance Attainment Associates, USA) will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation. | four weeks | |
Secondary | Hand grip strength | The strength will be recorded with Jamar Plus: Digital dynamometer to assess grip strength. | four weeks | |
Secondary | upper limb strength | The strength in upper limb movements will be recorded with the device "wireless MicroFET 2": Hand-held dynamometer for force assessment. | four weeks | |
Secondary | Pressure pain threshold | Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds. (Algometer model: Pain Testâ„¢ FPIX 10). | four weeks | |
Secondary | Kinesiophobia | The Tampa Scale for kinesiophobia (TSK-13) will be used. It is a patient-reported outcome measure designed to help identify kinesiophobia. This version is a 13-item questionnaire aimed at the assessment of fear of movement/re-injury. Each item is provided with a 4-points Likert scale with scoring alternatives ranging from "strongly disagree" [0] to "strongly agree" [4] . This gives a possible total raw score range from 0 to 52. | four weeks | |
Secondary | Catastrophism | Pain Catastrophizing Scale (PCS) will be used. People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52). | four weeks |
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