- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06346249
Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain.
Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain: a Five Week Intervention With a One Month Follow-up Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The subjects included in the sample will be evaluated according to the aforementioned parameters by researchers trained and assigned for this purpose.
The data collection of the different variables will be performed before and after the completion of the program designed for the study. The physiotherapy intervention for the experimental group will have a duration of 10 sessions, twice a week.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Badajoz, Spain, 06006
- María de los Ángeles Cardero Durán
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
IInclusion Criteria:
- Age range between 18-60 years.
- Cervical pain of non-specific origin or Cervicalgia type I and II according to the Quebec - Task Force on Spinal Disorders.
- Be willing to participate in the study and sign the informed consent form.
- Have at least one year of seniority in the company exercising the current professional activity within the team of socio-health personnel.
Exclusion Criteria:
- Cervicalgia with neurological involvement or caused by pathologies such as: inflammatory disease, neurological disease, rheumatic disease, severe osteoporosis, fracture, dislocation, vertebro-basilar insufficiency, neoplasia or infection.
- Spine surgery.
- Present metallic implants at the spinal column level.
- Have received physiotherapy or alternative treatment in the last 6 months before starting the study.
- To present any type of inconvenience to the application of electrotherapy (score ≥45 points in EAPP).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
The control group will not undergo any physiotherapy treatment therapy for neck pain.
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Experimental: Experimental Group
The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrical stimulation therapy in healthcare workers with non-specific neck pain.
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Ten Electrical Stimulation Therapy sessions lasting 30 minutes were carried out.
Analgesic currents of the TENS type, placed in the cervical region.
Manual Therapy consistin of soft tissue mobilization and release techniques over the neck and craniocervical regions.
Ten sessions.
The exercise therapeutic program consisting of neck movement control and stretching exercise.
Ten sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes Pressure Pain
Time Frame: 5 weeks
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Pressure Pain with Algometry. To assess the mechanosensitivity of the trigger points , the pain threshold was measured at the pressure. Unit of measure Kg/cm2. |
5 weeks
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Changes in Pain
Time Frame: 5 weeks
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A visual analog scale (VAS).
The scale is represented by a 10-centimeter line at the ends of which there are two adjectives whose ends there are two adjectives, absence of pain (0) and unbearable pain (10).
The higher the score, the greater the pain.
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5 weeks
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Changes in Disability
Time Frame: 5 weeks
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Neck Disability Index ( NDI) through which will give us the degree of disability neck pain.The NDI consists of 10 sections, 4 of them are related to subjective symptoms (pain intensity, headache, head, ability to concentrate and quality of sleep) and the other 6 are related to basic activities of daily living (ABVD) (personal care, ability to lift weights, reading, work, driving, leisure activities and free time).
Each of the sections presents 6 possible answers, scoring these from 0 to 5 according to the progression of functional disability.
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5 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in Range of Motion
Time Frame: 5 weeks
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Measurement of joint amplitude with goniometry. The Range of Motion (ROM) exploration was performed with the subjects in sitting in order to stabilize the pelvis and the thoracic-lumbar spine. From this position, the degrees of maximum position reached by the subjects in each of the 6 movements of space. Unit of measurement in degrees of articulation. |
5 weeks
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General Health.
Time Frame: 5 weeks
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The Physical and Mental Health summary scales-12 (SF-12) contains 12 questions distributed in each of the 8 dimensions.
The higher the score, the better the state of health.
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5 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: María de los Ángeles Cardero Durán, Doctor, Universidad de Extremadura
Publications and helpful links
General Publications
- Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
- de Campos TF, Maher CG, Steffens D, Fuller JT, Hancock MJ. Exercise programs may be effective in preventing a new episode of neck pain: a systematic review and meta-analysis. J Physiother. 2018 Jul;64(3):159-165. doi: 10.1016/j.jphys.2018.05.003. Epub 2018 Jun 19.
- Heintz MM, Hegedus EJ. Multimodal management of mechanical neck pain using a treatment based classification system. J Man Manip Ther. 2008;16(4):217-24. doi: 10.1179/106698108790818260.
- Guzman J, Hurwitz EL, Carroll LJ, Haldeman S, Cote P, Carragee EJ, Peloso PM, van der Velde G, Holm LW, Hogg-Johnson S, Nordin M, Cassidy JD; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. A new conceptual model of neck pain: linking onset, course, and care: the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S14-23. doi: 10.1097/BRS.0b013e3181643efb.
- Nyman T, Grooten WJ, Wiktorin C, Liwing J, Norrman L. Sickness absence and concurrent low back and neck-shoulder pain: results from the MUSIC-Norrtalje study. Eur Spine J. 2007 May;16(5):631-8. doi: 10.1007/s00586-006-0152-6. Epub 2006 Jun 2. Erratum In: Eur Spine J. 2007 May;16(5):639-40.
- Carroll LJ, Hogg-Johnson S, Cote P, van der Velde G, Holm LW, Carragee EJ, Hurwitz EL, Peloso PM, Cassidy JD, Guzman J, Nordin M, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Course and prognostic factors for neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S93-100. doi: 10.1097/BRS.0b013e31816445d4.
- Driessen MT, Proper KI, van Tulder MW, Anema JR, Bongers PM, van der Beek AJ. The effectiveness of physical and organisational ergonomic interventions on low back pain and neck pain: a systematic review. Occup Environ Med. 2010 Apr;67(4):277-85. doi: 10.1136/oem.2009.047548.
- Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30. Erratum In: J Orthop Sports Phys Ther. 2015 Feb;45(2):147. doi: 10.2519/jospt.2015.45.2.147.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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