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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06346249
Other study ID # 49/2024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2024
Est. completion date May 2024

Study information

Verified date February 2024
Source Universidad de Extremadura
Contact María de los Ángeles Cardero Durán, Doctor
Phone 635501301
Email mcarderod@unex.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 electrotherapy in healthcare workers with non-specific neck pain.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Electrical Stimulation Therapy
Ten Electrical Stimulation Therapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region.
Manual Therapy
Manual Therapy consistin of soft tissue mobilization and release techniques over the neck and craniocervical regions. Ten sessions.
Exercise Therapeutic
The exercise therapeutic program consisting of neck movement control and stretching exercise. Ten sessions.

Locations

Country Name City State
Spain María de los Ángeles Cardero Durán Badajoz

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Pain 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. 5 weeks
Primary Changes Pressure Pain 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
Primary Changes in Disability 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. 5 weeks
Secondary Changes in Range of Motion 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
Secondary General Health. 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. 5 weeks
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