Treatment of Cervical Syndrome With Physium Therapy

NCT03322683 | Completed

• 1 other identifier: physium therapy
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to investigate the effects of physium therapy for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).

Conditions

Cervical Syndrome

Keywords

Neck Pain; Physical Therapy Modalities; Massage; Manual Therapy

Outcome Measures

Primary Outcomes (1)

• The intensity of cervical pain

  A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.

  Baseline

Secondary Outcomes (5)

• The intensity of cervical pain

  Four weeks

• Active cervical range of motion

  Baseline and four weeks.

• Pressure pain thresholds in cervical trigger points

  Baseline and four weeks

• The multidimensional health related quality of life

  Baseline and four weeks

• This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.

  Baseline and four weeks.

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

The intervention for this group consisted of 5 massage sessions with the PHYSIUM device for a month.

Procedure: Physiotherapy treatment with physium device.

CONTROL GROUP

EXPERIMENTAL

The multimodal physical therapy program includes 10 sessions of: * ultrasound pulsatil therapy (US) for 10 minutes. * transcutaneous electric nerve stimulation (TENS) for 20 minutes. * massage for 20 minutes.

Procedure: Conventional physiotherapy treatmen

Interventions

Physiotherapy treatment with physium device. PROCEDURE

This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 45 minutes.

EXPERIMENTAL GROUP

Conventional physiotherapy treatmen PROCEDURE

The PT group will treated during two weeks (ten days/week) with ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage, in this order. Ultrasound will applied in pulse mode at an intensity of 1 megahertz for 10 minutes in the sub-occipital region and the vicinity of the trapezius muscles. TENS will applied with a pulse duration of 250 microseconds at a frequency of 80 Hertz for 20 minutes in the sub-occipital region and the trapezoids. Deep massage was applied at a slow speed for 20 minutes using sliding neutral creams. Massage therapy included gliding and kneading techniques applied over trapezius (upper, lower and middle fibers), splenius capitis and levator scapulae muscles with a therapeutic intention.

CONTROL GROUP

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes,
• Aged between 20 and 60 years, in an
• Active state of pain and diagnosed with a month of evolution.

You may not qualify if:

• \- Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - - Patients who have been treated with myofascial therapy a month earlier.

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Clínica Pastoriza

El Puerto de Santa María, Cádiz, 11500, Spain

Location

Related Publications (17)

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  PMID: 24482302 BACKGROUND

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  PMID: 23419913 BACKGROUND

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  PMID: 15999284 BACKGROUND

• Palmlof L, Skillgate E, Alfredsson L, Vingard E, Magnusson C, Lundberg M, Holm LW. Does income matter for troublesome neck pain? A population-based study on risk and prognosis. J Epidemiol Community Health. 2012 Nov;66(11):1063-70. doi: 10.1136/jech-2011-200783. Epub 2012 Mar 12.

  PMID: 22412154 BACKGROUND

• Noormohammadpour P, Mansournia MA, Koohpayehzadeh J, Asgari F, Rostami M, Rafei A, Kordi R. Prevalence of Chronic Neck Pain, Low Back Pain, and Knee Pain and Their Related Factors in Community-Dwelling Adults in Iran: A Population-based National Study. Clin J Pain. 2017 Feb;33(2):181-187. doi: 10.1097/AJP.0000000000000396.

  PMID: 27258995 BACKGROUND

• De Pauw R, Coppieters I, Kregel J, De Meulemeester K, Danneels L, Cagnie B. Does muscle morphology change in chronic neck pain patients? - A systematic review. Man Ther. 2016 Apr;22:42-9. doi: 10.1016/j.math.2015.11.006. Epub 2015 Dec 11.

  PMID: 26724855 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• Cook AJ, Wellman RD, Cherkin DC, Kahn JR, Sherman KJ. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes. Spine J. 2015 Oct 1;15(10):2206-15. doi: 10.1016/j.spinee.2015.06.049. Epub 2015 Jun 19.

  PMID: 26096474 BACKGROUND

• Liptan G, Mist S, Wright C, Arzt A, Jones KD. A pilot study of myofascial release therapy compared to Swedish massage in fibromyalgia. J Bodyw Mov Ther. 2013 Jul;17(3):365-70. doi: 10.1016/j.jbmt.2012.11.010. Epub 2013 Jan 3.

  PMID: 23768283 BACKGROUND

• Yuan SL, Matsutani LA, Marques AP. Effectiveness of different styles of massage therapy in fibromyalgia: a systematic review and meta-analysis. Man Ther. 2015 Apr;20(2):257-64. doi: 10.1016/j.math.2014.09.003. Epub 2014 Oct 5.

  PMID: 25457196 BACKGROUND

• Serrano-Aguilar P, Kovacs FM, Cabrera-Hernandez JM, Ramos-Goni JM, Garcia-Perez L. Avoidable costs of physical treatments for chronic back, neck and shoulder pain within the Spanish National Health Service: a cross-sectional study. BMC Musculoskelet Disord. 2011 Dec 21;12:287. doi: 10.1186/1471-2474-12-287.

  PMID: 22188790 BACKGROUND

• Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.

  PMID: 25768071 BACKGROUND

• Bervoets DC, Luijsterburg PA, Alessie JJ, Buijs MJ, Verhagen AP. Massage therapy has short-term benefits for people with common musculoskeletal disorders compared to no treatment: a systematic review. J Physiother. 2015 Jul;61(3):106-16. doi: 10.1016/j.jphys.2015.05.018. Epub 2015 Jun 17.

  PMID: 26093806 BACKGROUND

• Fletcher JP, Bandy WD. Intrarater reliability of CROM measurement of cervical spine active range of motion in persons with and without neck pain. J Orthop Sports Phys Ther. 2008 Oct;38(10):640-5. doi: 10.2519/jospt.2008.2680.

  PMID: 18827326 BACKGROUND

• Lopez-Lopez A, Alonso Perez JL, Gonzalez Gutierez JL, La Touche R, Lerma Lara S, Izquierdo H, Fernandez-Carnero J. Mobilization versus manipulations versus sustain apophyseal natural glide techniques and interaction with psychological factors for patients with chronic neck pain: randomized controlled trial. Eur J Phys Rehabil Med. 2015 Apr;51(2):121-32. Epub 2014 Oct 9.

  PMID: 25296741 BACKGROUND

• Bonilla D, Hortalá G, Temporal D, Carré Llopis C. PHYSIUM in the treatment of pain in patients with chronic low back pain. FisioGlía. 2015;2(3):50-55.

  BACKGROUND

• Canadell G. Effectiveness of PHYSIUM Massage in chronic neck pain in patients not responding to the standard physiotherapy. MC Health & Medical Publishing. 2011;1.

  BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Rodriguez Huguet

  University of Cadiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blind researcher
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 26, 2017
• Study Start: July 13, 2018
• Primary Completion: August 15, 2018
• Study Completion: September 15, 2018
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)