RecruitingACTRN12619001137189

"Modifications in patients with subacute or chronic mechanical neck pain after osteopathic treatment and conventional physiotherapeutic treatment"


Sponsor

"Fisioclinic" Physioteraphy private Clinic

Enrollment

50 participants

Start Date

May 4, 2020

Study Type

Interventional

Conditions

Summary

1. To evaluate the changes that occur in the experimental group after the application of osteopathic treatment in the variables. 2. To evaluate the changes that occur in the control group after the application of the conventional physiotherapy treatment, in the variables Hypothesis: The applied osteopathic treatment causes greater results in patients with subacute or chronic cervical pain after 2 sessions of treatment. than the conventional physiotherapy treatment.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Neck pain is one of the most common musculoskeletal problems, and it can persist for weeks or months if not properly treated. This study compares two treatment approaches for adults with subacute or chronic mechanical neck pain: osteopathic manual therapy (hands-on techniques targeting the joints, muscles, and connective tissues) versus conventional physiotherapy (typically exercises and manual techniques). Participants receive two sessions of their assigned treatment and are assessed for changes in pain levels, range of movement, and jaw opening (as the upper neck and jaw are closely linked). The study aims to determine whether osteopathic treatment produces greater improvements than conventional physiotherapy within this timeframe. You may be eligible if you are aged 18–50 with a diagnosis of subacute or chronic mechanical neck pain, have some restriction in jaw opening (less than 40 mm), and have not received osteopathic treatment in the past two months. People who have had surgery to the spine, head, or upper limbs at any point in their life are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Treatment Trial, randomized-controlled, parallel, double-blind, two-arm trial The capacity to carry out the study must be measured in the present availability of the means (material and human) nece

Treatment Trial, randomized-controlled, parallel, double-blind, two-arm trial The capacity to carry out the study must be measured in the present availability of the means (material and human) necessary to carry it out: Material resources: - Hydraulic stretcher without drop - One caliber to measure the amplitude of the opening of the mouth, scientifically validated. - One Algometer to measure the pressure pain threshold (PDP), scientifically validated. - One goniometer to measure the range of cervical mobility, Cervical Range of Motion35 (CROM) validated scientifically. - Wide and comfortable room with constant temperature. - For the performance of quality clinical trials, precise tools are required to measure the results that are properly validated. For this, the cervical pain measurement scale and / or associated disability is used: Neck Disability Index (NDI). Human resources: - One therapist who performs osteopathic manipulative treatment and / or conventional physiotherapy with more than five years of experience. - One external evaluator to assess the parameters (Amplitude of the opening of the mouth, pain threshold to pressure" (PTP) and cervical mobility) assessing the interobserver and intraobserver reliability (2 measurements each observer). Perfectly trained and more than 5 years of experience. - Patients that meet the inclusion criteria determined, in an amount necessary for compliance with the study. STUDY PROTOCOL: 1- Random assignment of control and experimental groups (Arm-1 and Arm-2) (neither the patient nor the evaluators know the group in which the patient is located, thus achieving double blindness of the study). The mode of delivery will be face to face it will be provided individually before the interventions. a- Experimental group: (Arm-1) - Determine the patient's compliance with the inclusion criteria and that does not meet the exclusion criteria. - Reading of informative sheet. - Reading and signing of informed consent. - Reading and filling out the "Neck Disability Index" (NDI) questionnaire. Measurement scale of cervical pain and / or associated disability, to be able to see the difference of score between the experimental group and the control group in said numerical scale. - Control of ambient temperature (17-25 ºC). - The patient lies on the stretcher 10 minutes with both arms at chest level. - Measurement of the active vertical opening of the mouth before the intervention .. - Measurement of the "pain threshold to pressure" (PTP) of the triggerspoints that the patient presents in both masseters before the intervention. - Measurement of the goniometry of the cervical spine: - Realization of the osteopathic treatment: OSTEOPATHIC TREATMENT: 1. Global manipulation technique Occipito-alto-axoidea (OAA) according to Fryette Bilateral: 2. DOG TECHNIQUE IN BILATERAL EXTENSION for manipulation of dorsal vertebrae: 3. PELVIS GLOBAL TECHNIQUE: 4. Suboccipital Inhibition Technique 5. Thrust technique on the occipito-mastoid suture 6. Technique Mobilization in Cervical Extension (MEC) 7. Technique for the Mediastinum Previous 8. Inhibition of the Phrenic Center Technique - New measurement of active vertical opening of the mouth after the intervention after passing 1min. - New measurement of "pain threshold to pressure" (PTP) in trigger points of masseters after the intervention. - New measurement of the goniometry of the cervical spine 7 - Do it during 2 sessions, one session per week (every 7 days). 2 session of an hour approximately, once per week during two weeks. - The invertention will be performs in a private Physiotherapy Clinic. - At the end of the 2nd session, fill out Neck Disability Index (NDI) again and show if there were changes. b- Control group: (Arm-2) - Determine the patient's compliance with the inclusion criteria and that does not meet the exclusion criteria. - Reading of informative sheet. - Reading and signing of informed consent. - Reading and filling out the "Neck Disability Index" (NDI) questionnaire. Measurement scale of cervical pain and / or associated disability, to be able to see the difference of score between the experimental group and the control group in said numerical scale. - Control of ambient temperature (17-25 ºC). - The patient lies on the table for 5 minutes with both arms at chest level. - Measurement of the active vertical opening of the mouth before the intervention. - Measurement of "pain threshold to pressure" (PTP) in trigger points of masseters before the intervention. - Measurement of cervical goniometry - Performing the conventional physiotherapy treatment: - New measurement of active vertical opening of the mouth after the intervention after passing 1min. - New measurement of "pain threshold to pressure" (PTP) in trigger points of masseters after the intervention. - New measurement of cervical goniometry. - Do it during 2 sessions, one session per week (every 7 days). 2 session of half an hour approximately, once per week during two weeks. - The invertention will be performs in a private Physiotherapy Clinic. - At the end of the 2nd session, fill out Neck Disability Index (NDI) again and show if there were changes. 2- Data registration and statistical analysis


Locations(1)

Chiclana de la Frontera (Cádiz), Spain

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ACTRN12619001137189