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Completed

NCT Number: NCT04856813

Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain

It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexander achalandabaso

Alcalá de Henares, Madrid, 28805, Spain

About this study

The study will be divided in two different groups:

  • A control group (group A) : they will receive a treatment with manual therapy and physical exercise.
  • An experimental group (group B) : they will receive the previous treatment, but also the pacient's do active muscle active contraction.

The exercise is compound by a home program of several exercises with diferent difficulties.

The contraction will consist on a combination of concentric and isometric work. being the patient's pain threshold the one that will guide us to the choice of the predominance of concentric or isometric contraction . Both groups will be joined by a five-minute work on pain education.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • accept to participate in the study, through informed consent
  • subjects with chronic nonspecific neck pain lasting equal to or more than 3 months

Exclusion criteria

  • Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases.
  • Cervical pathology of traumatic origin with less than 6 months of evolution.
  • Rheumatic diseases.
  • Neck pain with neurological signs such as: radiculopathy and myelopathy.
  • Previous surgery of the cervical spine.
  • Pregnancy.
  • Have received physiotherapeutic treatment in the cervical region during the month prior to the inclusion of the study.
  • Have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period.
  • Present serious mental disorders.

Treatment and study plan

Manual therapy active

Other

massage or ischemic compression with active contraction, tha will be isometric or concentric.

Manual therapy

Other

massage or isquemic compression without contraction

Primary outcomes

  1. Change in Neck disability

    Time frame: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.

    Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).

Secondary outcomes

  1. Change in pain perception

    Time frame: Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.

    Using the Visual Analog Scale (VAS) from 0 to 10

  2. Change in Range of motion (ROM)

    Time frame: Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.

    Using a inclinometer

  3. Change in craniocervical flexion

    Time frame: Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.

    Using the craniocervical flexion test (CCFT) we make a evaluation of the strength of the deep cervical flexor muscles. From 22 to 30 mmHg of preasure.

  4. Change in kinesophobia

    Time frame: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.

    Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia.

  5. Change in Catastrophism

    Time frame: Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.

    Using the Pain catastrophizing scale from 0 to 56

  6. Change in Sleep Quality

    Time frame: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.

    Using the Pittsburgh Sleep Quality Index

Sponsors and collaborators

Lead sponsor

Alexander Achalandabaso

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 23, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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