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

Not Applicable

Completed

• Conditions: Chronic Pain; Neck Pain
• Interventions: Other: Manual therapy active; Other: Manual therapy

• Registration Number: NCT04856813
• Lead Sponsor: Alexander Achalandabaso

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Study Start: 2021-08-01
• Primary Completion: 2021-12-09
• Study Completion: 2022-07-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active	Manual therapy active	this is the group that does a treatment with active movement, a program of pain education and a program of home exercise.
non active	Manual therapy	this is the group that does a treatment without active movement, a program of pain education and a program of home exercise.

Primary Outcome Measures

Name	Time	Method
Change in Neck disability	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 Outcome Measures

Name	Time	Method
Change in pain perception	Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.	Using the Visual Analog Scale (VAS) from 0 to 10
Change in Range of motion (ROM)	Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.	Using a inclinometer
Change in kinesophobia	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.
Change in Catastrophism	Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.	Using the Pain catastrophizing scale from 0 to 56
Change in Sleep Quality	Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.	Using the Pittsburgh Sleep Quality Index
Change in craniocervical flexion	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.

Trial Locations

Locations (1)

Alexander achalandabaso; 🇪🇸 Alcalá De Henares, Madrid, Spain