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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neck Pain
• Intervention / Treatment: Other: Manual therapy active; Other: Manual therapy

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Alexander achalandabaso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: active; this is the group that does a treatment with active movement, a program of pain education and a program of home exercise.	Other: Manual therapy active; massage or ischemic compression with active contraction, tha will be isometric or concentric.
ACTIVE_COMPARATOR: non active; this is the group that does a treatment without active movement, a program of pain education and a program of home exercise.	Other: Manual therapy; massage or isquemic compression without contraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neck disability	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).	Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexander Achalandabaso

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ACTUAL): December 9, 2021
• Study Completion (ACTUAL): July 9, 2022

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (ACTUAL): April 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Training; exercise; neck pain; Intervention; Endurance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Neck Pain
• Other Study ID Numbers: CEIM/HU/2020/5/055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No