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

Primary Purpose

Neck Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy active
Manual therapy
Sponsored by
Alexander Achalandabaso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, exercise, Endurance, Training, Intervention

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alexander achalandabaso

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

active

non active

Arm Description

this is the group that does a treatment with active movement, a program of pain education and a program of home exercise.

this is the group that does a treatment without active movement, a program of pain education and a program of home exercise.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in pain perception
Using the Visual Analog Scale (VAS) from 0 to 10
Change in Range of motion (ROM)
Using a inclinometer
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.
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.
Change in Catastrophism
Using the Pain catastrophizing scale from 0 to 56
Change in Sleep Quality
Using the Pittsburgh Sleep Quality Index

Full Information

First Posted
April 6, 2021
Last Updated
November 1, 2022
Sponsor
Alexander Achalandabaso
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1. Study Identification

Unique Protocol Identification Number
NCT04856813
Brief Title
Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain
Official Title
Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
July 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexander Achalandabaso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Pain
Keywords
neck pain, exercise, Endurance, Training, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
blind
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active
Arm Type
Experimental
Arm Description
this is the group that does a treatment with active movement, a program of pain education and a program of home exercise.
Arm Title
non active
Arm Type
Active Comparator
Arm Description
this is the group that does a treatment without active movement, a program of pain education and a program of home exercise.
Intervention Type
Other
Intervention Name(s)
Manual therapy active
Intervention Description
massage or ischemic compression with active contraction, tha will be isometric or concentric.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
massage or isquemic compression without contraction
Primary Outcome Measure Information:
Title
Change in Neck disability
Description
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).
Time Frame
Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Secondary Outcome Measure Information:
Title
Change in pain perception
Description
Using the Visual Analog Scale (VAS) from 0 to 10
Time Frame
Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Title
Change in Range of motion (ROM)
Description
Using a inclinometer
Time Frame
Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Title
Change in craniocervical flexion
Description
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.
Time Frame
Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Title
Change in kinesophobia
Description
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.
Time Frame
Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Title
Change in Catastrophism
Description
Using the Pain catastrophizing scale from 0 to 56
Time Frame
Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Title
Change in Sleep Quality
Description
Using the Pittsburgh Sleep Quality Index
Time Frame
Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso
Organizational Affiliation
University of Jaen
Official's Role
Study Director
Facility Information:
Facility Name
Alexander achalandabaso
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

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

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